A refined method for the meta-analysis of controlled clinical trials with binary outcome.

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 for assessing biosimilarity and drug interchangeability of follow-on biologics (biosimilar products) is studied. Unlike the generic products, the development of biosimilar products is much more complicated because of fundamental differences in functional structures and manufacturing processes. As a result,...

journal_title：Statistics in medicine

authors： Chow SC,Wang J,Endrenyi L,Lachenbruch PA

更新日期：2013-02-10 00:00:00

abstract：:Clinical trials of treatments for rare or fatal diseases must often use historical rather than randomized concurrent controls. Randomized trials may not be possible if (1) the number of patients available is quite small, (2) ethical considerations discourage the assignment of patients to control treatments known to be...

journal_title：Statistics in medicine

authors： Hoehler FK,Mantel N,Gehan E,Kahana E,Alter M

更新日期：1984-07-01 00:00:00

abstract：:For patients who were previously treated for prostate cancer, salvage hormone therapy is frequently given when the longitudinal marker prostate-specific antigen begins to rise during follow-up. Because the treatment is given by indication, estimating the effect of the hormone therapy is challenging. In a previous pape...

journal_title：Statistics in medicine

authors： Taylor JM,Shen J,Kennedy EH,Wang L,Schaubel DE

更新日期：2014-01-30 00:00:00

abstract：:Confounding is a major concern in observational studies. To adjust for confounding bias, the potential confounder(s) for a study must first be identified and measured. But this is not always possible. The unmeasured factors may also exhibit effect modification, and this further complicates the situation. In this paper...

journal_title：Statistics in medicine

authors： Lee WC

更新日期：2011-04-30 00:00:00

abstract：:A targeted poll was undertaken to compare and contrast models of data monitoring of randomized clinical trials sponsored by the National Institutes of Health. In an attempt to represent the institutes which conduct clinical trials, twelve individuals were selected and asked to respond to a questionnaire specifically p...

journal_title：Statistics in medicine

authors： Geller NL,Stylianou M

更新日期：1993-03-01 00:00:00

abstract：:Estimation of genetic and environmental contributions to cancers falls in the framework of generalized linear mixed modelling with several random effect components. Computational challenges remain, however, in dealing with binary or survival phenotypes. In this paper, we consider the analysis of melanoma onset in a po...

journal_title：Statistics in medicine

authors： Lindström L,Pawitan Y,Reilly M,Hemminki K,Lichtenstein P,Czene K

更新日期：2006-09-30 00:00:00

abstract：:The goal of phase I cancer trials is to determine the highest dose of a treatment regimen with an acceptable toxicity rate. Traditional designs for phase I trials, such as the Continual Reassessment Method (CRM) and the 3 + 3 design, require each patient or a cohort of patients to be fully evaluated for the dose-limit...

journal_title：Statistics in medicine

authors： Polley MY

更新日期：2011-07-30 00:00:00

abstract：:The Cardiac Arrythmia Suppression Trial was stopped much earlier than planned. Statistical considerations played a very important role in the decision. Flexible group sequential testing was developed for the trial by implementing a Lan and DeMets procedure with use of the permutation test. We compute P-values from the...

journal_title：Statistics in medicine

authors： Pawitan Y,Hallstrom A

更新日期：1990-09-01 00:00:00

abstract：:Hospital length of stay (LOS) is an important measure of healthcare utilization and is generally positively skewed and heterogeneous. We fit a Coxian phase-type distribution to LOS and identify the hidden states of the underlying latent homogeneous Markov model. We demonstrate that selecting an appropriate number of p...

journal_title：Statistics in medicine

authors： Tang X,Luo Z,Gardiner JC

更新日期：2012-06-30 00:00:00

abstract：:In a long-running longitudinal study using complex machinery to obtain measurements, it is sometimes necessary to replace the machine. This can result in lack of continuity in the measurements that can overwhelm any treatment effect or time trend. We propose a Bayesian procedure implemented using Markov chain Monte Ca...

journal_title：Statistics in medicine

authors： Ambrosius WT,Hui SL

更新日期：2004-09-30 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

abstract：:The relationship between association and surrogacy has been the focus of much debate in the surrogate marker literature. Recently, the individual causal association (ICA) has been introduced as a metric of surrogacy in the causal inference framework, when both the surrogate and the true endpoint are normally distribut...

journal_title：Statistics in medicine

authors： Meyvisch P,Alonso A,Van der Elst W,Molenberghs G

更新日期：2020-11-20 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：:Methodology for causal inference based on propensity scores has been developed and popularized in the last two decades. However, the majority of the methodology has concentrated on binary treatments. Only recently have these methods been extended to settings with multi-valued treatments. We propose a number of discret...

journal_title：Statistics in medicine

authors： Tchernis R,Horvitz-Lennon M,Normand SL

更新日期：2005-07-30 00:00:00

abstract：:The analysis of multivariate time-to-event (TTE) data can become complicated due to the presence of clustering, leading to dependence between multiple event times. For a long time, (conditional) frailty models and (marginal) copula models have been used to analyze clustered TTE data. In this article, we propose a gene...

journal_title：Statistics in medicine

authors： Tran TMP,Abrams S,Braekers R

更新日期：2020-05-30 00:00:00

abstract：:During a course of human immunodeficiency virus (HIV-1) infection, the viral load usually increases sharply to a peak following infection and then drops rapidly to a steady state, where it remains until progression to AIDS. This steady state is often referred to as the viral set point. It is believed that the HIV vira...

journal_title：Statistics in medicine

authors： Mei Y,Wang L,Holte SE

更新日期：2008-01-15 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 comparing two treatments under a typical sequential clinical trial setting, a 50-50 randomization design generates reliable data for making efficient inferences about the treatment difference for the benefit of patients in the general population. However, if the treatment difference is large and the endpoint of the...

journal_title：Statistics in medicine

authors： Yao Q,Wei LJ

更新日期：1996-11-15 00:00:00

abstract：:Bayesian methods are proposed for analysing matched case-control studies in which a binary exposure variable is sometimes measured with error, but whose correct values have been validated for a random sample of the matched case-control sets. Three models are considered. Model 1 makes few assumptions other than randomn...

journal_title：Statistics in medicine

authors： Prescott GJ,Garthwaite PH

更新日期：2005-02-15 00:00:00

abstract：:The back-calculation method has been used to estimate the number of HIV infections from AIDS incidence data in a particular population. We present an extension of back calculation that provides estimates of the numbers of HIV infectives in different stages of infection. We model the staging process with a time-depende...

journal_title：Statistics in medicine

authors： Longini IM Jr,Byers RH,Hessol NA,Tan WY

更新日期：1992-04-01 00:00:00

abstract：:This work is motivated by a longitudinal study of women and their ectopic pregnancy outcomes in Lund, Sweden. In this article, we review and apply the Liang-Zeger methodology to the Lund ectopic pregnancy data set. We further analyse the ectopic pregnancy data using conditional modelling approaches suggested by Rosner...

journal_title：Statistics in medicine

authors： Hadgu A,Koch G,Westrom L

更新日期：1997-11-15 00:00:00

abstract：:Comparative Poisson trials of prophylactic interventions, such as vaccines, can be lengthy and costly. We evaluate two easily implemented approaches to reduce numbers of disease cases and person years of follow up (N(u+t)) for comparative Poisson trials with fixed numbers of cases (T); (i) altering k the portion of N(...

journal_title：Statistics in medicine

authors： Hoover DR

更新日期：2004-04-30 00:00:00

abstract：:Day and Walter derived methods of joint maximum likelihood estimation for the sojourn time distribution and the false negative rate for a screening programme. Their methods are not directly applicable to a programme which uses alternate screening by two modalities whose sojourn times and false negative rates will diff...

journal_title：Statistics in medicine

authors： Alexander FE

更新日期：1989-06-01 00:00:00

abstract：:In this paper, we develop methods to combine multiple biomarker trajectories into a composite diagnostic marker using functional data analysis (FDA) to achieve better diagnostic accuracy in monitoring disease recurrence in the setting of a prospective cohort study. In such studies, the disease status is usually verifi...

journal_title：Statistics in medicine

authors： Li H,Gatsonis C

更新日期：2019-05-20 00:00:00

abstract：:In clinical research, investigators are interested in inferring the average causal effect of a treatment. However, the causal parameter that can be used to derive the average causal effect is not well defined for ordinal outcomes. Although some definitions have been proposed, they are limited in that they are not iden...

journal_title：Statistics in medicine

authors： Chiba Y

更新日期：2017-11-10 00:00:00

abstract：:Medical costs data with administratively censored observations often arise in cost-effectiveness studies of treatments for life-threatening diseases. Mean of medical costs incurred from the start of a treatment until death or a certain time point after the implementation of treatment is frequently of interest. In many...

journal_title：Statistics in medicine

authors： Jiang H,Zhou XH

更新日期：2004-11-15 00:00:00

abstract：:Identification of key factors associated with the risk of developing cardiovascular disease and quantification of this risk using multivariable prediction algorithms are among the major advances made in preventive cardiology and cardiovascular epidemiology in the 20th century. The ongoing discovery of new risk markers...

journal_title：Statistics in medicine

authors： Pencina MJ,D'Agostino RB Sr,D'Agostino RB Jr,Vasan RS

更新日期：2008-01-30 00:00:00

abstract：:When investigating health disparities, it can be of interest to explore whether adjustment for socioeconomic factors at the neighborhood level can account for, or even reverse, an unadjusted difference. Recently, we proposed new methods to adjust the effect of an individual-level covariate for confounding by unmeasure...

journal_title：Statistics in medicine

authors： Brumback BA,Zheng HW,Dailey AB

更新日期：2013-04-15 00:00:00

abstract：:We consider recurrent events of the same type that occur during alternating restraint and non-restraint time periods. This research is motivated by a study on juvenile recidivism, where the probationers were followed for re-offenses during alternating placement periods and free-time periods. During the placement perio...

journal_title：Statistics in medicine

authors： Li X,Chen Y,Li R

更新日期：2017-02-20 00:00:00