Study control, violators, inclusion criteria and defining explanatory and pragmatic trials.

abstract：:Many different methods have been proposed for the analysis of cluster randomized trials (CRTs) over the last 30 years. However, the evaluation of methods on overdispersed count data has been based mostly on the comparison of results using empiric data; i.e. when the true model parameters are not known. In this study, ...

journal_title：Statistics in medicine

authors： Durán Pacheco G,Hattendorf J,Colford JM Jr,Mäusezahl D,Smith T

更新日期：2009-10-30 00:00:00

abstract：:In the last decade or so, pharmaceutical drug development activities in the area of new antibacterial drugs for treating serious bacterial diseases have declined, and at the same time, there are worries that the increased prevalence of antibiotic-resistant bacterial infections, especially the increase in drug-resistan...

journal_title：Statistics in medicine

authors： Huque MF,Valappil T,Soon GG

更新日期：2014-11-10 00:00:00

abstract：:In the field of cluster detection, a weighted normal model-based scan statistic was recently developed to analyze regional continuous data and to evaluate the clustering pattern of pre-defined cells (such as state, county, tract, school, hospital) that include many individuals. The continuous measures of interest are,...

journal_title：Statistics in medicine

authors： Huang L,Tiwari RC,Pickle LW,Zou Z

更新日期：2010-10-15 00:00:00

abstract：:For the analysis of time to event data in contraceptive studies when individuals are subject to competing causes for discontinuation, some authors have recently advocated the use of the cumulative incidence rate as a more appropriate measure to summarize data than the complement of the Kaplan-Meier estimate of discont...

journal_title：Statistics in medicine

authors： Farley TM,Ali MM,Slaymaker E

更新日期：2001-12-15 00:00:00

abstract：:Geocoding a study population as completely as possible is an important data assimilation component of many spatial epidemiologic studies. Unfortunately, complete geocoding is rare in practice. The failure of a substantial proportion of study subjects' addresses to geocode has consequences for spatial analyses, some of...

journal_title：Statistics in medicine

authors： Zimmerman DL,Fang X,Mazumdar S

更新日期：2008-09-20 00:00:00

abstract：:The log-rank test is the most powerful non-parametric test for detecting a proportional hazards alternative and thus is the most commonly used testing procedure for comparing time-to-event distributions between different treatments in clinical trials. When the log-rank test is used for the primary data analysis, the s...

journal_title：Statistics in medicine

authors： Zhang D,Quan H

更新日期：2009-02-28 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：: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：:We develop analysis methods for clinical trials with time-to-event outcomes which correct for treatment changes during follow-up, yet are based on comparisons of randomized groups and not of selected groups. A causal model relating observed event times to event times that would have been observed under other treatment...

journal_title：Statistics in medicine

authors： White IR,Babiker AG,Walker S,Darbyshire JH

更新日期：1999-10-15 00:00:00

abstract：:A method is proposed to infer the randomized treatment effect on survival after an adjustment for a post-randomization variable. The post-randomization variable is made independent of the treatment assignment and is considered a surrogate for baseline prognostic factors. The relationship between the post-randomization...

journal_title：Statistics in medicine

authors： Heller G

更新日期：2001-11-30 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：: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 the development of a new treatment in oncology, phase II trials play a key role. On the basis of the data obtained during phase II, it is decided whether the treatment should be studied further. Therefore, the decision to be made on the basis of the data of a phase II trial must be as accurate as possible. For ethi...

journal_title：Statistics in medicine

authors： Kunz CU,Kieser M

更新日期：2012-12-30 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：:Funnel plots are widely used to visualize grouped data, for example, in institutional comparison. This paper extends the concept to a multi-level setting, displaying one level at a time, adjusted for the other levels, as well as for covariates at all levels. These level-adjusted funnel plots are based on a Markov chai...

journal_title：Statistics in medicine

authors： Lindhagen L,Darkahi B,Sandblom G,Berglund L

更新日期：2014-09-20 00:00:00

abstract：:In a medical study we are often interested in graphically displaying the relationship between continuous variables and clinical events indicating disease progression. Often, it is reasonable to make the minimal assumption that the risk of progression is an arbitrary monotone function of the continuous variable. Someti...

journal_title：Statistics in medicine

authors： Ancukiewicz M,Finkelstein DM,Schoenfeld DA

更新日期：2003-10-30 00:00:00

abstract：:A mediator acts as a third variable in the causal pathway between a risk factor and an outcome. In this paper, we consider the estimation of the mediation effect when the mediator is a binary variable. We give a precise definition of the mediation effect and examine asymptotic properties of five different estimators o...

journal_title：Statistics in medicine

authors： Li Y,Schneider JA,Bennett DA

更新日期：2007-08-15 00:00:00

abstract：:In this paper we describe Bonferroni-based multiple testing procedures (MTPs) as strategies to split and recycle test mass. Here, 'test mass' refers to (parts of) the nominal level alpha at which the family-wise error rate is controlled. Briefly, test mass is split between different null hypotheses, and whenever a nul...

journal_title：Statistics in medicine

authors： Burman CF,Sonesson C,Guilbaud O

更新日期：2009-02-28 00:00:00

abstract：:This paper considers the regression analysis of CD4 cell counts, a commonly used indicator and prognostic factor of AIDS progression. For this purpose, a number of methods have been proposed and most of them are based on random effects models. We present an alternative that is based on a mean function regression model...

journal_title：Statistics in medicine

authors： Sun J

更新日期：2001-11-15 00:00:00

abstract：:Often in randomized clinical trials and observational studies in occupational and environmental health, a non-negative continuously distributed response variable denoting some metabolites of environmental toxicants is measured in treatment and control groups. When observations occur in both unexposed and exposed subje...

journal_title：Statistics in medicine

authors： Chu H,Nie L,Kensler TW

更新日期：2008-06-15 00:00:00

abstract：:Childhood acute lymphoblastic leukaemia is treated with long-term intensive chemotherapy. During the latter part of the treatment, the maintenance therapy, the patients receive oral doses of two cytostatics. The doses are tailored to blood counts measured on a weekly basis, and the treatment is therefore highly dynami...

journal_title：Statistics in medicine

authors： Rosthøj S,Keiding N,Schmiegelow K

更新日期：2012-02-28 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：:Statistical methods for analyzing recurrent events have attracted significant attention. The majority of existing works consider situations in which subjects are observed over time periods and events of interest that occurred during the course of follow-up are recorded. In some applications, a subject may leave the st...

journal_title：Statistics in medicine

authors： Su PF,Zhong J,Ou HT

更新日期：2019-04-15 00:00:00

abstract：:We investigate population-averaged (PA) and cluster-specific (CS) associations for clustered binary logistic regression in the context of a longitudinal clinical trial that investigated the association between tooth-specific visual elastase kit results and periodontal disease progression within 26 weeks of follow-up. ...

journal_title：Statistics in medicine

authors： Ten Have TR,Landis JR,Weaver SL

更新日期：1995-02-28 00:00:00

abstract：:When data are dichotomous, this paper notes the utility of inverse sampling in establishing equivalence with respect to the risk ratio. This paper develops an exact equivalence test that accounts for the risk ratio under inverse sampling and further discusses the relationship between the exact equivalence test and the...

journal_title：Statistics in medicine

authors： Lui KJ

更新日期：1997-08-15 00:00:00

abstract：:A trial of Duchenne muscular dystrophy involved tracking boys of all ages through a one-year baseline period, followed by a one-year trial of leucine versus placebo treatment. In this paper we develop a model for a total-muscle-strength score that uses the data of the extended baseline period in the evaluation of the ...

journal_title：Statistics in medicine

authors： Madsen KS,Miller JP,Province MA

更新日期：1986-05-01 00:00:00

abstract：:The application of Bayesian hierarchical models to measure spatial effects in time to event data has not been widely reported. This case study aims to estimate the effect of area of residence on waiting times to coronary artery bypass graft (CABG) and to assess the role of important individual specific covariates (age...

journal_title：Statistics in medicine

authors： Crook AM,Knorr-Held L,Hemingway H

更新日期：2003-09-30 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：:An observed confidence distribution is proposed as a measure of strength of evidence for practically equivalent efficacies of two treatments. The concept is independent of prior opinions about relevant sizes of a difference in efficacy. It also avoids retrospective power calculations for trials with missed recruitment...

journal_title：Statistics in medicine

authors： Mau J

更新日期：1988-12-01 00:00:00

abstract：:In many practical applications, count data often exhibit greater or less variability than allowed by the equality of mean and variance, referred to as overdispersion/underdispersion, and there are several reasons that may lead to the overdispersion/underdispersion such as zero inflation and mixture. Moreover, if the c...

journal_title：Statistics in medicine

authors： Chen XD,Fu YZ,Wang XR

更新日期：2013-04-15 00:00:00