Alpha calculus in clinical trials: considerations and commentary for the new millennium.

abstract：:Meta-analysis to investigate the joint effect of multiple factors in the aetiology of a disease is of increasing importance in epidemiology. This task is often challenging in practice, because studies typically concentrate on studying the effect of only one exposure, sometimes may report the interaction between two ex...

journal_title：Statistics in medicine

authors： Salanti G,Higgins JP,White IR

更新日期：2006-12-30 00:00:00

abstract：:Biostatisticians have frequently uncritically accepted the measurements provided by their medical colleagues engaged in clinical research. Such measures often involve considerable loss of information. Particularly, unfortunate is the widespread use of the so-called 'responder analysis', which may involve not only a lo...

journal_title：Statistics in medicine

authors： Senn S,Julious S

更新日期：2009-11-20 00:00:00

abstract：:Epidemiologic and clinical studies routinely collect longitudinal measures of multiple outcomes, including biomarker measures, cognitive functions, and clinical symptoms. These longitudinal outcomes can be used to establish the temporal order of relevant biological processes and their association with the onset of cli...

journal_title：Statistics in medicine

authors： Yang L,Gao S

更新日期：2013-03-15 00:00:00

abstract：:Summarizing the information of many studies using a meta-analysis becomes more and more important, also in the field of diagnostic studies. The special challenge in meta-analysis of diagnostic accuracy studies is that in general sensitivity and specificity are co-primary endpoints. Across the studies both endpoints ar...

journal_title：Statistics in medicine

authors： Zapf A,Hoyer A,Kramer K,Kuss O

更新日期：2015-12-20 00:00:00

abstract：:Non-linear mixed-effects models (NLMEMs) are used to improve information gathering from longitudinal studies and are applied to treatment evaluation in disease-evolution studies, such as human immunodeficiency virus (HIV) infection. The estimation of parameters and the statistical tests are critical issues in NLMEMs s...

journal_title：Statistics in medicine

authors： Samson A,Lavielle M,Mentré F

更新日期：2007-11-30 00:00:00

abstract：:Testing involving the intra-class kappa coefficient is commonly performed in order to assess agreement involving categorical ratings. A number of procedures have been proposed, which make use of the limiting null distribution as the sample size goes to infinity in order to compute the observed significance. As with ma...

journal_title：Statistics in medicine

authors： Wilding GE,Consiglio JD,Shan G

更新日期：2014-07-30 00:00:00

abstract：:In this paper we give an informal introduction to a robust method for survival analysis which is based on a modification of the usual partial likelihood estimator (PLE). Large sample results lead us to expect reduced bias for this robust estimator compared with the PLE whenever there are even slight violations of the ...

journal_title：Statistics in medicine

authors： Minder CE,Bednarski T

更新日期：1996-05-30 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：BACKGROUND:It has been recommended that onset of antidepressant action be assessed using survival analyses with assessments taken at least twice per week. However, such an assessment schedule is problematic to implement. The present study assessed the feasibility of comparing onset of action between treatments using a ...

journal_title：Statistics in medicine

authors： Mallinckrodt CH,Detke MJ,Kaiser CJ,Watkin JG,Molenberghs G,Carroll RJ

更新日期：2006-07-30 00:00:00

abstract：:This paper considers the analysis of longitudinal data complicated by the fact that during follow-up patients can be in different disease states, such as remission, relapse or death. If both the response of interest (for example, quality of life (QOL)) and the amount of missing data depend on this disease state, ignor...

journal_title：Statistics in medicine

authors： le Cessie S,de Vries EG,Buijs C,Post WJ

更新日期：2009-12-30 00:00:00

abstract：:Many epidemiologic investigations are designed to study the effects of multiple exposures. Most of these studies are analysed either by fitting a risk-regression model with all exposures forced in the model, or by using a preliminary-testing algorithm, such as stepwise regression, to produce a smaller model. Research ...

journal_title：Statistics in medicine

authors： Greenland S

更新日期：1993-04-30 00:00:00

abstract：:Algorithms for identifying public health threats or disease outbreaks are vulnerable to false alarms arising from sudden shifts in health-care utilization or data participation. This paper describes a method of reducing false alerts in automated public health surveillance algorithms, and in particular, automated syndr...

journal_title：Statistics in medicine

authors： Peter W,Najmi AH,Burkom HS

更新日期：2011-06-30 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：:We compared eight nominal 95 per cent confidence intervals for the ratio of two Poisson parameters, both assumed small, on their true coverage (the probability that the interval includes the ratio of Poisson parameters) and median width. The commonly used log-linear interval, justified by asymptotic considerations, pr...

journal_title：Statistics in medicine

authors： Barker L,Cadwell BL

更新日期：2008-09-10 00:00:00

abstract：:Bivariate survival data arise, for example, in twin studies and studies of both eyes or ears of the same individual. Often it is of interest to regress the survival times on a set of predictors. In this paper we extend Wei and Tanner's multiple imputation approach for linear regression with univariate censored data to...

journal_title：Statistics in medicine

authors： Pan W,Kooperberg C

更新日期：1999-11-30 00:00:00

abstract：:Knee replacement is the most commonly used surgical treatment for knee arthritis. It has been reported that knee replacement rates vary across both regions and counties. This paper used data from Medicare patients to develop explanations for the variation. One problem with our data is that we do not have patient level...

journal_title：Statistics in medicine

authors： Zhou XH,Katz BP,Holleman E,Melfi CA,Dittus R

更新日期：1996-09-15 00:00:00

abstract：:We discuss some of the statistical approaches to the design and analysis of phase I clinical trials in cancer. An attempt is made to identify the issues, particular to this type of trial, that should be addressed by an appropriate methodology. A brief review of schemes currently in use is provided together with our vi...

journal_title：Statistics in medicine

authors： O'Quigley J,Chevret S

更新日期：1991-11-01 00:00:00

abstract：:Clinical studies that involve the recording of two or more distinct and well-defined events on each subject give rise to multiple event data. Treatment comparisons are usually reported in univariate analyses of time to first event or number of events observed. However, this approach may not uncover the 'full story' of...

journal_title：Statistics in medicine

authors： Barai U,Teoh N

更新日期：1997-04-30 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：: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：:In this paper statistical methods are proposed to estimate the distribution of a CD4 T-cell number at the time of a clinical AIDS endpoint from serial measurements of CD4 T-cell values in a cohort study. The statistical formulation of the problem is that of survival analysis with interval censored data, but in which t...

journal_title：Statistics in medicine

authors： Taylor JM,Kim DK

更新日期：1994-10-15 00:00:00

abstract：:The proposed guidelines for the assessment of the effect of new pharmaceutical agents on the QT interval (beginning of QRS complex to end of T wave on the electrocardiogram) are based on the maximum of a series over time of simple one-sided 95 per cent upper confidence bounds. This procedure is typically very conserva...

journal_title：Statistics in medicine

authors： Boos DD,Hoffman D,Kringle R,Zhang J

更新日期：2007-09-10 00:00:00

abstract：:The risk that a drug newly introduced into medical use will occasionally cause adverse reactions is neither negligible nor totally avoidable. Only well organized systems of monitoring can bring early detection and appropriate action. These in turn require either detailed supervision or spontaneous reporting. The paper...

journal_title：Statistics in medicine

authors： Finney DJ

更新日期：1982-04-01 00:00:00

abstract：:In biomedical literature, numerous prediction models for clinical outcomes have been developed based either on clinical data or, more recently, on high-throughput molecular data (omics data). Prediction models based on both types of data, however, are less common, although some recent studies suggest that a suitable c...

journal_title：Statistics in medicine

authors： De Bin R,Sauerbrei W,Boulesteix AL

更新日期：2014-12-30 00:00:00

abstract：:In this paper, we investigate the impact of time-invariant covariates when fitting transition mixed models. This is carried out by emphasizing on the role of baseline responses on the estimation process. Transition models are allowed for two cases of exogenous and endogenous baseline responses. We illustrate these con...

journal_title：Statistics in medicine

authors： Rikhtehgaran R,Kazemi I,Verbeke G

更新日期：2014-11-30 00:00:00

abstract：:Biomedical studies often measure variables with error. Examples in the literature include investigation of the association between the change in some outcome variable (blood pressure, cholesterol level etc.) and a set of explanatory variables (age, smoking status etc.). Typically, one fits linear regression models to ...

journal_title：Statistics in medicine

authors： Yanez ND 3rd,Kronmal RA,Shemanski LR

更新日期：1998-11-30 00:00:00

abstract：:This paper is a compendium of exact and asymptotic formulae and tables for estimating the sample size in a clinical trial with two treatment groups and a dichotomous outcome. The paper provides separate formulae for equal and unequal treatment group sizes, formulae for the calculation of power given the sample size, a...

journal_title：Statistics in medicine

authors： Sahai H,Khurshid A

更新日期：1996-01-15 00:00:00

abstract：:A method for detecting deviations from the Loewe additive drug combination reference model for in vitro drug combination experimentation is described. It is often difficult to fit a response surface model to drug combination data, especially in situations where the experimental design contains a sparse set of combinat...

journal_title：Statistics in medicine

authors： Novick SJ

更新日期：2013-12-20 00:00:00

abstract：:Delay in the outcome variable is challenging for outcome-adaptive randomization, as it creates a lag between the number of subjects accrued and the information known at the time of the analysis. Motivated by a real-life pediatric ulcerative colitis trial, we consider a case where a short-term predictor is available fo...

journal_title：Statistics in medicine

authors： Kim MO,Liu C,Hu F,Lee JJ

更新日期：2014-10-15 00:00:00

abstract：:In analysis of longitudinal data, the variance matrix of the parameter estimates is usually estimated by the 'sandwich' method, in which the variance for each subject is estimated by its residual products. We propose smooth bootstrap methods by perturbing the estimating functions to obtain 'bootstrapped' realizations ...

journal_title：Statistics in medicine

authors： Li Y,Wang YG

更新日期：2008-03-30 00:00:00