Clinical trials: some reflections.

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：:In phase 3 clinical trials, ethical and financial concerns motivate sequential analyses in which the data are analyzed prior to completion of the entire planned study. Existing group sequential software accounts for the effects of these interim analyses on the sampling density by assuming that the contribution of subs...

journal_title：Statistics in medicine

authors： Shoben AB,Emerson SS

更新日期：2014-12-20 00:00:00

abstract：:The coefficient of individual equivalence is a permutation-based measure of agreement between two observers making replicated readings on each subject. It compares the observed disagreement between the observers to the expected disagreement under individual equivalence. Individual equivalence of observers requires tha...

journal_title：Statistics in medicine

authors： Pan Y,Haber M,Gao J,Barnhart HX

更新日期：2012-09-10 00:00:00

abstract：:The matched case-control designs are commonly used to control for potential confounding factors in genetic epidemiology studies especially epigenetic studies with DNA methylation. Compared with unmatched case-control studies with high-dimensional genomic or epigenetic data, there have been few variable selection metho...

journal_title：Statistics in medicine

authors： Sun H,Wang S

更新日期：2013-05-30 00:00:00

abstract：:This paper presents a procedure for obtaining short-term projections and lower bounds on the size of the acquired immunodeficiency syndrome (AIDS) epidemic. The method is similar to that proposed by Brookmeyer and Gail but adapted to the situation where individual dates of AIDS diagnosis are available. It gives result...

journal_title：Statistics in medicine

authors： Tango T

更新日期：1989-12-01 00:00:00

abstract：:Statisticians have long argued that randomized controlled trials should be sufficiently large to achieve their purpose, and for common diseases with major public health implications this has brought many benefits. However, there are many instances where it is unrealistic to expect clinicians to provide the information...

journal_title：Statistics in medicine

authors： Matthews JN

更新日期：1995-01-30 00:00:00

abstract：:A popular method to control multiplicity in confirmatory clinical trials is to use a so-called hierarchical, or fixed sequence, test procedure. This requires that the null hypotheses are ordered a priori, for example, in order of clinical importance. The procedure tests the hypotheses in this order using alpha-level t...

journal_title：Statistics in medicine

authors： Edwards D,Madsen J

更新日期：2007-12-10 00:00:00

abstract：:The availability of large data sets together with the growth in power and storage capabilities of computers have made the analysis of the spatial distribution of disease rates an increasingly important tool in public health research. Use of existing geographic divisions or groupings tends to result either in unstable ...

journal_title：Statistics in medicine

authors： Morris RD,Munasinghe RL

更新日期：1993-10-01 00:00:00

abstract：:There is a rich literature that considers whether an observed relation between treatment and response is due to an unobserved covariate. In order to quantify this unmeasured bias, an assumption is made about the distribution of this unobserved covariate; typically that it is either binary or at least confined to the u...

journal_title：Statistics in medicine

authors： Wang L,Krieger AM

更新日期：2006-07-15 00:00:00

abstract：:The stability-controlled quasi-experiment (SCQE) is an approach to study the effects of nonrandomized, newly adopted treatments. While covariate adjustment techniques rely on a "no unobserved confounding" assumption, SCQE imposes an assumption on the change in the average nontreatment outcome between successive cohort...

journal_title：Statistics in medicine

authors： Hazlett C,Maokola W,Wulf DA

更新日期：2020-12-10 00:00:00

abstract：:A mixed effect model is proposed to jointly analyze multivariate longitudinal data with continuous, proportion, count, and binary responses. The association of the variables is modeled through the correlation of random effects. We use a quasi-likelihood type approximation for nonlinear variables and transform the prop...

journal_title：Statistics in medicine

authors： Li H,Zhang Y,Carroll RJ,Keadle SK,Sampson JN,Matthews CE

更新日期：2017-11-10 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：:We propose to use a very simple model to test whether a cancer cluster is due to chance alone. We focus on the acute childhood leukaemia cluster in Columbus, Ohio. In 1975, 12 leukaemia cases were observed in Columbus while the expected number is 6 cases per year. According to our simple model, the probability of such...

journal_title：Statistics in medicine

authors： Schinazi RB

更新日期：2000-08-30 00:00:00

abstract：:Quality of life (QOL) assessment is a key component of many clinical studies and frequently requires the use of single global summary measures that capture the overall balance of findings from a potentially wide-ranging assessment of QOL issues. We propose and evaluate an irregular multilevel latent variable model sui...

journal_title：Statistics in medicine

authors： Kifley A,Heller GZ,Beath KJ,Bulger D,Ma J,Gebski V

更新日期：2012-05-20 00:00:00

abstract：:Health questionnaires are often built up from sets of questions that are totaled to obtain a sum score. An important consideration in designing questionnaires is to minimize respondent burden. An increasingly popular method for efficient measurement is computerized adaptive testing; unfortunately, many health question...

journal_title：Statistics in medicine

authors： Smits N,Finkelman MD

更新日期：2014-02-10 00:00:00

abstract：:Box-Cox transformation is investigated for regression models for left-censored data. Examples are provided using coronary calcification data from the Multi-Ethnic Study of Atherosclerosis and pharmacokinetic data of a nicotine nasal spray. ...

journal_title：Statistics in medicine

authors： Han C,Kronmal R

更新日期：2004-12-15 00:00:00

abstract：:Both the variation of positive responses (negative responses) among individuals and the internal correlation among responses for the same individual affect the precision of the estimate of sensitivity (specificity). To estimate the sensitivity (specificity) of a medical diagnostic test, this paper proposes a Bayesian ...

journal_title：Statistics in medicine

authors： Lui KJ

更新日期：1989-10-01 00:00:00

abstract：:Kappa coefficients are measures of correlation between categorical variables often used as reliability or validity coefficients. We recapitulate development and definitions of the K (categories) by M (ratings) kappas (K x M), discuss what they are well- or ill-designed to do, and summarize where kappas now stand with ...

journal_title：Statistics in medicine

authors： Chmura Kraemer H,Periyakoil VS,Noda A

更新日期：2002-07-30 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：:To study the effect of a mega hydropower dam in southwest Ethiopia on malaria incidence, we have set up a longitudinal study. To gain insight in temporal and spatial aspects, that is, in time (period  =  year-season combination) and location (village), we need models that account for these effects. The frailty model w...

journal_title：Statistics in medicine

authors： Getachew Y,Janssen P,Yewhalaw D,Speybroeck N,Duchateau L

更新日期：2013-08-15 00:00:00

abstract：:In any field in which decisions are subject to measurements, interchangeability between the methods used to obtain these measurements is essential. To consider methods as interchangeable, a certain degree of agreement is needed between the measurements they provide. The concordance correlation coefficient is an index ...

journal_title：Statistics in medicine

authors： Carrasco JL,Jover L

更新日期：2005-12-30 00:00:00

abstract：:We present an approach for inference on contrasts of clinically meaningful functionals of a survivor distribution (e.g., restricted mean, quantiles) that can avoid strong parametric or semiparametric assumptions on the underlying structure of the data. In this multistage approach, we first use an adaptive predictive m...

journal_title：Statistics in medicine

authors： Rudser KD,LeBlanc ML,Emerson SS

更新日期：2012-07-20 00:00:00

abstract：:When analyzing time to disease recurrence, we sometimes need to work with data where all the recurrences are recorded, but no information is available on the possible deaths. This may occur when studying diseases of benign nature where patients are only seen at disease recurrences or in poorly-designed registries of b...

journal_title：Statistics in medicine

authors： Štupnik T,Pohar Perme M

更新日期：2016-03-30 00:00:00

abstract：:This paper reviews Bayesian strategies for monitoring clinical trial data. It focuses on a Bayesian stochastic curtailment method based on the predictive probability of observing a clinically significant outcome at the scheduled end of the study given the observed data. The proposed method is applied to derive efficac...

journal_title：Statistics in medicine

authors： Dmitrienko A,Wang MD

更新日期：2006-07-15 00:00:00

abstract：:In the recent two decades, data mining methods for signal detection have been developed for drug safety surveillance, using large post-market safety data. Several of these methods assume that the number of reports for each drug-adverse event combination is a Poisson random variable with mean proportional to the unknow...

journal_title：Statistics in medicine

authors： Hu N,Huang L,Tiwari RC

更新日期：2015-08-30 00:00:00

abstract：:In this paper, an approach to estimating the cumulative mean function for history process with time dependent covariates and right censored time-to-event variable is developed using the combined technique of joint modeling and inverse probability weighting method. The consistency of proposed estimator is derived. Theo...

journal_title：Statistics in medicine

authors： Deng D

更新日期：2016-11-10 00:00:00

abstract：:We have developed a method to longitudinally classify subjects into two or more prognostic groups using longitudinally observed values of markers related to the prognosis. We assume the availability of a training data set where the subjects' allocation into the prognostic group is known. The proposed method proceeds i...

journal_title：Statistics in medicine

authors： Komárek A,Hansen BE,Kuiper EM,van Buuren HR,Lesaffre E

更新日期：2010-12-30 00:00:00

abstract：:A three-component, competing-risk mortality model, developed for animal survival data, fits human life table data for all ages over a range of mean life spans from 16 to 74 years. The competing risks are a novel exponentially-decreasing hazard, dominant during immaturity; a constant hazard, dominant during adulthood; ...

journal_title：Statistics in medicine

authors： Siler W

更新日期：1983-07-01 00:00:00

abstract：:Two correction methods are considered for multiple logistic regression models with some covariates measured with error. Both methods are based on approximating the complicated regression model between the response and the observed covariates with simpler models. The first model is the logistic approximation proposed b...

journal_title：Statistics in medicine

authors： Kuha J

更新日期：1994-06-15 00:00:00

abstract：:Patients who switch treatment groups in randomized clinical trials can cause problems in the interpretation of the results. Although the intention-to-treat method is recognized as being the most reliable analysis, it may result in an underestimate of the treatment effect if there have been patients who switch treatmen...

journal_title：Statistics in medicine

authors： Law MG,Kaldor JM

更新日期：1996-10-15 00:00:00