A copula-based mixed Poisson model for bivariate recurrent events under event-dependent censoring.

abstract：:Adaptive designs or flexible designs in a broader sense have increasingly been considered in planning pivotal registration clinical trials. Sample size reassessment design and adaptive selection design are two of such designs that appear in regulatory applications. At the design stage, consideration of sample size rea...

journal_title：Statistics in medicine

authors： Hung HM,Wang SJ,O'Neill R

更新日期：2011-06-15 00:00:00

abstract：:Statistical methods for testing and interval estimation of the ratio of marginal probabilities in the matched-pair setting are considered in this paper. We are especially interested in the situation where the null value is not one, as in one-sided equivalence trials. We propose a Fieller-type statistic based on constr...

journal_title：Statistics in medicine

authors： Nam JM,Blackwelder WC

更新日期：2002-03-15 00:00:00

abstract：:In natural history studies of chronic disease, it is of interest to understand the evolution of key variables that measure aspects of disease progression. This is particularly true for immunological variables among persons infected with the human immunodeficiency virus (HIV). The natural time scale for such studies is...

journal_title：Statistics in medicine

authors： Vittinghoff E,Malani HM,Jewell NP

更新日期：1994-06-15 00:00:00

abstract：:In Part I we presented a covariance structure model for analysing measurement error in the assessment of nitrogen intake. In this paper we include data on urine nitrogen excretion which allows a critical assessment of the model proposed. Inclusion of urine nitrogen data produces more pessimistic estimates of the quali...

journal_title：Statistics in medicine

authors： Plummer M,Clayton D

更新日期：1993-05-30 00:00:00

abstract：:Inference for randomized clinical trials is generally based on the assumption that outcomes are independently and identically distributed under the null hypothesis. In some trials, particularly in infectious disease, outcomes may be correlated. This may be known in advance (e.g. allowing randomization of family member...

journal_title：Statistics in medicine

authors： Proschan M,Follmann D

更新日期：2008-03-15 00:00:00

abstract：:Correct specification of the inverse probability weighting (IPW) model is necessary for consistent inference from a marginal structural Cox model (MSCM). In practical applications, researchers are typically unaware of the true specification of the weight model. Nonetheless, IPWs are commonly estimated using parametric...

journal_title：Statistics in medicine

authors： Karim ME,Platt RW,BeAMS study group.

更新日期：2017-06-15 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：:Randomized clinical trial designs commonly include one or more planned interim analyses. At these times an external monitoring committee reviews the accumulated data and determines whether it is scientifically and ethically appropriate for the study to continue. With failure-time endpoints, it is common to schedule an...

journal_title：Statistics in medicine

authors： Bagiella E,Heitjan DF

更新日期：2001-07-30 00:00:00

abstract：:Adaptive designs have been proposed for clinical trials in which the nuisance parameters or alternative of interest are unknown or likely to be misspecified before the trial. Although most previous works on adaptive designs and mid-course sample size re-estimation have focused on two-stage or group-sequential designs ...

journal_title：Statistics in medicine

authors： Bartroff J,Lai TL

更新日期：2008-05-10 00:00:00

abstract：:A study of long term survival of 1487 patients given an allogeneic bone marrow transplant for acute myelogenous leukaemia and 729 patients given a transplant for severe aplastic anaemia was conducted by the International Bone Marrow Transplant Registry. One aim of this study is to determine if the mortality rates of t...

journal_title：Statistics in medicine

authors： Andersen PK,Horowitz MM,Klein JP,Socie G,Stone JV,Zhang MJ

更新日期：1999-06-30 00:00:00

abstract：:This article deals with determination of a sample size that guarantees the success of a trial. We follow a Bayesian approach and we say an experiment is successful if it yields a large posterior probability that an unknown parameter of interest (an unknown treatment effect or an effects-difference) is greater than a c...

journal_title：Statistics in medicine

authors： Brutti P,De Santis F,Gubbiotti S

更新日期：2008-06-15 00:00:00

abstract：:Assessing the QT prolongation potential of a drug is typically done based on pivotal safety studies called thorough QT studies. Model-based estimation of the drug-induced QT prolongation at the estimated mean maximum drug concentration could increase efficiency over the currently used intersection-union test. However,...

journal_title：Statistics in medicine

authors： Dosne AG,Bergstrand M,Karlsson MO,Renard D,Heimann G

更新日期：2017-10-30 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：:In recent years, there has been an increasing trend in conducting seamless phase 2/3 clinical trials for drug development in the pharmaceutical industry due to the visible advantages compared with traditional approaches for separate phase 2 and 3 development. Innovative study designs have been proposed for seamless ph...

journal_title：Statistics in medicine

authors： Teng Z,Liang L,Liu G,Liu Y

更新日期：2018-12-10 00:00:00

abstract：:I reflect on the statistical methods of the Christakis-Fowler studies on network-based contagion of traits by checking the sensitivity of these kinds of results to various alternate specifications and generative mechanisms. Despite the honest efforts of all involved, I remain pessimistic about establishing whether bin...

journal_title：Statistics in medicine

authors： Thomas AC

更新日期：2013-02-20 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 frequent objective in medical research is the investigation of differences in patient survival between several experimental treatments and one standard treatment. In order to assess these differences statistically, we have to apply adjustments for multiple comparisons to prevent an increased number of false-positive...

journal_title：Statistics in medicine

authors： Herberich E,Hothorn T

更新日期：2012-01-13 00:00:00

abstract：:The continual reassessment method (CRM) is an adaptive design for Phase I trials whose operating characteristics, including appropriate sample size, probability of correctly identifying the maximum tolerated dose, and the expected proportion of participants assigned to each dose, can only be determined via simulation....

journal_title：Statistics in medicine

authors： Braun TM

更新日期：2020-09-16 00:00:00

abstract：:There has been substantial statistical literature in the last several decades on assessing agreement, and coverage probability approach was selected as a preferred index for assessing and improving measurement agreement in a core laboratory setting. With this approach, a satisfactory agreement is based on pre-specifie...

journal_title：Statistics in medicine

authors： Barnhart HX

更新日期：2016-08-15 00:00:00

abstract：:This paper introduces a dynamic clustering methodology based on multi-valued descriptors of dermoscopic images. The main idea is to support medical diagnosis to decide if pigmented skin lesions belonging to an uncertain set are nearer to malignant melanoma or to benign nevi. Melanoma is the most deadly skin cancer, an...

journal_title：Statistics in medicine

authors： Cozza V,Guarracino MR,Maddalena L,Baroni A

更新日期：2011-09-10 00:00:00

abstract：:For the meta-analysis of controlled clinical trials with binary outcome a test statistic for testing an overall treatment effect is proposed, which is based on a refined estimator for the variance of the treatment effect estimator usually used in the random-effects model of meta-analysis. In simulation studies it is s...

journal_title：Statistics in medicine

authors： Hartung J,Knapp G

更新日期：2001-12-30 00:00:00

abstract：:Small but important therapeutic effects of new treatments can be most efficiently detected through the study of large randomized prospective series of patients. Such large scale clinical trials are nowadays commonplace. The alternative is years of polemic and debate surrounding several trials each too small to detect ...

journal_title：Statistics in medicine

authors： McPherson K

更新日期：1982-01-01 00:00:00

abstract：:The most popular model used for survival analysis is the proportional hazards regression model proposed by Cox. This is mainly due to its exceptional simplicity. Nevertheless the fundamental assumption of the Cox model is the proportionality of the hazards. For many applications, however, this assumption is doubtful. ...

journal_title：Statistics in medicine

authors： Berger U,Schäfer J,Ulm K

更新日期：2003-04-15 00:00:00

abstract：:Pearson's chi-squared, the likelihood-ratio, and Fisher-Freeman-Halton's test statistics are often used to test the association of unordered r x c tables. Asymptotical, exact conditional, or exact conditional with mid-p adjustment methods are commonly used to compute the p-value. We have compared test power and signif...

journal_title：Statistics in medicine

authors： Lydersen S,Pradhan V,Senchaudhuri P,Laake P

更新日期：2007-10-15 00:00:00

abstract：:Logistic regression analysis may well be used to develop a prognostic model for a dichotomous outcome. Especially when limited data are available, it is difficult to determine an appropriate selection of covariables for inclusion in such models. Also, predictions may be improved by applying some sort of shrinkage in t...

journal_title：Statistics in medicine

authors： Steyerberg EW,Eijkemans MJ,Harrell FE Jr,Habbema JD

更新日期：2000-04-30 00:00:00

abstract：:This paper presents a general approach for simultaneously assessing, from serial data, diagnostic consistency, interrater reliability and incidence of a strictly progressive disease. Observed data are viewed as incomplete: diagnostic errors are not distinguished from true diagnoses. We introduce a broad class of model...

journal_title：Statistics in medicine

authors： Espeland MA,Murphy WC,Leverett DH

更新日期：1988-03-01 00:00:00

abstract：:Down's syndrome screening is currently carried out using a combination of biochemical markers measured in maternal serum samples; these include MSAFP, Total hCG, uE3 and Free beta-hCG. Recently a number of papers have compared the effectiveness of different combinations of these markers. Some recommend MSAFP, Total hC...

journal_title：Statistics in medicine

authors： Dunstan FD,Gray JC,Nix AB,Reynolds T

更新日期：1997-07-15 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：:When interpreting screening mammograms radiologists decide whether suspicious abnormalities exist that warrant the recall of the patient for further testing. Previous work has found significant differences in interpretation among radiologists; their false-positive and false-negative rates have been shown to vary widel...

journal_title：Statistics in medicine

authors： Woodard DB,Gelfand AE,Barlow WE,Elmore JG

更新日期：2007-03-30 00:00:00

abstract：:Unmeasured confounding is a common concern when researchers attempt to estimate a treatment effect using observational data or randomized studies with nonperfect compliance. To address this concern, instrumental variable methods, such as 2-stage predictor substitution (2SPS) and 2-stage residual inclusion (2SRI), have...

journal_title：Statistics in medicine

authors： Wan F,Small D,Mitra N

更新日期：2018-05-30 00:00:00