Meta-analysis combining parallel and cross-over clinical trials. II: Binary outcomes.

abstract：:This paper presents a statistically optimal exact hypothesis testing procedure for detecting changes in sales adjusted adverse drug reaction (ADR) rates between historical and current periods, with a computer program that implements this test appended. We provide discussions and illustrations on how to monitor ADR rat...

journal_title：Statistics in medicine

authors： Norwood PK,Sampson AR

更新日期：1988-10-01 00:00:00

abstract：:Typical analyses of lifetime data treat the time to death or failure as the response variable and use a variety of modelling strategies such as proportional hazards or fully parametric, to investigate the relationship between the response and covariates. In certain circumstances it may be more natural to view the dist...

journal_title：Statistics in medicine

authors： Ghahramani M,Dean CB,Spinelli JJ

更新日期：2001-07-15 00:00:00

abstract：:Disease incidence or disease mortality rates for small areas are often displayed on maps. Maps of raw rates, disease counts divided by the total population at risk, have been criticized as unreliable due to non-constant variance associated with heterogeneity in base population size. This has led to the use of model-ba...

journal_title：Statistics in medicine

authors： Stern HS,Cressie N

更新日期：2000-09-15 00:00:00

abstract：:Longitudinal designs are important in medical research and in many other disciplines. Complete longitudinal studies, in which each subject is evaluated at each measurement occasion, are often very expensive and motivate a search for more efficient designs. Recently developed statistical methods foster the use of inten...

journal_title：Statistics in medicine

authors： Helms RW

更新日期：1992-10-01 00:00:00

abstract：:Although radical changes in drug regulation are rare (e.g., the Federal Food, Drug and Cosmetic Act of 1938 and the 1962 amendment to the Act creating an effectiveness requirement), regulations and guidance do evolve significantly in the face of new problems and accumulating experience. Recent changes have been driven...

journal_title：Statistics in medicine

authors： Temple R

更新日期：2002-10-15 00:00:00

abstract：:With considerable current interest in longitudinal epidemiologic studies, little is available regarding sample size requirements. This paper considers a method for analysis of longitudinal data, where one compares the mean rates of change for two or more groups, and proposes a statistic for use in determining sample s...

journal_title：Statistics in medicine

authors： Lefante JJ

更新日期：1990-04-01 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：:Reference ranges which take time (such as age) into account are often required in medicine, but simple, systematic and efficient statistical methods for constructing them are lacking. A method is described which is based on low order polynomial curves (linear, quadratic or occasionally cubic), together with guidelines...

journal_title：Statistics in medicine

authors： Royston P

更新日期：1991-05-01 00:00:00

abstract：:It is not uncommon for a continuous outcome variable Y to be dichotomized and analysed using logistic regression. Moser and Coombs (Statist. Med. 2004; 23:1843-1860) provide a method for converting the output from a standard linear regression analysis using the original continuous outcome Y to give much more efficient...

journal_title：Statistics in medicine

authors： Jiang Y,Scott A,Wild CJ

更新日期：2009-01-30 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：:Two important qualities of controlled clinical trials are that they reduce dependence on historical standards for evaluating therapy and separate the effect of treatment from the confounding influence of time. Whatever the theory of the clinical trial, however, time has not easily been banished from the analysis of me...

journal_title：Statistics in medicine

authors： Senn SJ

更新日期：1989-11-01 00:00:00

abstract：:We construct nonparametric regression estimators of a number of temporal functions in a multistate system based on a continuous univariate baseline covariate. These estimators include state occupation probabilities, state entry, exit, and waiting (sojourn) time distribution functions of a general progressive (e.g., ac...

journal_title：Statistics in medicine

authors： Mostajabi F,Datta S

更新日期：2013-07-30 00:00:00

abstract：:The Response Evaluation Criteria in Solid Tumors are used as standard guidelines for the clinical evaluation of cancer treatments. The assessment is based on the anatomical tumor burden: change in size of target lesions and evolution of nontarget lesions (NTL). Despite unquestionable advantages of this standard tool, ...

journal_title：Statistics in medicine

authors： Król A,Tournigand C,Michiels S,Rondeau V

更新日期：2018-06-15 00:00:00

abstract：:The change in c-statistic is frequently used to summarize the change in predictive accuracy when a novel risk factor is added to an existing logistic regression model. We explored the relationship between the absolute change in the c-statistic, Brier score, generalized R(2) , and the discrimination slope when a risk f...

journal_title：Statistics in medicine

authors： Austin PC,Steyerberg EW

更新日期：2013-02-20 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：:A common but not necessarily logical requirement in drug development is that a 'limit of quantitation' be set for chemical assays and that observations that fall below the limit should not be treated as real data but should be labelled as below the limit and set aside for special treatment. We examine five of seven ap...

journal_title：Statistics in medicine

authors： Senn S,Holford N,Hockey H

更新日期：2012-12-30 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：:In many medical applications, combining information from multiple biomarkers could yield a better diagnosis than any single one on its own. When there is a lack of a gold standard, an algorithm of classifying subjects into the case and non-case status is necessary for combining multiple markers. The aim of this paper ...

journal_title：Statistics in medicine

authors： Zhang J,Zhang Y,Chaloner K,Stapleton JT

更新日期：2016-04-15 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：:Variation in heart disease (HD) mortality rates across census tracts is greater than expected given binomial error and available explanatory variables. We extended an extra-binomial variation model for rates standardized by the direct method. The overdispersion parameter accounted for 36 per cent of the observed varia...

journal_title：Statistics in medicine

authors： Jarjoura D,Logue E

更新日期：1990-10-01 00:00:00

abstract：:The U.S. Food and Drug Administration (FDA) has proposed new regulations that address the 'prescribability' and 'switchability' of new formulations of already-approved drugs. These new criteria are known, respectively, as population and individual bioequivalence. Two methods have been proposed in the bioequivalence li...

journal_title：Statistics in medicine

authors： McNally RJ,Iyer H,Mathew T

更新日期：2003-01-15 00:00:00

abstract：:We present a method to determine the number of subjects, k, and number of repeated measurements, n, that minimize the overall cost of conducting a reliability study, while providing acceptable power for tests of hypotheses concerning the reliability coefficient rho. Tables showing optimal choices of k and n under vari...

journal_title：Statistics in medicine

authors： Eliasziw M,Donner A

更新日期：1987-09-01 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：:Frequently, multiple doses of an active treatment and multiple endpoints are simultaneously considered in the designs of clinical trials. For these trials, traditional multiplicity adjustment procedures such as Bonferroni, Hochberg and Hommel procedures can be applied when treating the comparisons of different doses t...

journal_title：Statistics in medicine

authors： Quan H,Luo X,Capizzi T

更新日期：2005-07-30 00:00:00

abstract：:Interval-censored data are commonly found in studies of diseases that progress without symptoms, which require clinical evaluation for detection. Several techniques have been suggested with independent assumption. However, the assumption will not be valid if observations come from clusters. Furthermore, when the clust...

journal_title：Statistics in medicine

authors： Kim YJ

更新日期：2010-12-10 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：:A decision-theoretic framework is proposed for designing sequential dose-finding trials with multiple outcomes. The optimal strategy is solvable theoretically via backward induction. However, for dose-finding studies involving k doses, the computational complexity is the same as the bandit problem with k-dependent arm...

journal_title：Statistics in medicine

authors： Fan SK,Wang YG

更新日期：2006-05-30 00:00:00

abstract：:The objective of a phase II cancer clinical trial is to screen a treatment that can produce a similar or better response rate compared to the current treatment results. This screening is usually carried out in two stages as proposed by Simon. For ineffective treatment, the trial should terminate at the first stage. En...

journal_title：Statistics in medicine

authors： Chen TT

更新日期：1997-12-15 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：: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