Predicting analysis times in randomized clinical trials.

abstract：:The identification of counties burdened by exceptionally high rates of mortality is a fundamental step in the development of state-based intervention and prevention strategies. However, the estimation of rates from small geographic areas presents special problems, especially for rare events. This paper compares the us...

journal_title：Statistics in medicine

authors： Stevenson JM,Olson DR

更新日期：1993-02-01 00:00:00

abstract：:Proportional hazards (or Cox) regression is a popular method for modelling the effects of prognostic factors on survival. Use of cubic spline functions to model time-by-covariate interactions in Cox regression allows investigation of the shape of a possible covariate-time dependence without having to specify a specifi...

journal_title：Statistics in medicine

authors： Hess KR

更新日期：1994-05-30 00:00:00

abstract：:The use of the last observation carried forward (LOCF) method for imputing missing outcome data in randomized clinical trials has been much criticized and its shortcomings are well understood. However, only recently have published studies widely started using more appropriate imputation methods. Consequently, meta-ana...

journal_title：Statistics in medicine

authors： Mavridis D,Salanti G,Furukawa TA,Cipriani A,Chaimani A,White IR

更新日期：2019-02-28 00:00:00

abstract：:When investigating health disparities, it can be of interest to explore whether adjustment for socioeconomic factors at the neighborhood level can account for, or even reverse, an unadjusted difference. Recently, we proposed new methods to adjust the effect of an individual-level covariate for confounding by unmeasure...

journal_title：Statistics in medicine

authors： Brumback BA,Zheng HW,Dailey AB

更新日期：2013-04-15 00:00:00

abstract：:Three-arm trials including the experimental treatment, an active reference treatment and a placebo are recommended in the guidelines of the ICH and EMEA/CPMP as a useful approach to the assessment of assay sensitivity. Generally, the acceptable non-inferiority margin Δ has been defined as the maximum clinically irrele...

journal_title：Statistics in medicine

authors： Hida E,Tango T

更新日期：2011-02-10 00:00:00

abstract：:We propose a two-step procedure to personalize drug dosage over time under the framework of a log-linear mixed-effect model. We model patients' heterogeneity using subject-specific random effects, which are treated as the realizations of an unspecified stochastic process. We extend the conditional quadratic inference ...

journal_title：Statistics in medicine

authors： Zhu X,Qu A

更新日期：2016-10-30 00:00:00

abstract：:Many Americans rely on cardiac surgical procedures and devices such as pacemakers and thrombolytic catheters to treat or manage their cardiovascular diseases. However, the failure of these cardiac devices and procedures could have grave consequences. One reason cardiac devices tended to fail was due to physician error...

journal_title：Statistics in medicine

authors： Govindarajulu U,Bedi S,Kluger A,Resnic F

更新日期：2018-12-10 00:00:00

abstract：:Screening for a disease such as cancer is often regarded as a beneficial and successful strategy for reducing mortality. However, as with any clinical treatment or intervention, benefit cannot be assumed, and screening can entail both costs and harms, so the screening as a 'treatment' must undergo evaluation. An evalu...

journal_title：Statistics in medicine

authors： Kafadar K,Prorok PC

更新日期：2005-02-28 00:00:00

abstract：:The relative importance of prognostic factors in regression can be measured either by standardized regression coefficients or by percentages of explained variation in a dependent variable. One advantage of using explained variation is the direct comparability of qualitative prognostic factors with others, or of groups...

journal_title：Statistics in medicine

authors： Schemper M

更新日期：1993-12-30 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：: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：:A targeted poll was undertaken to compare and contrast models of data monitoring of randomized clinical trials sponsored by the National Institutes of Health. In an attempt to represent the institutes which conduct clinical trials, twelve individuals were selected and asked to respond to a questionnaire specifically p...

journal_title：Statistics in medicine

authors： Geller NL,Stylianou M

更新日期：1993-03-01 00:00:00

abstract：:We describe how trends in the vaccination coverage at 19 months of age vary by race/ethnicity; explore the extent to which data required to evaluate a child's up-to-date vaccination status is missing as a result of the scattering of vaccination records among many vaccination providers; evaluate how the prevalence of t...

journal_title：Statistics in medicine

authors： Smith PJ,Stevenson J

更新日期：2008-09-10 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：: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：:Equal allocation of patients to treatment in a randomized clinical trial may have disadvantages ethically if the new treatment is believed to be at least as beneficial as the standard treatment. Others have considered, in a non-sequential setting, unbalanced randomized designs which allocate fewer patients to the pote...

journal_title：Statistics in medicine

authors： Lesser ML

更新日期：1982-07-01 00:00:00

abstract：:Although the literature on contraceptive failure is vast and is expanding rapidly, our understanding of the relative efficacy of methods is quite limited because of defects in the research design and in the analytical tools used by investigators. Errors in the literature range from simple arithmetical mistakes to outr...

journal_title：Statistics in medicine

authors： Trussell J

更新日期：1991-02-01 00:00:00

abstract：:Laboratory determinations on children aged 6 to 10 years obtained over a 5-year period are analysed by a method described in detail for differentiating between children from exposed and control areas of Seveso, Italy. In the analysis, stratification is employed to distinguish the separate days of laboratory measuremen...

journal_title：Statistics in medicine

authors： Mantel N,Mocarelli P,Marocchi A,Brambilla P,Baretta R

更新日期：1983-04-01 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：:Slow recruitment in clinical trials leads to increased costs and resource utilization, which includes both the clinic staff and patient volunteers. Careful planning and monitoring of the accrual process can prevent the unnecessary loss of these resources. We propose two hierarchical extensions to the existing Bayesian...

journal_title：Statistics in medicine

authors： Jiang Y,Simon S,Mayo MS,Gajewski BJ

更新日期：2015-02-20 00:00:00

abstract：:Genetic markers can be used as instrumental variables, in an analogous way to randomization in a clinical trial, to estimate the causal relationship between a phenotype and an outcome variable. Our purpose is to extend the existing methods for such Mendelian randomization studies to the context of multiple genetic mar...

journal_title：Statistics in medicine

authors： Burgess S,Thompson SG,CRP CHD Genetics Collaboration.,Burgess S,Thompson SG,Andrews G,Samani NJ,Hall A,Whincup P,Morris R,Lawlor DA,Davey Smith G,Timpson N,Ebrahim S,Ben-Shlomo Y,Davey Smith G,Timpson N,Brown M,Ricket

更新日期：2010-05-30 00:00:00

abstract：:Outcomes research often requires estimating the impact of a binary treatment on a binary outcome in a non-randomized setting, such as the effect of taking a drug on mortality. The data often come from self-selected samples, leading to a spurious correlation between the treatment and outcome when standard binary depend...

journal_title：Statistics in medicine

authors： Bhattacharya J,Goldman D,McCaffrey D

更新日期：2006-02-15 00:00:00

abstract：:One is often interested in the ratio of two variables, for example in genetics, assessing drug effectiveness, and in health economics. In this paper, we derive an explicit geometric solution to the general problem of identifying the two tangents from an arbitrary external point to an ellipse. This solution permits num...

journal_title：Statistics in medicine

authors： Walter SD,Gafni A,Birch S

更新日期：2008-12-10 00:00:00

abstract：:Studies involving longitudinal binary responses are widely applied in the health and biomedical sciences research and frequently analyzed by generalized estimating equations (GEE) method. This article proposes an alternative goodness-of-fit test based on the nonparametric smoothing approach for assessing the adequacy ...

journal_title：Statistics in medicine

authors： Lin KC,Chen YJ,Shyr Y

更新日期：2008-09-30 00:00:00

abstract：:We suggest measures to quantify the degrees of necessity and of sufficiency of prognostic factors for dichotomous and for survival outcomes. A cause, represented by certain values of prognostic factors, is considered necessary for an event if, without the cause, the event cannot develop. It is considered sufficient fo...

journal_title：Statistics in medicine

authors： Gleiss A,Schemper M

更新日期：2019-10-15 00:00:00

abstract：:The mixed effect models for repeated measures (MMRM) analysis is sometimes used as a primary analysis in longitudinal randomized clinical trials. The SE for the treatment effect in the MMRM analysis is usually estimated by assuming the orthogonality of the fixed effect and variance-covariance parameters, which is the ...

journal_title：Statistics in medicine

authors： Maruo K,Ishii R,Yamaguchi Y,Doi M,Gosho M

更新日期：2020-04-30 00:00:00

abstract：:Risk prediction procedures can be quite useful for the patient's treatment selection, prevention strategy, or disease management in evidence-based medicine. Often, potentially important new predictors are available in addition to the conventional markers. The question is how to quantify the improvement from the new ma...

journal_title：Statistics in medicine

authors： Uno H,Tian L,Cai T,Kohane IS,Wei LJ

更新日期：2013-06-30 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：:With reference to a real data on cataract surgery, we discuss the problem of zero-inflated circular-circular regression when both covariate and response are circular random variables and a large proportion of the responses are zeros. The regression model is proposed, and the estimation procedure for the parameters is ...

journal_title：Statistics in medicine

authors： Jha J,Biswas A

更新日期：2018-01-15 00:00:00

abstract：:In many studies, a K degree of freedom large sample chi2 test is used to assess the effect of treatment on a multivariate response, such as an omnibus T2-like test of a difference between two treatment groups in any of K repeated measures. Alternately, a K df chi2 test may be used to test the equality of K+1 groups in...

journal_title：Statistics in medicine

authors： Lachin JM,Greenhouse SW,Bautista OM

更新日期：2003-11-15 00:00:00