Independent data monitoring committees: rationale, operations and controversies.

abstract：:The problem of evaluating an averaged functional magnetic resonance imaging (fMRI) response for repeated block design experiments was considered within a semiparametric regression model with autocorrelated residuals. We applied functional data analysis (FDA) techniques that use a least-squares fitting of B-spline expa...

journal_title：Statistics in medicine

authors： Vakorin VA,Borowsky R,Sarty GE

更新日期：2007-09-20 00:00:00

abstract：:The EQ-5D, a widely used multiattribute utility instrument, is commonly used in health economic evaluations where the goal is to decide on which treatments to reimburse. Like other instruments, value sets of the EQ-5D are constructed using valuation studies typically valuing a subset of the health states and using pre...

journal_title：Statistics in medicine

authors： Shams S,Pullenayegum E

更新日期：2020-10-15 00:00:00

abstract：:Treatment effects for multiple outcomes can be meta-analyzed separately or jointly, but no systematic empirical comparison of the two approaches exists. From the Cochrane Library of Systematic Reviews, we identified 45 reviews, including 1473 trials and 258,675 patients, that contained two or three univariate meta-ana...

journal_title：Statistics in medicine

authors： Trikalinos TA,Hoaglin DC,Schmid CH

更新日期：2014-04-30 00:00:00

abstract：:Statistical methods are available for performing a meta-analysis when the response variable of interest is the same in each study. Problems arise when studies exploring a common therapeutic question use different patient response types. This article presents statistical methods for combining studies which involve diff...

journal_title：Statistics in medicine

authors： Whitehead A,Jones NM

更新日期：1994-12-15 00:00:00

abstract：:The introduction of potent antiretroviral therapies for treatment of HIV infection typically results in a dramatic reduction in plasma HIV RNA concentration, often to levels undetectable by current measurement practices. However, although a high proportion of patients achieve 'undetectability', many then experience a ...

journal_title：Statistics in medicine

authors： McKinnon EJ,James IR,John M,Mallal SA

更新日期：2003-02-15 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：:Huntington's disease (HD) is a neurodegenerative disorder with a dominant genetic mode of inheritance caused by an expansion of CAG repeats on chromosome 4. Typically, a longer sequence of CAG repeat length is associated with increased risk of experiencing earlier onset of HD. Previous studies of the association betwe...

journal_title：Statistics in medicine

authors： Ma Y,Wang Y

更新日期：2014-04-15 00:00:00

abstract：:It is often of interest to use observational data to estimate the causal effect of a target exposure or treatment on an outcome. When estimating the treatment effect, it is essential to appropriately adjust for selection bias due to observed confounders using, for example, propensity score weighting. Selection bias du...

journal_title：Statistics in medicine

authors： Parast L,Griffin BA

更新日期：2020-08-15 00:00:00

abstract：:The identification of new adverse drug reactions is often tricky. For a given case, the relationship between drug exposure and symptom occurrence is usually questionable. It could be investigated statistically from a series of drug-event association cases with an independence test between the two variables. Analysing ...

journal_title：Statistics in medicine

authors： Tubert P,Begaud B

更新日期：1991-06-01 00:00:00

abstract：:In the field of cluster detection, a weighted normal model-based scan statistic was recently developed to analyze regional continuous data and to evaluate the clustering pattern of pre-defined cells (such as state, county, tract, school, hospital) that include many individuals. The continuous measures of interest are,...

journal_title：Statistics in medicine

authors： Huang L,Tiwari RC,Pickle LW,Zou Z

更新日期：2010-10-15 00:00:00

abstract：:Day and Walter derived methods of joint maximum likelihood estimation for the sojourn time distribution and the false negative rate for a screening programme. Their methods are not directly applicable to a programme which uses alternate screening by two modalities whose sojourn times and false negative rates will diff...

journal_title：Statistics in medicine

authors： Alexander FE

更新日期：1989-06-01 00:00:00

abstract：:The incremental life expectancy, defined as the difference in mean survival times between two treatment groups, is a crucial quantity of interest in cost-effectiveness analyses. Usually, this quantity is very difficult to estimate from censored survival data with a limited follow-up period. The paper develops estimati...

journal_title：Statistics in medicine

authors： Titman AC

更新日期：2016-09-10 00:00:00

abstract：:Conditional power based on summary statistic by comparing outcomes (such as the sample mean) directly between 2 groups is a convenient tool for decision making in randomized controlled trial studies. In this paper, we extend the traditional summary statistic-based conditional power with a general model-based assessmen...

journal_title：Statistics in medicine

authors： Zou B,Cai J,Koch GG,Zhou H,Zou F

更新日期：2017-12-30 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：:A new exponentially weighted moving average (EWMA) control chart well suited for 'online' routine surveillance of medical procedures is introduced. The chart is based on inter-event counts for failures recorded when the failures occur. The method can be used for many types of hospital procedures and activities, such a...

journal_title：Statistics in medicine

authors： Spliid H

更新日期：2007-01-15 00:00:00

abstract：:Writing the variance of the Mantel-Haenszel estimator under the null of homogeneity and inverting the corresponding test, we arrive at an improved confidence interval for the common risk difference in stratified 2 × 2 tables. This interval outperforms a variety of other intervals currently recommended in the literatur...

journal_title：Statistics in medicine

authors： Klingenberg B

更新日期：2014-07-30 00:00:00

abstract：:Subjects in randomized controlled trials do not always comply to the treatment condition they have been assigned to. This may cause the estimated effect of the intervention to be biased and also affect efficiency, coverage of confidence intervals, and statistical power. In cluster randomized trials non-compliance may ...

journal_title：Statistics in medicine

authors： Moerbeek M,Schie SV

更新日期：2019-11-20 00:00:00

abstract：:In this paper, we develop methods to combine multiple biomarker trajectories into a composite diagnostic marker using functional data analysis (FDA) to achieve better diagnostic accuracy in monitoring disease recurrence in the setting of a prospective cohort study. In such studies, the disease status is usually verifi...

journal_title：Statistics in medicine

authors： Li H,Gatsonis C

更新日期：2019-05-20 00:00:00

abstract：:Phase II studies in oncology are frequently conducted as two-stage single-arm trials with a binary endpoint indicating tumor response. As a common feature of these designs, the sample sizes of the two stages and the decision rules for the interim and the final analysis have to be pre-specified and adhered to strictly ...

journal_title：Statistics in medicine

authors： Englert S,Kieser M

更新日期：2015-06-15 00:00:00

abstract：:The use of outcome-dependent sampling with longitudinal data analysis has previously been shown to improve efficiency in the estimation of regression parameters. The motivating scenario is when outcome data exist for all cohort members but key exposure variables will be gathered only on a subset. Inference with outcom...

journal_title：Statistics in medicine

authors： Zelnick LR,Schildcrout JS,Heagerty PJ

更新日期：2018-06-15 00:00:00

abstract：:In conventional survival analysis there is an underlying assumption that all study subjects are susceptible to the event. In general, this assumption does not adequately hold when investigating the time to an event other than death. Owing to genetic and/or environmental etiology, study subjects may not be susceptible ...

journal_title：Statistics in medicine

authors： Chen CH,Tsay YC,Wu YC,Horng CF

更新日期：2013-10-30 00:00:00

abstract：:In the pharmaceutical industry, an assay method is considered validated if the accuracy and precision for an assay meet some acceptable limits. This paper discusses the assessment of assay precision in terms of the estimation of total variability of an assay from a one-way random effects model which is often considere...

journal_title：Statistics in medicine

authors： Chow SC,Tse SK

更新日期：1991-10-01 00:00:00

abstract：:When the event time of interest depends on the censoring time, conventional two-sample test methods, such as the log-rank and Wilcoxon tests, can produce an invalid test result. We extend our previous work on estimation using auxiliary variables to adjust for dependent censoring via multiple imputation, to the compari...

journal_title：Statistics in medicine

authors： Hsu CH,Taylor JM

更新日期：2009-02-01 00:00:00

abstract：:Zero-inflated Poisson regression is a popular tool used to analyze data with excessive zeros. Although much work has already been performed to fit zero-inflated data, most models heavily depend on special features of the individual data. To be specific, this means that there is a sizable group of respondents who endor...

journal_title：Statistics in medicine

authors： Lin TH,Tsai MH

更新日期：2013-04-30 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：:In repeated measures settings, modeling the correlation pattern of the data can be immensely important for proper analyses. Accurate inference requires proper choice of the correlation model. Optimal efficiency of the estimation procedure demands a parsimonious parameterization of the correlation structure, with suffi...

journal_title：Statistics in medicine

authors： Simpson SL,Edwards LJ,Muller KE,Sen PK,Styner MA

更新日期：2010-07-30 00:00:00

abstract：:Diagnostic problems in medicine are sometimes polytomous, meaning that the outcome has more than two distinct categories. For example, ovarian tumors can be benign, borderline, primary invasive, or metastatic. Extending the main measure of binary discrimination, the c-statistic or area under the ROC curve, to nominal ...

journal_title：Statistics in medicine

authors： Van Calster B,Van Belle V,Vergouwe Y,Timmerman D,Van Huffel S,Steyerberg EW

更新日期：2012-10-15 00:00:00

abstract：:Patient compliance (adherence) with prescribed medication is often erratic, while clinical outcomes are causally linked to actual, rather than nominal medication dosage. We propose here a hierarchical Markov model for patient compliance. At the first stage, conditional upon individual random effects and a set of indiv...

journal_title：Statistics in medicine

authors： Girard P,Blaschke TF,Kastrissios H,Sheiner LB

更新日期：1998-10-30 00:00:00

abstract：:Mediation analysis is a standard approach to understanding how and why an intervention works in social and medical sciences. However, the presence of missing data, especially missing not at random data, poses a great challenge for the applicability of this approach in practice. Current methods for handling such missin...

journal_title：Statistics in medicine

authors： Li W,Zhou XH

更新日期：2017-11-10 00:00:00

abstract：:Two features commonly exhibited by randomized trials of health promotion interventions are cluster randomization and stratification. Ignoring correlations between individuals within clusters can lead to an inflated type I error rate and hence a P-value which overstates the significance of the result. This paper compar...

journal_title：Statistics in medicine

authors： Dobbins TA,Simpson JM

更新日期：2002-12-30 00:00:00