Monitoring potential adverse event rate differences using data from blinded trials: the canary in the coal mine.

abstract：:Algorithms for identifying public health threats or disease outbreaks are vulnerable to false alarms arising from sudden shifts in health-care utilization or data participation. This paper describes a method of reducing false alerts in automated public health surveillance algorithms, and in particular, automated syndr...

journal_title：Statistics in medicine

authors： Peter W,Najmi AH,Burkom HS

更新日期：2011-06-30 00:00:00

abstract：:Although population-based molecular association studies are becoming increasingly popular, methodology for the meta-analysis of these studies has been neglected, particularly with regard to two issues: testing Hardy-Weinberg equilibrium (HWE), and pooling results in a manner that reflects a biological model of gene ef...

journal_title：Statistics in medicine

authors： Thakkinstian A,McElduff P,D'Este C,Duffy D,Attia J

更新日期：2005-05-15 00:00:00

abstract：:In randomised trials, continuous endpoints are often measured with some degree of error. This study explores the impact of ignoring measurement error and proposes methods to improve statistical inference in the presence of measurement error. Three main types of measurement error in continuous endpoints are considered:...

journal_title：Statistics in medicine

authors： Nab L,Groenwold RHH,Welsing PMJ,van Smeden M

更新日期：2019-11-30 00:00:00

abstract：:We propose a probability distribution for an equivalence class of classification trees (that is, those that ignore the value of the cutpoints but retain tree structure). This distribution is parameterized by a central tree structure representing the true model, and a precision or concentration coefficient representing...

journal_title：Statistics in medicine

authors： Shannon WD,Banks D

更新日期：1999-03-30 00:00:00

abstract：:In a medical study we are often interested in graphically displaying the relationship between continuous variables and clinical events indicating disease progression. Often, it is reasonable to make the minimal assumption that the risk of progression is an arbitrary monotone function of the continuous variable. Someti...

journal_title：Statistics in medicine

authors： Ancukiewicz M,Finkelstein DM,Schoenfeld DA

更新日期：2003-10-30 00:00:00

abstract：:For clinical trials with multiple treatment arms or endpoints a variety of sequentially rejective, weighted Bonferroni-type tests have been proposed, such as gatekeeping procedures, fixed sequence tests, and fallback procedures. They allow to map the difference in importance as well as the relationship between the var...

journal_title：Statistics in medicine

authors： Bretz F,Maurer W,Brannath W,Posch M

更新日期：2009-02-15 00:00:00

abstract：:We develop parametric maximum likelihood methods to adjust for treatment changes during follow-up in order to assess the causal effect of treatment in clinical trials with time-to-event outcomes. The accelerated failure time model of Robins and Tsiatis relates each observed event time to the underlying event time that...

journal_title：Statistics in medicine

authors： Walker AS,White IR,Babiker AG

更新日期：2004-02-28 00:00:00

abstract：BACKGROUND:The need to deliver interventions targeting multiple diseases in a cost-effective manner calls for integrated disease control efforts. Consequently, maps are required that show where the risk of co-infection is particularly high. Co-infection risk is preferably estimated via Bayesian geostatistical multinomi...

journal_title：Statistics in medicine

authors： Schur N,Gosoniu L,Raso G,Utzinger J,Vounatsou P

更新日期：2011-06-30 00:00:00

abstract：:Meta-analysis to investigate the joint effect of multiple factors in the aetiology of a disease is of increasing importance in epidemiology. This task is often challenging in practice, because studies typically concentrate on studying the effect of only one exposure, sometimes may report the interaction between two ex...

journal_title：Statistics in medicine

authors： Salanti G,Higgins JP,White IR

更新日期：2006-12-30 00:00:00

abstract：:A general method is presented that allows the researcher to change statistical design elements such as the residual sample size during the course of an experiment, to include an interim analysis for early stopping when no formal rule for early stopping was foreseen, to increase or reduce the number of planned interim ...

journal_title：Statistics in medicine

authors： Müller HH,Schäfer H

更新日期：2004-08-30 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：: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：: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：:Maps of estimated disease rates over multiple time periods are useful tools for gaining etiologic insights regarding potential exposures associated with specific locations and times. In this paper, we describe an extension of the Gangnon-Clayton model for spatial clustering to spatio-temporal data. As in the purely sp...

journal_title：Statistics in medicine

authors： Gangnon RE

更新日期：2010-09-30 00:00:00

abstract：:Standard randomization-based tests of sharp null hypotheses in randomized clinical trials, that is, intent-to-treat analyses, are valid without extraneous assumptions, but generally can be appropriately powerful only with alternative hypotheses that involve treatment assignment having an effect on outcome. In the cont...

journal_title：Statistics in medicine

authors： Rubin DB

更新日期：1998-02-15 00:00:00

abstract：:Binary matched-pairs data occur commonly in longitudinal studies, such as in cross-over experiments. Many analyses for comparing the matched probabilities of a particular outcome do not utilize pairs having the same outcome for each observation. An example is McNemar's test. Some methodologists find this to be counter...

journal_title：Statistics in medicine

authors： Agresti A,Min Y

更新日期：2004-01-15 00:00:00

abstract：:There is growing interest in how best to adapt and readapt treatments to individuals to maximize clinical benefit. In response, adaptive treatment strategies (ATS), which operationalize adaptive, sequential clinical decision making, have been developed. From a patient's perspective an ATS is a sequence of treatments, ...

journal_title：Statistics in medicine

authors： Almirall D,Compton SN,Gunlicks-Stoessel M,Duan N,Murphy SA

更新日期：2012-07-30 00:00:00

abstract：:We present an estimate of the kappa-coefficient of agreement between two methods of rating based on matched pairs of binary responses and show that the estimate depends on the common intraclass correlation coefficient between the pairs. Via Monte Carlo simulation, we investigate power of the test of significance on ka...

journal_title：Statistics in medicine

authors： Shoukri MM,Martin SW,Mian IU

更新日期：1995-01-15 00:00:00

abstract：:An important problem in oncology is comparing chemotherapy (chemo) agents in terms of their effects on survival or progression-free survival time. When the goal is to evaluate individual agents, a difficulty commonly encountered with observational data is that many patients receive a chemo combination including two or...

journal_title：Statistics in medicine

authors： Thall PF,Liu DD,Berrak SG,Wolff JE

更新日期：2011-07-10 00:00:00

abstract：:The FDA Guidance, while highly appropriate for industry sponsored trials, need not be imposed on publicly (e.g. NIH) financed clinical trials. While the potential for conflicts of interest exist in the latter, they are in general manageable and pose an acceptable low risk of threatening the integrity of a study. Howev...

journal_title：Statistics in medicine

authors： Lachin JM

更新日期：2004-05-30 00:00:00

abstract：:In multiple-record systems estimation it is usually assumed that all registration relate to the same population. In this paper, we develop a method which can be used when the registrations relate to different populations, in the sense that they cover, for example, different time periods or regions. We show that under ...

journal_title：Statistics in medicine

authors： Zwane EN,van der Pal-de Bruin K,van der Heijden PG

更新日期：2004-07-30 00:00:00

abstract：:Binary classification rules based on covariates typically depend on simple loss functions such as zero-one misclassification. Some cases may require more complex loss functions. For example, individual-level monitoring of HIV-infected individuals on antiretroviral therapy requires periodic assessment of treatment fail...

journal_title：Statistics in medicine

authors： Xu Y,Liu T,Daniels MJ,Kantor R,Mwangi A,Hogan JW

更新日期：2019-05-20 00:00:00

abstract：:In the analysis of composite endpoints in a clinical trial, time to first event analysis techniques such as the logrank test and Cox proportional hazard test do not take into account the multiplicity, importance, and the severity of events in the composite endpoint. Several generalized pairwise comparison analysis met...

journal_title：Statistics in medicine

authors： Verbeeck J,Spitzer E,de Vries T,van Es GA,Anderson WN,Van Mieghem NM,Leon MB,Molenberghs G,Tijssen J

更新日期：2019-12-30 00:00:00

abstract：:We consider statistical procedures for hypothesis testing of real valued functionals of matched pairs with missing values. In order to improve the accuracy of existing methods, we propose a novel multiplication combination procedure. Dividing the observed data into dependent (completely observed) pairs and independent...

journal_title：Statistics in medicine

authors： Amro L,Konietschke F,Pauly M

更新日期：2019-07-30 00:00:00

abstract：:We consider the problem of identifying a subgroup of patients who may have an enhanced treatment effect in a randomized clinical trial, and it is desirable that the subgroup be defined by a limited number of covariates. For this problem, the development of a standard, pre-determined strategy may help to avoid the well...

journal_title：Statistics in medicine

authors： Foster JC,Taylor JM,Ruberg SJ

更新日期：2011-10-30 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：:This paper considers the problem of selecting a set of regressors when the response variable is distributed according to a specified parametric model and observations are censored. Under a Bayesian perspective, the most widely used tools are Bayes factors (BFs), which are undefined when improper priors are used. In or...

journal_title：Statistics in medicine

authors： Cabras S,Castellanos ME,Perra S

更新日期：2014-11-20 00:00:00

abstract：:New combination regimens evaluated in phase II cancer clinical trials often show promising results compared to the standard therapy for a disease system. Selection of patients with a better prognosis can be a prominent factor for this optimism. For most disease systems, prognostic variables that are related to the out...

journal_title：Statistics in medicine

authors： Mazumdar M,Fazzari M,Panageas KS

更新日期：2001-03-30 00:00:00

abstract：:Performance of a diagnostic test is ideally evaluated by a comparison of the test results to a gold standard for all the patients in a study. In practice, however, it is common for a subset of study patients to have the gold standard not verified (missing) due to ethical or expense considerations. Sensitivity and spec...

journal_title：Statistics in medicine

authors： Kosinski AS,Chen Y,Lyles RH

更新日期：2010-07-10 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