An examination of the efficiency of some quality assurance methods commonly employed in clinical trials.

abstract：:Many models for clinical prediction (prognosis or diagnosis) are published in the medical literature every year but few such models find their way into clinical practice. The reason may be that since in most cases models have not been validated in independent data, they lack generality and/or credibility. In this pape...

journal_title：Statistics in medicine

authors： Royston P,Parmar MK,Sylvester R

更新日期：2004-03-30 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：:Summarizing the information of many studies using a meta-analysis becomes more and more important, also in the field of diagnostic studies. The special challenge in meta-analysis of diagnostic accuracy studies is that in general sensitivity and specificity are co-primary endpoints. Across the studies both endpoints ar...

journal_title：Statistics in medicine

authors： Zapf A,Hoyer A,Kramer K,Kuss O

更新日期：2015-12-20 00:00:00

abstract：:The purpose of this research was to develop appropriate methods for analysing repeated ordinal categorical data that arose in an intervention trial to prevent oesophageal cancer. The measured response was the degree of oesophageal dysplasia at 2.5 and 6 years after randomization. An important feature was that some res...

journal_title：Statistics in medicine

authors： Mark SD,Gail MH

更新日期：1994-03-15 00:00:00

abstract：:The log-rank test is the most powerful non-parametric test for detecting a proportional hazards alternative and thus is the most commonly used testing procedure for comparing time-to-event distributions between different treatments in clinical trials. When the log-rank test is used for the primary data analysis, the s...

journal_title：Statistics in medicine

authors： Zhang D,Quan H

更新日期：2009-02-28 00:00:00

abstract：:Repeated cross-sectional samples are common in national surveys of health like the National Health Interview Survey (NHIS). Because population health outcomes generally evolve slowly, pooling data across years can improve the precision of current-year annual estimates of disease prevalence and other health outcomes. P...

journal_title：Statistics in medicine

authors： Lockwood JR,McCaffrey DF,Setodji CM,Elliott MN

更新日期：2011-02-28 00:00:00

abstract：:We present graphical and numerical methods for assessing the adequacy of the logistic regression model for stratified case-control data. The proposed methods are derived from the cumulative sum of residuals over the covariate or linear predictor. Under the assumed model, the cumulative residual process converges weakl...

journal_title：Statistics in medicine

authors： Arbogast PG,Lin DY

更新日期：2005-01-30 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：:In multivariate network meta-analysis (NMA), the piecemeal nature of the evidence base means that there may be treatment-outcome combinations for which no data is available. Most existing multivariate evidence synthesis models are either unable to estimate the missing treatment-outcome combinations, or can only do so ...

journal_title：Statistics in medicine

authors： Waddingham E,Matthews PM,Ashby D

更新日期：2020-10-30 00:00:00

abstract：:Many complex diseases are known to be affected by the interactions between genetic variants and environmental exposures beyond the main genetic and environmental effects. Study of gene-environment (G×E) interactions is important for elucidating the disease etiology. Existing Bayesian methods for G×E interaction studie...

journal_title：Statistics in medicine

authors： Ren J,Zhou F,Li X,Chen Q,Zhang H,Ma S,Jiang Y,Wu C

更新日期：2020-02-28 00:00:00

abstract：:Prediction performance of a risk scoring system needs to be carefully assessed before its adoption in clinical practice. Clinical preventive care often uses risk scores to screen asymptomatic population. The primary clinical interest is to predict the risk of having an event by a prespecified future time t0 . Accuracy...

journal_title：Statistics in medicine

authors： Yuan Y,Zhou QM,Li B,Cai H,Chow EJ,Armstrong GT

更新日期：2018-05-10 00:00:00

abstract：:Childhood acute lymphoblastic leukaemia is treated with long-term intensive chemotherapy. During the latter part of the treatment, the maintenance therapy, the patients receive oral doses of two cytostatics. The doses are tailored to blood counts measured on a weekly basis, and the treatment is therefore highly dynami...

journal_title：Statistics in medicine

authors： Rosthøj S,Keiding N,Schmiegelow K

更新日期：2012-02-28 00:00:00

abstract：:Outcome-dependent sampling (ODS) scheme is a cost-effective sampling scheme where one observes the exposure with a probability that depends on the outcome. The well-known such design is the case-control design for binary response, the case-cohort design for the failure time data, and the general ODS design for a conti...

journal_title：Statistics in medicine

authors： Lu TS,Longnecker MP,Zhou H

更新日期：2017-03-15 00:00:00

abstract：:Equivalence trials aim to show that two treatments have equivalent therapeutic effects. The approach is to define, in advance, a range of equivalence -d to +d for the treatment difference such that any value in the range is clinically unimportant. If the confidence interval for the difference, calculated after the tri...

journal_title：Statistics in medicine

authors： Ebbutt AF,Frith L

更新日期：1998-08-15 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：:We present a model for describing correlated binocular data from reader-based diagnostic studies, where the same group of readers evaluates the presence or absence of certain diseases on binocular organs (e.g., fellow eyes) of patients. Multiple random effects are incorporated to meaningfully delineate various associa...

journal_title：Statistics in medicine

authors： Withanage N,de Leon AR,Rudnisky CJ

更新日期：2015-12-20 00:00:00

abstract：:Propensity score analysis is widely used in observational studies to adjust for confounding and estimate the causal effect of a treatment on the outcome. When the outcome is survival time, there are special considerations on the definition of the causal estimand, point, and variance estimation that have not been thoro...

journal_title：Statistics in medicine

authors： Mao H,Li L,Yang W,Shen Y

更新日期：2018-11-20 00:00:00

abstract：:The estimation of attributable risk in the presence of confounding and effect modification is studied in this paper. Different adjustment methods for the attributable risk are reviewed. The results of a stimulation study comparing these methods under the unrestricted multinomial sampling model are reported. From the s...

journal_title：Statistics in medicine

authors： Gefeller O

更新日期：1992-12-01 00:00:00

abstract：:Two correction methods are considered for multiple logistic regression models with some covariates measured with error. Both methods are based on approximating the complicated regression model between the response and the observed covariates with simpler models. The first model is the logistic approximation proposed b...

journal_title：Statistics in medicine

authors： Kuha J

更新日期：1994-06-15 00:00:00

abstract：:When analyzing time to disease recurrence, we sometimes need to work with data where all the recurrences are recorded, but no information is available on the possible deaths. This may occur when studying diseases of benign nature where patients are only seen at disease recurrences or in poorly-designed registries of b...

journal_title：Statistics in medicine

authors： Štupnik T,Pohar Perme M

更新日期：2016-03-30 00:00:00

abstract：:Health questionnaires are often built up from sets of questions that are totaled to obtain a sum score. An important consideration in designing questionnaires is to minimize respondent burden. An increasingly popular method for efficient measurement is computerized adaptive testing; unfortunately, many health question...

journal_title：Statistics in medicine

authors： Smits N,Finkelman MD

更新日期：2014-02-10 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：:We consider Cox proportional hazards regression when the covariate vector includes error-prone discrete covariates along with error-free covariates, which may be discrete or continuous. The misclassification in the discrete error-prone covariates is allowed to be of any specified form. Building on the work of Nakamura...

journal_title：Statistics in medicine

authors： Zucker DM,Spiegelman D

更新日期：2008-05-20 00:00:00

abstract：:In this paper we study the problem of variable selection for the proportional odds model, which is a useful alternative to the proportional hazards model and might be appropriate when the proportional hazards assumption is not satisfied. We propose to fit the proportional odds model by maximizing the marginal likeliho...

journal_title：Statistics in medicine

authors： Lu W,Zhang HH

更新日期：2007-09-10 00:00:00

abstract：:The sojourn time, time spent in the preclinical detectable phase (PCDP) for chronic diseases, for example, breast cancer, plays an important role in the design and assessment of screening programmes. Traditional methods to estimate it usually assume a uniform incidence rate of preclinical disease from a randomized con...

journal_title：Statistics in medicine

authors： Duffy SW,Chen HH,Tabar L,Day NE

更新日期：1995-07-30 00:00:00

abstract：:Non-tumor cell-based model systems have recently gained interest in pharmacogenetic research as a hypothesis generating tool. The hypotheses generated from these model systems can be followed up in functional studies, or tested in individuals taking the same investigational agents. The current cellular phenotypes (e.g...

journal_title：Statistics in medicine

authors： Fridley BL,Jenkins G,Schaid DJ,Wang L

更新日期：2009-09-20 00:00:00

abstract：:In vaccine safety studies, subjects are considered at increased risk for adverse events for a period of time after vaccination known as risk window. To our knowledge, risk windows for vaccine safety studies have tended to be pre-defined and not to use information from the current study. Inaccurate specification of the...

journal_title：Statistics in medicine

authors： Xu S,Zhang L,Nelson JC,Zeng C,Mullooly J,McClure D,Glanz J

更新日期：2011-03-30 00:00:00

abstract：:Recurrent event data are commonly encountered in health-related longitudinal studies. In this paper time-to-events models for recurrent event data are studied with non-informative and informative censorings. In statistical literature, the risk set methods have been confirmed to serve as an appropriate and efficient ap...

journal_title：Statistics in medicine

authors： Wang MC,Chiang CT

更新日期：2002-02-15 00:00:00

abstract：:A number of variance formulae for the attributable fraction have been presented, but none is consistent in sparse data, such as found in individually matched case-control studies. This paper employs Mantel-Haenszel estimation to derive variance estimators for attributable fractions that are dually consistent, that is,...

journal_title：Statistics in medicine

authors： Greenland S

更新日期：1987-09-01 00:00:00

abstract：:The focus of this paper is dietary intervention trials. We explore the statistical issues involved when the response variable, intake of a food or nutrient, is based on self-report data that are subject to inherent measurement error. There has been little work on handling error in this context. A particular feature of...

journal_title：Statistics in medicine

authors： Keogh RH,Carroll RJ,Tooze JA,Kirkpatrick SI,Freedman LS

更新日期：2016-11-10 00:00:00