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61.
We derive estimators of the mean of a function of a quality-of-life adjusted failure time, in the presence of competing right
censoring mechanisms. Our approach allows for the possibility that some or all of the competing censoring mechanisms are associated
with the endpoint, even after adjustment for recorded prognostic factors, with the degree of residual association possibly
different for distinct censoring processes. Our methods generalize from a single to many censoring processes and from ignorable
to non-ignorable censoring processes. 相似文献
62.
Two-stage designs offer substantial advantages for early phase II studies. The interim analysis following the first stage allows the study to be stopped for futility, or more positively, it might lead to early progression to the trials needed for late phase II and phase III. If the study is to continue to its second stage, then there is an opportunity for a revision of the total sample size. Two-stage designs have been implemented widely in oncology studies in which there is a single treatment arm and patient responses are binary. In this paper the case of two-arm comparative studies in which responses are quantitative is considered. This setting is common in therapeutic areas other than oncology. It will be assumed that observations are normally distributed, but that there is some doubt concerning their standard deviation, motivating the need for sample size review. The work reported has been motivated by a study in diabetic neuropathic pain, and the development of the design for that trial is described in detail. 相似文献
63.
Elevation in C-reactive protein (CRP) is an independent risk factor for cardiovascular disease progression and levels are reduced by treatment with statins. However, on-treatment CRP, given baseline CRP and treatment, is not normally distributed and outliers exist even when transformations are applied. Although classical non-parametric tests address some of these issues, they do not enable straightforward inclusion of covariate information. The aims of this study were to produce a model that improved efficiency and accuracy of analysis of CRP data. Estimation of treatment effects and identification of outliers were addressed using controlled trials of rosuvastatin. The robust statistical technique of MM-estimation was used to fit models to data in the presence of outliers and was compared with least-squares estimation. To develop the model, appropriate transformations of the response and baseline variables were selected. The model was used to investigate how on-treatment CRP related to baseline CRP and estimated treatment effects with rosuvastatin. On comparing least-squares and MM-estimation, MM-estimation was superior to least-squares estimation in that parameter estimates were more efficient and outliers were clearly identified. Relative reductions in CRP were higher at higher baseline CRP levels. There was also evidence of a dose-response relationship between CRP reductions from baseline and rosuvastatin. Several large outliers were identified, although there did not appear to be any relationships between the incidence of outliers and treatments. In conclusion, using robust estimation to model CRP data is superior to least-squares estimation and non-parametric tests in terms of efficiency, outlier identification and the ability to include covariate information. 相似文献
64.
There has been increasing use of quality-of-life (QoL) instruments in drug development. Missing item values often occur in QoL data. A common approach to solve this problem is to impute the missing values before scoring. Several imputation procedures, such as imputing with the most correlated item and imputing with a row/column model or an item response model, have been proposed. We examine these procedures using data from two clinical trials, in which the original asthma quality-of-life questionnaire (AQLQ) and the miniAQLQ were used. We propose two modifications to existing procedures: truncating the imputed values to eliminate outliers and using the proportional odds model as the item response model for imputation. We also propose a novel imputation method based on a semi-parametric beta regression so that the imputed value is always in the correct range and illustrate how this approach can easily be implemented in commonly used statistical software. To compare these approaches, we deleted 5% of item values in the data according to three different missingness mechanisms, imputed them using these approaches and compared the imputed values with the true values. Our comparison showed that the row/column-model-based imputation with truncation generally performed better, whereas our new approach had better performance under a number scenarios. 相似文献
65.
For semiparametric models, interval estimation and hypothesis testing based on the information matrix for the full model is a challenge because of potentially unlimited dimension. Use of the profile information matrix for a small set of parameters of interest is an appealing alternative. Existing approaches for the estimation of the profile information matrix are either subject to the curse of dimensionality, or are ad-hoc and approximate and can be unstable and numerically inefficient. We propose a numerically stable and efficient algorithm that delivers an exact observed profile information matrix for regression coefficients for the class of Nonlinear Transformation Models [A. Tsodikov (2003) J R Statist Soc Ser B 65:759-774]. The algorithm deals with the curse of dimensionality and requires neither large matrix inverses nor explicit expressions for the profile surface. 相似文献
66.
苏联民族学正处于两个五年计划之交,应当对它前五年的发展作一主要总结,为后五年的民族学研究勾画出基本的发展前景。前五年,苏联民族学保持了传统民族学作为历史知识的一个专门领域的优良成果,在从广泛的历史角度认识和阐述当代世界的族体一民族过程及其发展预测方面,迈出了明显的一步。同时,它和人类学、民俗学、社会学、地理学、人口学、医学、心理学等学科之间,发展了广泛的联系。对民族学理论问题的研究更加重视。研究方法扩展了,丰富了。群众性调查、预测、资料的电脑处理等,尤其得到广泛运用。苏联民族学家从民族学是关于民族(народ—зтнос)·的科学这一观点出发,继续深入研究了本学科的一般理论问题。民族理论的一些重要方面,如确定民族在其他人类共同体中 相似文献
67.
地处阿拉伯海怀抱的拉克代夫群岛属印度最小的中央直辖区,是由36个小小的珊瑚岛组成。虽然从外表看来似乎默默无闻,但实际上它却具有强烈的吸引力和独特的重要性。拉克代夫群岛总面积并不大,只有32平方公里。但是,如果将它附近的大约4200平方公里的累恭(Legūna)地区(即被珊瑚礁 相似文献
68.
同孩子的生命(包括孩子出生)有关的习俗和礼仪跟结婚仪式一样,在民族学著作中通常被看成是一系列特殊的家庭礼仪,这些仪礼只有一个目的,即保障社会新成员平安出世及生活顺利。目前还没有描述阿布哈兹人生儿育女的一系列习俗和礼仪的专门著作。本文在某种程度上填补了这个空白。它是在作者对阿布哈兹人的日常生活进行多年观察的基础上写出来的,同时还利用了1982年收集到的实地考察资料。孩子出生在阿布哈兹人家里被看作是极为重要的事情。特别高兴的是生了儿子,人们把他看作是 相似文献
69.
This study examined whether the efficacy of keepin' it REAL, a model program for substance use prevention in schools, was moderated by gender, ethnicity, and acculturation. Gender differences in program efficacy may arise through boys' higher risk of drug use, inadequate attention to girls' developmental issues, or cultural factors like polarized gender expectations. Data came from a randomized trial in 35 Phoenix, Arizona, middle schools involving 4,622 mostly Latino 7th graders. Using multi-level mixed models and multiple imputation missing techniques, results for the total sample showed no gender differences in program effects on recent substance use, but the program was more effective in fostering boys' than girls' anti-drug norms. Subgroup analyses demonstrated several more beneficial program effects for boys than girls (less alcohol and cigarette use and stronger anti-drug norms), but only among less acculturated Latinos. There were no gender differences in program effects among more acculturated Latinos, nor among non-Latino whites. 相似文献
70.
In order to achieve the intended impact on a community, comprehensive community initiatives must sustain programs once they have been implemented. However, planning for sustainability is challenging and is rarely incorporated in the planning process of an initiative. The current study examined 19 5-year plans developed during the planning phase of the Comprehensive Strategy for Serious, Violent and Chronic Juvenile Offenders. Quantitative and qualitative methods were employed to assess the extent to which the construct of sustainability was incorporated. The plan analysis was supplemented with results from other components of the complex evaluation design implemented as part of the process evaluation of Comprehensive Strategy. Results suggested that sustainability was not accounted for during the planning phase of this initiative. The implications of these findings, including the importance of planning for sustainability in order to achieve sustainability, are discussed. 相似文献