Predictive Hierarchic Modeling of Operational Characteristics in Clinical Trials

An analytic methodology for patient enrollment modeling using a Poisson-gamma model is developed by Anisimov & Fedorov (2005–2007). For modeling hierarchic processes associated with enrollment, a new methodology using evolving stochastic processes is proposed. This provides rather general and unified framework to describe various operational processes associated with enrollment. The technique for calculating predictive distributions, mean, and credibility bounds for evolving processes is developed. Some applications to modeling operational characteristics in clinical trials are considered with focus to modeling events associated with incoming and follow-up patients in different settings. For these models, predictive characteristics are derived in a closed form.     

Adaptive designs for single‐arm phase II trials in oncology

Clinical phase II trials in oncology are conducted to determine whether the activity of a new anticancer treatment is promising enough to merit further investigation. Two‐stage designs are commonly used for this situation to allow for early termination. Designs proposed in the literature so far have the common drawback that the sample sizes for the two stages have to be specified in the protocol and have to be adhered to strictly during the course of the trial. As a consequence, designs that allow a higher extent of flexibility are desirable. In this article, we propose a new adaptive method that allows an arbitrary modification of the sample size of the second stage using the results of the interim analysis or external information while controlling the type I error rate. If the sample size is not changed during the trial, the proposed design shows very similar characteristics to the optimal two‐stage design proposed by Chang et al. (Biometrics 1987; 43:865–874). However, the new design allows the use of mid‐course information for the planning of the second stage, thus meeting practical requirements when performing clinical phase II trials in oncology. Copyright © 2012 John Wiley & Sons, Ltd.     

Cognitive-Behavioral Therapy for Bipolar Disorder: Implications for Clinical Social Workers

ABSTRACT

The purposes of this review article are to orient clinical social workers to cognitive-behavioral theory, intervention, and research on bipolar disorder (BD); identify pros and cons of applying cognitive-behavioral therapy (CBT) to social work clients with BD; and identify specific implications for clinical social work practice. Of the 545 articles that were obtained via the systematic review, 18 studies were identified as being potentially eligible for inclusion, and 9 of those studies ultimately satisfied the inclusion criteria. The results of each study were summarized via identifying statistically significant (p< .05) differences that existed between experimental cohorts who received CBT (plus pharmacotherapy) and control cohorts who received treatment as usual. Outcomes showed CBT cohorts as having significant improvement over their respective control groups. The review's implications for clinical social workers and the need for future research are discussed.     

Randomization tests in recursive response-adaptive randomization procedures

In a randomized clinical trial, response-adaptive randomization procedures use the information gathered, including the previous patients' responses, to allocate the next patient. In this setting, we consider randomization-based inference. We provide an algorithm to obtain exact p-values for statistical tests that compare two treatments with dichotomous responses. This algorithm can be applied to a family of response adaptive randomization procedures which share the following property: the distribution of the allocation rule depends only on the imbalance between treatments and on the imbalance between successes for treatments 1 and 2 in the previous step. This family includes some outstanding response adaptive randomization procedures. We study a randomization test to contrast the null hypothesis of equivalence of treatments and we show that this test has a similar performance to that of its parametric counterpart. Besides, we study the effect of a covariate in the inferential process. First, we obtain a parametric test, constructed assuming a logit model which relates responses to treatments and covariate levels, and we give conditions that guarantee its asymptotic normality. Finally, we show that the randomization test, which is free of model specification, performs as well as the parametric test that takes the covariate into account.     

An improved cluster two-stage randomized response model

In this paper, Abdelfatah and Mazloum's (2015) two-stage randomized response model is extended to unequal probability sampling and stratified unequal probability sampling, both with and without replacement. The extended models result in more efficient estimators than Lee et al.'s (2014) estimators of the proportion of the population having a sensitive attribute.     

A Study of Clinical Change in Individual Career Counseling

This study examined the clinical significance of career counseling effects. Participants were 111 university students (83% women) who participated in individual career counseling sessions at their university. All participants completed the French version of the Outcome Questionnaire–30.2 (OQ‐30.2; Lambert, Finch, Okiishi, & Burlingame, 2005) immediately before the 1st session (pretest) and at the beginning of the last session (posttest). The OQ‐30.2 assesses 3 client life domains: subjective discomfort, problems in interpersonal relationships, and problems in social role satisfaction. Using Jacobson and Truax’s (1991) statistical approach to assessing clinical change, the authors compared clients’ pretest OQ‐30.2 scores with their posttest scores. Among clients with a “dysfunctional” score (n = 59) at the study’s inception, 34% recovered and 14% improved, whereas 41% of clients with functional scores (n = 52) at the study’s inception improved. The results suggest that individual career counseling can make a difference in the lives of many clients; they also highlight the importance of further outcome research that accounts for possible variability in clients’ responses to career counseling.     

神经内科临床见习教学中几种方法的应用及体会

为适应现代社会对医学人才的要求,在临床教学中应注重对学生能力的培养。结合神经内科临床见习教学,进行了一系列的探索和实践,利用PBL教学模式,借助多媒体等辅助教学工具,采用教与学互动的教学方法,充分调动学生学习积极性、训练正确的临床思维方法,提高了学生分析和解决问题的能力。     

法律诊所式教育可行性对策思考

法律诊所式教育在弥补了传统法学教育的弊端的基础上近年在中国获得了飞速的发展。但是,对其“本土化”的争论引起了人们的思考。法律诊所式教育应该如何适用,影响法律诊所式教育可行性的原因有哪些,本文基于此,结合中国的现实,提出了相应具有实际意义的解决对策,期望对中国的法律诊所式教育的发展做出一定的贡献。     

骨科教学改革的对策与思考

以骨科教学为例,分析了当前教学中的困惑和思考①落后的教材与日益更新的诊疗技术;②应试教育的现实与素质教育的理想;③传统教学手段的根深蒂固与先进教学方法的大胆尝试;④"灌输式”教学的质疑与"创新性”教学的期盼.作者提出了对策.