Utilizing Bayesian predictive power in clinical trial design

The Bayesian paradigm provides an ideal platform to update uncertainties and carry them over into the future in the presence of data. Bayesian predictive power (BPP) reflects our belief in the eventual success of a clinical trial to meet its goals. In this paper we derive mathematical expressions for the most common types of outcomes, to make the BPP accessible to practitioners, facilitate fast computations in adaptive trial design simulations that use interim futility monitoring, and propose an organized BPP-based phase II-to-phase III design framework.     

Response‐adaptive designs for binary responses: How to offer patient benefit while being robust to time trends?

Response‐adaptive randomisation (RAR) can considerably improve the chances of a successful treatment outcome for patients in a clinical trial by skewing the allocation probability towards better performing treatments as data accumulates. There is considerable interest in using RAR designs in drug development for rare diseases, where traditional designs are not either feasible or ethically questionable. In this paper, we discuss and address a major criticism levelled at RAR: namely, type I error inflation due to an unknown time trend over the course of the trial. The most common cause of this phenomenon is changes in the characteristics of recruited patients—referred to as patient drift. This is a realistic concern for clinical trials in rare diseases due to their lengthly accrual rate. We compute the type I error inflation as a function of the time trend magnitude to determine in which contexts the problem is most exacerbated. We then assess the ability of different correction methods to preserve type I error in these contexts and their performance in terms of other operating characteristics, including patient benefit and power. We make recommendations as to which correction methods are most suitable in the rare disease context for several RAR rules, differentiating between the 2‐armed and the multi‐armed case. We further propose a RAR design for multi‐armed clinical trials, which is computationally efficient and robust to several time trends considered.     

Enacting reflective and deliberative practices in action research

ABSTRACT

We consider action research as a form of deliberative policy analysis. This analysis explores a “reconstruction clinic” in which stakeholders and public officials engaged memories, hopes and obligations as they sought to resolve controversies over details of policy implementation. We ask how institutional design shaped participants’ reflective and deliberative progress. Reflection in action can prompt not only changes in cognitive frames, but new behavioural capacities for action. Deliberative practices can shape new relationships between parties through the work of apology, recognition, appreciation, and emergent collaboration.     

Integrating self-care into clinical practice with trauma clients

ABSTRACT

Self-care is recognized as an important aspect of social work practice. Beginning in educational settings, developing social workers are encouraged to learn about and practice self-care. However, self-care is typically promoted through strategies and approaches outside of the practice context. Social workers are oftentimes encouraged to use individualized self-care plans, which often feature a variety of relaxation and secondary techniques; focus on self-awareness and self-reflection; and have proper use of supervision. Although these strategies are invaluable, they do little to directly benefit the social worker during direct practice or while in session with a client which is a time period when clinicians are particularly vulnerable to distress or burnout. The importance of real-time self-care strategies is particularly critical for clinicians, especially those who engage in trauma work, given the sensitivity of topics that clients may have endured or benefit from assistance in processing. Further, little information has been published on the use of self-care techniques during a session with a client or in a clinical context. The purpose of the present paper is to discuss self-care strategies that can be useful both outside of and within a clinical setting and present a model of such strategies that focus on integrating self-care in clinical practice particularly for those engaging in trauma work. The paper will conclude by discussing the relevancy of the developed model in practice.     

习近平新时代体育外交的实践探析

运用文献资料法和逻辑分析法等研究方法,以构建人类命运共同体为切入视角,对习近平新时代体育外交思想进行深入分析。研究认为,习近平新时代体育外交主要内容包括:赛事外交是主流;足球外交成亮点;多边合作是关键。习近平新时代体育外交思想是中国外交思想的重要组成部分之一,是对中共历代领导人体育外交思想的继承和发展,也是建设新时代体育强国的内在要求。习近平新时代体育外交思想内涵丰富且意蕴深远,不仅展现了我国新时代外交多元化发展的一面,也促进了中国对外沟通、交流及合作,具有十分重要的意义。     

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.     

关于职业学校实施品牌战略的思考

创建学校品牌有助于提高生源质量,提高教学质量,提升职业学校形象。     

论坚持“以德为先”选用干部

我们党选用干部标准的思想经历了从毛泽东提出的＂德才兼备＂到胡锦涛明确提出的＂德才兼备、以德为先＂的历史的、理论的发展演变过程。从宏观上和战略上看,坚持＂以德为先＂选用干部,在理论层面和现实需求层面上都具有重大的价值意义。要使＂以德为先＂用人标准不致于流于形式,就必须健全完善与时俱进的党员干部＂德＂之衡量标准。     

柳亚子与新南社

南社社友虽然在辛亥革命中发挥了巨大的积极作用,但自民国成立后便开始消沉失落。新文化运动中,为了重振南社昔日的雄风,迎上革命的新潮,柳亚子与叶楚伧等共同发起成立了新南社,制定章程,选举柳亚子为社长。国民党改组后由于柳亚子忙于党内斗争以及国民党右派的反对,新南社只存在一年即告停顿,却在宣传新三民主义和动员群众投身国民革命方面发挥了积极作用。     

福建省高校五人制足球开展研究

通过对福建省开展五人制足球较成熟的4所高校的调查,分析五人制足球运动在福建高校开展的意义、状况。在此基础上,提出了一些建议与设想,明确了应该在福建省各个高校内积极开展与推广五人制足球,最终推动大众足球运动的普及与发展的意见。