Blinded continuous monitoring in clinical trials with recurrent event endpoints

In studies with recurrent event endpoints, misspecified assumptions of event rates or dispersion can lead to underpowered trials or overexposure of patients. Specification of overdispersion is often a particular problem as it is usually not reported in clinical trial publications. Changing event rates over the years have been described for some diseases, adding to the uncertainty in planning. To mitigate the risks of inadequate sample sizes, internal pilot study designs have been proposed with a preference for blinded sample size reestimation procedures, as they generally do not affect the type I error rate and maintain trial integrity. Blinded sample size reestimation procedures are available for trials with recurrent events as endpoints. However, the variance in the reestimated sample size can be considerable in particular with early sample size reviews. Motivated by a randomized controlled trial in paediatric multiple sclerosis, a rare neurological condition in children, we apply the concept of blinded continuous monitoring of information, which is known to reduce the variance in the resulting sample size. Assuming negative binomial distributions for the counts of recurrent relapses, we derive information criteria and propose blinded continuous monitoring procedures. The operating characteristics of these are assessed in Monte Carlo trial simulations demonstrating favourable properties with regard to type I error rate, power, and stopping time, ie, sample size.     

An Interview with Joyce Edward: Exemplary Clinician, Advocate, and Scholar

Over the years, noteworthy social workers have been interviewed for the Clinical Social Work Journal. This article features an interview with Joyce Edward who is recognized for her many extraordinary contributions to clinical social work. Joyce has co-written or co-edited three exceptional books for the social work clinician, she has been an esteemed teacher and a vocal activist for quality mental health care. In this interview Joyce reflects on family influences, her work as a social caseworker, the psychoanalytic luminaries with whom she trained, her concerns about the clinical education of today's social work students, and finally, her perspective on managed mental health care.     

对开拓中医药成人高等教育潜在市场的思考

我国的成人高等教育 ,在实现从计划经济到市场经济转变后 ,出现了前所未有的竞争场面。作为行业性很强的中医药成人高等教育 ,要想生存和进一步发展 ,必须在积极参加市场竞争的同时 ,根据自身的优势和特点 ,从社会发展的高度 ,大力开拓潜在市场 ,努力寻找中医药成人高等教育的发展空间     

谈中药知识产权保护的现状与对策

中国加入WTO之后,中国民族医药产业将面临着机遇和挑战,加强中药知识产权的保护工作意义尤其重大。作者在详尽分析了我国中药知识产权方面的现状之后,进一步提出了我国在中药知识产权保护方面的对策。     

论医学模式的演变与医务社会工作概念的发展

医务社会工作是社会工作的一个重要的实务领域,自诞生之日起,其内涵就始终在不断的发展与丰富.医务社会工作的发展不仅受到经济社会发展的影响,更受到了医学模式发展的深切影响.本文主要对医学模式的演变与医务社会工作发展之间的关系进行了分析,认为医学模式由传统向现代模式的转变,使医务社会工作的内涵得以深化,理念得以提升.     

Improving the contributions of technology assessment to the health care system of the U.S.A.

Summary Based on 14 case studies of highly effective therapies and the reasons they succeeded less frequently than they could, we propose a variety of steps to improve the health care system of the U.S.A. Whatever proposal emerges from current national debates until innovations are shown to be safe and effective, they should not be supported; when slightly better technologies are much more expensive than other good ones we need to consider appropriate choices carefully; simplified billing and bookkeping would reduce our costs; when a technology is rapidly introduced cautionnary measures may be needed; tracking immunization and repairing their omissions requires a new system; educational programs such as seen effective in hypertension should be applied in other areas such as vaccination; in organ transplantation the nation should consider “presumed consent”; our payment system sometimes creates perverse incentives and therefore needs review; and the preferences of the public in allocation of health resources need to be discovered once the public is informed about the issues. Research supported by Andrew W. Mellon Foundation.     

提高高等医学院校临床教学质量的若干思考

提高医学院校的临床教学质量应做好四个方面的工作:提高认识、增强教学意识,调动临床教学工作的积极性;加强临床教师队伍的建设,注重提高临床教学效果;加强临床教学管理规范化制度化建设;深化临床教学改革。     

建立有中国特色的保护中药知识产权的法律体系

文章分析了中药知识产权的专利保护、商标保护、行政保护和商业秘密保护的现状 ,指出了存在的问题 ,提出了除运用现有的办法外 ,应着重改善和加强中药的专利保护 ,利用高新技术解决专利侵权不能认定等问题 ,从而建立起有效保护中药知识产权的法律体系     

影响普通高等医学院校科技工作的几点思考

本文通过对影响医学高校科技工作的几个主要因素的分析 ,探讨并阐述了医学高校如何开展科技工作及科技工作的定位。