Innovative Thinking on Endpoint Selection in Clinical Trials

ABSTRACT

In clinical trials, selection of appropriate study endpoints is critical for an accurate and reliable evaluation of safety and effectiveness of a test treatment under investigation. In practice, however, there are usually multiple endpoints available for measurement of disease status and/or therapeutic effect of the test treatment under study. For example, in cancer clinical trials, overall survival, response rate, and/or time to disease progression are usually considered as primary clinical endpoints for evaluation of safety and effectiveness of the test treatment under investigation. Once the study endpoints have been selected, sample size required for achieving a desired power is then determined. It, however, should be noted that different study endpoints may result in different sample sizes. In practice, it is usually not clear which study endpoint can best inform the disease status and measure the treatment effect. Moreover, different study endpoints may not translate one another although they may be highly correlated one another. In this article, we intend to develop an innovative endpoint namely therapeutic index based on a utility function to combine and utilize information collected from all study endpoints. Statistical properties and performances of the proposed therapeutic index are evaluated theoretically. A numerical example concerning a cancer clinical trial is given to illustrate the use of the proposed therapeutic index.     

Leading together towards a stronger ‘us’: An experimental test of the effectiveness of the 5R Shared Leadership Program (5RS) in basketball teams

ObjectivesLeadership has been suggested to be a key factor in gaining a competitive advantage as a team, with shared leadership being a better predictor of team functioning than vertical leadership. Although the benefits of shared leadership are well-documented, evidence about how to implement a shared leadership structure remains sparse. This leaves coaches with three key challenges: (1) identifying the best leaders; (2) defining what roles those leaders should fulfill; and (3) developing their leadership skills. Solutions to these challenges have been proposed in the 5R Shared Leadership Program (5R^S) — a leadership development program that seeks to implement an effective structure of shared leadership within sports teams.DesignTo test the effectiveness of 5R^S program, we conducted an experimental-comparison group intervention in which eight national-level basketball teams (N = 96) completed a questionnaire at two points in time (i.e., pre- and posttest). The teams in the intervention condition completed the 5R^S program, in which we identified the leadership structure in their teams (through Shared Leadership Mapping), appointed the best leaders in their leadership role, and then developed their identity leadership skills.ResultsThe results revealed that the 5R^S program was successful in strengthening athlete leaders’ identity leadership skills, and as a result also team members’ identification with their team. Furthermore, in contrast to athletes in the comparison condition, athletes in the 5R^S condition were able to maintain their levels of intrinsic motivation and commitment to team goals, while also reporting improved well-being.ConclusionsThe present study provides encouraging evidence that, by implementing a structure of shared leadership and by promoting athlete leaders’ identity leadership skills, the 5R^S program is able to improve the team’s functioning and the well-being of its members.     

论护士长的管理技巧对团队凝聚力的影响

阐述护士长的自身素质和管理技巧对团队凝聚力的影响及护士长应具备的管理技巧,认为提高护士长的自身素质和管理技巧是充分调动护理人员工作积极性从而提高护理质量的必要条件。     

中文科技期刊封面设计与探索——以《协和医学杂志》为例

【目的】 探索中文科技期刊封面发展的可行途径。【方法】 分析我国科技期刊封面设计现状以及制约中文科技期刊封面发展的瓶颈,并以《协和医学杂志》为例,介绍其封面设计团队的建立和运营经验,展示封面设计在其期刊品牌建设中发挥的作用。【结果】 中文科技期刊在编委人才梯队化建设过程中,通过主动发现和利用青年人才,能够建立稳定的封面设计团队,呈现高水平的封面设计,进而显著提升期刊品牌影响力。【结论】 封面质量建设对提升期刊品牌影响力具有重要作用,紧密结合中文期刊自身发展特点,善于借助可利用的优势资源,是中文科技期刊突破封面发展瓶颈的可行途径。     

多学科协作诊疗助力直肠癌手术质量提升

目的探讨多学科协作诊疗在直肠癌手术中的开展成效。方法将进入多学科协作的患者和未进入多学科协作的患者分别设为观察组和对照组,通过多项指标量化分析直肠癌多学科协作开展成效。结果观察组的术后住院时长短于对照组,差异有统计学意义（P<0.05）;术后首次下床时间短于对照组,差异有统计学意义（P<0.05）;手术总费用、检查费、床位费少于对照组,差异有统计学意义（P<0.05）。观察组低位直肠癌手术有效保肛率高于对照组;在术后早期并发症中,观察组病例数少于对照组;在Ⅲ期直肠癌患者术后无进展生存时间上,观察组要高于对照组,差异有统计学意义（P<0.05）。观察组在生存量表总分、生理领域、心理领域得分均高于对照组,差异有统计学意义（P<0.05）。结论多学科协作在直肠癌诊疗中效果明显,能够确保直肠癌患者手术安全,缩短术后住院时长,降低手术费用,并减少术后并发症发生率,提升低位直肠癌有效保肛率,延长Ⅲ期直肠癌患者术后无进展生存时间,改善患者生存质量。     

2005年淮安市部分乙型病毒性肝炎病例核实诊断结果分析

[目的]了解淮安市乙型病毒性肝炎（乙肝）疫情报告质量，分析乙肝疫情现状，为今后规范乙肝疫情报告工作提供科学依据。[方法]2005年8月，疾病预防控制机构与医疗机构合作，对淮安市2005年8～9月由全市各级各类医疗机构通过国家疾病监测信息报告管理系统报告的现住本市的乙肝病例进行核实诊断调查。[结果]调查260例乙肝病例，经流行病学调查与血清学检测，最后判定为新发乙肝病例165例，复发乙肝病例77例，乙肝病毒携带者7例，诊断依据不足10例，1例排除肝炎。[结论]疾病预防控制机构与医疗机构密切配合，对开展相关疾病的核实诊断工作是可行的方法。     

藿胆丸微生物限度检查方法学验证实验

目的探讨藿胆丸的微生物限度检查方法的验证实验。方法按《中华人民共和国药典》2010年版一部微生物限度检查方法进行验证实验。结果藿胆丸对枯草芽孢杆菌、金黄色葡萄球菌具有很强的抑制作用,根据方法验证实验结果采用薄膜过滤法（200m/膜）进行本品的细菌计数,常规法进行霉菌及酵母菌计数,常规法进行控制菌检查。结论严格按照《中华人民共和国药典》要求,选择5株阳性菌株进行药品的微生物限度检查方法学验证实验极为必要。