Integrating quality into the cycle of therapeutic development
Integrating quality into the cycle of therapeutic development
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DOI：
10.1016/s0735-1097(02)02537-8
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发表时间：
2002-12-04
影响因子：
24
通讯作者：
Smith, SC
中科院分区：
文献类型：
--
作者：
Califf, RM;Peterson, ED;Smith, SC
卫生保健的质量，特别是当前实践与现有证据所反映的质量，已成为国家卫生政策讨论的一个主要焦点。提供高质量护理所需的关键组成部分包括：1)根据具体实践指南制定质量指标和绩效衡量标准；2)更好地传播此类指南和措施；3)开发支持工具以促进标准化实践。尽管理性决策和实践指南的制定依赖于随机试验和结果研究的结果，但并非所有问题都可以通过随机试验来回答，许多治疗决策在治疗个体时必然反映生理、直觉和经验。关于“循证医学”的作用的争论也引发了对将试验结果应用于实践的价值的质疑，一些人对所倡导的临床有效性衡量标准（质量的基本定义）是否真正反映了改善医疗实践的一种有价值的方法持怀疑态度。我们通过描述一个模型，将质量和性能的定量测量整合到现有和未来治疗方法的开发周期中，为这个问题提供了一个视角。这种模式将作为心血管医学的基本方法，对于那些希望为患者提供最佳护理的人来说，这是必要的，但还不够。(C) 2002年由美国心脏病学会基金会发布。
The quality of healthcare, particularly as reflected in current practice versus the available evidence, has become a major focus of national health policy discussions. Key components needed to provide quality care include: 1) development of quality indicators and performance measures from specific practice guidelines, 2) better ways to disseminate such guidelines and measures, and 3) development of support tools to promote standardized practice. Although rational decision-making and development of practice guidelines have relied upon results of randomized trials and outcomes studies, not all questions can be answered by randomized trials, and many treatment decisions necessarily reflect physiology, intuition, and experience when treating individuals. Debate about the role of "evidence-based medicine" also has raised questions about the value of applying trial results in practice, and some skepticism has arisen about whether advocated measures of clinical effectiveness, the basic definition of quality, truly reflect a worthwhile approach to improving medical practice. We provide a perspective on this issue by describing a model that integrates quantitative measurements of quality and performance into the development cycle of existing and future therapeutics. Such a model would serve as a basic approach to cardiovascular medicine that is necessary, but not sufficient, to those wishing to provide the best care for their patients. (C) 2002 by the American College of Cardiology Foundation.