摘要
临床真实性与临床对照试验的方法相互影响的持续存在是很理想的。一项良好的试验设计应能反映医生、特别是患者的观点,相反,熟悉临床试验也能改进日常工作方法。换句话说,每种方法学原理都源于临床实践。例如:随机化(建设性的怀疑作为其实践的对象)、独立性(对医药公司善意的不信任)、知情同意(让患者了解不确定性)、Ⅰ类错误(在一项试验后不错误的乐观)、Ⅱ类错误(在一项试验后不错误的悲观)、选择正确的转归指标(恰当性比准确性更重要)、意向处理原则(注重实效的分析)以及亚组分析的危险性(“我的最后一例患者综合征”)。
Ideally, there is continuous interaction between clinical reality and the methods of controlled clinical trials. The design of a proper trial ought to reflect the physician's and especially the patient's point of view, and conversely a familiarity with clinical trials improves the methods of daily practice. In other words, every methodological principle is rooted in clinical practice. Some examples are: randomisation (with constructive doubt as its practical counterpart), independence (a healthy mistrust of drug companies), informed consent (sharing uncertainty with patients), type I error (no false optimism after a single trial), type II error (no false pessimism after a single trial), choosing the right measure of outcome (relevance outweighs precision), the intention-to-treat principle (pragmatic analysis), and the dangers of subgroup analysis (the 'my-last-patient syndrome').
出处
《国外医学（脑血管疾病分册）》
2004年第1期7-10,共4页
Foreign Medical Sciences Cerebrovascular Diseases
关键词
循证医学
卒中
临床试验
方法学
临床实践
evidence-based medicine stroke randomised controlled clinical trials
