THE N-OF-1 RANDOMIZED CONTROLLED TRIAL - CLINICAL USEFULNESS OUR 3-YEAR EXPERIENCE
THE N-OF-1 RANDOMIZED CONTROLLED TRIAL - CLINICAL USEFULNESS OUR 3-YEAR EXPERIENCE
复制标题
DOI：
10.7326/0003-4819-112-4-293
复制
发表时间：
1990-02-15
影响因子：
39.2
通讯作者：
NEWHOUSE, MT
中科院分区：
文献类型：
--
作者：
GUYATT, GH;KELLER, JL;NEWHOUSE, MT
目的：评价n-of-1随机对照试验(n-of-1试验)在临床应用中的可行性和有效性。设计：单项试验为双盲、随机、多交叉试验。N-of-1试验的影响是通过激发医生S在每次试验前后对这些计划的管理和信心来确定的。单位：应社区和学术医生的要求提供n-of-1试验的转诊服务。分析目标：所有试验均由n-of-1服务计划、开始和完成。结果的衡量标准：已完成的计划中的n-of-1试验的比例以及提供明确的临床或统计学答案的比例。如果n-of-1试验导致医生S对管理计划有很高的信心，那么就得到了明确的临床答案。制定了具体的标准，将n-of-1试验归类为提供了明确的统计答案。主要结果：在不同的临床情况下，计划进行73个n-of-1试验。在开始的70个n-of-1试验中，57个已经完成。未完成n-of-1试验的原因是患者“”或医生“不依从”或“患者”并发疾病。在完成的57项n-of-1试验中，50项提供了明确的临床或统计学答案。在15个试验中(39%的试验中有适当的数据可用)，结果促使医生改变了他们在试验前的管理计划(在11个试验中，医生停止了他们计划无限期继续的药物治疗)。结论：我们的研究结果支持了n-of-1试验在临床实践中的可行性和有效性。
Objective: To review the feasibility and effectiveness of n-of-1 randomized controlled trials (n-of-1 trials) in clinical practice. Design: Individual trials were double-blind, randomized, multiple crossover trials. The impact of n-of-1 trials was determined by eliciting physician''s plants of management and confidence in those plans before and after each trial. Setting: Referral service doing n-of-1 trials at the requests of community and academic physicians. Objective of Analysis: All trials were planned, started, and completed by the n-of-1 service. Measures of Outcome: The proportion of planned n-of-1 trials that were completed and the proportion that provided a definite clinical or statistical answer. A definite clinical answer was achieved if an n-of-1 trial resulted in a high level of physician''s confidence in the management plan. Specific criteria were developed for classifying an n-of-1 trial as providing a definite statistical answer. Main Results: Seventy-three n-of-1 trials were planned in various clinical situations. Of 70 n-of-1 trials begun, 57 were completed. The reasons for not completing n-of-1 trials were patients'' or physicians'' noncompliance or patients'' concurrent illness. Of 57 n-of-1 trials completed, 50 provided a definite clinical or statistical answer. In 15 trials (39% of trials in which appropriate data were available), the results prompted physicians to change their "prior to the trial" plan of management (in 11 trials, the physicians stopped the drug therapy that they had planned to continue indefinitely). Conclusion: We interpret the results as supporting the feasibility and usefulness of n-of-1 trials in clinical practice.