Keller J L, Guyatt G H, Roberts R S, Adachi J D, Rosenbloom D
Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario.
Scand J Gastroenterol Suppl. 1988;147:22-9. doi: 10.3109/00365528809099154.
The N of 1 service at our institution acts as a full referral service for clinicians who want a definitive answer to a difficult management question, and an instructional environment for clinicians who have more time and want to learn to run their own N of 1 RCT. The trial design is a double blind, randomized pair, multiple crossover. A number of methodologic issues are discussed, such as appropriateness of the patients problem to N of 1 trials, feasibility, types of measurement, such as clinical objective measurement and quality of life measurement, as well as timing of these measurements. The analysis issues include developing a reporting method which is statistically powerful and understandable to clinicians with little research background. Some of these issues have been well investigated and some have not.
我们机构的单病例试验服务，对于那些希望得到棘手管理问题明确答案的临床医生而言，是一项全面的转诊服务；对于那些有更多时间且希望学习自行开展单病例随机对照试验的临床医生来说，是一个指导环境。试验设计为双盲、随机配对、多次交叉试验。文中讨论了一些方法学问题，比如患者问题对单病例试验的适用性、可行性、测量类型（如临床客观测量和生活质量测量）以及这些测量的时机。分析问题包括开发一种报告方法，这种方法在统计学上具有说服力，并且对于几乎没有研究背景的临床医生来说易于理解。其中一些问题已经得到充分研究，而有些则尚未研究。
