Backman C L, Harris S R
Department of Health Care & Epidemiology, School of Rehabilitation Sciences, The University of British Columbia, Vancouver, Canada.
Am J Phys Med Rehabil. 1999 Mar-Apr;78(2):170-6. doi: 10.1097/00002060-199903000-00022.
Case studies, single-subject research designs, and N of 1 randomized clinical trials are methods of scientific inquiry applied to an individual or small group of individuals. A case study is a form of descriptive research that seeks to identify explanatory patterns for phenomena and generates hypotheses for future research. Single-subject research designs provide a quasi-experimental approach to investigating causal relationships between independent and dependent variables. They are characterized by repeated measures of an observable and clinically relevant target behavior throughout at least one pretreatment (baseline) and intervention phase. The N of 1 clinical trial is similar to the single-subject research design through its use of repeated measures over time but also borrows principles from the conduct of large, randomized controlled trials. Typically, the N of 1 trial compares a therapeutic procedure with placebo or compares two treatments by administering the two conditions in a predetermined random order. Neither the subject nor the clinician is aware of the treatment condition in any given period of time. All three approaches are relatively easy to integrate into clinical practice and are useful for documenting individualized outcomes and providing evidence in support of rehabilitation interventions.
案例研究、单受试者研究设计以及n-of-1随机临床试验是应用于个体或一小群个体的科学探究方法。案例研究是一种描述性研究形式，旨在识别现象的解释模式并为未来研究生成假设。单受试者研究设计提供了一种准实验方法，用于研究自变量和因变量之间的因果关系。它们的特点是在至少一个预处理（基线）和干预阶段对可观察到的且与临床相关的目标行为进行重复测量。n-of-1临床试验通过其随时间的重复测量与单受试者研究设计相似，但也借鉴了大型随机对照试验的实施原则。通常，n-of-1试验将一种治疗程序与安慰剂进行比较，或者通过以预定的随机顺序给予两种治疗条件来比较两种治疗方法。在任何给定时间段内，受试者和临床医生都不知道治疗情况。所有这三种方法相对容易整合到临床实践中，并且对于记录个体化结果和提供支持康复干预的证据很有用。
