Case studies, single-subject research, and N of 1 randomized trials - Comparisons and contrasts

Case studies, single-subject research, and N of 1 randomized trials - Comparisons and contrasts
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DOI:
10.1097/00002060-199903000-00022
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发表时间:
1999-03-01
影响因子:
3
通讯作者:
Harris, SR
Harris, SR
中科院分区:
医学3区
文献类型:
--
作者:
Backman, CL;Harris, SR

文献摘要

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个案研究、单一受试者研究设计和N/1随机临床试验是应用于个人或一小群人的科学研究方法。案例研究是一种描述性研究形式,旨在确定现象的解释模式,并为未来的研究生成假设。单一受试者研究设计为研究自变量和因变量之间的因果关系提供了一种准实验方法。它们的特点是在至少一个治疗前(基线)和干预阶段重复测量可观察到的和临床相关的目标行为。N of 1临床试验类似于单一受试者的研究设计,它随着时间的推移使用重复测量,但也借鉴了大型随机对照试验的进行原理。通常,N of 1试验将治疗过程与安慰剂进行比较,或者通过按预定的随机顺序给予两种情况来比较两种治疗方法。在任何给定的时间段内,受试者和临床医生都不知道治疗情况。所有这三种方法都相对容易整合到临床实践中,对于记录个性化的结果和提供支持康复干预的证据都是有用的。
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.