Punja Salima, Bukutu Cecilia, Shamseer Larissa, Sampson Margaret, Hartling Lisa, Urichuk Liana, Vohra Sunita
Department of Pediatrics, University of Alberta, 1702 College Plaza, 8215-112 Street NW, Edmonton, Alberta T6G 2C8, Canada.
Department of Pediatrics, University of Alberta, 1702 College Plaza, 8215-112 Street NW, Edmonton, Alberta T6G 2C8, Canada; Knowledge Utilization Studies Program, Faculty of Nursing, University of Alberta, 3rd Floor Edmonton Clinic Health Academy, Edmonton, Alberta T6G 1C9, Canada.
J Clin Epidemiol. 2016 Aug;76:47-56. doi: 10.1016/j.jclinepi.2016.03.023. Epub 2016 Apr 11.
To summarize the methods of design, analysis, and meta-analysis used in N-of-1 trials.
Electronic search for English language articles published from 1950 to 2013. N-of-1 trials were selected if they followed an ABAB design and if they assessed a health intervention for a medical condition. Elements of design, analysis, and meta-analysis were extracted.
We included 100 reports representing 1,995 participants. N-of-1 trials have been conducted in over 50 health conditions. Most reports incorporated the use of elements that maintain methodological rigor, including randomization, blinding, and formal outcome assessment; however, many failed to address trial registration, funding source, and adverse events. Most reports statistically analyzed individual N-of-1 trials; however, only a small proportion of included series meta-analyzed their results.
N-of-1 trials have the ability to assess treatment response in individual participants and can be used for a variety of health interventions for a wide range of medical conditions in both clinical and research settings. Considerable heterogeneity exists in the methods used in N-of-1 trials.
总结单病例试验中使用的设计、分析和荟萃分析方法。
对1950年至2013年发表的英文文章进行电子检索。如果单病例试验采用ABAB设计且评估了针对某种疾病的健康干预措施，则将其纳入。提取设计、分析和荟萃分析的要素。
我们纳入了100份报告，涉及1995名参与者。单病例试验已在50多种健康状况中进行。大多数报告采用了保持方法学严谨性的要素，包括随机化、盲法和正式的结局评估；然而，许多报告未涉及试验注册、资金来源和不良事件。大多数报告对单个单病例试验进行了统计分析；然而，纳入的系列中只有一小部分对其结果进行了荟萃分析。
单病例试验有能力评估个体参与者的治疗反应，可用于临床和研究环境中针对多种疾病的各种健康干预措施。单病例试验所使用的方法存在相当大的异质性。
