Romeiser Logan Lynne, Hickman Robbin R, Harris Susan R, Heriza Carolyn B
Tone Management and Mobility Program, Upstate Medical University, Syracuse, NY, USA.
Dev Med Child Neurol. 2008 Feb;50(2):99-103. doi: 10.1111/j.1469-8749.2007.02005.x.
The aim of this article is to present a set of evidence levels, accompanied by 14 quality or rigor questions, to foster a critical review of published single-subject research articles. In developing these guidelines, we reviewed levels of evidence and quality/rigor criteria that are in wide use for group research designs, e.g. randomized controlled trials, such as those developed by the Treatment Outcomes Committee of the American Academy for Cerebral Palsy and Developmental Medicine. We also reviewed methodological articles on how to conduct and critically evaluate single-subject research designs (SSRDs). We then subjected the quality questions to interrater agreement testing and refined them until acceptable agreement was reached. We recommend that these guidelines be implemented by clinical researchers who plan to conduct single-subject research or who incorporate SSRD studies into systematic reviews, and by clinicians who aim to practise evidence-based medicine and who wish to critically review pediatric single-subject research.
本文的目的是提出一套证据水平，并附带14个关于质量或严谨性的问题，以促进对已发表的单病例研究文章进行批判性审查。在制定这些指南时，我们回顾了广泛用于群组研究设计（如随机对照试验）的证据水平和质量/严谨性标准，例如由美国脑性麻痹和发育医学学会治疗结果委员会制定的标准。我们还回顾了关于如何进行和批判性评估单病例研究设计（SSRDs）的方法学文章。然后，我们对质量问题进行了评分者间一致性测试，并对其进行完善，直到达成可接受的一致性。我们建议，这些指南应由计划进行单病例研究或将SSRD研究纳入系统评价的临床研究人员，以及旨在实施循证医学并希望对儿科单病例研究进行批判性审查的临床医生来实施。
