Sheehan David V, Giddens Jennifer M, Sheehan Kathy Harnett
Dr. D. Sheehan is Distinguished University Health Professor Emeritus at the University of South Florida College of Medicine, Tampa, Florida; J. Giddens is the Co-founder of the Tampa Center for Research on Suicidality, Tampa, Florida; and Dr. K. Sheehan is Associate Professor Emeritus at the University of South Florida College of Medicine, Tampa, Florida.
Innov Clin Neurosci. 2014 Sep;11(9-10):54-65.
Standard international classification criteria require that classification categories be comprehensive to avoid type II error. Categories should be mutually exclusive and definitions should be clear and unambiguous (to avoid type I and type II errors). In addition, the classification system should be robust enough to last over time and provide comparability between data collections. This article was designed to evaluate the extent to which the classification system contained in the United States Food and Drug Administration 2012 Draft Guidance for the prospective assessment and classification of suicidal ideation and behavior in clinical trials meets these criteria.
A critical review is used to assess the extent to which the proposed categories contained in the Food and Drug Administration 2012 Draft Guidance are comprehensive, unambiguous, and robust. Assumptions that underlie the classification system are also explored.
The Food and Drug Administration classification system contained in the 2012 Draft Guidance does not capture the full range of suicidal ideation and behavior (type II error). Definitions, moreover, are frequently ambiguous (susceptible to multiple interpretations), and the potential for misclassification (type I and type II errors) is compounded by frequent mismatches in category titles and definitions. These issues have the potential to compromise data comparability within clinical trial sites, across sites, and over time.
These problems need to be remedied because of the potential for flawed data output and consequent threats to public health, to research on the safety of medications, and to the search for effective medication treatments for suicidality.
标准国际分类标准要求分类类别全面，以避免II类错误。类别应相互排斥，定义应清晰明确（以避免I类和II类错误）。此外，分类系统应足够稳健，以长期使用，并在数据收集之间提供可比性。本文旨在评估美国食品药品监督管理局2012年关于临床试验中自杀意念和行为的前瞻性评估与分类的指导草案中所含分类系统符合这些标准的程度。
采用批判性综述来评估食品药品监督管理局2012年指导草案中提议的类别在全面性、明确性和稳健性方面的程度。还探讨了分类系统所依据的假设。
2012年指导草案中所含的食品药品监督管理局分类系统没有涵盖自杀意念和行为的全部范围（II类错误）。此外，定义常常含糊不清（容易产生多种解释），类别标题和定义之间频繁不匹配加剧了错误分类的可能性（I类和II类错误）。这些问题有可能损害临床试验场所内、不同场所之间以及不同时间的数据可比性。
由于存在数据输出有缺陷的可能性，以及随之而来的对公众健康、药物安全性研究以及寻找自杀有效药物治疗方法的威胁，这些问题需要得到纠正。
