Epstein A E, Carlson M D, Fogoros R N, Higgins S L, Venditti F J
Department of Medicine, University of Alabama at Birmingham 35294-0006, USA.
J Am Coll Cardiol. 1996 Feb;27(2):433-42. doi: 10.1016/0735-1097(95)00482-3.
We sought to develop and apply a new scheme for the classification of death to be used in trials of antiarrhythmia treatments.
Because presently accepted classifications of death do not fully describe or tabulate all significant aspects of terminal events, nor do they consider unique aspects of arrhythmia investigations, a new classification scheme that addresses these issues is desirable.
A classification scheme of deaths that occur in antiarrhythmia trials was developed using the following categories: 1) primary organ cause (cardiac [arrhythmic, nonarrhythmic or unknown], noncardiac or unknown); 2) temporal course (sudden, nonsudden or unknown); 3) documentation (witnessed, monitored [yes, no or unknown]); 4) operative relation (preoperative, perioperative or postoperative); and 5) system relation (procedure related, pulse generator related and lead related [yes, no or unknown]).
The classification scheme was used in a clinical trial of a new implantable cardioverter-defibrillator (1,250 patients, of whom 79 died) and used in an application for device market approval. Application of the classification to data reported using an older classification scheme is demonstrated.
We propose a descriptive classification scheme that 1) fully describes and tabulates all significant aspects of terminal events; 2) incorporates previously used categorizations of death and new categorizations that address unique aspects of arrhythmia investigations; and 3) tabulates sufficient data to allow comparison with other studies. Events in a clinical trial of implantable defibrillator therapy were classified using the new classification scheme.
我们试图开发并应用一种新的死亡分类方案，用于抗心律失常治疗试验。
由于目前公认的死亡分类并未充分描述或列表呈现终末事件的所有重要方面，也未考虑心律失常研究的独特方面，因此需要一种解决这些问题的新分类方案。
使用以下类别制定抗心律失常试验中发生死亡的分类方案：1）主要器官病因（心脏[心律失常性、非心律失常性或不明]、非心脏性或不明）；2）时间进程（突然、非突然或不明）；3）记录情况（有目击者、监测到[是、否或不明]）；4）手术相关性（术前、围手术期或术后）；5）系统相关性（与手术操作相关、与脉冲发生器相关和与导线相关[是、否或不明]）。
该分类方案用于一项新型植入式心脏复律除颤器的临床试验（1250例患者，其中79例死亡），并用于设备上市批准申请。展示了将该分类应用于使用旧分类方案报告的数据的情况。
我们提出一种描述性分类方案，该方案：1）充分描述并列表呈现终末事件的所有重要方面；2）纳入了先前使用的死亡分类以及针对心律失常研究独特方面的新分类；3）列表呈现足够的数据以便与其他研究进行比较。使用新分类方案对植入式除颤器治疗临床试验中的事件进行了分类。
