Eisebitt R, Lehmacher W, Lefering R
Inst. for Numerical Statistics IFNS GmbH, Cologne, Germany.
Eur J Surg Suppl. 1999(584):68-9. doi: 10.1080/11024159950188592.
The ATMI study of prevention of mediastinitis after cardiac surgery uses the total amount of therapeutic interventions measured by the TISS-28 score as the primary endpoint. The study is designed as an adaptive group-sequential plan with three sequences, as experiences with the TISS-28 in cardiac intensive care units are scarce. According to the Bauer-Köhne method the sample sizes of the second and third sequences can be calculated in a data-driven manner after the results of the previous interim analyses are available. Thus the first trial phase can be considered as an internal pilot study.
心脏手术后纵隔炎预防的ATMI研究采用TISS - 28评分测量的治疗干预总量作为主要终点。由于心脏重症监护病房中TISS - 28的经验较少，该研究设计为具有三个序列的适应性组序贯计划。根据鲍尔 - 克内方法，在前一次中期分析结果出来后，可以以数据驱动的方式计算第二和第三序列的样本量。因此，第一个试验阶段可被视为一项内部预试验研究。
