Open AccessConsiderations on the statistical design of the ATMI study
Author(s) -
Eisebitt R.,
Lehmacher Walter,
Lefering Rolf
Publication year - 1999
Publication title -
european journal of surgery
Language(s) - English
Resource type - Journals
eISSN - 1741-9271
pISSN - 1102-4151
DOI - 10.1080/11024159950188592
Subject(s) - medicine , interim analysis , interim , clinical endpoint , mediastinitis , intensive care , psychological intervention , cardiac surgery , surgery , sample size determination , intensive care medicine , emergency medicine , randomized controlled trial , statistics , nursing , archaeology , mathematics , history
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. Copyright © 1999 Taylor and Francis Ltd.