Considerations on the statistical design of the ATMI study.
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.
Eisebitt
R
R
Inst. for Numerical Statistics IFNS GmbH, Cologne, Germany.
Lehmacher
W
W
Lefering
R
R
D018806:APACHE; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D003422:Critical Care; D004311:Double-Blind Method; D006801:Humans; D007070:Immunoglobulin A / Q000627:therapeutic use; D007075:Immunoglobulin M / Q000627:therapeutic use; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D008480:Mediastinitis / Q000517:prevention & control*; D015337:Multicenter Studies as Topic; D010865:Pilot Projects; D010919:Placebos; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D018401:Sample Size; D013223:Statistics as Topic; D013530:Surgical Wound Infection / Q000517:prevention & control; D016896:Treatment Outcome
D007070:Immunoglobulin A; D007075:Immunoglobulin M; D016756:Immunoglobulins, Intravenous; D010919:Placebos; C060166:pentaglobulin