Considerations on the statistical design of the ATMI study.

Area of Science:

• Cardiac Surgery
• Intensive Care Medicine
• Clinical Trial Design

Background:

• Mediastinitis is a significant complication following cardiac surgery.
• Accurate measurement of therapeutic interventions is crucial for clinical studies.
• Limited data exists on the TISS-28 score's utility in cardiac intensive care units.

Purpose of the Study:

• To evaluate the effectiveness of therapeutic interventions in preventing mediastinitis after cardiac surgery.
• To utilize the Therapeutic Intervention Scoring System (TISS-28) as a primary endpoint.
• To implement an adaptive group-sequential design for the clinical trial.

Main Methods:

• The study employs an adaptive group-sequential plan with three sequences.
• Sample sizes for subsequent sequences are determined using the Bauer-Köhne method.
• The initial phase serves as an internal pilot study for data-driven adjustments.

Main Results:

• The study is ongoing, and results are pending.
• The adaptive design allows for flexible sample size recalculation based on interim analyses.
• The Bauer-Köhne method facilitates data-driven sample size adjustments.

Conclusions:

• The adaptive group-sequential design is suitable for trials with limited prior experience with specific endpoints like TISS-28 in cardiac surgery.
• The ATMI study aims to provide valuable insights into mediastinitis prevention and therapeutic intervention measurement.
• The internal pilot phase enhances the efficiency and robustness of the trial design.