DOUBLE-BLIND CLINICAL-TRIALS IN SEPSIS RESEARCH - PROBLEMS CONNECTED WITH PHYSICIANS AND PATIENTS EXPECTANCIES - DISCUSSION

The argument is brought forth that double-blinding in the strict sense, i.e. the elimination of differential expectations concerning treatment effectiveness, can hardly be achieved in sepsis trials because of the complexity of the clinical problem and of available treatment regimens. Recommendations for an improved study design include assessments of doctors' expectancies concerning treatment outcome, or the experimental induction of optimistic expectations vs. neutral expectations. However, in planning and conducting such an experimental expectancy-control design, a number of ethical requirements have to be considered and met.