chapter  24
28 Pages

How to Design Clinical Studies for Preventing Ventilator-Induced Lung Injury

WithLaurent Brochard, Christian Me´lot, and Alain Mercat

Choosing the study question is the critical step when initiating a research project. Hulley suggested the following criteria (FINER) for choosing a

good study question (1):

Feasible in terms of resources, expertise, etc. Interesting to the investigator Novel: ideally the question should generate new data or confirm or

refute earlier findings

Ethical Relevant The randomized, controlled trial (RCT) is now considered the ideal

proving ground for new treatments. RCTs must have sufficient power to

detect a clinically important difference in outcome between patients receiv-

ing the experimental treatment and controls receiving standard treatment

only. Strict methodological rules must be followed, and many of them are

described in this chapter. As an introduction to the conduct of RCTs, however, several major points must be emphasized.