DESIGN AND PERFORMANCE OF CLINICAL-TRIALS IN EMERGENCY-MEDICINE - AN APPLIED CLASSIFICATION

Clinical studies are usually conceived of as controlled randomized tri als, as retrospective patient statistics or as single case reports. Ho wever, such a classification is too narrow and overlooks many other fo rms of study designs. This review,therefore, offers a more encompassin g and practical classification of clinical studies for the field of em ergency medicine. Randomized controlled trials fulfill scientific crit eria at the highest level (gold standard): comparison, repeatability, objective measurement. At the same time, randomized trials also have t o comply with demanding ethical criteria and must be justifiable in th e individual patient. Therefore, comparable uncertainty with regard to the superiority of the treatment options under investigation is a sin e qua non. In addition to randomized trials, six other groups of clini cal trials have the potential to solve scientific questions in emergen cy medicine: observational studies, decision analysis, meta analysis, public health care studies, case reports and descriptive summary stati stics and studies on ethical problems. This variability in trial desig ns calls for a clinically oriented methodologist; the concept and inst itutionalization of theoretical surgery has been a response to this de mand. All study types in this review are illustrated by examples in em ergency medicine. Literature for advanced reading in particular trial methodologies can be found in the reference list. A checklist summariz es all elements for designing and conducting randomized trials in emer gency medicine. All clinical trials striving for a high standard of qu ality whether randomized or not - depend on the following prerequisite s: professional organization,time effort, a supportive social environm ent and a scientific culture.