Statistical significance versus clinical relevance in cardiovascular medicine.

Evidence-based medicine is the foundation of everyday clinical practices and large clinical trials investigating the effects of various interventions on morbidity and survival and generally provide the most robust evidence. Cardiovascular medicine is considered one of the most evidence-based disciplines of medicine. However, there are a number of limitations to the general applicability of clinical trial results in cardiovascular medicine. Although generally useful to the clinician, clinical trials have often been suboptimally designed from 1 or several points of view. As a consequence of flaws in the design and the execution of the trials, statistical significance is quite often not equal to clinical relevance. This article outlines some of the shortcomings of designing and carrying out clinical trials, as well as inadequacies concerning the publication, interpretation, and implementation of the trial results. Evidence-based medicine is obviously not always as solid as one might think. Copyright 2001 by W.B. Saunders Company