RATIONALE, OBJECTIVES, AND INTERPRETATION OF RANDOMIZED CONTROLLED TRIALS

A randomized controlled trial (RCT) is the most definitive tool for ev aluation of the effectiveness of an intervention and can establish a c ause-and-effect relationship between an intervention and an improved d isease outcome. However, the undertaking of an RCT does not guarantee valid results, and the findings of RCTs of the same intervention are o ften discrepant. While many reported trials are of high quality, a sig nificant number have deficiencies in design, conduct, analysis, or int erpretation of results. Medical practitioners must become familiar wit h the methodology of RCTs in order to assess the validity of the repor ted findings and the relevance of the results to their own patients. T rialists must report sufficient information about the methods used se that readers can judge for themselves if the trial worked as planned. (C) 1997 Wiley-Liss, Inc.