UNBIASED RESEARCH AND THE HUMAN SPIRIT - THE CHALLENGES OF RANDOMIZEDCONTROLLED TRIALS

Research by Klein and associates provides useful information on the re lation between episiotomy and outcomes such as perineal trauma, but th e methodologic implications of their work are especially fascinating. Physicians who participated in their randomized controlled trial (RCT) were supposed to adhere to a policy of either liberal or restrictive use of episiotomy according to the study arm to which each patient was assigned. However, some used the procedure for approximately 90% of p atients regardless of allocation. Klein and associates' post-hoc study (see pages 769 to 779 of this issue) sheds light on the relation betw een physician attitudes and the practice of episiotomy. The author con tends that the noncompliance encountered by Klein and associates refle cts the fact that randomized trials are anathema to the human spirit. He offers suggestions for making RCTs more meaningful and stresses tha t, although RCTs are indispensible to the advancement of medical knowl edge they necessitate assiduous attention to matters of design and imp lementation.