Unbiased research and the human spirit: The challenges of randomized controlled trials

Journal/Book: Can Med Assoc J. 1995; 153: 1867 Alta Vista Dr, Ottawa on K1G 3Y6, Canada. Canadian Medical Association. 783-786.

Abstract: Research by Klein and associates provides useful information on the relation between episiotomy and outcomes such as perineal trauma, but the 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 patients regardless of allocation. Klein and associates' post-hoc study (see pages 769 to 779 of this issue) sheds light on the relation between physician attitudes and the practice of episiotomy. The author contends that the noncompliance encountered by Klein and associates reflects the fact that randomized trials are anathema to the human spirit. He offers suggestions for making RCTs more meaningful and stresses that, although RCTs are indispensible to the advancement of medical knowledge they necessitate assiduous attention to matters of design and implementation.

Note: Editorial KF Schulz, Ctr Dis Control & Prevent, Natl Ctr Prevent Serv, Div STD HIV Prevent, CDC Mailstop E02, Atlanta, GA 30333 USA

Keyword(s): DESIGN AFFECTS OUTCOMES; CLINICAL-TRIALS; THERAPY; BIAS

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