Historical controversy in health technology assessment: the case of electronic fetal monitoring.

Electronic fetal monitoring (EFM) was introduced in the late 1950s as an alternative to traditional auscultation by stethoscope or fetoscope in the management of labor and delivery. The new technology was seen as a valuable tool in the prevention of cerebral palsy and other adverse fetal outcomes and diffused rapidly into clinical practice. In the late 1970s, some scepticism began to be voiced about the evidence for the effectiveness of EFM. The authors published a systematic review of the evidence in 1979 that concluded that there was insufficient evidence for the effectiveness of the routine use of EFM and a clear rise in the cesarean delivery rate associated with its use. The analysis was based on a thorough review of approximately 600 books and articles, but focused heavily on the evidence of four randomized clinical trials (RCTs) that had been published. An economic analysis further underscored the importance of this issue. The report was met with harsh ad hominem criticism from clinicians both in public venues and in the medical literature. Subsequently, additional RCTs were conducted and other analyzes were published, and in 1987 the American College of Obstetricians and Gynecologists recommended that auscultation was an acceptable alternative to EFM in routine labor and delivery. Yet, today EFM continues to be the standard of practice, used in 80% of labors in this country. The most important conclusion drawn from this experience is the need to evaluate new technologies before their widespread diffusion into clinical practice.