Randomized controlled trials: not always the "gold standard" for evidence in obstetrics and gynecology.

ABSTRACT

Randomized controlled trials are considered the "gold standard" for therapeutic interventions, and it is not uncommon for sweeping changes in medical practice to follow positive results from such trials. However, randomized controlled trials are not without their limitations. Physicians frequently view randomized controlled trials as infallible, whereas they tend to dismiss evidence derived from sources other than randomized controlled trials as less credible or reliable. In several situations in obstetrics and gynecology, there are no randomized controlled trials to help guide the clinician. In these circumstances, it is important to evaluate the entire body of evidence including observational studies, rather than dismiss interventions altogether simply because no randomized controlled trials exist. Randomized controlled trials and observational studies should be viewed as complementary rather than at odds with each other. Some reversals in widely adopted clinical practice have recently been implemented following subsequent studies that contradicted the outcomes of major randomized controlled trials. The most notable of these was the withdrawal from the market of 17-hydroxyprogesterone caproate for preterm birth prevention. Such reversals could potentially have been averted if the inherent limitations of randomized controlled trials were carefully considered before implementing these universal practice changes. This Clinical Opinion underscores the limitations of an exclusive reliance on randomized controlled trials while disregarding other evidence in determining how best to care for patients. Solutions are proposed that advocate that clinicians adopt a more balanced perspective that considers the entirety of the available medical evidence and the individual patient characteristics, needs, and wishes.