Screening Tests for Preeclampsia: in Search of Clinical Utility.

Abstract

The research and implementation process for a new screening test should involve two steps. First, one has to demonstrate that the test can predict a certain outcome or appropriately stratify the patients based on risk for the outcome. The second step requires evidence of clinical utility. The Food and Drug Administration has approved screening tests for risk stratification or progression of preeclampsia despite the absence of data on clinical utility. Introduction into clinical practice and eventual integration into the standard of care might follow quickly, making a clinical utility trial challenging to accomplish. This manuscript provides an overview of the research and regulatory pathways used for screening and diagnostic tests in medicine in general and obstetrics in particular. For illustration purposes, we review the relevant data gathered so far regarding tests that are promoted for prediction, risk stratification, and progression of preeclampsia. We then discuss the importance of proving clinical utility before introducing tests into clinical practice and the potential unintended consequences of adoption prior to proving clinical utility.