Review of Patient-Reported Outcome Measures for Sexual Dysfunction

Recently, the high prevalence of sexual dysfunctions in our society has become a topic of public awareness and has encouraged a substantial interest in the media and on the part of the pharmaceutical industry in the field of sexual functioning. This attention has resulted in an expansion in the development of measures of sexual function/dysfunction for use as outcome measures in clinical drug trials. The instruments tend to be brief self-report inventories, typically requiring no more than 20 min of respondent time for completion. All of these instruments must adhere to recently prescribed rigorous guidelines set forth by the FDA and be valid and reliable indicators of the sexual function constructs they purport to measure. The constructs that provide the framework of our diagnostic system for sexual dysfunctions are not amenable to direct physical measurement, so that they must be assessed via patient-reported outcome (PRO) measures. Although not as precise as physical measures, these psychological instruments do a capable job of quantifying and representing sexual functioning status in a concise and rigorous manner and have become indispensable tools in our clinical and research programs.