Stringency in Polycystic Ovary Syndrome (PCOS) Criteria and Application in Clinical Study

Abstract

In this manuscript, we review the various criteria used to diagnose PCOS and discuss how the specific diagnostic criteria used can impact recruitment for PCOS studies. PCOS is a common diagnosis but with several differing definitions. We were interested in addressing these differing stringencies and application in a clinical trial, such as our group’s PCOS diet study. For our study on the effects of diets to alter insulin resistance, we adopted the one using more stringent criteria, consisting of biochemical abnormalities, menstrual abnormalities, insulin resistance, and abnormal ovarian size and structure. Our study actively recruits from PCOS clinics in the Bay Area. We reported some women successfully recruited using our PCOS diagnosis stringency, and how these numbers differ from women referred to PCOS clinics in the Bay Area. We also report the reasons patients did not fit our diagnosis criteria to shed insight into how diagnoses differ between healthcare professionals. To our surprise, the vast majority of subjects seen in the tertiary referral PCOS center at UCSF did not qualify for the study. The definition of PCOS may be important in study design and can impact the ability to recruit for the study. Date of registration: June 20, 2014, NIH ClinicalTrials.gov identifier: NCT02190097.