A clinic‐academic partnership for recruitment using an electronic medical record (EMR) in a trial of diets for treating polycystic ovary syndrome (PCOS) in overweight and obese adolescents and young adults

BACKGROUND The Androgen Excess and PCOS Society Position Statement specifies lifestyle modification as the primary therapy for obesity in PCOS. However, consensus on optimal diet is lacking. Routine clinical care often includes OCPs and/or insulin sensitizers to lower androgens. OBJECTIVE To recruit girls with PCOS in a tertiary care center for a 6‐mo pilot RCT of low‐fat vs. low‐glycemic load diets on bioavailable testosterone (primary outcome). Use of medications that mask dietary effects is exclusionary. METHODS A partnership between the clinic and research teams facilitated recruitment using a flagging protocol to identify potentially eligible patients based on age (13–21y), BMI (≥85th percentile), and PCOS‐related keywords pertaining to visit reason in an EMR. When appropriate, providers presented the RCT as a first‐line non‐pharmacologic treatment option. RESULTS Over a 2‐y period, 1026 girls have been flagged, with the majority identified from the Division of Adolescent Medicine at BCH and its Reproductive Endocrinology Clinic (>;40%). Primary visit reasons were irregular menses (46%) and PCOS (34%). Medication use was the most frequent reason for exclusion (26%). CONCLUSION Partnerships using an EMR offer a contemporary approach to recruitment for RCTs of non‐routine clinical therapies. The ongoing RCT will examine the effects of different macronutrient diets on hyperandrogenism in PCOS. Grant Funding Source : Thrasher Research Fund