Abstract
OBJECTIVE: To evaluate the potential harms and ovarian cancer outcomes associated with symptom-triggered diagnostic evaluation of all women with symptoms of ovarian cancer. METHODS: Five thousand twelve women older than age 40 years were prospectively enrolled in a cohort study of proactive symptom-triggered diagnostic evaluation. Women who tested positive on a symptom index were offered testing with CA 125 and transvaginal ultrasonography. Results of these tests and any subsequent procedures were recorded. Assessment of ovarian cancer outcomes for all participants through Surveillance, Epidemiology, and End Results was performed 1 year after enrollment was complete. RESULTS: A positive symptom index was found in 241 (4.8%) participating patients, and 211 (88%) underwent CA 125 testing, transvaginal ultrasound screening, or both. Twenty surgical procedures (laparoscopy, laparotomy, vaginal) were performed in the study population (0.4% of participating women). However, only six (0.12%) were performed for a suspicious ovarian mass and only four (0.08%) were performed solely as a result of study participation. A total of eight ovarian cancers were diagnosed, 31-843 days after symptom assessment (50% distant, 50% local or regional). Of the two cancers diagnosed within 6 months, one was symptom index-positive. CONCLUSIONS: Proactive symptom-triggered diagnostic evaluation for ovarian cancer results in minimal unindicated surgery. A small number of ovarian cancers was identified solely on the basis of symptom-triggered diagnostic testing. LEVEL OF EVIDENCE: II.