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
Proactive symptom-triggered diagnostic evaluation for ovarian cancer results in minimal unindicated surgery.
Fred Hutchinson Cancer Research Center and School of Public Health and Community Medicine, University of Washington, Exponent Health Sciences, and the Department of Obstetrics and Gynecology, University of Washington School of Medicine, Seattle, Washington.
Corresponding author: Barbara A. Goff, MD, Department of Obstetrics and Gynecology, Box 356460, University of Washington School of Medicine, Seattle, WA 98195-6460; e-mail: email@example.com.
Supported by a Gynecologic Cancer Foundation/Ovarian Cancer Research Foundation Grant for Early Detection of Ovarian Cancer (Principal Investigator: Barbara A. Goff) and by grant number R21NR011571 from the National Institute of Nursing Research (Principal Investigator: M. Robyn Andersen).
The contents are solely the responsibility of the authors and do not necessarily represent the official view of the National Institutes of Health, the National Institute of Nursing Research, or the Gynecologic Cancer Foundation.
Financial Disclosure The authors did not report any potential conflicts of interest.