Uterine Fibroids: Risk Factors for Uterine Leiomyomas
An NIEHS hybrid case-control/followup study of uterine fibroid tumors was conducted by Social & Scientific Systems. Women were initially identified through HMO records at George Washington University Medical Center in Washington, D.C., and sampled to ensure that approximately 50 percent of the study participants would be African American women. At baseline, participants were invited to come to the medical center for a sonogram, anthropometric measurements, and collection of a blood sample. First morning urine samples were separately collected by and shipped to us by participants. Case status was determined by ultrasound. Women scheduled for hysterectomies due to fibroids constituted a second group of cases. Surgical reports and surgical tissue (tumor and normal tissue) were collected from these cases. Controls included women from the same base population with no ultrasound evidence of fibroids.
Beginning in 1996, 1,885 women categorized into nine groups by menopausal and fibroid status were enrolled in the study. Social & Scientific Systems initially enrolled participants by mail and provided onsite clinical study coordination at the George Washington HMO for scheduling sonograms, blood draws, and urine collection. For surgical patients, we provided support for the collection of surgical tissue and pathology reports. We designed and collected self-administered questionnaires, including a modified Block dietary questionnaire and a menstrual diary, and conducted a 45-minute telephone interview questionnaire. Participants were sent lipid level results, sonogram reports, and nutrient intake summaries.
CATIs were conducted in 2001 and again in 2004, targeting the approximately 1,100 premenstrual women in the original baseline cohort. We maintained the cohort through regular newsletter mailings and was able to retain 82 percent of the cohort through the third interview. We coded and edited all data and have provided data management, analytic programming, and assistance on study publications since 1998.