The purpose of this study is to determine whether higher dietary and supplemental intake of vitamins C or E, or beta-carotene is associated with lower rates of infections in postmenopausal women. The study subjects are enrollees of Group Health Cooperative of Puget Sound (GHC), a large Seattle-based health maintenance organization, and were screenees for the Fracture Intervention Trial (FIT), a randomized trial of alendronate, which was recently approved for treatment of osteoporosis. This study is using automated data from the subjects records at GHC for the study period from 1992 (FIT baseline) through 1997. In addition, medical record reviews of hospital and outpatient chart have been conducted to validate the use of the automated records for identifying hospital associated and outpatient treated infections. Approvals for this research were obtained from the GHC Human Subjects Review Committee and from the FIT Publications Committee. The primary task that is being conducted as part of this contract is the setting up of a dataset to identify the occurrence of infections in the 1,517 study subjects. Data will be obtained from the following GHC automated databases: pharmacy (antibiotic prescriptions), laboratory (urinalysis, complete blood count, cultures), and utilization (ICD-9 codes from hospital discharge summary). Analyses have been completed investigating risk factors for hospital associated infections. The manuscript for these analyses is currently under review at a scientific journal. Through collaboration with professors in the School of Pharmacy at the University of Washington, a new method for identifying antibiotic- treated infections was developed using the automated pharmacy records. A manuscript has been drafted for the analysis which validated the new method through a comparison with infections identified in outpatient medical record reviews, performed on a random sample of subjects charts. Subsequent analyses will examine whether dietary antioxidants reduced the risk for inpatient and community infections. - antioxidants, infections, postmenopausal women - Human Subjects
