A49 Ascertainment of the primary end point in the multicenter study of hydroxyurea in sickle cell anemia (MSH)

Abstract

s 67s A49 ASCERTAINMENT OF THE PRIMARY END POINT IN THE MULTICENTER STUDY OF HYDROXYUREA IN SICKLE CELL ANEMIA (MSH) F. Barton, M. Terrin, R. Moore, R. P. McMahon and S. Charache and the MSH Investigators Maa and were questioned about doctor visits at bi-weekly clinic visits, and monthly by a central telephone caller from the study chairman’s offtce. Information from these three sources was electronically cross-checked at the Data Coordinating Center @CC). Clinic staff evaluated this cross+zheck to identify confirmed medial contacts (MC), which required completion of an event form. Average follow-up was 28 months with a range of 20-36 months (mean 61, range 43-78 two-week periods). The % of two-week periods with confirmed MCs was related to the of number of sources noting a doctor visit: Any One Source Any Two Sources All Three Sources Hydroxyurea 26.8% 67.6% 91.8% Placebo 34.1% 71.0% 94.6% Clinics varied in rates of confvmed MCs both overall and by source. Studywide, the number of confirmed MC by calendar quarter was stable after recruitment ended. Multiple information sources and a timely crosscheck were essential in ascertaining events in a manner that provided possible bias in the primary end point. A50 LOCAL VERSUS CENTRAL READINGS OF ENDOMETRIAL BIOPSIES IN A MULTICENTER CLINICAL TRIAL Claudine Legault and Carol Wasilauskas for the Postmenopausal Estrogen/Prog&in Trial (PEPI) investigators Bowman Gray School of Medicine Winston-Salem, North Carolina A total of 2,418 endometrial biopsies were performed on 596 women during this 3-year, 7center randomized, double-masked trial designed to assess the effect of 4 estrogen/progestin regimens on heart disease risk factors. Biopsies were performed mostly with a Pipelle cannula. 2,394 of these biopsy slides were read both by local pathologists at the clinic site and by a single central reader. Overall, with the central reading as the gold standard, relative sensitivity and specifmity of 80.6% and 95.8% were achieved. Agreement between the local and central readers