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133rd Annual Meeting & Exposition December 10-14, 2005 Philadelphia, PA |
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Christine Unson, PhD1, Christine McCauley Ohannessian, PhD2, Alison Kleppinger, MS3, and Karen Prestwood, MD3. (1) Communication Department, Western Connecticut State University, 181 White St, Danbury, CT 06819, 2038378871, Unsonc@wcsu.edu, (2) Department of Individual Family Studies, University of Delaware, 110 Alison Hall, Newark, DE 19716, (3) Center on Aging, University of Connecticut Health Center, 263 Farmington Avenue, Farmington, CT 06030-6147
BACKGROUND: Understanding factors associated with attrition in clinical trials may inform strategies to reduce attrition rates. HYPOTHESIS: Low scores on physical performance and self-rated health measures, adjusted for BMI and sociodemographic factors will be associated with increased attrition rates. METHOD: The study analyzed the baseline measures of physical performance (EPESE), SF-36 Physical (PCS) and Mental Component Summary (MCS) scores, BMI, education, age and race/ethnicity, of 167 women, 65 years old or older who enrolled in a estrogen and osteoporosis clinical trial. The measures were included in a multinomial logistic regression model to predict completion, attrition within the first three months, and attrition post-three months. RESULTS: The average age of the women at enrollment was 74.3 (SD 5.5). 59.3% of the women were white, 17.4% African American, 23.3% Hispanic. Of 57 dropouts, 26% withdrew within three months after randomization. The reasons for withdrawal were a) illness (39%), b) loss of interest/concern about ERT (49%), and c) other reasons (12%). The overall model was significant (÷2 = 38.9, df=12, p<.001). Compared to the women who completed the study, the women who withdrew within three months were older (OR=1.2, p<.01), had lower MCS scores (OR=.93, p<.05), and were more likely to be Hispanic than white (OR=.19, p <.05). Compared to the women who completed the study, the women who dropped out four months or later had lower MCS scores (OR=.94, p <.05), higher BMI (OR=1.1, p<.05), and were more likely to be African-American than white (OR=3.9, p<.05).
Learning Objectives:
Keywords: Clinical Trials, Quality of Life
Presenting author's disclosure statement:
I wish to disclose that I have NO financial interests or other relationship with the manufactures of commercial products, suppliers of commercial services or commercial supporters.
The 133rd Annual Meeting & Exposition (December 10-14, 2005) of APHA