QUALITY-OF-LIFE ASSESSMENT IN INTERNATIONAL BREAST-CANCER STUDY-GROUP(IBCSG) TRIALS - PRACTICAL ISSUES AND FACTORS ASSOCIATED WITH MISSINGDATA

We report on our experience of quality of life (QL) assessment in adju vant clinical trials of the International Breast Cancer Study Group (I BCSG), with special emphasis on cultural and logistical aspects of int ernational organization that are unique to this group. Data are presen ted regarding submission rates of assessments before and after treatme nt failure, and timing of assessments relative to chemotherapy adminis tration. To identify areas where rates might be improved, we investiga ted the association between missing data and sociodemographic and biom edical factors, treatment assignment, institution, chemotherapy compli ance and toxicity in a trial of adjuvant chemoendocrine therapy for po st-menopausal patients with breast cancer (IBCSG VII). The factors mos t highly associated with missing data were institution and chemotherap y compliance. (C) 1998 John Wiley & Sons, Ltd.