RESPONSIVENESS TO CHANGE IN HEALTH-RELATED QUALITY-OF-LIFE IN A RANDOMIZED CLINICAL-TRIAL - A COMPARISON OF THE PROSTATE-CANCER SPECIFIC QUALITY-OF-LIFE INSTRUMENT (PROSQOLI) WITH ANALOGOUS SCALES FROM THE EORTC QLQ-C30 AND A TRIAL SPECIFIC MODULE

Introduction: The Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) was developed to be a pragmatic outcome measure for clinica l trials in symptomatic men with advanced hormone-resistant prostate c ancer. Design and Setting: A comparative assessment of responsiveness was made with longitudinal data from a positive multicenter randomized trial of palliative chemotherapy in 161 symptomatic men with advanced hormone-resistant prostate cancer. Instruments:The PROSQOLI, the Euro pean Organisation for Research and Treatment of Cancer (EORTC) core qu ality of life questionnaire (QLQ-C30), and a specific quality of life module for advanced prostate cancer [QLM-P14] were administered every 3 weeks while patients received their allocated treatment. Findings: S ixteen of the 19 health-related quality of life (HRQL) scales demonstr ated improvements in palliative responders. All three pain scales dete cted a beneficial effect of palliative chemotherapy. The relative effi ciency statistics favored the PROSQOLI for physical symptoms and physi cal function but the QLQ-C30 for emotional function, social function, and global perceptions. The PROSQOLI linear analog scale was the most responsive measure of pain. Bootstrap confidence intervals for the rel ative efficiency statistics were wide. Conclusions: Both the PROSQOLI and the analogous scales from the QLQ-C30 were responsive to improveme nts in HRQL. Differences between the instruments were generally subtle . The PROSQOLI is a short, simple, responsive measure of HRQL in men r eceiving systemic treatment for advanced hormone-resistant prostate ca ncer. (C) 1998 Elsevier Science Inc.