Pcn457 the Sisaqol Initiative: Establishing International Standards and Recommendations for the Analysis of Patient-Reported Outcomes and Quality of Life Data in Oncology Randomized Clinical Trials

Abstract

analyzed. Completion rates across EORTC-QLQ-C30 items were high (92.2%-94.6% overall rate of non-missing values). Large variation across countries have been observed in mean scores on functional scores as well as symptom scales. Eastern vs Western Europe contrasted sharply, with Serbia and Poland reporting lower functional and much higher symptom scores for fatigue, nausea and vomiting, pain and insomnia. Mean mapped utility scores and standard deviations (SD) were 0.72 (0.17) for Eastern Europe, with 0.72 (0.20), 0.81 (0.13), 0.73 (0.16) and 0.66 (0.17) for CY/H/ P/RS respectively and 0.77 (SD=0.17) for Western Europe countries with 0.76 (0.17), 0.83 (0.12), 0.78 (0.17) and 0.78 (0.19) for BE/ES/NL/UK respectively. Conclusions: mCRC has important detrimental effect on HRQoL, and even more so among real-world mCRC patients than those participating in clinical trials. Variations across countries and compared to trials require further analysis.