Variance of mean baseline health-related quality of life across phase III clinical trials in metastatic renal cell carcinoma.

Abstract

329 Background: Health-related quality of life (HRQoL) instruments in clinic trials provide insight into the impacts a disease and therapy have on a person’s well-being. Baseline measurements of global HRQoL reflect a trial population’s quality of life at the start of a trial. It is unknown how baseline mean HRQoL values vary across trials. Our hypothesis: The HRQoL for trials populations would decrease with later lines of therapy but would not be affected by chronological time. Methods: The year the first patient was enrolled in a trial, the number of prior lines of therapy, the HRQoL instrument(s) used, and the trial’s name was recorded along with the intervention arm’s global HRQoL summary statistics (i.e., mean value, standard deviation, and number of respondents). The intervention arm (as opposed to a combination of both arms of the study) was analyzed since the HRQoL at baseline was often balanced between the two arms but baseline HRQoL summary statistics for the entire trial population was not typically available. The baseline HRQoL means were compared across trials using common HRQoL instruments via one-way ANOVA (https://statpages.info/anova1sm.html). A p-value of less than 0.05 indicated there was a significant difference in mean HRQoL values somewhere among the various groups. The Tukey honestly significantly different post-hoc test was used to evaluate which groups were significantly different from others. Results: Mean baseline HRQoL varied significantly across trials for the FKSI-19 (p < 0.001) and the EQ-5D (p = 0.004) instruments. Conclusions: While HRQoL varied across trials for the FKSI-19 and the EQ-5D instruments, post-hoc tests indicated that only the FKDI-19 varied as hypothesized by line of therapy. The EQ-5D baseline HRQoL values variation correlated more by year of first participant. Future research should focus on the applicability of the EQ-5D and EQ-VAS HRQoL instruments in a modern population of patients with metastatic RCC.[Table: see text]