Grading financial toxicity based upon its impact on health-related quality of life (HRQol).

Abstract

6618 Background: Financial toxicity (FT) is an important patient-centered outcome. The impact of this toxicity on patients’ HRQoL is not well known. We hypothesized that FT can be graded based on statistically significant and clinically meaningful decreases in HRQoL. Methods: FT was assessed by the quantitative COST (COmprehensive Score for financial Toxicity). Gradations of FT’s impact on HRQoL were based on established conventions for clinically meaningful small, medium and large effect sizes (e.s.) for the FACT-G HRQoL instrument. The optimal COST cutoff scores for FT grades were determined by ROC curve analyses maximizing the sum of the sensitivity and specificity in comparison with normative FACT-G values for the general adult population. Following FACIT standards, higher FT was represented by lower COST values. Demographics, tumor type, length of disease, chemotherapy use, resource utilization, HRQoL, and symptoms (EORTC QLQ-C30 symptom scales) were collected. Data were analyzed using Pearson correlations, linear regression, and chi-square tests. Results: A total of 233 patients who had completed at least 3 months of chemotherapy were assessed. The correlation between the COST and FACT-G was r = 0.42, p < .001. ROC curve analyses produced optimal COST FT grades (G) as follows: G0 ≥ 26 (n = 99 patients, 42%), G1: ≥ 14-25 (n = 71, 31%) and G2: > 0-14 (n = 58, 25%). Five patients (2%) had scores of 0 (G3). On multivariate analyses, pts with G0 had no impact of FT in their HRQoL; G1 had a statistically significant small and meaningful e.s. difference compared to G0 (0.26, p < .05); G2 had a statistically significant and medium e.s. (0.47, p < .001); G3 had a significant and clinically meaningful large e.s. (0.99, p < .005). There was a significant relationship between FT (grades 1-3) and younger age (p < .01), non-Caucasians ( < .05), less than a college degree ( < .01), unemployment (.001), Medicaid ( < .05), and lower income ( < .001). Conclusions: We developed a FT grading system based on clinically meaningful changes in HRQoL. There were 134 (58%) patients with Grades 1-3 FT. Financial distress as it relates to HRQoL is a meaningful event that can be objectively measured, and should be included in the assessment of patient-centered outcomes.