Validation of a financial toxicity (FT) grading system.

Abstract

6615 Background: FT is an important adverse event (AE) that should be objectively measured in clinical practice. We previously developed an evidence-based FT grading system based on differences in HRQoL, analogous to the NCI-Common Terminology Criteria for Adverse Events (grade 1, mild AE; grade 2, moderate AE; grade 3, severe AE ,de Souza et al - ASCO 2015). We aimed to validate this grading system using a new sample of cancer patients (pts) and report its association with bankruptcy. Methods: FT was assessed by the COST (COmprehensive Score for financial Toxicity) in 2 sets of cancer pts. In the previously reported Development Set (DS), gradations of FT were determined by ROC analyses based on conventions for clinically meaningful small (0.2), medium (0.5) and large (0.8) effect sizes (e.s.) for independent FACT-G differences attributable to FT in pts with Stage IV cancers on chemotherapy. In the Validation Set (VS), differences in HRQoL and the odds ratio for a pt to have declared bankruptcy after the cancer diagnosis were assessed in a larger cohort of cancer pts on chemotherapy. Results: The grading system was developed in 888 cancer pts with cancer (233 pts in the DS and 655 in the VS). In the DS, ROC analyses produced 4 FT grades (G): G0, no FT, COST ≥26 (99 pts, 42%); G1, mild FT: ≥ 14-26 (71 pts, 31%); G2, moderate FT: > 0-14 (58 pts, 25%); and G3, severe FT: COST = 0 (5 pts, 2%). Applying the FT grading to the 655 pts in VS, we had: G0, 146 pts (22%); G1, 281 (43%); G2, 215 (33%); and G3, 13 (2%). The decreases in FACT-G HRQoL measured in e.s. per FT grading in comparison with G0 were small for G1: -0.4 (95%CI: -0.6 – -0.25); large for G2: -0.9 (95%CI: -1.1 – -0.7); and even larger for G3: -1.5 (95%CI: -2.0 – -0.9), all with p < 0.001. In the VS, 23 pts (4%) had declared bankruptcy after their cancer diagnosis. Compared to FT G0, the odds of having declared bankruptcy were 8.6 (95%CI: 1.1 – 67, p = 0.04) times higher for pts with FT G2, and 29 times higher (95% CI: 2.4 – 355, p = 0.008) for those with G3 FT. Conclusions: We developed a FT grading system anchored on independent differences in HRQoL. We applied the system in a different set of cancer pts and it retained its validity. We also found an larger incidence of bankruptcy after the cancer diagnosis in higher grades of FT, adding to the grading’s meaningful use.

Evaluating meaningful levels of financial toxicity in gynecologic cancers

“…5 6 Various thresholds for financial toxicity have been proposed using the COST score, often based on the median or percentile within discrete patient cohorts. [7][8][9] A system proposed by the creators of the COST tool used effect sizes for quality of life scores to develop financial toxicity grades (grades 0-3) using COST scores. The grading system was further validated based on the odds of patients declaring bankruptcy within each group.…”

“…The grading system was further validated based on the odds of patients declaring bankruptcy within each group. 9 Currently, there are limited data on what levels of financial toxicity measured by COST are linked to costcoping strategies such as economic behavior change and non-compliance with medications, which can lead to clinically meaningful worse health outcomes. 7 8 There have been two single institution studies examining financial toxicity using the COST tool in patients with gynecologic cancer, which found that 40-50% of patients experience financial toxicity.…”

Value-based genomics

“…Beyond the toxicities associated with cancer therapies, the financial toxicity associated with cancer care is becoming increasingly relevant in the face of rising cancer care costs and given that out-of-pocket expenses, copayments, and insurance premiums can often cause significant financial stress and burden to cancer patients that can adversely affect QOL and outcomes [ 21 , 22 ]. Accordingly, evidence-based financial toxicity grading systems analogous to the NCI-Common Terminology Criteria for Adverse Events grading system have been developed and are undergoing validation [ 215 ].…”

Psychometric Evaluation of the Comprehensive Score for Financial Toxicity Scale Among Iranian Cancer Patients

“…Cancer has been identified as a fatal disease, a growing health concern and economic burden worldwide (1)(2)(3). During the past decade, with the help of medical advancements in early detection, the survival rate of cancer patients has risen with a concomitant increase in treatment costs (4,5).…”

“…Moreover, the Japanese version (12) and Chinese version (16) of the COST have shown good reliability and validity. However, in less developed societies that are expected to face more difficulties (mortality and costs) among cancer patients and their family, research is relatively scarce (1)(2)(3)17). Besides income, patients from different social, and cultural backgrounds may experience different financial toxicity.…”