Int J Radiat Oncol Biol Phys. 2023 Aug 14:S0360-3016(23)07747-7. doi: 10.1016/j.ijrobp.2023.08.009. Online ahead of print.
ABSTRACT
PURPOSE: This study aimed to define the minimal clinically important difference (MCID) for the FACT Hepatobiliary (FACT-Hep) questionnaire, allowing meaningful evaluation of the effect of radiotherapy (RT) on quality of life (QOL) in patients treated for pancreatic cancer (PC).
METHODS AND MATERIALS: The cohort included patients with PC who received RT as a component of curative intent therapy, who completed the FACT-Hep at baseline and end of treatment (EOT). The MCID was determined for the FACT-Hep and subdomains using anchor-based and distribution-based approaches. In the anchor-based approach, improvement and deterioration in age-adjusted regression models for change in scores were defined using the overall health assessment item of the PROMIS-10 as the anchor. The MCID was calculated as 0.3 and 0.5 standard deviation (SD) for distribution-based analysis. MCID point estimate using 0.5 SD (range) was averaged across time points and by approach, and the ranges are reported as minimum and maximum values across methods.
RESULTS: The FACT-Hep domain with the lowest MCID was the emotional domain (deterioration 0.8-1.8). The hepatobiliary cancer subscale (HCS) has the highest and widest MCID range. A positive change of 2.9-4.3 in HCS should be considered a clinically relevant improvement. MCID estimates from 0.3 SD were in exact agreement with the anchor-based estimates for the physical domain (1.6-2.4). The MCID range for the Fact-Hep total score was 6.9-10.5 and 6.5-10.5 for improvement and deterioration, respectively.
CONCLUSION: The MCID for the FACT-Hep subdomains and totals were calculated using a combination of anchor- and distribution-based approaches. These findings are fundamental to determine whether there is meaningful improvement or deterioration in QOL for patients with PC receiving RT. Evaluating a different anchor for determining the MCID of the social domain is recommended.
PMID:37586614 | DOI:10.1016/j.ijrobp.2023.08.009
