Validation of the simplified chinese version of FACT-Hep for patients with hepatocellular carcinoma based on classical test theory and generalizability theory

Background Quality of life (QOL) is now concerned worldwide in cancer clinical fields and the specific instrument FACT-Hep (Functional Assessment of Cancer Therapy- Hepatobiliary questionnaire) is widely used in English-spoken countries. However, the specific instruments for hepatocellular carcinoma patients in China were seldom and no formal validation on the Simplified Chinese Version of the FACT-Hep was carried out. This study was aimed to validate the Chinese FACT-Hep based on Combinations of Classical Test Theory and Generalizability Theory. Methods The Chinese Version of FACT-Hep and the QLICP-LI were used to measure QOL three times before and after treatments from a sample of 114 in-patients of hepatocellular carcinoma. The scale were evaluated by indicators such as validity and reliability coefficients Cronbach α, Pearson r, intra-class correlation (ICC), and standardized response mean. The Generalizability Theory (G theory) was also applied to addresses the dependability of measurements and estimation of multiple sources of variance. Results The Internal consistency Cronbach’s α coefficients were greater than 0.70 for all domains, and test-retest reliability coefficients for all domains and the overall were greater than 0.80 (exception of emotional Well-being 0.74) with the range from 0.81 to 0.96. G-coefficients and Ф-coefficients confirmed the reliability of the scale further with exact variance components. The domains of PWB, FWB and the overall scale had significant changes after treatments with SRM ranging from 0.40 to 0.69. Conclusions The Chinese version of FACT-Hep has good validity, reliability, and responsiveness, and can be used to measure QOL for patients with hepatocellular carcinoma in China.