This international field validation study examined the psychometric properties and clinical validity of the European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module for hepatocellular carcinoma, the EORTC QLQ-HCC18. The EORTC QLQ-HCC18 was administered with the core questionnaire, the EORTC QLQ-C30 to 272 patients from seven centres in six countries. Patient acceptability of the module was examined with a debriefing questionnaire and psychometric and clinical properties were assessed. Multi-trait scaling analyses confirmed the hypothesised scale structure without any scaling error and the fatigue scale demonstrated satisfactory internal consistency. The test-retest reliability scores were high for all scales except abdominal swelling and sexual interest. The correlations between of all scales of the QLQ-HCC18 and the QLQ-C30 were low or moderate and many scales could distinguish patients with different clinical conditions. The module demonstrated responsiveness to clinical change in pain before and after surgery and some borderline change in patients undergoing systemic treatment. Conclusion: The EORTC QLQ-HCC18 can be used as a supplementary module for the EORTC QLQ-C30 in clinical trials for patients with HCC.
