This international field validation study examined the psychometric properties and clinical validity of the European Organization for Research and Treatment of Cancer (EORTC) questionnaire module for hepatocellular carcinoma (HCC), the EORTC quality-of-life questionnaire (QLQ)-HCC18. The EORTC QLQ-HCC18 was administered with the core questionnaire, the EORTC QLQ-C30, to 272 patients from seven centers in 6 countries. Patient acceptability of the module was examined with a debriefing questionnaire, and psychometric and clinical properties were assessed. Multitrait scaling analyses confirmed the hypothesized 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 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.

There were significant differences in QoL deterioration across different treatment groups. This information may assist patients and providers when selecting patient-centered treatment approaches for HCC.

Our three-stage pooled plasma HCV RNA testing successfully identified HCV viremia in high-risk PLWH with a testing cost reduction of 84.5%. Simulation analysis offered detailed information regarding the selection of pool and mini-pool sizes in settings of different HCV epidemiology and the performance of HCV RNA testing to optimize the cost reduction.

In 1998, the International Conference on Harmonization (ICH) published a guidance to facilitate the registration of medicines among ICH regions including the European Union, the United States, and Japan by recommending a framework for evaluating the impact of ethnic factors on a medicine's effect, such as its efficacy and safety at a particular dosage and dose regimen (ICH E5, 1998). The purpose of ICH E5 is not only to evaluate the ethnic factor influence on safety, efficacy, dosage, and dose regimen, but also more importantly to minimize duplication of clinical data and allow extrapolation of foreign clinical data to a new region. In this article, statistical methods for evaluation of bridging studies based on the concepts of consistency (Shih, 2001), reproducibility/generalizability (Shao and Chow, 2002), the weighted Z-tests for the design of bridging studies (Lan et al., 2005), and similarity between the new and original region based in terms of positive treatment effect (Hsiao et al., 2007) are studied. The relative merits and disadvantages of these methods are compared by several examples.