Health-related quality of life (HR-QOL) has become one of the important endpoints in cancer clinical trials. However, a relatively small proportion of oncologists truly understand the concepts and uses of QOL assessments. In this article, I discuss in detail the psychometric properties that should be verified with QOL instruments, the range of QOL concepts that should be assessed in oncology, how to choose the appropriate QOL instruments, cross-cultural issues and statistical problems. Several examples of QOL assessments in cancer clinical trials are also introduced.

Objective: To investigate the perception of the prevalence of mental diseases in breast cancer patients and the therapeutic approach to depression undertaken by oncologists. Method: Self-reported questionnaires were sent to 352 breast cancer specialists. The survey contains 11 categories to elicit the perception and identification of mental illnesses in patients, diagnostic procedure, and details of antidepressant prescribed. Logistic regression was used to explore the association of oncologists' characteristics and management of depression in breast cancer patients. Results: Survey response rate was 31.3%. Ninety percent of the oncologists perceived the prevalence of depression to be less than 20%, while half believed that the proportion was less than 5%. The most commonly-used medication for the treatment of depression was BZDs (41.5% [n=39]), followed by Selective Serotonin Reuptake Inhibitors (SSRIs) (30.9% [n=29]). Benzodiazepines (BZDs) were most frequently prescribed (41.5%) despite its known ineligible dependency, followed by Selective Serotonin Reuptake Inhibitors (SSRIs) (30.9%). Choice of BZDs was significantly associated with the career length of oncologists (Odds Ratio [OR]=8.20), and safety of drug (OR=5.57). Contrarily, prescription of SSRIs was associated with efficiency of drug (OR=7.07). Conclusion: Relative to anxiety and insomnia, a lower awareness regarding depression was common among study oncologists. In addition, the quality of care varied among these oncologists. It is necessary to improve both the awareness and management of mental illnesses in order to enhance the total clinical care of breast cancer patients.

In the 21st century, in addition to “evidence-based medicine” (EBM), with its focus on life extension, “value-based medicine” (VBM), which considers quality of life (QOL) improvement, has become widespread. Assessment of QOL and patient-reported outcomes (PRO) in cost-effectiveness analysis―a mainstay of VBM―contributes to successful introduction of health technology assessment (HTA) in Japan. PRO is an umbrella term for a broad variety of concepts that measure the health status of patients as subjectively perceived by them. QOL and PRO differ in terms of concepts and depth they signify, but the latter often substitutes for the former as the subjectively reported endpoint of clinical trials, and is a term that covers perceived symptoms, physical functions, health satisfaction, and health-related QOL. This study explains the EuroQol-5 Dimensions (EQ-5D), a patient-reported outcome measure (PROM) whose application is exemplified in the official guideline issued by the Central Social Insurance Medical Council (Chuikyo) for the economic evaluation of drugs/medical devices. This study also discusses the importance and challenges of QOL/PRO measurements in cost-effectiveness analysis, as well as the need for international standardization for PROMs. Finally, it introduces the issues associated with the assessment of QOL/PRO in the trial introduction of cost-effectiveness analysis；that is, the necessity of evidence data, differences in evaluations of medicines and medical equipment, mappings that convert non-preference-based utility scores to preference-based EQ-5D scores in cases where preference-based utility scores were not measured during the clinical trials, and sensitivity analysis. HTA is thus expected to be adequately conducted in Japan.