Outcome evaluation in health science : Cross-cultural equivalence in the quality of life scoring procedure

在健康科学领域，与健康相关的生活质量（QOL）的评估一直是一个重要的问题，国际比较也成为一个关键问题。有必要开展国际桥梁研究来澄清生活质量量表的跨文化有效性，在不同的文化背景下平等地评估每个量表项目，展示适当的项目反应相关性并构建量表的效度。本研究的目的是建立一个标准化的、跨文化等效的评估程序，将生活质量评估作为癌症临床试验的结果衡量标准。为了实现这一主要目标，本研究旨在利用荷兰和日本的数据，研究问卷的生活质量评分和评分方法。首先，比较了EORTC QLQ-C30和HRQOL-20的评分和评分方法。研究对象为荷兰和日本的癌症患者（肺癌、乳腺癌、消化道癌和前列腺癌）。采用汇总统计法对数据进行汇总。采用因子分析和对应分析对问卷结构进行检验。因子分析（PROMAX solution）分析的因素在两国之间存在一定差异。然而，结果表明，总分（QL2）以及主要子量表可以用于两国的跨文化比较。其次，为了建立一套标准化的生活质量评价程序，作为癌症临床试验的结果衡量标准，我们对荷兰和日本患者的生活质量评分程序进行了跨文化效度检验。研究对象仅限于乳腺癌和肺癌患者。总结了基本统计数据。随后将进行详细的分析。

In the field of health science, assessment of Health related Quality of Life (QOL) has been important and international comparison becoming critical issue. It is essential to conduct international bridging studies to clarify cross-cultural validity of QOL scales, evaluating each scale item equally in divergent contexts of cultures, demonstrating appropriate item-response correlations and construct validity of the scales.The aim of the study was to establish a standardized, cross-culturally equivalent, evaluation procedure for QOL assessment as an outcome measure in cancer clinical trials. For this major goal, the study aimed at to examine QOL scores and scoring methods of the questionnaires using the data from the Netherlands and Japan.First, a comparison of the scores and scoring methods of the EORTC QLQ-C30 and HRQOL-20 was conducted. Subjects were cancer patients (lung, breast, digestive, and prostate cancer) in the Netherlands and Japan. The data were summarized using summary statistics. The structures of the questionnaires were examined using factor analysis and correspondence analysis. The factors analyzed by factor analysis (PROMAX solution) were somewhat different from each other in the both countries. However, the results suggest that total score (QL2) as well as main subscales could be useful for cross-cultural comparison of the two countries.Second, in order to establish a standardized evaluation procedure for QOL assessment as an outcome measure in cancer clinical trials, cross-cultural validity between two different cultures in the QOL scoring procedure is examined for the patients in the Netherlands and Japan. The subjects were restricted to breast and lung cancer patients. The basic statistics were summarized. The detailed analysis will be subsequently conducted.