胃癌是常见的恶性肿瘤之一。虽然,目前医疗技术的发展和医学整体水平的提高已经明显延长了胃癌患者的生存期,但其带来的各种心理和社会问题越来越受到人们的关注。在胃癌临床疗效评价和预后评估中,除了传统的终点事件,生存质量(quality of life,QOL)的评估已为越来越多的学者所认同。并已经逐步应用于临床。生存质量测定的核心是研制适宜的测评量表,目前在胃癌研究方面,还没肓一个国际公认的测评量表标准。
Objective: To establish questionnaire scaling and reliability and examine the clinical and psychometric validity of the quality of life assessment based on Traditional Chinese Medicine for advanced gastric cancer(QLASTCM-Ga). Methods: The QLASTCM-Ga was developed based on programmed decision procedures with multiple nominal and focus group discussions, in-depth interview, pretesting and quantitative statistical procedures. The questionnaire was administered to 240 patients diagnosed with advanced gastric cancer before and after treatment. Structured group methods were employed to establish a general and a specific module respectively. The psychometric properties of the scale were evaluated with respect to validity, reliability and responsiveness. Results: The three identified scales of the QLASTCM-Ga and the total score demonstrated good psychometric properties. Test-retest reliability of the total scale and all domains ranged from 0.90 to 0.94, and internal consistency ranged from 0.86 to 0.93. Correlation and factor analysis demonstrated good construct validity. Significant difference in the subscales and the total score were found among groups differing in traditional Chinese medicine syndrome, supporting the clinical sensitivity of the QLASTCM-Ga. Statistically significant changes were found for each scale and the total score. Responsiveness was also good. Conclusions: The QLASTCM-Ga demonstrates good psychometric and clinical validity to assess quality of life in patients with advanced gastric cancer undergoing traditional Chinese medicine therapy. This study is an important first step for future research in this area.