癌症患者生命质量测定量表体系的开发应用及其相关问题研究

With the changing disease spectrum, renewing of health concepts and transforming of medical models, quality of life (QOL), which is an integrated and 'patient-oriented' indicator，has been gaining increasing attention in medical fields. Based on the theory of development of quality of life instruments including combinations of classical test theory (CTT) with modern test theories such as item response theory (IRT) and generalizability theory (GT), this study is aimed to develop the system of quality of life instruments for cancer patients (QLICP) with Chinese cultural background in the way of the general module combining with disease-specific modules. And psychometrics (reliability, validity, responsiveness etc.) of these scales will be evaluated in the clinical field tests in large samples. The system includes a general module (QLICP-GM) which can be used in all kinds of cancers and 16 specific modules for 16 common cancers such as lung cancer, liver cancer, esophageal cancer. .Also, the relationships between quality of life and socio-economic factors and clinical indicators for each cancer will be studied. And thus minimal clinically importance difference (MCID) for each cancer will be computed by the combinations of distribution-based methods with anchor-based methods. Moreover, different treatments effects for some selected cancers will be studied based on quality of life or quality of life combining with traditional effect indicators such as survivals. Also the relationships between quality of life and genes for some selected cancers will be preliminarily explored. Integrated applications studies not only present some concrete means for relevant cancers, but also useful methodology. .On finishing the study, a new system of QOL instruments will be established in China with all Chinese patients with cancers being measured by the specific scale or the general scale, QLICP-GM. It provides comprehensive evidences and useful tools for treatments selections, evaluations of interventions and health resources allocation. It is of outstanding significance in speeding up QOL researches in clinical field in China, internationalization of traditional Chinese medicine and establishment of a new integrated evaluation system of treatments effects for cancers.

疾病谱与健康观改变后日益重视体现"整体观"和"以患者为中心"的生命质量。本项目按共性模块与特异模块结合方式，采用现代测量理论中的项目反应理论和概化理论并结合经典测量理论来系统地研制癌症患者生命测定量表体系QLICP(含1个共性量表和16个常见癌症的特异量表), 并对其测量学特性(信度、效度、反应度等)在临床测试中进行评价。.同时，探讨生命质量与临床和实验指标间的关系，并用基于得分分布和基于"锚定位"相结合的方法制定出各癌症的最小临床重要性差异MCID；对个别选定癌症分别以生命质量和生命质量结合传统临床疗效指标来评价，从而比较和筛选不同的抗癌药物或治疗方法，也初步探讨生命质量与基因的关系。.项目完成后实际上已覆盖所有癌症，形成一个相对全面的量表体系，为治疗方案筛选、预防干预措施和卫生资源配置评价提供综合依据和工具。对推动中医国际化和促进新的肿瘤临床疗效评价体系构建也具有重要意义。

随着疾病谱与健康观的改变，传统的仅关注生命的保存与局部躯体功能改善的一些方法和评价指标体系面临严重挑战。人们日益重视具有整体性、综合性和体现“以人为本”、“以患者为中心”的生命质量这一主观感受性指标的研究。本研究按共性模块与特异模块结合方式，采用现代测量理论中的项目反应理论和概化理论并结合经典测量理论来系统地研制具有中国文化特色的癌症患者生命质量测定量表体系。.经过一年的研究，本课题主要完成共性模块QLICP（V2.0）的再分析和修订，形成正式版的共性模块，并通过实际测定说明了量表具有较好的信度、效度和反应度。同时，也完成部分癌症如卵巢癌、白血病、膀胱癌、脑癌的特异模块筛选。.在此基础上可相对容易和有效地进一步开发出其它癌症的特异量表，最终形成较完整的量表体系，为治疗方案筛选、预防干预措施和卫生资源配置评价提供综合依据和工具。对推动中医国际化和促进新的肿瘤临床疗效评价体系构建也具有重要意义。.已经发表论文9篇，其中1篇SCI收录。

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