慢性病患者报告结局测定量表体系研制及其得分的最小临床有意义差异制定

With the changing disease spectrum, renewing of health concepts and transforming of medical models, patient-reported outcomes (PRO), which is an integrated and 'patient-oriented' indicator，has been gaining increasing attention in medical fields. Based on the existed quality of life instruments for chronic diseases (QLICD) and methodology of 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 patient-reported outcomes instruments for chronic disease (PROICD) 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 (PROICD-GM) which can be used in all kinds of chronic diseases and 11 specific modules for 11 common/severe diseases such as hypertension, diabetes，COPD,rheumatoid arthritis. Also, the minimal clinically importance difference (MCID) for each disease will be computed by the combinations of distribution-based methods with anchor-based methods. It not only present relatively easy way to explian PRO scores, but also speed up applications of PRO researches in clinical field in China. On finishing the study, a new system of PRO instruments will be established in China with diseases can being measured by the specific scale or the general scale. 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 internationalization of traditional Chinese medicine and establishment of a new integrated evaluation system of treatments effects for chronic diseases. It also present useful methodolgy for MCID for many instruments used in clinical field.

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"的患者报告结局PRO。本项目在我们研制的生命质量测定量表体系QLICD基础上，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慢性病的患者报告结局测定量表体系PROICD, 并对其测量学特性(信度、效度、反应度等)进行评价。该体系含1个共性量表和11个常见或严重疾病的特异量表，包括高血压、糖尿病、COPD、类风湿性关节炎等。 同时，用基于得分分布和基于"锚定位"相结合的方法制定出各疾病的最小临床有意义差异MCID，便于量表得分的解释及推广应用。 项目完成后形成一个相对全面的量表体系，为治疗方案筛选、干预措施评价和卫生资源配置提供综合依据和工具，对推动中医国际化和促进新的临床疗效评价体系构建也具有重要意义。对临床中大量使用的量表制定MCID也提供方法借鉴。

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”的患者报告结局PRO。本项目在我们研制的生命质量测定量表体系QLICD基础上，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慢性病的患者报告结局测定量表体系PROISCD, 并对其测量学特性(信度、效度、反应度等)进行评价。经过4年研制，已经研制出符合测量学特性的16个量表构成的测定体系，包括1个共性量表和15个常见或严重疾病的特异量表，即高血压、冠心病、慢性阻塞性肺病、慢性肺原性心脏病、糖尿病、骨关节炎、类风湿性关节炎、系统性红斑狼疮、脑卒中、肺结核、HIV/AIDS、消化性溃疡、慢性胃炎、焦虑症、痛风等。在此基础上，可以很容易和快速地研制其它疾病的特异量表，最终可形成较完整的测定量表体系。.同时，用基于得分分布和基于“锚定位”相结合的方法制定出各疾病的最小临床有意义差异MCID，便于量表得分的解释及推广应用。 .项目完成后形成一个相对全面的量表体系，为治疗方案筛选、干预措施评价和卫生资源配置提供综合依据和工具，对推动中医国际化和促进新的临床疗效评价体系构建也具有重要意义。对临床中大量使用的量表制定MCID也提供方法借鉴。.已经发表论文25篇，其中2篇SCI收录。