基于病证结合COPD测评工具的研制与评价关键技术研究

Development the patient reported outcome instrument based on the mode of combination of disease and traditional Chinese medicine (TCM) syndrome is an important component of clinical efficacy evaluation for TCM. Currently, the scale or questionnaire is mostly established by the classical test theory, in which are some shortcomings, such as too many items, too much length of the items and lack of information. In addition, the minimal clinically important differences of the instruments can not be determined. At present, item response theory, computerized adaptive testing and minimal clinically important differences are the key technologies for development and evaluation the instrument. We will carry out the following study. To begin with, based on the initial established specific patient reported outcome scale for COPD patients (COPD-PRO) and the Effectiveness Satisfaction Questionnaire of COPD (ESQ-COPD), summarize and concise the concept of lung in TCM, especially for COPD through ancient and modern literatures, improve the established theoretical basis and add the items to the item bank, and combined with the modem test theory, such as item response theory and computerized adaptive testing. Then evaluate the subjects' ability and the difficulty of the items, shorten the testing time and the calculation amount, and accurate individualized evaluation of the subjects, improve the measuring accuracy and comprehensiveness, and finally form the computerized adaptive testing version. What's more, according to the large sample and multi-center clinical trials, assess the practicability and maneuverability of COPD-PRO by determining the minimal clinically important differences through the combination of anchor-based method and distribution-based method, to reflect the clinical efficacy evaluation for TCM. The established methods will provide the inspirations and methods for other chronic disease researches.

基于病证结合理论的测评工具是中医药临床疗效评价的重要部分。目前已有量表/问卷多建立在经典测量理论基础上，或存在条目冗长或信息量缺失等缺点，且缺乏临床最小差异值的估算，亟需完善。项目反应理论和计算机自适测试及最小差异值是目前测评工具研制与评价的关键技术。本研究在前期研制的COPD患者报告结局量表、COPD患者疗效满意度问卷基础上，进一步总结和凝练中医肺系病理论，完善理论模型和条目库，并结合项目反应理论和计算机自适应测试等现代测量技术，评价被试者的能力和条目难度，缩短测试时间和计算量，做出个体化的精确评价，形成COPD测评工具的修订版和计算机自适测试版。进一步基于多中心的随机对照试验，采用锚定法和分布法估算临床最小差异值，评价测评工具的实用性和可操作性，为临床诊疗决策提供量化依据，为中医药的临床疗效评价提供客观标准。所建立的测评工具研制与评价关键技术将为其他疾病的研究提供可借鉴的思路与方法。

基于病证结合理论的测评工具是中医药临床疗效评价的重要部分。目前已有测评工具的研制与评价多建立在经典测量理论基础上，存在一定局限，且缺乏最小临床重要差值（MCID），亟需完善。项目反应理论和计算机自适应测试及MCID是目前测评工具研制与评价的关键技术。本研究在前期研制的COPD患者报告结局量表（COPD-PRO）、COPD 患者疗效满意度问卷（ESQ-COPD）基础上，基于病证结合理论，进一步优化概念框架与条目池，并结合项目反应理论和计算机自适应测试等现代测量技术，形成COPD-PRO、ESQ-COPD的修订版和计算机自适应测试版；基于多中心随机对照试验，采用锚定法和分布法估算COPD-PRO、ESQ-COPD的MCID。研究显示，形成的COPD-PRO、ESQ-COPD修订版和计算机自适应测试版具有良好的心理测量学特性；初步确定并验证了COPD-PRO、ESQ-COPD的MCID，可为临床诊疗决策提供参考。所建立的测评工具研制与评价关键技术将为其他疾病的研究提供可借鉴的思路与方法。

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