脾胃系疾病计算机自适应测评体系的临床解释度和属性考评研究

Many developed instruments were never used in clinical practices and researchers, because the patients and doctors did not understand the scores meanings and the scales usually have extensive burdens. To solve the problem, we applied for this project entitled 'Clinical interpretation and psychometric assessment of Patient Reported Outcomes Instrument for Patients with Gastrointestinal Diseases Based on Computer Adaptive Test'. This project aims to: 1) describe the meaningful interpretations of health status using the developed Patient Reported Outcomes Instrument for Patients with Gastrointestinal Diseases Based on Computer Adaptive Test (GD-CAT); ii) develop intellectual platforms for GD-CAT assessments in clinical environments and patient's daily life, such as in computer and telephone, etc; iii) explore the clinical interpretation research methodologies and translational ways for primary clinical practices. This study adopted the combination of prospective, longitudinal, cohort and retrospective design. In step 1, the patients with Gastric Stuffiness or Gastric Pain (Chronic gastritis or Functional dyspepsia in western medicine) will be prospective enrolled in the field out-department and in-department of hospital and online survey. With the Patient Reported Outcomes Instrument for Patients with Gastric Stuffiness Based on Computer Adaptive Test (GS-CAT) and Patient Reported Outcomes Instrument for Patients with Gastric Pain Based on Computer Adaptive Test (GP-CAT), data will be collected on the admission and 14 days later. Meanwhile, the retrospective data from previous studies performed between 2010 and 2012 were also included. After statistical process control, SPSS13.0, RUMM2030, Lisert8.70, MULTILOG7.03, FASTtest Web, et al. will be used for analysis. Items and scales properties will be evaluated with comparative fit index (CFI), Root Mean Square Error of Approximation (RMSEA), Factor loadings, item information curves (IIC), item characteristic curves (ICCs), etc., and the health status, 90% Confidence interval (90%CI), reliable change index (RCI) etc. will be also evaluated for interpretations establishment. In step 2, to evaluate the scientific and clinical properties of GS-CAT and GP-CAT interpretations, we will first develop the intellectual platforms in independent computer, mobile telephone or network for GD-CAT assessments which used in clinical environments and patient's daily life. Adopted the prospective, longitudinal, cohort study design, data will also be collected on the admission and 14 days later with GD-CAT intellectual platforms and primary clinical interpretation system. SPSS13.0, RUMM2030, Lisert8.70, MULTILOG7.03, FASTtest Web, et al. will be used for analysis in items, scale property, patients health and clinical feasibility assessment. The final interpretation system will be established after above mentioned analysis. It will decrease the burdens and promote the clinical application of developed instruments.

基于计算机自适应测试和项目反应理论下的量表临床意义解释研究是促进量表向一线临床实践转化的重要途径。本研究采用前瞻、纵向、队列研究和回顾性病例调查相结合设计，通过医院和网络调查招募胃痞和胃痛（慢性胃炎和功能性消化不良）患者，分别在纳入研究和随访结束时以胃痞患者报告结局量表计算机自适应测试版、胃痛患者报告结局量表计算机自适应测试版进行数据收集，使用RUMM2030、Lisert8.70、MULTILOG7.03、FASTtest Web等软件分析各条目、领域特征并计算受试者健康水平等，进而建立量表初步的临床解释方法与体系； 然后，在上述工作基础上采用相同研究设计，以基于独立电脑和互联网络研发胃痞和胃痛患者报告结局量表的网络智能终端测试体系在纳入研究和随访结束时收集数据，对量表的临床解释体系进行科学性考评，评估量表临床解释标准的临床可信性，进而降低量表回答负担和管理负担，促进量表向临床实践转化。