胸腰椎骨折患者报告临床结局量表的编制与初步测评

The Preparation and Evaluation of Patient-reported Outcome Scale for Patients with Thoracolumbar Fracture

目的:编制胸腰椎压缩骨折患者报告的临床结局(PRO)评价量表,应用于临床疗效评价,完善胸腰椎骨折的疗效评价体系。方法:基于PRO量表的制作规范,回顾文献,结合胸腰椎压缩性骨折的理论知识以及患者、照料者访谈、骨科专家访谈等建立条目池;再在专家指导下进行量表语言调适和要素完善,设计量表答案的形式及格式,小范围认知测试,据测试结果形成初选量表;量表预调查,优化量表结构,从而建立《胸腰椎压缩性骨折疗效评价量表》;对量表信度、效度和反应度进行科学性测评。结果:初步形成一个具有3个域体系(生理状况、心理状态及社会关系与治疗)、20个条目的量表。该量表重测信度是0.843,总克朗巴赫系数α(Cronbach's α)为0.943。折半信度(Split-Cronbach's α)分析为0.951,量表KMO统计量为0.835.将胸腰椎压缩性骨折患者与健康者作对比,比较量表3个领域得分及总的得分,结果示两组在量表3个领域的得分及总分的比较P值均小于0.01,差异均有统计学意义。结论:该量表具有较高的信度、效度、反应度,经进一步优化后可作为胸腰椎压缩骨折患者报告的临床疗效评价的量表进行推广应用。

Objective：To compile the patient-reported outcome scale for patients with thoracolumbar compression fractures and to improve the curative effect evaluation system of thoracolumbar fractures.Methods：According to the and processing principle of PRO scale and review of literature,combined with the theoretical knowledge of thoracolumbar compression fractures and interviews of patients,caregivers and orthopedic expert,the item pool is formed.Under the guidance of experts,the language adjustment and elements improving were completed,and the form and format of the questionnaire are designed.The primary scale was formed according to the results of a small range of cognitive tests.The scale was optimized by the pre investigation,so as to set up the evaluation scale of thoracolumbar compression fracture.The reliability,validity and responsiveness of the scale were evaluated.Results：A scale of 3 domains（physical,psychological,social and therapeutic）and 20 items were initially established.The reliability of the scale was 0.843; the Cronbach＇s α coefficient about the scale is 0.943; the physiological status domain is 0.951 and the KMO（Kaiser-Meyer-Olkin Measure of Sampling Adequacy）value was 0.835.Patients with thoracolumbar vertebral compression fractures were compared with those of healthy subjects by scores of the 3 domains and the total score.The results showed that the P values of the two groups in the scores of 3 areas and the total score were less than 0.01,which were statistically significant.Conclusion：The scale has high reliability,validity and responsiveness,and can be used to evaluate the clinical efficacy of thoracolumbar compression fracture after further optimization.