基于胸腰椎压缩骨折患者报告的临床结局评价量表的初步构建和统计分析

Preliminary construction and statistical analysis of efficacy evaluation based on thoracolumbar vertebrae compression fractures patients reported outcomes

目的建立基于胸腰椎压缩骨折患者报告的临床结局(PRO)评价量表,从患者报告的角度为胸腰椎压缩骨折临床疗效评价提供一个新的方法。方法采用文献资料查询、专家咨询等方法,参考患者日常就诊时的主诉,结合国内外临床常用量表的条目,进一步完善量表并形成PRO初始量表。结果初步形成一个具有4个域体系(躯体症状、躯体感觉、心理状态和社会交往)、16个条目的量表。该量表总克朗巴赫系数α(Cronbach'sα)为0.878。折半信度(Split-Cronbach'sα)分析为0.783。量表KMO统计量为0.831,通过Bartlett检验,各变量间信息的重叠程度较高(2=1 921.243,P<0.01),适合做因子分析。结论该量表具有较高的信度、效度,可作为胸腰椎压缩骨折患者报告的临床疗效评价的初级量表。

Objective It is to compile the efficacy evaluation scale based on patient reported outcomes （PRO） of thoraco- lumbar vertebrae compression fractures patients to provide a new way of evaluation of clinical effect from the viewpoint of pa- tients＂ report. Methods Literature consulting, talking with patients, and consulting to experts were adopted to establish domain system containing physical symptoms, physical sensation, mental status and social communication and then set up the items. Results A questionnaire which contained 4 localized system（ body syndrome, body feeling, mental state and social interaction） and 16 items was established. The total Cronbach＇s Alpha of the questionnaire was 0. 878. By Split - Cronbach Alpha analysis, the Split - Cronbachg Alpha value was 0. 783. The KMO（ Kaiser - Meyer - Olkin Measure of Sampling Adequacy） value was 0. 831, by Bartlett test （P 〈0. 001, x2 = 1 921. 243 ） , indicating that it was rationale to make factor analysis because of the high overlapness among the variables, and that the questionnaire had a high validity statistically. Conclusion The very PRO Scale was high in reliability and validity and was usable primarily for the clinical efficacy evaluation based on （PRO） in patients with thoracolumbar vertebrae compression fractures.