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目的对原发性骨质疏松症患者报告的临床结局(patient-reported outcomes,PRO)量表的科学性进行考核评价。方法重测52位原发性骨质疏松症患者及92名健康者,运用经典测试理论和现代项目反应理论等方法对研制出的量表的难度、区分度、信度、效度和可行性一一分析评价。结果项目反应理论(item response theory,IRT)分析显示量表的难度和区分度均在合格的参数范围之内,表明量表具有较好的难度和区分度,信度方面:总量表的克朗巴哈系数(Cronbach’sα)为0.801,疾病主要症状、全身表现、心理维度、社会关系维度、日常活动能力方面、满意度方面的Cronbach’sα分别为0.907、0.780、0.849、0.807、0.799、0.877,具有较好的内部一致性。重测信度Pearson相关系数为0.925,Kendall相关系数为0.759,提示良好的重测信度。效度分析:结构效度结果说明量表中多维度的测量满足专业上的预想结构。可行性分析:抽样调查原发性骨质疏松症患者,量表总完成率为90.34%,作答时间约15分钟。结论经过经典统计检验和项目反应理论的科学性考核,OPPRO量表具有较好的难度、区分度、信度、效度和可行性。本研究步骤标准严谨,具有充分的中华文化特色,研究范围来源广泛,方法学和报道质量较高,具有良好的创新性和科研及临床意义,可用于原发性骨质疏松症患者的临床疗效评价。
Objective To assess the scientificity of the reported patient-reported outcomes (PRO) scale in patients with primary osteoporosis. Methods Fifty-two patients with primary osteoporosis and 92 healthy individuals were retested. The difficulty, discernibility, reliability, validity and feasibility of the developed scale were tested using classical test theory and modern project response theory One by one analysis and evaluation. Results The item response theory (IRT) analysis showed that the difficulty and discrimination of the scale were within the range of qualified parameters, indicating that the scale has good difficulty and distinguishing degree. In terms of reliability, the total scale of the krone Cronbach’sα was 0.801. The Cronbach’s α in terms of the main symptoms, systemic manifestations, psychological dimensions, social relationship dimensions and daily activities were 0.907,0.780,0.849,0.807,0.799,0.877 , With good internal consistency. The test-retest reliability Pearson correlation coefficient was 0.925 and the Kendall correlation coefficient was 0.759, suggesting a good test-retest reliability. Validity Analysis: Structural Validity The results show that the multidimensional measurements in the scale satisfy the professional predictive structure. Feasibility Analysis: Sampling survey of patients with primary osteoporosis, the scale of the total completion rate of 90.34%, response time of about 15 minutes. Conclusion After the classical statistic test and the scientific assessment of project response theory, OPPRO scale has good difficulty, discrimination, reliability, validity and feasibility. The steps of this study are rigorous and standard, with full Chinese culture characteristics, wide range of research sources, high quality methodologies and reports, good innovation and scientific and clinical significance, which can be used in the clinical treatment of patients with primary osteoporosis Evaluation.