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| 原发性骨质疏松症PRO量表的科学性考核 |
| The scientific quality of patient-reported outcome instrument for primary osteoporosis |
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| DOI：10.3969/j.issn.1006.7108.2016.08.014 |
| 中文关键词: 原发性骨质疏松症 患者报告的临床结局 量表 科学性考评 项目反应理论 |
| 英文关键词:Primary osteoporosis Patient-reported outcomes Instrument Evaluating the Scientific quality Item response theory |
| 基金项目:2014广东省科学技术厅-广东省中医药科学院联合科研专项（2014A032500005) |
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| 中文摘要: |
| 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’s α)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's α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。 |
| 英文摘要: |
| Objective To evaluate the scientific quality of the patient-reported outcome instrument for primary osteoporosis. Methods We retested 52 primary osteoporosis patients and 92 healthy volunteers to evaluate the difficulty, discrimination, reliability, validity and feasibility of the OPPRO instrument by using the classical test theory and modern item response theory methods. Results The IRT analysis showed that the difficulty and discrimination of the OPPRO instrument are within acceptable parameters. For reliability, the Cronbach’s coefficient of the whole instrument is 0. 801，the coefficient of the main symptoms aspect of the instrument is 0. 907, the systemic performance aspect 0. 780，the psychological aspect 0. 849, the social aspect 0. 807，the performance in daily activities aspect 0. 799, and the performance satisfaction aspect 0. 877. All of these results represented a good internal consistency of the instrument. The Pearson correlation coefficient of the retest reliability of the instrument is 0. 925，the Kendall correlation coefficient is 0. 759, both of them suggests a good retest reliability. For validity, the structural validity of the results indicates that the multidimensional structure of the instrument meets to our professional expectations. For the feasibility analysis, the sampling survey of the primary osteoporosis patients showed that the total completion rate of the instrument is 90. 34% and the time required to complete is about 15 minutes. Conclusion By using the classical statistical testing and the item response theory to analyze the items of the patient-reported outcomes of primary osteoporosis, we found that the OPPR instrument has good difficulty, discrimination, reliability, validity and feasibility. The study was conducted strictly in standard steps and took consideration of Chinese culture. The scope of the research, the methodology and the reporting methods are of a high quality, which represents good innovation, scientific quality and as well as clinical significance. The OPPRO is a useful tool for evaluating the clinical outcomes in patients with primary osteoporosis. |
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