原发性骨质疏松症PRO量表的初步研制

Development of the patient-reported outcome index for primary osteoporosis

目的在中西医学理论以及计算机自适应的指导下,运用经典测试理论和现代项目测试反应理论进行研制原发性骨质疏松症患者报告结局量表。方法通过成立研究组,制定量表的基本特征,规范基本概念和术语,构建量表的理论框架,收集所有关于骨质疏松症患者条目的相关文献,经过条目库构建和条目的初步筛选,初步概念框架的修订,条目定性评阅,专家评阅,认知采访,制定出调查量表的初稿,然后现场调查,收集380例骨质疏松症患者报告的条目以及92例健康者对照,进行定性研究,运用经典测试理论方法和现代项目反应理论等方法综合筛选以得出最终的原发性骨质疏松症PRO量表。结果经现场调查,整理数据,通过6种分析综合评价,从71个条目的调查量表中删除27个条目,最终建立建立了包括疾病生理、心理、社会、治疗领域4个领域,疾病表现、全身表现、心理表现、社会关系、日常活动能力、满意度等6个维度,共44个条目的原发性骨质疏松症PRO量表。结论最终研制出包含1个疾病、4个领域、6个维度的44个条目的骨质疏松症PRO量表。

Obje ctive A patient-reported outcome（ PRO） index of primary osteoporosis was designed based on the computer adaptive test theory and the item response theory. The index was strictly under the guidance of traditional Chinese medicine and Western medicine theory. Me thods A research working group was established to develop the index feature,basic concept,the terminology,and to construct the theoretical framework of the index. All the relative symptom items of osteoporosis from the literatures were collected. The preliminary framework of the index was established after the item pool construction,screening,and revision. After that,the conception framework was qualitatively evaluated and cognitively interviewed. A total of 380 patients and92 healthy people were enrolled in this study. They were qualitatively studied and the PRO index was obtained after comprehension statistical analysis according to the classic test and modern IRT theory. Re sults The PRO index of osteoporosis was finally developed after out-patient investigation,data collection,and the final comprehensive statistical analysis. 27 out of 71 items were excluded. The final index were 44 items including physical,psychological,social,therapeutic aspects,disease manifestations,systemic manifestations,mental performance,social relations,daily activities,and patient satisfaction. Conclusion We finally developed the PRO index of primary osteoporosis,mainly containing 4 dimensions,6 aspects,and 44 items.