| Objective 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. Methods 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 and 92 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 modem IRT theory. Results 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. |