目的：根据美国食品与药品管理局（FDA）所规定的患者报告结局（PRO）量表的制作原则与流程，开发肝硬化患者报告的临床结局评价量表。方法通过文献查阅、患者访谈及参照国内外有关量表，收集和提取肝硬化患者的重要信息，构建概念框架，进而形成条目池。再经由患者认知测试、患者评价及专家评审，完善条目池，形成最初的量表。用此量表分别在山西省不同地区的不同级别的8所医院进行小规模的预调查，回收问卷后，应用经典测量理论、项目反应理论（IRT）共7种方法对条目进行筛选，将其结果与专业知识结合后删除不符合要求的条目，形成初始量表。最后使用初始量表在上述8所医院开展大规模的正式调查，用与预调查相同的方法对条目进行第二次筛选，形成终选量表。结果终选量表含有50个条目，分为生理、心理、社会、治疗4个领域，共计13个维度。结论形成的终选量表基本符合理论框架，筛选出的条目能够较好地反映肝硬化患者生命质量的内涵。%Objective To develop a patient-reported outcome (PRO) instrument for patients with liver cirrhosis based on principles and procedure stipulated by the US Food and Drug Administration (FDA). Methods Review of literature, patient interviews and reference to relevant domestic and international scales were conducted. Important data were collected and extracted from patients with cirrhosis. Thereby we built up a conceptual framework that finally formed the item pool. Through patient cognitive tests, patient evaluation and expert assessment, the item pool was re-fined and subsequently an earliest version of scale was developed. This scale was used in small preliminary question-naire surveys in eight hospitals of different levels at several parts of Shanxi Province. After the questionnaires were re-trieved, seven methods including the classical test theory and item response theory (IRT) were used to screen for the questionnaire items. Taking into account the professional considerations, the findings lead to deletion of unnecessary items and formation of an initial scale. The initial scale was then used in the above eight hospitals for a large-scale survey. A second screening for items was performed by using the seven methods as with the first attempt, which subse-quently led to formation of a finalized scale. Results The finalized scale contained 50 items divided into physiologi-cal, psychological, social, and therapeutic domains, accounting for a total of 13 dimensions. Conclusion The final-ized scale is compatible with theoretical framework, and it contains a selection of items which may well reflect quality of life in patients with liver cirrhosis.
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