基于关节炎患者报告结局量表的条目筛选

目的研制关节炎患者报告结局量表,为临床疗效评价提供工具。方法依照美国食品药品管理局(FDA)规定的量表制作流程,建立条目池,编制初量表,对太原市3家医院的322个调查对象实行多中心临床调查,回收后利用项目反应理论、离散趋势法、因子分析法、相关系数法、克朗巴赫系数法、重测信度法6种方法联合筛选条目。结果综合考虑分析结果,最终形成包含生理、心理、社会、治疗4个领域的量表,涵盖了躯体症状、自理能力、抑郁、焦虑、自信、个人关系、社会支持、社会活动、依从性、满意度、药物不良反应11个方面,共45个条目。结论最终量表全面反映了关节炎患者生命质量的内涵,对临床疗效评价具有指导意义。

Item screening of patient-reported outcome scale in paitents with arthritis

Objective To develop patient-reported outcome scale in patients with arthritis, thus offering tools for efficacy assessment. Methods We conducted a multi-center clinical survey among 322 subjects in three hospi- tals in Taiyuan, based on the scale production flow by American Federal Drug Administration for subsequent estab- lishment of item pool and preparation of the preliminary scale. Following scale retrieval, all items were screened ac- cording to item response theory, discrete tendency method, factor analysis, correlation coefficient method, Krona-Bach coefficient method and heavy reliability method. Results Four domains-namely, physiological, psychological, social and treatment-were included in the scale following comprehensive decision-making of the results, covering 11 objec- tives in terms of symptoms, self-management, depression, anxiety, confidence, interpersonal relationship, social support and social activities, compliance, satisfaction and side-effects of treatment that yielded a total of 45 items. Conclusion The final version of scale globally reflected the quality of life in patients with arthritis and may clinically steer efficacy assessment.