哮喘患者报告临床结局量表的研制和条目筛选

目的研制具有良好信度、效度与反应度,适用于新药临床试验或临床疗效评价的哮喘患者报告临床结局(PRO)量表。方法遵照美国食品药品管理局(FDA)PRO量表研制的程序化方法,建立量表的理论框架,建立条目池,并通过专家咨询、患者访谈等修改量表,得到含有72个条目的初量表。现场调查共收集108例样本,使用离散趋势法、因子分析法、相关系数法、克朗巴赫α系数法及修正条目的总相关系数法和项目反应理论5种方法对初量表进行条目筛选。结果经过条目筛选,调整量表的框架结构,共保留67个条目,分为生理、心理、社会、治疗4个领域及13个方面。结论哮喘PRO量表严格按照国际量表的操作原则和方法进行,科学性强、结论可信,有利于临床研究中推广使用。

The development and item screening of patient-reported outcomes scale for patients with asthma

Objective To investigate the patient-reported outcomes（PRO） scale with good reliability,validity and responsiveness and can be used in asthma patients undergoing new drug clinical trials or clinical efficacy evaluation.Methods According to the programmatic method of PRO scale developed by U.S.Food and Drug Administration（FDA）,the theoretical framework and item pool of the scale were established.Moreover,the scale was then modified by expert consultation and patient interview for the primary scale with 72 item pools.A total of 108 samples were collected in on-the-spot investigation.Thereafter,the primary scale was then performed item screening by 5 methods including discrete tendency,factor analysis,correlation coefficient,Cronbach’s corrected item-total correlation and item response theory.Results After item screening and adjustment of the framework of scale,67 items were retained and divided into 4 fields including physiology,psychology,social and treatment and 13 aspects.The instrument contains 13 parts.Conclusion The PRO scale for asthma patients was strictly established according to the operating principle and methods of international scale,which had strong scientificity and credible conclusion hence promotion and application in clinical researches.