National Heart & Lung Institute, Imperial College London, Royal Brompton Hospital NHS, London, United Kingdom.
Division of Allergy and Immunology, University of South Florida, Tampa, Fla.
J Allergy Clin Immunol Pract. 2019 May-Jun;7(5):1450-1461.e6. doi: 10.1016/j.jaip.2019.01.015. Epub 2019 Feb 20.
Although regulatory authorities have recently recommended the use of a combined symptom-medication score as a primary efficacy end point, none has been psychometrically validated. Here, we sought to determine to what extent allergic rhinitis (AR)-related patient-reported outcomes (symptom scores, medication scores, disease control scores, and satisfaction or quality-of-life scales) have been assessed for construct, content, and/or criterion validity, reliability, responsiveness, and the minimal clinically important difference. We searched the PubMed database from January 1997 to June 2018 with logical combinations of key words related to validation, AR, and patient-rated outcomes and scales. From a total of 1705 potentially relevant publications, 55 were reviewed. Despite the current emphasis on a combined symptom-medication score for evaluating the efficacy of allergen immunotherapy in AR, symptom scores have not been extensively validated, and we did not find any publications describing the validation of a medication score. Disease control scales (mainly the Rhinitis Control Assessment Test, the Control of Allergic Rhinitis and Asthma Test, and the Allergic Rhinitis Control Test) and health-related quality-of-life scales (mainly the Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ] and the mini-RQLQ) have been extensively validated in AR but have some practical disadvantages as primary efficacy criteria in clinical trials.
尽管监管机构最近建议使用综合症状-药物评分作为主要疗效终点，但尚未对其进行心理计量学验证。在这里，我们旨在确定过敏性鼻炎（AR）相关的患者报告结局（症状评分、药物评分、疾病控制评分以及满意度或生活质量量表）在何种程度上已针对构建、内容和/或标准有效性、可靠性、反应性以及最小临床重要差异进行了评估。我们使用与验证、AR 和患者评定结果和量表相关的关键词进行逻辑组合，在 1997 年 1 月至 2018 年 6 月期间对 PubMed 数据库进行了搜索。在总共 1705 篇可能相关的出版物中，我们对 55 篇进行了综述。尽管目前强调使用综合症状-药物评分来评估变应原免疫治疗在 AR 中的疗效，但症状评分尚未得到广泛验证，我们也没有发现任何描述药物评分验证的出版物。疾病控制量表（主要是鼻炎控制评估测试、过敏性鼻炎和哮喘控制测试以及过敏性鼻炎控制测试）和健康相关生活质量量表（主要是鼻结膜炎生活质量问卷[RQLQ]和 mini-RQLQ）已在 AR 中得到广泛验证，但作为临床试验中的主要疗效标准存在一些实际缺点。
