UPRES EA220, Foch Hospital, University Versailles Saint-Quentin, University Paris-Saclay, Suresnes, France.
Dermakiel, Allergie und Hautzentrum, Kiel, Germany.
Allergy. 2019 Nov;74(11):2191-2198. doi: 10.1111/all.13925. Epub 2019 Jul 29.
House dust mite (HDM) allergens are responsible for the most prevalent persistent respiratory allergies. Clinical trials in this field often use a four-component nasal symptom score (T4NSS) as a measure of efficacy.
The present observational, prospective, multinational, multicenter study determined the minimal important difference (MID) for a T4NSS in children, adolescents, and adults with physician-diagnosed HDM-induced allergic rhinoconjunctivitis (AR). Patients rated the T4NSS daily, a 15-point global rating of change scale (GRCS) and the Rhinoconjunctivitis Quality of Life Questionnaire weekly. The MID was determined primarily by using a regression method with a GRCS threshold of 2.
A total of 546 patients (210 adults, 133 adolescents, and 203 children) were included; 92.6% of the patients had moderate-to-severe AR, and 30.1% had concomitant mild asthma. During the first week, the mean ± standard deviation T4NSS was 5.68 ± 2.76 in adults, 5.34 ± 2.66 in adolescents, and 5.07 ± 2.48 in children. In a GRCS regression analysis, the MID [95% confidence interval] for the T4NSS was -0.90 [-1.06;-0.75] overall (n = 509), -0.94 [-1.19;-0.69] in children (n = 187), -0.74 [-1.07;-0.41] in adolescents (n = 125), and -1.04 [-1.29;-0.79] in adults (n = 197). The MID did not differ greatly from one disease severity tertile to another. Confirmatory distribution-based analyses yielded overall MID values of -0.87 for the first week of the study and -0.93 for the week 2-week 1 difference.
The MID for improvement in the T4NSS is at least -0.90 units in children, adolescents, and adults suffering from HDM-induced AR This value could be rounded up to -1 unit for convenience.
屋尘螨（HDM）过敏原是最常见的持续性呼吸道过敏的原因。该领域的临床试验通常使用四分量鼻症状评分（T4NSS）作为疗效的衡量标准。
本观察性、前瞻性、多国、多中心研究确定了经医生诊断为屋尘螨引起的过敏性鼻炎-结膜炎（AR）的儿童、青少年和成人的 T4NSS 的最小有意义差异（MID）。患者每天评估 T4NSS、15 分的整体变化量表（GRCS）和鼻结膜炎生活质量问卷每周评估一次。MID 主要通过使用具有 2 分 GRCS 阈值的回归方法来确定。
共纳入 546 例患者（210 例成人、133 例青少年和 203 例儿童）；92.6%的患者有中重度 AR，30.1%的患者同时患有轻度哮喘。在第一周，成人的平均±标准偏差 T4NSS 为 5.68±2.76，青少年为 5.34±2.66，儿童为 5.07±2.48。在 GRCS 回归分析中，T4NSS 的 MID [95%置信区间]在 509 例患者中为-0.90[-1.06;-0.75]，在 187 例儿童中为-0.94[-1.19;-0.69]，在 125 例青少年中为-0.74[-1.07;-0.41]，在 197 例成人中为-1.04[-1.29;-0.79]。MID 在不同疾病严重程度三分位之间差异不大。基于分布的验证性分析得出，研究第一周的总体 MID 值为-0.87，第 2 周至第 1 周的差异为-0.93。
在患有屋尘螨引起的 AR 的儿童、青少年和成人中，T4NSS 改善的 MID 至少为-0.90 个单位。为方便起见，此值可四舍五入至-1 个单位。
