INTRODUCTION Symptom improvement was assessed as changes in the Chronic Respiratory Infection Symptom Score (CRISS) during intravenous antimicrobial exacerbation treatments among subjects from study NCT02109822. METHODS Median daily CRISS reduction (i.e., improvement) and covariates associated with CRISS reduction by Day 14 were assessed by logistic regression. RESULTS Among 173 subjects, median baseline CRISS was 49 [IQR 41, 56]; 93.6% had a CRISS reduction of ≥11 (minimal clinically important difference); median time to -11 reduction was 2 days [95% CI 2, 3]. The greatest median CRISS difference from baseline, on Day 17, was -26 [-29, -23]. Odds of -26 CRISS change by Day 14 were greater in subjects with higher baseline CRISS (P=.006) and younger ages (P=.041). CONCLUSIONS CRISS response has good dynamic range and may be a useful efficacy endpoint for PEx interventional trials. The optimal use of CRISS change as an endpoint remains uncharacterized.

中文翻译：

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症状评分的变化作为囊性纤维化肺恶化治疗研究的潜在临床终点

介绍 症状改善评估为 NCT02109822 研究对象在静脉抗菌药物恶化治疗期间慢性呼吸道感染症状评分 (CRISS) 的变化。方法通过逻辑回归评估中位数每日 CRISS 减少（即改善）和与第 14 天 CRISS 减少相关的协变量。结果 在 173 名受试者中，中位基线 CRISS 为 49 [IQR 41, 56]；93.6% 的 CRISS 降低≥11（最小的临床重要差异）；-11 减少的中位时间为 2 天 [95% CI 2, 3]。在第 17 天，与基线的最大 CRISS 差异中位数为 -26 [-29, -23]。在基线 CRISS 较高 (P=.006) 和年龄较小 (P=.041) 的受试者中，到第 14 天 -26 CRISS 变化的几率更大。结论 CRISS 反应具有良好的动态范围，可能是 PEx 介入试验的有用疗效终点。CRISS 变化作为终点的最佳使用仍未确定。