Dubinsky Marla, Vadhariya Aisha, Su Sylvia, Zhou Xian, Durand Frederick, Clucas Claudine, Stassek Larissa, Kawata Ariane K, Travis Simon
Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Eli Lilly and Company, 893 S Delaware St., Indianapolis, IN, 46225, USA.
Adv Ther. 2025 Feb;42(2):1044-1060. doi: 10.1007/s12325-024-03081-8. Epub 2024 Dec 18.
Bowel urgency has recently been recognized as a Crohn's disease (CD) symptom that substantially impacts patients' quality of life. The Urgency NRS is a single-item patient-reported outcome measure assessing bowel urgency severity in the past 24 h (0-10 scale). We aimed to evaluate the psychometric properties of the Urgency Numeric Rating Scale (NRS) in adults with moderately to severely active CD and to estimate thresholds for meaningful improvement and bowel urgency remission.
Psychometric analyses used pooled data from the Phase 3 VIVID-1 study of mirikizumab, where participants with CD completed the Urgency NRS and other assessments. The Patient Global Rating of Severity (PGRS) and Patient Global Impression of Change (PGIC) were used as primary anchors to estimate Urgency NRS thresholds representing meaningful improvement and remission.
The Urgency NRS showed good test-retest reliability in participants who were stable based on PGRS and PGIC. It was moderately correlated with similar assessments and weakly correlated with endoscopic/laboratory assessments. It differentiated between participant subgroups varying in disease severity and quality of life based on PGRS and other assessments. It was sensitive to change, as Urgency NRS improvements during the trial differed between most PGRS change and PGIC categories. A 3-5-point reduction on the Urgency NRS represented meaningful improvement and a score of ≤ 2 represented remission.
The Urgency NRS demonstrated strong psychometric properties in the VIVID-1 population of moderately to severely active CD. Analyses also suggested meaningful improvement and remission thresholds.
Clinicaltrials.gov, NCT03926130. Registered 23 April 2019, https://clinicaltrials.gov/study/NCT03926130 .
肠道急迫感最近被认为是克罗恩病（CD）的一种症状，会严重影响患者的生活质量。急迫感数字评定量表（Urgency NRS）是一项由患者报告的单项结局指标，用于评估过去24小时内肠道急迫感的严重程度（0至10分）。我们旨在评估急迫感数字评定量表（NRS）在中度至重度活动性CD成人患者中的心理测量特性，并估计有意义改善和肠道急迫感缓解的阈值。
心理测量分析使用了mirikizumab 3期VIVID-1研究的汇总数据，CD患者参与了该研究并完成了急迫感NRS及其他评估。患者总体严重程度评分（PGRS）和患者总体变化印象（PGIC）被用作主要参照指标，以估计代表有意义改善和缓解的急迫感NRS阈值。
根据PGRS和PGIC判断病情稳定的参与者中，急迫感NRS显示出良好的重测信度。它与类似评估呈中度相关，与内镜/实验室评估呈弱相关。根据PGRS和其他评估，它能够区分疾病严重程度和生活质量不同的参与者亚组。它对变化敏感，因为在试验期间，大多数PGRS变化和PGIC类别中，急迫感NRS的改善情况有所不同。急迫感NRS降低3至5分代表有意义的改善，评分≤2分代表缓解。
在中度至重度活动性CD的VIVID-1研究人群中，急迫感NRS显示出较强的心理测量特性。分析还提出了有意义改善和缓解的阈值。
Clinicaltrials.gov，NCT03926130。2019年4月23日注册，https://clinicaltrials.gov/study/NCT03926130 。
