The Urgency Numeric Rating Scale: Psychometric Evaluation in Adults with Crohn’s Disease

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2024-12-18 DOI:10.1007/s12325-024-03081-8

Marla Dubinsky, Aisha Vadhariya, Sylvia Su, Xian Zhou, Frederick Durand, Claudine Clucas, Larissa Stassek, Ariane K. Kawata, Simon Travis

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引用次数: 0

Abstract

Introduction

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.

Methods

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.

Results

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.

Conclusion

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.

Trial Registration

Clinicaltrials.gov, NCT03926130. Registered 23 April 2019, https://clinicaltrials.gov/study/NCT03926130.

查看原文本刊更多论文

急迫性数字分级量表：对成人克罗恩病患者的心理测量学评估。

肠急症最近被认为是克罗恩病（CD）的一种症状，严重影响患者的生活质量。急迫性NRS是一项单项患者报告的结果测量，评估过去24小时内肠道急迫性严重程度（0-10分）。我们的目的是评估中度至重度活动性乳糜泻成人患者急症数值评定量表（NRS）的心理测量特性，并估计有意义的改善和肠道急症缓解的阈值。方法：心理测量分析使用mirikizumab 3期VIVID-1研究的汇总数据，其中患有CD的参与者完成了Urgency NRS和其他评估。患者总体严重程度评分（PGRS）和患者总体变化印象评分（PGIC）被用作评估紧急NRS阈值的主要锚点，代表有意义的改善和缓解。结果：在PGRS和PGIC稳定的受试者中，急迫性NRS具有良好的重测信度。它与类似评估中度相关，与内窥镜/实验室评估弱相关。它根据PGRS和其他评估区分了不同疾病严重程度和生活质量的参与者亚组。它对变化很敏感，因为在试验期间，紧迫性NRS的改善在大多数PGRS变化和PGIC类别之间存在差异。急迫性NRS评分降低3-5分代表有意义的改善，得分≤2分代表缓解。结论：Urgency NRS在中度至重度活动性CD的VIVID-1人群中显示出强大的心理测量特性。分析还提示有意义的改善和缓解阈值。试验注册：Clinicaltrials.gov, NCT03926130。2019年4月23日注册，https://clinicaltrials.gov/study/NCT03926130。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.