Introduction: Individuals living with Crohn's disease (CD) experience burdensome symptoms. As such, it is important to measure CD symptom severity in clinical research. The goal of this study was to evaluate the content validity, psychometric performance, and score interpretability of a new patient-reported instrument, the Crohn's Symptom Severity (CSS) questionnaire, among adolescents and adults with moderately to severely active CD.
Methods: Cognitive debriefing interviews (N = 30; n = 20 adults, n = 10 adolescents) were conducted to evaluate the content validity of the CSS. Additionally, the CSS scores were evaluated for reliability and validity using data from a phase 3 randomized clinical trial of risankizumab (NCT03105128; N = 850). Meaningful within-patient change (MWPC) thresholds were estimated using anchor-based methods.
Results: All interview participants (n = 30/30, 100.00%) reported the CSS was easy to complete and most participants (n = 28/29, 96.55%) reported that the CSS was relevant to their experience of CD. Among the clinical trial subjects (N = 850) the following was found for the CSS: mostly acceptable item-total correlations (0.26-0.79); weak to moderate inter-item correlations (r = 0.07-0.57), good internal consistency (Cronbach's α = 0.76-0.87); intraclass correlation coefficients ranged from 0.48 to 0.70, not consistently exceeding the acceptable range for test-retest reliability (0.70); acceptable convergent validity and known-groups results; and demonstrated sensitivity to change. Analyses supported an MWPC estimate of 6-11 points.
Conclusions: This study supports use of the CSS for measuring CD symptoms and sleep impact among adolescents and adults aged 16 and older with moderately to severely active CD in clinical research.
Trial Registration: NCT03105128 (registration date 4 April 2017).
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11349822 | PMC |
| http://dx.doi.org/10.1007/s12325-024-02923-9 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
The Multimorbidity Questionnaire (MMQ1): English translation and validation of a Danish patient reported outcome measure for quality of life in people with multiple long-term conditions in a cross-sectional survey.
Qual Life Res
January 2025
Centre of General Practice, Department of Public Health, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.
Purpose: MMQ1 is a Danish-language patient-reported outcome measure (PROM) for quality of life (QOL) in people with multiple long-term conditions (MLTC). It measures needs-based QOL across six scales: Physical ability, Concerns and worries, Limitations in daily life, Social life, Personal finances and Self-image. There is currently no such measure available in English.
View Article and Find Full Text PDFDevelopment and Validation of a Decision Support Tool for Baby Formula Prescription.
Matern Child Health J
January 2025
Postgraduate Program in Collective Health, Faculty of Health Sciences of Trairi, Federal University of Rio Grande do Norte, Santa Cruz, Brazil.
Introduction: Although there are acceptable medical reasons for the use of food supplements, most prescriptions for newborns do not comply with current recommendations, putting continued breastfeeding at risk. This study aimed to create and validate a flowchart for newborn supplement prescription.
Methods: The flowchart was created and submitted to two rounds of assessments by a panel of judges, who calculated the content validity index (CVI) (acceptable > 0.
The Multifactorial Relationship Between Bone Tissue Water and Stiffness at the Proximal Femur.
Calcif Tissue Int
January 2025
Department of Bioengineering, Temple University, 1947 N. 12th St, Philadelphia, PA, 19122, USA.
Bone mechanical function is determined by multiple factors, some of which are still being elucidated. Here, we present a multivariate analysis of the role of bone tissue composition in the proximal femur stiffness of cadaver bones (n = 12, age 44-93). Stiffness was assessed by testing under loading conditions simulating a sideways fall onto the hip.
View Article and Find Full Text PDFWhole-Heart Histological and CMR Validation of Electroanatomic Mapping by Multielectrode Catheters in an Ovine Model.
JACC Clin Electrophysiol
January 2025
Department of Cardiology, Westmead Hospital, Sydney, New South Wales, Australia; Westmead Applied Research Centre, University of Sydney, Sydney, New South Wales, Australia. Electronic address:
Background: Accurate electroanatomic mapping is critical for identifying scar and the long-term success of ventricular tachycardia ablation.
Objectives: This study sought to determine the accuracy of multielectrode mapping (MEM) catheters to identify scar on cardiac magnetic resonance (CMR) and histopathology.
Methods: In an ovine model of myocardial infarction, we examined the effect of electrode size, spacing, and mapping rhythm on scar identification compared to CMR and histopathology using 5 multielectrode mapping catheters.
Addressing Vaccine Hesitancy: Validating the PACV Survey for Croatian Parents.
Infect Dis Rep
January 2025
University Department of Health Studies, University of Split, Ruđera Boškovića 35, 21000 Split, Croatia.
Vaccine hesitancy, recognized by the WHO as a significant global health threat, undermines vaccination efforts. This study aimed to adapt and validate the Parent Attitudes about Childhood Vaccines (PACV) Survey for Croatian parents to understand vaccine hesitancy better. A cross-sectional study with 1814 Croatian parents was conducted using the PACV survey, translated using a double-back translation method.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!