Valvular & structural heart diseaseCohort study
Validation of the Kansas City Cardiomyopathy Questionnaire in Patients With Tricuspid Regurgitation
- Cohort study (psychometric validation, pooled data from 11 trials)
- prespecified analyses
- pooled individual-patient data
- independent analysis centre
Data harmonized and anonymized by the US FDA before analysis by an independent center; data collected December 2015 to April 2023
Authors' conclusion
In this cohort study, the KCCQ had strong psychometric properties in patients with severe TR, including reliability, responsiveness, and validity.
Study context
- Population
- Patients with severe tricuspid regurgitation (TR) enrolled in 11 manufacturer-sponsored trials of transcatheter tricuspid valve intervention (TTVI), 2015–2023
- Participants
- 2,693 patients · 11 trials
- Exposure
- Single-arm vs Randomized
- Single-armn = 1,517
- Randomizedn = 1,176
- Outcome
- Psychometric properties of the Kansas City Cardiomyopathy Questionnaire (KCCQ): internal consistency, reproducibility, responsiveness, construct validity and predictive validity
Main finding
As reported in the abstract
- Internal consistency within individual domains (Cronbach α)
- .77-.83
- Reproducibility: mean changes in clinically stable patients between 1 and 6 months (points)
- −0.1 to 1.9
- Responsiveness: mean changes 1 month after TTVI (points)
- 12.1-21.4
- Construct validity vs best available reference measures (Spearman correlations)
- 0.47-0.69
- Predictive validity: mortality, HR per 10-point KCCQ Overall Summary (KCCQ-OS) decrement
- 1.34 (95% CI 1.22-1.47)
- Predictive validity: HF hospitalization, HR per 10-point KCCQ-OS decrement
- 1.24 (95% CI 1.17-1.31)
Observational data: associations, not effects.
Original publication
Validation of the Kansas City Cardiomyopathy Questionnaire in Patients With Tricuspid Regurgitation. JAMA Cardiol. Published 1 February 2025. doi:10.1001/jamacardio.2024.4266
Summarised from the published abstract; every number is checked against it