ImportanceImproving patients’ health status is a key goal of treating tricuspid regurgitation (TR). The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a heart failure disease-specific health status measure used to capture the health status impact of TR and the benefit of transcatheter tricuspid valve intervention (TTVI), but its validity in this clinical setting is unknown.ObjectiveTo evaluate the psychometric properties of the KCCQ in patients with TR.Design, Setting, and ParticipantsData were pooled from patients with severe TR enrolled in 11 manufacturer-sponsored trials of TTVI. The data were transferred to the US Food and Drug Administration to harmonize and anonymize prior to analysis by an independent center. Data were collected from December 2015 to April 2023, and data analysis was performed from July to October 2023.Main Outcomes and MeasuresPrespecified analyses included evaluation of internal consistency, reproducibility, responsiveness, construct validity, and predictive validity. Outcomes were determined using Cronbach α, score comparisons, intraclass correlation, Cohen d, Spearman correlations with best available reference measures, and association of scores and changes in scores with risk of subsequent clinical events.ResultsThe study cohort was composed of 2693 patients enrolled in either single-arm (n = 1517) or randomized (n = 1176) investigations of TTVI. Mean (SD) patient age was 78.6 (8.0) years, 1658 of 2693 patients (61.6%) were female, and the mean (SD) baseline KCCQ Overall Summary (KCCQ-OS) score was 50 (23). There was strong internal consistency within individual domains (Cronbach α, .77-.83). Among clinically stable patients between 1 and 6 months, there were small mean changes in KCCQ domain and summary scores (differences of −0.1 to 1.9 points), demonstrating reproducibility. In contrast, domain and summary scores of patients who underwent TTVI showed large improvements at 1 month after treatment (mean changes, 12.1-21.4 points), indicating excellent perceived responsiveness. Construct validity was moderately strong when domains were compared with best available reference measures (Spearman correlations, 0.47-0.69). In both cross-sectional and longitudinal analyses, the KCCQ-OS was associated with clinical events, with lower scores associated with an increased risk of mortality (hazard ratio, 1.34 per 10-point decrement; 95% CI, 1.22-1.47) and heart failure hospitalization (hazard ratio, 1.24 per 10-point decrement; 95% CI, 1.17-1.31).Conclusions and RelevanceIn this cohort study, the KCCQ had strong psychometric properties in patients with severe TR, including reliability, responsiveness, and validity. These data support use of the KCCQ in patients with severe TR as a measure of their symptoms, function, and quality of life and also for assessing the impact of interventions, such as TTVI, in rigorously controlled trials.

中文翻译：

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堪萨斯城心肌病问卷在三尖瓣反流患者中的验证


重要性改善患者的健康状况是治疗三尖瓣反流 （TR） 的关键目标。堪萨斯城心肌病问卷 （KCCQ） 是一种心力衰竭疾病特异性健康状况测量方法，用于捕捉 TR 对健康状况的影响以及经导管三尖瓣介入治疗 （TTVI） 的益处，但其在这种临床环境中的有效性尚不清楚。目的为了评估 KCCQ 在 TR.Design 患者中的心理测量特性，将 11 项制造商赞助的 TTVI 试验中入组的严重 TR 患者的数据合并。数据被传输到美国食品和药物管理局，以便在由独立中心进行分析之前进行协调和匿名化。数据收集时间为 2015 年 12 月至 2023 年 4 月，数据分析时间为 2023 年 7 月至 10 月。使用 Cronbach α、评分比较、类内相关性、Cohen d、Spearman 相关性与最佳可用参考指标以及评分和评分变化与后续临床事件风险的关联来确定结局。结果研究队列由 2693 例患者组成，他们参加了单组 （n = 1517） 或随机 （n = 1176） 的 TTVI 调查。患者平均 （SD） 年龄为 78.6 （8.0） 岁，2693 例患者中有 1658 例 （61.6%） 为女性，平均 （SD） 基线 KCCQ 总体总结 （KCCQ-OS） 评分为 50 （23）。各个领域内有很强的内部一致性 （Cronbach α， .77-.83）。在 1 至 6 个月之间临床稳定的患者中，KCCQ 域和总分的平均变化很小（差异为 -0.1 至 1。9 分），证明可重复性。相比之下，接受 TTVI 的患者的领域和总分在治疗后 1 个月显示大幅改善 （平均变化，12.1-21.4 分），表明感知反应性极佳。当将结构域与最佳可用参考指标进行比较时，构建体效度中等强 （Spearman 相关性，0.47-0.69）。在横断面和纵向分析中，KCCQ-OS 与临床事件相关，较低的分数与死亡风险增加相关（风险比，每 10 个点递减 1.34;95% CI，1.22-1.47）和心力衰竭住院风险（风险比，每 10 个点递减 1.24;95% CI，1.17-1.31）。结论和相关性在这项队列研究中，KCCQ 在严重 TR 患者中具有很强的心理测量特性，包括可靠性、反应性和有效性。这些数据支持在严重 TR 患者中使用 KCCQ 作为衡量其症状、功能和生活质量的指标，也用于评估严格对照试验中干预措施（如 TTVI）的影响。