Echocardiography (2DE) is integral for screening and longitudinal evaluation of pulmonary arterial hypertension (PAH) in systemic sclerosis (SSc). In the present study, we sought to establish the reliability, repeatability, and reproducibility of 2DE parameters in SSc patients with and without PAH and to define the minimal detectable difference (MDD), the smallest change detected beyond measurement error. SSc patients without known PAH and with invasively confirmed PAH on stable therapies underwent 2DE with strain at two time points. Analysis of variance (ANOVA) and coefficients of variation (CV) were calculated to assess for repeatability, reliability, and reproducibility. Intra- and inter-observer agreement were assessed using intraclass correlation. Bland-Altman analysis explored the level of agreement between evaluations. MDD was calculated using the standard error of measurement for each parameter by cohort. ANOVA demonstrated few significant differences between evaluations across groups. Global right ventricular longitudinal systolic strain (GRVLSS, 9.7%) and fractional area change (FAC, 21.3%) had the largest CV, while tricuspid annular plane excursion (TAPSE), S’ wave, and right ventricular outflow track velocity time integral (RVOT VTI) were 0.87%, 3.2%, and 6.0%, respectively. Intra- and inter-observer agreement was excellent. MDD for TAPSE, FAC, S’ wave, RVOT VTI, GRVLSS, and RVSP were 0.11 cm, 0.03%, 1.27 cm/s, 0.81 cm, 1.14%, and 6.5 mmHg, respectively. We demonstrate minimal measurement error in clinically important 2DE-based measures in SSc patients with and without PAH. Defining the MDD in this population has important implications for PAH screening, assessment of therapeutic response, and sample size calculations for future clinical trials.

中文翻译：

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定义系统性硬化症右心室功能超声心动图测量的最小可检测差异

超声心动图 (2DE) 是筛查和纵向评估系统性硬化症 (SSc) 肺动脉高压 (PAH) 不可或缺的部分。在本研究中，我们试图在有和没有 PAH 的 SSc 患者中确定 2DE 参数的可靠性、可重复性和可重复性，并定义最小可检测差异 (MDD)，即检测到的超出测量误差的最小变化。没有已知 PAH 的 SSc 患者和经侵入性确认的 PAH 接受稳定治疗的患者在两个时间点接受了带应变的 2DE。计算方差分析 (ANOVA) 和变异系数 (CV) 以评估可重复性、可靠性和再现性。使用组内相关性评估观察者内和观察者间的一致性。Bland-Altman 分析探讨了评估之间的一致性水平。MDD 是使用队列中每个参数的标准测量误差计算的。方差分析表明各组之间的评估几乎没有显着差异。整体右心室纵向收缩应变 (GRVLSS, 9.7%) 和分数面积变化 (FAC, 21.3%) 具有最大的 CV，而三尖瓣环平面偏移 (TAPSE)、S' 波和右心室流出道速度时间积分 (RVOT) VTI）分别为 0.87%、3.2% 和 6.0%。观察者内部和观察者间的一致性非常好。TAPSE、FAC、S'波、RVOT VTI、GRVLSS 和 RVSP 的 MDD 分别为 0.11 厘米、0.03%、1.27 厘米/秒、0.81 厘米、1.14% 和 6.5 毫米汞柱。我们在有和没有 PAH 的 SSc 患者中证明了临床上重要的基于 2DE 的测量的最小测量误差。在该人群中定义 MDD 对 PAH 筛查具有重要意义，