Defining minimal detectable difference in echocardiographic measures of right ventricular function in systemic sclerosis.

Defining minimal detectable difference in echocardiographic measures of right ventricular function in systemic sclerosis.
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DOI:
10.1186/s13075-022-02835-5
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发表时间:
2022-06-18
影响因子:
4.9
通讯作者:
--
中科院分区:
医学2区
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超声心动图 (2DE) 对于系统性硬化症 (SSc) 肺动脉高压 (PAH) 的筛查和纵向评估不可或缺。在本研究中,我们试图确定患有和不患有 PAH 的 SSc 患者的 2DE 参数的可靠性、重复性和再现性,并定义最小可检测差异 (MDD),即超出测量误差的最小检测变化。没有已知 PAH 且接受稳定疗法的侵入性确诊 PAH 的 SSc 患者在两个时间点接受带应变的 2DE。计算方差分析 (ANOVA) 和变异系数 (CV) 以评估重复性、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程度。 MDD 是使用队列中每个参数的测量标准误差来计算的。方差分析表明,各组的评估之间几乎没有显着差异。右心室整体纵向收缩应变(GRVLSS,9.7%)和面积变化分数(FAC,21.3%)的CV最大,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之间的一致性非常好。 TAPSE、FAC、S’波、RVOT VTI、GRVLSS 和 RVSP 的 MDD 分别为 0.11 cm、0.03%、1.27 cm/s、0.81 cm、1.14% 和 6.5 mmHg。我们在患有和不患有 PAH 的 SSc 患者中证明了临床上重要的基于 2DE 的测量误差最小。定义该人群的 MDD 对于 PAH 筛查、治疗反应评估以及未来临床试验的样本量计算具有重要意义。在线版本包含可在 10.1186/s13075-022-02835-5 获取的补充材料。
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. The online version contains supplementary material available at 10.1186/s13075-022-02835-5.
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