Abstract：
Objective: Although studies have shown that digital measures of speech detected ALS speech impairment and correlated with the ALSFRS-R speech item, no study has yet compared their performance in detecting speech changes. In this study, we compared the performances of the ALSFRS-R speech item and an algorithmic speech measure in detecting clinically important changes in speech. Importantly, the study was part of a FDA submission which received the breakthrough device designation for monitoring ALS; we provide this paper as a roadmap for validating other speech measures for monitoring disease progression. Methods: We obtained ALSFRS-R speech subscores and speech samples from participants with ALS. We computed the minimum detectable change (MDC) of both measures; using clinician-reported listener effort and a perceptual ratings of severity, we calculated the minimal clinically important difference (MCID) of each measure with respect to both sets of clinical ratings. Results: For articulatory precision, the MDC (.85) was lower than both MCID measures (2.74 and 2.28), and for the ALSFRS-R speech item, MDC (.86) was greater than both MCID measures (.82 and .72), indicating that while the articulatory precision measure detected minimal clinically important differences in speech, the ALSFRS-R speech item did not. Conclusion: The results demonstrate that the digital measure of articulatory precision effectively detects clinically important differences in speech ratings, outperforming the ALSFRS-R speech item. Taken together, the results herein suggest that this speech outcome is a clinically meaningful measure of speech change.
摘要：
目标：尽管研究表明，语音的数字测量检测到ALS语音障碍，并与ALSFRS-R语音项目相关，尚未有研究比较他们在检测语音变化方面的表现。在这项研究中,我们比较了ALSFRS-R语音项和算法语音测量在检测临床重要语音变化方面的表现.重要的是,该研究是FDA提交的报告的一部分,该报告获得了用于ALS监测的突破性设备名称;我们提供本文作为验证用于监测疾病进展的其他语音措施的路线图.方法：我们从ALS患者中获得ALSFRS-R语音子分数和语音样本。我们计算了两种测量的最小可检测变化（MDC）；使用临床医生报告的听众努力和严重程度的感知评级，我们计算了两组临床评分的各项指标的最小临床重要差异(MCID).结果：对于关节精度，MDC（.85）低于两个MCID指标（2.74和2.28），对于ALSFRS-R语音项目，MDC（.86）大于两个MCID度量（.82和.72），这表明，虽然发音精度测量检测到最小的临床上重要的语音差异，ALSFRS-R语音项目没有。结论：结果表明，发音精度的数字测量有效地检测出语音评分的临床重要差异，优于ALSFRS-R语音项。一起来看,本文的结果表明，这种语音结果是一种有临床意义的语音变化量度。
