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An Evaluation of Empirical Approaches for Defining Cognitive Impairment in Amyotrophic Lateral Sclerosis
medRxiv - Neurology Pub Date : 2020-12-26 , DOI: 10.1101/2020.12.23.20248410
Corey T. McMillan , Joanne Wuu , Katya Rascovsky , Stephanie Cosentino , Murray Grossman , Lauren Elman , Colin Quinn , Luis Rosario , Jessica H. Stark , Volkan Granit , Hannah Briemberg , Sneha Chenji , Annie Dionne , Angela Genge , Wendy Johnston , Lawrence Korngut , Christen Shoesmith , Lorne Zinman , Sanjay Kalra , Michael Benatar ,

Importance: Amyotrophic lateral sclerosis (ALS) is a multi-system disorder characterized primarily by motor neuron degeneration, but may be accompanied by cognitive dysfunction. Statistically appropriate criteria for establishing cognitive impairment (CI) in ALS are lacking. Objective: Define thresholds for CI in ALS using quantile regression (QR) that accounts for age and education in a North American (NAmer) cohort. Design: QR of cross-sectional data from a multi-center NAmer cohort of healthy adults was used to model the 5th percentile of cognitive scores on the Edinburgh Cognitive and Behavioral ALS Screen (ECAS). The QR approach was compared to a traditional 2 standard deviation (SD) cut-off approach using the same NAmer cohort (2SD-NAmer) and to existing UK-based normative data derived using the 2SD approach (2SD-UK) to assess the impact of cohort selection and statistical model in identifying CI ALS patients. Participants: 269 healthy adults from NAmer, recruited by the University of Pennsylvania (PENN; N=82), the University of Miami through the CRiALS study (CRiALS; N=40), and the Canadian ALS Neuroimaging Consortium (CALSNIC; N=147) were included to establish ECAS thresholds for defining CI. We then evaluated the frequency of CI in 182 ALS patients from PENN. Main Outcomes: We defined two new sets of normative thresholds, based on NAmer heathy adult performance, for each ECAS domain score and the composite scores using QR and 2SD statistical approaches. We then applied the 2SD-NAmer and QR-NAmer, as well as the previously established and widely-used 2SD-UK, thresholds to evaluate the frequency of CI in ALS patients. Results: QR-NAmer models revealed that increased age and reduced educational attainment negatively impact cognitive performance on the ECAS. Based on the QR-NAmer normative cutoffs, the prevalence of CI in the 182 PENN ALS patients was 15.9% for ECAS ALS-Specific and 15.4% for ECAS Total. These estimates are more conservative than estimates ranging from 15.4%-34.6% impaired based on 2SD approaches. Conclusions and Relevance: This report establishes normative thresholds for using ECAS to identify whether ALS patients in the NAmer population have CI. The choice of statistical method and normative cohort has a substantial impact on defining CI in ALS.

中文翻译:

定义肌萎缩性侧索硬化症认知障碍的经验方法的评价

重要性:肌萎缩性侧索硬化症(ALS)是一种多系统疾病,主要表现为运动神经元变性,但可能伴有认知功能障碍。缺乏建立ALS认知障碍(CI)的统计上适当的标准。目的:使用分位数回归(QR)定义ALS中CI的阈值,该阈值考虑了北美(NAmer)队列中的年龄和受教育程度。设计:使用来自健康成年人多中心NAmer队列的横截面数据QR在爱丁堡认知与行为ALS屏幕(ECAS)上对认知得分的第5个百分位数建模。使用相同的NAmer队列(2SD-NAmer)将QR方法与传统的2标准差(SD)截止方法进行比较,并使用2SD方法(2SD-UK)将QR方法与基于英国的现有标准数据进行比较,以评估影响人群选择和统计模型对CI ALS患者的识别 参与者:269位来自NAmer的健康成年人,分别由宾夕法尼亚大学(PENN; N = 82),迈阿密大学通过CRiALS研究(CRiALS; N = 40)和加拿大ALS神经影像学协会(CALSNIC; N = 147)招募)包含在内,以建立用于定义CI的ECAS阈值。然后,我们评估了来自PENN的182名ALS患者的CI发生率。主要结果:我们根据NAmer健壮的成人表现定义了两组新的规范性阈值,使用QR和2SD统计方法对每个ECAS域得分和综合得分进行评估。然后,我们使用2SD-NAmer和QR-NAmer以及先前建立和广泛使用的2SD-UK阈值来评估ALS患者的CI频率。结果:QR-NAmer模型显示年龄增加和教育程度降低对ECAS的认知表现产生负面影响。根据QR-NAmer规范性标准,在182例PENN ALS患者中,对于ECAS ALS-Specific,CI的患病率为15.9%,对于ECAS总数为15.4%。这些估计比基于2SD方法受损的15.4%-34.6%的估计更为保守。结论与相关性:本报告建立了使用ECAS识别NAmer人群中ALS患者是否患有CI的标准阈值。
更新日期:2020-12-26
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