Superior Test-Retest Reliability of Cognitive Assessment with Cognivue® vs Slums During an 18-Month Longitudinal Study

Fred Ma,

Published on: 2021-01-25

Abstract

Background: Cognivue® is an FDA-cleared computerized testing tool designed to assess early signs of cognitive impairment. In an FDA-regulated clinical study for device clearance, Cognivue demonstrated good agreement with the St. Louis University Mental Status (SLUMS) and other neuropsychological tests, and superior test re-test reliability compared to SLUMS across 2 sessions, 1 to 2 weeks apart (Cognivue regression fit: R2 = 0.81, r = 0.90); SLUMS regression fit: R2 = 0.67, r = 0.82). Further follow-up long-term data analysis within this cohort was done to study Cognivue’s test re-test reliability vs SLUMS over time.

Methods: 238 subjects from the FDA-regulated clinical study for device clearance enrolled in the longitudinal study. They underwent the Cognivue test and SLUMS at up to 5 sessions over the course of 18 months. Sessions 1 and 2 were 1 week apart and were in addition to the FDA sessions. These were followed by sessions at 6, 12, and 18 months. An analysis of linear regression test-retest reliability was performed for both tests. In a separate sub-analysis, the medical records of those subjects were analyzed to determine the correlation, if any, between comorbidities or medication usage and Cognivue score.

Results: Among these 238 patients, Cognivue demonstrated similar linear regression scores across comparisons (test session 1&2: regression fit: R2 = 0.76; r = 0.87; test session 1&3: regression fit: R2 = 0.72; r = 0.85; test session 1&4: regression fit: R2 = 0.73; r = 0.86). The SLUMS test demonstrated greater variability in regression scores across test sessions (test session 1&2: regression fit: R2 = 0.63; r = 0.79; test session 1&3: regression fit: R2 = 0.43 r = 0.65; test session 1&4: regression fit: R2 = 0.64; r = 0.80).

In the sub analysis, medical records of 203 subjects were analyzed. Overall, an increased co-morbidity count significantly decreased subjects’ Cognivue scores (correlation -0.21; P=0.01). Cardiopulmonary comorbidities had the largest impact on a patient’s Cognivue score (78.0 average score for those without this comorbidity vs 67.1 average score for those with; P<0.001). Use of anti-HTN medications was significantly correlated with a decrease in subjects’ Cognivue scores (correlation -0.2; P=0.02).

Conclusions: Cognivue demonstrated maintained superior test re-test reliability compared to SLUMS over up to 5 test sessions in a period of 18 months after the FDA-regulated clinical study for device clearance. An increased comorbidity count and cardiopulmonary comorbidities significantly decreased a subject’s Cognivue.

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