Observational Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Psychiatr. Jan 19, 2020; 10(1): 1-11
Published online Jan 19, 2020. doi: 10.5498/wjp.v10.i1.1
Validity, reliability, and psychometric properties of a computerized, cognitive assessment test (Cognivue®)
Diego Cahn-Hidalgo, Paul W Estes, Reina Benabou
Diego Cahn-Hidalgo, Internal Medicine of Brighton, Rochester, NY 14623, United States
Paul W Estes, Reina Benabou, Cognivue Inc., Victor, NY 14564, United States
Author contributions: Cahn-Hidalgo D drafted the initial manuscript; Estes PW and Benabou R performed data analysis for this research; and all three authors reviewed and revised the initial draft, and subsequently reviewed and approved the final, submitted manuscript.
Institutional review board statement: The study was reviewed and approved by the Western Institutional Review Boards (WIRB).
Informed consent statement: All study participants provided informed written consent about personal and medical data collection prior to study enrolment.
Conflict-of-interest statement: Dr. Cahn-Hidalgo has acted as a consultant and speaker for Cognivue Inc. Estes PW and Dr. Benabou are employees of Cognivue Inc.
Data sharing statement: Statistical analysis and dataset available from the corresponding author at rbenabou@cognivue.com. Study subjects gave informed consent for anonymized data sharing.
STROBE statement: The authors have read the STROBE statement checklist of items, and the manuscript was prepared and revised according to the STROBE statement checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Reina Benabou, MD, PhD, Cognivue Inc., 7911 Rae Blvd, Victor, NY 14564, United States. rbenabou@cognivue.com
Received: June 20, 2019
Peer-review started: June 23, 2019
First decision: August 20, 2019
Revised: November 14, 2019
Accepted: November 26, 2019
Article in press: November 26, 2019
Published online: January 19, 2020
Research background

The assessment of declining cognitive function due to age or dementia is often impeded by multiple factors such as testing bias, cost, poor measurement efficacy, test inconsistency, and test length. Some tools also specifically require administration by a clinician, adding further constraint to routine testing in clinical practice. Prior research on the neural mechanisms of functional impairment in memory, aging, and dementia has led to the development of a novel computerized testing method.

Research motivation

There is a need for a reliable, easy-to-use, novel method for the early identification, testing, and monitoring of cognitive impairment in at-risk patient populations. Cognivue® is a safe and effective automated method for identifying and tracking cognitive impairment in a more convenient and efficient manner than traditional question and answer paper and pencil testing.

Research objectives

The main objective of the first clinical study was to establish cut-off values for Cognivue® (e.g., impaired, intermediate, and unimpaired cognitive function) relative to the St. Louis University Mental Status (SLUMS). The main objectives of the second study were to clinically validate the agreement between Cognivue® and SLUMS classifications, assess retest reliability of Cognivue®, and assess Cognivue®'s psychometric properties.

Research methods

Participants in the first study completed both the SLUMS and Cognivue® tests. Optimization methods used to determine cut-off values included a minimization algorithm to optimize the negative percent agreement and positive percent agreement between test scores in the objective function and a minimization algorithm with two measures in the objective function (inaccuracy, error bias). Participants in the second study also completed both the SLUMS and Cognivue® tests as well as other traditional neuropsychological tests. Regression analyses of agreement and retest reliability, as well as rank linear regression and factor analysis for psychometric comparisons were conducted, and agreement analysis of the impairment classifications derived from the first study was also performed.

Research results

It was found that Cognivue® scores ≤ 50 would avoid misclassification of an impaired person while providing a conservative standard consistent with cognitive impairment, and that scores ≥ 75 would avoid misclassification of an unimpaired person while providing a conservative cut-off consistent with no impairment. In the second study, Cognivue® demonstrated good validity and psychometric properties, as well as superior test-retest reliability compared to the SLUMS.

Research conclusions

With its unique adaptive psychophysics technology, Cognivue® provides a computerized tool for the automated assessment of cognitive functioning free from many of the biases and limitations of the more traditional paper and pencil methods such as sensitivity, subjectivity, test-retest reliability, and educational, language, gender, and cultural biases. Improved prognosis and decreased morbidity may be possible with an earlier implementation of management strategies in patients with cognitive impairment identified earlier in its course. Because Cognivue® is self-administered it provides clinicians with a safe, effective, and time-saving method to efficiently assist in the assessment and monitoring of cognitive impairment in their patients.

Research perspectives

Trials assessing the utility of Cognivue® in other, specific patient populations are currently in progress. Additionally, the ability of Cognivue® to monitor the deterioration of cognitive function over time is currently being assessed in longitudinal studies.