Validity, reliability, and psychometric properties of a computerized, cognitive assessment test (Cognivue®)

Table 1 Components of the Cognivue^® quantitative assessment tool

Sub-battery and Sub-test	Description
Basic motor and visual ability
Adaptive motor control test	Assesses visuomotor responsiveness using speed and accuracy measures
	Measures subject’s ability to control the rotatory movement of the CogniWheel™ in response to rotational visual stimuli
Visual salience test	Assesses basic visual processing functions
	Measures the subject’s ability to identify a wedge filled by a random pattern of black and white dots shown on an neutral (gray) background
Perceptual processing
Letter discrimination	Measures the subject’s perceptual processing of different forms, despite the addition of increasing amounts of clutter
	Discriminate real English letters from a variety of non-letter, letter-like shapes
Word discrimination	As above
	Discriminate real 3-letter words from 3-letter non-words
Shape discrimination	As above
	Discriminate a circle filled with a common shape from the rest of the display filled with other common shapes
Motion discrimination	As above
	Discriminate a circle filled with one direction of dot motion from the rest of the display filled with another direction of dot motion
Memory processing
Letter memory	Assesses memory using specialized sets of visual stimuli
	Measures the subject’s ability to recall which letter was presented as a pre-cue, and then select that letter from a display of alternative items, despite the addition of increasing amounts of clutter
	Select the correct letter of the English alphabet
Word memory	As above
	Select the correct 3-letter word
Shape memory	As above
	Select the correct shape
Motion memory	As above
	Select the correct direction of motion

Table 2 Summary of the purpose and analyses of the components of the Food and Drug Administration pivotal clinical trial of Cognivue^®

Validation of classification scores	Purpose: Assess the validity of the previously defined Cognivue® cut-off scores in a larger sample of subjects
	Methods: Scores on Cognivue® and SLUMS were compared using regression and classification analyses. PPA and NPA were calculated
Assessment of retest reliability	Purpose: Compare scores from repeated administration of Cognivue® to assess retest reliability, compare findings to parallel results from SLUMS
	Methods: Repeated Cognivue® and SLUMS testing was conducted in 2 sessions 1-2 wk apart with regression and rank linear regression analysis being performed
Assessment of score psychometrics vs other neuropsychological tests	Purpose: Compare scores on Cognivue® and other neuropsychological tests to describe relationship and compare them to SLUMS
	Methods: 401 participants completed 10 different tests [SLUMS, SLUMS-clock drawing1, SLUMS-animal naming1, RAVLT, TMT-A, TMT-B, Benton JOLO, figural memory, PPB, HVCS, GDS (15-item)]; rank linear regression analysis and factor analysis performed

¹Scored separately from overall St. Louis University Mental Status. GDS: Geriatric Depression Scale; HVCS: Hamilton-Veale Contrast Sensitivity; JOLO: Judgment of line orientation; NPA: Negative percent agreement; PPA: Positive percent agreement; PPB: Purdue Peg Board; RAVLT: Rey Auditory Verbal Learning Test; SLUMS: St. Louis University Mental Status; TMT-A: Trail Making Test-A; TMT-B: Trail Making Test-B.

Table 3 Summary of Cognivue^® cut-off score analysis

	SLUMS cut-off scores		Cognivue® cut-off scores
Impaired	< 21	→	≤ 50
Mildly impaired (intermediate)	21-26	→	51-74
Unimpaired	> 26	→	≥ 75

SLUMS: St. Louis University Mental Status.

Table 4 Proportion of participants classified in each impairment category by first and second Cognivue^® tests

2nd Test	1st Test
	Impaired	Intermediate	Unimpaired	Total
Impaired	42 (89%)	21	0	63
Intermediate	5	41 (57%)	32	78
Unimpaired	0	10	207 (87%)	217
Total	47	72	239	358

Table 5 Factor analysis component matrix for the neuropsychological test scores indicating correlations with Cognivue^®

	Component
	1	2	3	4	5
SLUMS-clock drawing	0.420	0.338	0.038	0.367	-0.049
SLUMS-animal naming	0.5291	0.346	0.146	0.365	-0.125
RAVLT-A-1	0.7181	0.209	0.034	0.128	-0.040
RAVLT-A-2	0.8201	0.204	0.080	0.157	-0.138
RAVLT-A-3	0.8321	0.193	0.120	0.190	-0.057
RAVLT-A-4	0.8471	0.200	0.143	0.184	-0.040
RAVLT-A-5	0.8631	0.210	0.080	0.182	-0.013
RAVLT-B-1	0.5791	0.213	0.104	0.178	-0.060
RAVLT-A-6	0.8521	0.134	0.093	0.170	-0.051
RAVLT-A-7	0.8601	0.159	0.117	0.164	-0.040
RAVLT-hits	0.6701	0.052	0.128	0.252	-0.003
RAVLT-fps	-0.408	-0.017	-.111	-0.041	0.125
Peg Board-Left	0.247	0.7962	0.297	0.120	-0.090
Peg Board-Right	0.297	0.7522	0.206	0.160	-0.186
Peg Board-Bimanual	0.293	0.8222	0.230	0.134	-0.137
Contrast-Left	0.146	0.133	0.8013	0.110	-0.068
Contrast-Right	0.160	0.156	0.8023	0.094	-0.106
Contrast-Binocular	0.189	0.183	0.8333	0.132	-0.153
TMT-B-Time	-0.312	-0.088	-0.213	-0.7884	0.116
TMT-B-Errors	-0.266	-0.072	-0.197	-0.8154	0.085
Benton JOLO	0.185	0.196	-0.024	0.4994	-0.344
TMT-A-Time	-0.115	-0.185	-0.158	-0.150	0.8625
TMT-A-Errors	-0.081	-0.058	-0.134	-0.068	0.9025
Figural memory	0.272	0.243	0.202	0.376	0.047
GDS	-0.119	-0.341	0.207	-0.329	-0.008

¹Cognivue^® scores most closely correlated with verbal processing (animal naming and Rey Auditory Verbal Learning Test);

²Cognivue^® scores most closely correlated with manual dexterity and speed (Peg Board);

³Cognivue^® scores most closely correlated with visual acuity (contrast sensitivity);

⁴Cognivue^® scores most closely correlated with visuospatial and executive function (Trails B and judgment of line orientation);

⁵Cognivue^® scores most closely correlated with speed and sequencing (Trails A). Fps: Frames per second; GDS: Geriatric Depression Scale; JOLO: Judgment of line orientation; RAVLT: Rey Auditory Verbal Learning Test; SLUMS: St. Louis University Mental Status; TMT: Trail Making Test.