The aim of the present study was to develop and validate the CogSAS, which includes the assessment of cognitive domains impaired in AD patients. Compared with previous mobile health scales, the CogSAS is suitable for use in large populations and has good validity, reliability, and feasibility. The scale also demonstrated high diagnostic accuracy for cognitive impairment due to AD, supporting its feasibility for screening and early detection of cognitive impairment due to AD.
The scale was developed through a rigorous process that ensures its credibility and feasibility. During the scale development process, we used Delphi techniques to ensure scale expertise. In addition, CogSAS items were optimized for use in large populations to improve diagnostic accuracy, whereas other scales were mainly reviewed by an expert panel.[22] Unlike in the opinion of experts, database optimization of the CogSAS was more credible. Furthermore, we recruited participants with AD pathology, which improved the credibility of identifying cognitive impairment due to AD. Additionally, we used speech recognition and other human–computer interaction techniques on this scale to reduce the influence of education level. Compared to text, the use of voice prompting and speech recognition could broaden the application of this tool in community screening, regardless of education level. We have also made efforts in Mandarin accent recognition to promote its application in more regions of China. Overall, due to the rigorous development process, the CogSAS has solid credibility and feasibility.
Through the development process, the CogSAS was validated and showed relatively good validity, reliability, and high diagnostic accuracy. The Cronbach’s alpha was 0.81, and the test-retest reliability was 0.82; both of these values are within the acceptable range (0.70–0.90).[23] The validity of previous digital scales was comparable to 0.77 for CANS-MCI, while some others were not well validated.[24] Furthermore, construct validity was 0.74, and criterion validity was 0.77 in the CogSAS. This test thus reached acceptable validity.[25] Previous digital scales showed variable criterion validity (0.21–0.62) and construct validity (0.76–0.77).[24, 26, 27] These results suggest that the CogSAS is credible for identifying people with cognitive impairment.
Diagnostic accuracy was reflected in the sensitivity, specificity, and likelihood ratio. An ideal screening scale should have high sensitivity to ensure follow-up diagnosis in vulnerable individuals,[28] while moderate specificity is acceptable. The CogSAS showed high sensitivity (up to 1.00) and acceptable specificity, suggesting that it is an ideal tool for community screening. Compared with existing digital scales, the sensitivity of these scales varies from 0.41–1.00, and the specificity varies from 0.6–0.96.[4] The CogSAS also showed acceptable likelihood ratios (positive likelihood 2.73–4.54, negative likelihood ratio 0.00–0.15)[29].
The CogSAS showed good performance for discriminating cognitive impairment from AD pathology. First, the scale was designed primarily for participants with cognitive impairment due to AD, using minimal assessments and the most feasible methods. Memory loss is a hallmark of AD, with an emphasis on the characteristic effect on episodic and working memory.[30, 31] Here, we used the sentence memory task to assess episodic memory and a contradicting direction test to assess both working memory and executive function. Second, in assessing criterion validity, a high correlation coefficient was found with both the MMSE and the MoCA, which are well recognized for diagnosing MCI and dementia due to AD.[32] Finally, a higher sensitivity (1.00) was found for detecting cognitive impairment due to AD pathology. Compared with the sensitivities of 0.7–0.9 for existing scales that discriminate cognitive impairment,[4] the CogSAS showed higher sensitivity, suggesting that it may allow more accurate screening for cognitive impairment due to AD.
Despite its strengths, this study was not without limitations. First, the number of subgroups with biomarkers was relatively small; therefore, replication with larger samples is a priority. Second, sensitivity and specificity were assessed only in the clinic; future studies should thus focus on longitudinal community monitoring and mass screening. Finally, the study recruited mainly participants with MCI and mild AD, while subjective cognitive decline (SCD) was included with earlier intervention.