Audio review as a measure of quality assurance and control of cognitive assessments in Alzheimer's disease studies: An experience from Japanese Trial-Ready Cohort Study.

Background: Clinical trials targeting preclinical Alzheimer's disease (AD) require accurate cognitive assessments to detect subtle changes over time. Audio review of assessment sessions has been proposed as a quality assurance (QA) and control (QC) measure, yet evidence regarding its effectiveness remains limited.

Objective: We aim to investigate how audio review contributes to the QA/QC process.

Methods: In the Japanese Trial-Ready Cohort (J-TRC) onsite study, 194 Preclinical Alzheimer's Cognitive Composite (PACC) sessions were audio-recorded and independently reviewed. Examiners were certified psychometrists who had undergone pre-training. Audio reviewers issued "queries" for scoring deviations warranting score amendments and "comments" for procedural deviations or recommended improvements. Mixed-effects models analyzed associations between the number of queries/comments and (1) cumulative PACC examination experience and (2) cumulative received feedback for individual examiners.

Results: Of 194 reviewed sessions, 63.4% contained at least one query, and 84.5% included one or more comments. A higher cumulative number of PACC sessions by each examiner was associated with fewer queries and smaller score changes over time. Notably, the cumulative number of feedback reports was significantly associated with a lower number of comments, suggesting targeted feedback helped refine examiners' testing manner. However, cumulative feedback was not clearly linked to the frequency of scoring deviations (queries).

Conclusions: These findings indicate that audio review can serve as an effective QA/QC measure by reducing non-adherence to assessment standards.