Sato Kenichiro, Ihara Ryoko, Niimi Yoshiki, Suzuki Kazushi, Iwata Atsushi, Iwatsubo Takeshi
Department of Neuropathology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital, Tokyo, Japan.
J Alzheimers Dis Rep. 2025 Jun 9;9:25424823251349188. doi: 10.1177/25424823251349188. eCollection 2025 Jan-Dec.
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.
We aim to investigate how audio review contributes to the QA/QC process.
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.
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).
These findings indicate that audio review can serve as an effective QA/QC measure by reducing non-adherence to assessment standards.
针对临床前阿尔茨海默病（AD）的临床试验需要准确的认知评估，以检测随时间推移的细微变化。评估环节的音频审查已被提议作为一种质量保证（QA）和质量控制（QC）措施，但关于其有效性的证据仍然有限。
我们旨在研究音频审查如何促进QA/QC流程。
在日本试验就绪队列（J-TRC）现场研究中，对194次临床前阿尔茨海默病认知综合测试（PACC）环节进行了音频录制并独立审查。审查人员是经过预培训的认证心理测量师。音频审查员针对需要修改分数的评分偏差发出“询问”，针对程序偏差或建议改进发出“评论”。混合效应模型分析了询问/评论数量与（1）PACC检查累计经验和（2）单个审查员收到的累计反馈之间的关联。
在194次审查的环节中，63.4%至少包含一个询问，84.5%包含一个或多个评论。每位审查员的PACC环节累计数量越多，询问数量越少，且随着时间推移分数变化越小。值得注意的是，反馈报告的累计数量与评论数量显著减少相关，表明有针对性的反馈有助于改进审查员的测试方式。然而，累计反馈与评分偏差（询问）的频率没有明显关联。
这些发现表明，音频审查可通过减少对评估标准的不遵守作为一种有效的QA/QC措施。
