阿尔茨海默病合作研究 - 轻度认知障碍日常生活活动量表（ADCS-MCI-ADL）的心理测量特性：ADCS ADC-008 试验的事后分析。
Psychometric properties of the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Mild Cognitive Impairment (ADCS-MCI-ADL) scale: a post hoc analysis of the ADCS ADC-008 trial.
机构信息
Biogen, Cambridge, MA, USA.
ICON Plc, South San Francisco, CA, USA.
出版信息
BMC Geriatr. 2023 Mar 6;23(1):124. doi: 10.1186/s12877-022-03527-0.
BACKGROUND
The Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale for use in Mild Cognitive Impairment (MCI), the ADCS-ADL-MCI, is an evaluation scale with information provided by an informant/caregiver to describe the functional impairment of patients with MCI. As the ADCS-ADL-MCI has yet to undergo a full psychometric evaluation, this study aimed to evaluate the measurement properties of the ADCS-ADL-MCI in subjects with amnestic MCI.
METHODS
Measurement properties, including item-level analysis, internal consistency reliability, test-retest reliability, construct validity (convergent/discriminant, known-groups validity), and responsiveness were evaluated using data from the ADCS ADC-008 trial, a 36-month, multicenter, placebo-controlled study in 769 subjects with amnestic MCI (defined by clinical criteria and a global clinical dementia rating, CDR, score of 0.5). Due to most subjects' mild condition at baseline and resulting low variance in scores, psychometric properties were assessed using both baseline and 36-month data.
RESULTS
Ceiling effects were not apparent at the total score level, with 3% of the cohort reaching the maximum score of 53, despite most subjects having a relatively high score at baseline (mean score = 46.0 [standard deviation = 4.8]). Item-total correlations were overall weak at baseline, most likely due to low variability in responses; however, at month 36, good item homogeneity was found. Cronbach's alpha values ranged from acceptable (0.64 at baseline) to good (0.87 at month 36), indicating overall very good internal consistency reliability. Further, moderate to good test-retest reliability was found (intraclass correlation coefficients ranging from 0.62-0.73). The analyses also largely supported convergent/discriminant validity, especially at month 36. Finally, the ADCS-ADL-MCI discriminated well between groups showing good known-groups validity, and was responsive in patients who indicated a longitudinal change in other instruments.
CONCLUSIONS
This study provides a comprehensive psychometric evaluation of the ADCS-ADL-MCI. Findings suggest that the ADCS-ADL-MCI is a reliable, valid and responsive measure capable of capturing functional abilities in patients with amnestic MCI.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT00000173.
背景
阿尔茨海默病合作研究 - 日常生活活动量表用于轻度认知障碍（MCI），即 ADCS-ADL-MCI，是一种评估量表，由知情者/护理人员提供信息，以描述 MCI 患者的功能障碍。由于 ADCS-ADL-MCI 尚未进行全面的心理计量学评估，因此本研究旨在评估 ADCS-ADL-MCI 在遗忘型 MCI 患者中的测量特性。
方法
使用来自 ADCS ADC-008 试验的数据评估测量特性，包括项目水平分析、内部一致性信度、重测信度、结构效度（收敛/区分、已知组有效性）和反应性，该试验是一项为期 36 个月、多中心、安慰剂对照的研究，纳入 769 例遗忘型 MCI 患者（根据临床标准和全球临床痴呆评定量表，CDR，评分为 0.5）。由于大多数患者在基线时病情较轻，评分差异较小，因此使用基线和 36 个月的数据评估心理计量特性。
结果
尽管大多数患者在基线时的得分相对较高（平均得分 46.0 [标准差 4.8]），但总分水平并未出现明显的上限效应，只有 3%的患者达到 53 分的最高得分。在基线时，项目与总分的相关性总体较弱，这可能是由于反应的变异性较低；然而，在 36 个月时，发现项目具有良好的同质性。克朗巴赫的 α 值在基线时为可接受（0.64）到良好（0.87），表明总体内部一致性信度非常好。此外，还发现具有中度至良好的重测信度（组内相关系数范围为 0.62-0.73）。分析还在很大程度上支持了收敛/区分效度，尤其是在 36 个月时。最后，ADCS-ADL-MCI 在显示出良好的已知组有效性的组之间很好地区分，并且对其他仪器显示出纵向变化的患者具有反应性。
结论
本研究对 ADCS-ADL-MCI 进行了全面的心理计量学评估。研究结果表明，ADCS-ADL-MCI 是一种可靠、有效且敏感的测量工具，能够捕捉遗忘型 MCI 患者的功能能力。
临床试验注册
ClinicalTrials.gov 标识符：NCT00000173。
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