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真实世界、多国、回顾性观察性研究:ADAS-Cog 与阿尔茨海默病患者医疗资源利用的关联。

Real-World, Multinational, Retrospective Observational Survey of the ADAS-Cog and Associations with Healthcare Resource Utilization in Patients with Alzheimer's Disease.

出版信息

J Alzheimers Dis. 2018;64(3):899-910. doi: 10.3233/JAD-180306.

Abstract

BACKGROUND

Alzheimer's disease (AD) is one of the most costly conditions, both economically and regarding patient disability and dependency. The huge costs coupled with the predicted increase in prevalence worldwide are likely to challenge healthcare systems in the future. The classic version of the Alzheimer's Disease Assessment Scale-Cognition subscale (ADAS-Cog) is generally seen as the current gold standard primary outcome measure of cognitive symptom progression in dementia clinical trials.

OBJECTIVE

This study evaluated the relationship between ADAS-Cog scores as a measure of clinical progression and the healthcare resource utilization (HCRU)-measured burden of cognitive impairment in patients with mild cognitive impairment, AD, or suspected AD in the real world.

METHODS

A retrospective observational survey of physicians and their consulting patients with multiple ADAS-Cog scores. Regression models were constructed for HCRU variables (e.g., consultations, hospitalizations, caregiving requirements) with ADAS-Cog rate of change, baseline ADAS-Cog, and their interaction included as exposure variables.

RESULTS

651 patient records were completed by 154 physicians. Approximately 70% of patients had mild to moderate dementia. In 56.7% of patients, clinical progression was maintained/stable from baseline. Mean change in ADAS-Cog (adjusted to 12 months) was 2.8 points and change scores increased with increasing dementia severity. Most HCRU variables increased significantly (p < 0.05; joint test) with increasing ADAS-Cog scores (indexing clinical deterioration).

CONCLUSION

The results suggest that further understanding the relationship between HCRU and ADAS-Cog changes in real-world clinical practice could potentially provide a baseline upon which the success of disease-modifying, as well as newer symptomatic, dementia therapies can be judged.

摘要

背景

阿尔茨海默病(AD)是最昂贵的疾病之一,无论是在经济方面,还是在患者的残疾和依赖方面。巨大的成本加上全球预计的患病率增加,未来可能会对医疗保健系统构成挑战。阿尔茨海默病评估量表认知分量表(ADAS-Cog)的经典版本通常被视为痴呆症临床试验中认知症状进展的当前黄金标准主要结局测量指标。

目的

本研究评估了 ADAS-Cog 评分作为临床进展的衡量指标与在现实世界中轻度认知障碍、AD 或疑似 AD 患者的认知障碍医疗资源利用(HCRU)测量负担之间的关系。

方法

对多名具有多次 ADAS-Cog 评分的医生及其就诊患者进行回顾性观察性调查。使用 ADAS-Cog 变化率、基线 ADAS-Cog 及其交互项作为暴露变量,构建了 HCRU 变量(如咨询、住院、护理需求)的回归模型。

结果

154 名医生完成了 651 份患者记录。大约 70%的患者患有轻度至中度痴呆。在 56.7%的患者中,临床进展从基线开始保持/稳定。ADAS-Cog 的平均变化(调整至 12 个月)为 2.8 分,且变化评分随痴呆严重程度的增加而增加。大多数 HCRU 变量(联合检验,p<0.05)随 ADAS-Cog 评分(指示临床恶化)的增加而显著增加。

结论

研究结果表明,进一步了解现实临床实践中 HCRU 与 ADAS-Cog 变化之间的关系,可能为判断疾病修饰以及新型症状性痴呆症疗法的成功提供基线。

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