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性格特征会影响参与临床试验吗?

Could Temperamental Features Modulate Participation in Clinical Trials?

作者信息

Cintoli Simona, Elefante Camilla, Radicchi Claudia, Brancati Giulio Emilio, Bacciardi Silvia, Bonaccorsi Joyce, Siciliano Gabriele, Maremmani Icro, Perugi Giulio, Tognoni Gloria

机构信息

Neurology Unit, Santa Chiara University Hospital, 56126 Pisa, Italy.

Psychiatry Unit, Department of Clinical and Experimental Medicine, University of Pisa, 56126 Pisa, Italy.

出版信息

J Clin Med. 2023 Jan 31;12(3):1121. doi: 10.3390/jcm12031121.

Abstract

The prodromal stages of Alzheimer's disease (AD) are the primary focus of research aimed at slowing disease progression. This study explores the influence of affective temperament on the motivation of people with mild cognitive impairment (MCI) and subjective cognitive decline (SCD) to participate in clinical trials. One hundred four subjects with MCI and SCD were screened for participation in pharmacological and non-pharmacological trials. Affective temperament was assessed based on the Temperament Evaluation of the Memphis, Pisa, Paris and San Diego (TEMPS) scale. Demographic variables and temperament subscales scores were compared between MCI and SCD patients and among patients participating in the pharmacological trial, the non-pharmacological trial and refusing participation. Twenty-one subjects consented to participate in the pharmacological trial, seventy consented to the non-pharmacological trial and thirteen refused to participate in any trial. Patients with SCD had greater education and more depressive temperamental traits than those with MCI. While older age, higher education and anxious temperament were negatively associated with participation in the pharmacological trial, irritable temperamental positively predicted pharmacological trial participation. In conclusion, temperamental features may affect the willingness of patients with MCI and SCD to take part in clinical trials and, especially, the choice to participate in pharmacological studies.

摘要

阿尔茨海默病(AD)的前驱期是旨在减缓疾病进展的研究的主要焦点。本研究探讨了情感气质对轻度认知障碍(MCI)和主观认知下降(SCD)患者参与临床试验动机的影响。对104名患有MCI和SCD的受试者进行了筛选,以参与药物和非药物试验。基于孟菲斯、比萨、巴黎和圣地亚哥气质评估(TEMPS)量表对情感气质进行评估。比较了MCI和SCD患者之间以及参与药物试验、非药物试验和拒绝参与的患者之间的人口统计学变量和气质子量表得分。21名受试者同意参与药物试验,70名同意参与非药物试验,13名拒绝参与任何试验。与MCI患者相比,SCD患者受教育程度更高,抑郁气质特征更多。虽然年龄较大、受教育程度较高和焦虑气质与参与药物试验呈负相关,但易怒气质正向预测药物试验参与情况。总之,气质特征可能会影响MCI和SCD患者参与临床试验的意愿,尤其是参与药物研究的选择。

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