Capacity to consent to research in older adults with normal cognitive functioning, mild and major neurocognitive disorder: an Italian study

Background: A specific evaluation of the capacity to consent to research in older adults with cognitive decline is often not included routinely in research practice. However, there is a need to evaluate this competence adopting brief standardized instruments to guarantee their ethical rights. The pr...

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Main Authors: Federica Del Signore, Alessia Rosi, Rocco Palumbo, Nicola Allegri, Alfredo Costa, Stefano Govoni, Elena Cavallini
Format: Article
Language:English
Published: University of Messina 2023-04-01
Series:Mediterranean Journal of Clinical Psychology
Subjects:
Online Access:https://cab.unime.it/journals/index.php/MJCP/article/view/3620
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author Federica Del Signore
Alessia Rosi
Rocco Palumbo
Nicola Allegri
Alfredo Costa
Stefano Govoni
Elena Cavallini
author_facet Federica Del Signore
Alessia Rosi
Rocco Palumbo
Nicola Allegri
Alfredo Costa
Stefano Govoni
Elena Cavallini
author_sort Federica Del Signore
collection DOAJ
description Background: A specific evaluation of the capacity to consent to research in older adults with cognitive decline is often not included routinely in research practice. However, there is a need to evaluate this competence adopting brief standardized instruments to guarantee their ethical rights. The present study evaluated in older adults with normal cognitive functioning, and major and mild neurocognitive disorders whether the Mini-Mental State Examination (MMSE) and a brief battery of neuropsychological tests are sensitive and specific to discriminate subjects able to provide consent to research. Methods: 54 participants with Major Neurocognitive Disorder (MajorNCD), 22 with Mild Neurocognitive Disorder (MildNCD), and 37 Normal Cognitive Functioning individuals (NCF). The capacity to provide consent was assessed using the MacArthur Competence Assessment Tool for Clinical Research. Cognitive functioning was assessed using the MMSE, Verbal Fluency Tests, Trail Making Test (TMT-A), Immediate and Delayed Recall Test. Results: In the MildNCD and NCF groups, the aggregate score of neuropsychological tests showed high sensitivity and specificity in classifying subjects able to provide consent to research. In the MajorNCD group, MMSE, Recall test, and TMT-A performed better than the aggregate score in classifying subjects as able of consenting to the hypothetical research. Conclusion: The choice of the best tool to assess the ability to provide consent to research may depend on the degree of cognitive impairment. MMSE is a good tool for subjects with MajorNCD. A more comprehensive battery of neuropsychological tests would represent a better tool in NCF and MildNCD individuals.
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spelling doaj.art-6d8e9f1ccd9940f5bf1bda7f54f610122023-05-08T09:48:27ZengUniversity of MessinaMediterranean Journal of Clinical Psychology2282-16192023-04-0111310.13129/2282-1619/mjcp-36202964Capacity to consent to research in older adults with normal cognitive functioning, mild and major neurocognitive disorder: an Italian studyFederica Del Signore0Alessia Rosi1Rocco Palumbo2Nicola Allegri3Alfredo Costa4Stefano Govoni5Elena Cavallini6<p>Golgi Cenci Foundation, Abbiategrasso; Fondazione Marzotto, Mortara</p><p>Brain and Behavioral Sciences Department, University of Pavia, Pavia</p><p>Department of Psychological, Health and Territorial Sciences, University G. d’Annunzio of Chieti-Pescara, Chieti</p><p>CEFAT (Center of Pharmaceuticals Economics and Medical Technologies Evaluation), University of Pavia, Pavia; IRCCS Mondino Foundation, Pavia</p>Brain and Behavioral Sciences Department, University of Pavia, Pavia; IRCCS Mondino Foundation, PaviaCEFAT (Center of Pharmaceuticals Economics and Medical Technologies Evaluation), University of Pavia, Pavia; Drug Sciences Department, University of Pavia, PaviaBrain and Behavioral Sciences Department, University of Pavia, PaviaBackground: A specific evaluation of the capacity to consent to research in older adults with cognitive decline is often not included routinely in research practice. However, there is a need to evaluate this competence adopting brief standardized instruments to guarantee their ethical rights. The present study evaluated in older adults with normal cognitive functioning, and major and mild neurocognitive disorders whether the Mini-Mental State Examination (MMSE) and a brief battery of neuropsychological tests are sensitive and specific to discriminate subjects able to provide consent to research. Methods: 54 participants with Major Neurocognitive Disorder (MajorNCD), 22 with Mild Neurocognitive Disorder (MildNCD), and 37 Normal Cognitive Functioning individuals (NCF). The capacity to provide consent was assessed using the MacArthur Competence Assessment Tool for Clinical Research. Cognitive functioning was assessed using the MMSE, Verbal Fluency Tests, Trail Making Test (TMT-A), Immediate and Delayed Recall Test. Results: In the MildNCD and NCF groups, the aggregate score of neuropsychological tests showed high sensitivity and specificity in classifying subjects able to provide consent to research. In the MajorNCD group, MMSE, Recall test, and TMT-A performed better than the aggregate score in classifying subjects as able of consenting to the hypothetical research. Conclusion: The choice of the best tool to assess the ability to provide consent to research may depend on the degree of cognitive impairment. MMSE is a good tool for subjects with MajorNCD. A more comprehensive battery of neuropsychological tests would represent a better tool in NCF and MildNCD individuals.https://cab.unime.it/journals/index.php/MJCP/article/view/3620informed consentdecision makingcognitive dysfunctionagingexecutive functionmemory.
spellingShingle Federica Del Signore
Alessia Rosi
Rocco Palumbo
Nicola Allegri
Alfredo Costa
Stefano Govoni
Elena Cavallini
Capacity to consent to research in older adults with normal cognitive functioning, mild and major neurocognitive disorder: an Italian study
Mediterranean Journal of Clinical Psychology
informed consent
decision making
cognitive dysfunction
aging
executive function
memory.
title Capacity to consent to research in older adults with normal cognitive functioning, mild and major neurocognitive disorder: an Italian study
title_full Capacity to consent to research in older adults with normal cognitive functioning, mild and major neurocognitive disorder: an Italian study
title_fullStr Capacity to consent to research in older adults with normal cognitive functioning, mild and major neurocognitive disorder: an Italian study
title_full_unstemmed Capacity to consent to research in older adults with normal cognitive functioning, mild and major neurocognitive disorder: an Italian study
title_short Capacity to consent to research in older adults with normal cognitive functioning, mild and major neurocognitive disorder: an Italian study
title_sort capacity to consent to research in older adults with normal cognitive functioning mild and major neurocognitive disorder an italian study
topic informed consent
decision making
cognitive dysfunction
aging
executive function
memory.
url https://cab.unime.it/journals/index.php/MJCP/article/view/3620
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