Publication
Title
Deliberating clinical research with cognitively impaired older people and their relatives : an ethical add-on study to the protocol "effects of temporary discontinuation of antihypertensive treatment in the elderly (DANTE) with cognitive impairment"
Author
Abstract
Objectives: To explore the decision-making process involving elderly subjects with mild cognitive impairment and a relative when asked to participate in a clinical trial. Design, Setting, and Participants: In this qualitative study, we investigated the decision-making process during the informed consent conversations between the researchers of a clinical trial and 18 persons aged 75 years and older, with a Minie Mental State Examination score >= 21 and <= 27. This assessment was performed by both observation and a standardized interview with the older person and a close relative who could act as a proxy (surrogate) decision maker, if necessary. The informed consent conversation and procedure took place at the home of the potential participants. Measurements: Videotapes or audiotapes were transcribed and analyzed by using coding schemes. Results: The participants were able to formulate substantial reasons why they would want to participate in the clinical trial. Willingness to help others and contribute to medical knowledge, combined with the absence of substantial risks, were predominant reasons for participation. Most older subjects did consult their relatives, who generally considered them capable of deciding for themselves. Conclusions: Notwithstanding their (mild) cognitive impairment, these older subjects were able to formulate substantiated reasons for participation in a clinical trial. Thus, it is plausible that they were capable of making this decision themselves, which was affirmed by their relatives. Recognition of the desire to contribute unselfishly to research that might benefit others has important implications for future clinical research conducted in older people with mild cognitive impairment.
Language
English
Source (journal)
American journal of geriatric psychiatry. - Arlington, Va
Publication
Arlington, Va : 2014
ISSN
1064-7481
DOI
10.1016/J.JAGP.2013.04.005
Volume/pages
22 :11 (2014) , p. 1233-1240
ISI
000343856600019
Full text (Publisher's DOI)
UAntwerpen
Faculty/Department
Research group
Publication type
Subject
External links
Web of Science
Record
Identifier
Creation 17.11.2016
Last edited 16.02.2023
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