Demented patients' participation in a clinical trial: factors affecting the caregivers' decision

Elad, P.; Treves, T. A.; Drory, Margalit; Verchovsky, R.; Klimovitsky, S.; Ben-Laish, S.; Yaron, S.; Ginzburg, Karni; Korczyn, Amos D.

doi:10.1002/(sici)1099-1166(200004)15:4<325::aid-gps117>3.0.co;2-9

Cited by 23 publications

(25 citation statements)

References 13 publications

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“…Little is known about the attitudes of bowel-treatment clinical trial groups clinical trial participants: their opinion (Madsen et al, 2000), outpatients (Madof clinical research, their expectations sen et al, 1999), and carers of dementia of trial participation, or their experipatients (Elad et al, 2000; Karlawish et ence during trials (Karlawish et al, al., 2001). We sought to explore these 2001).…”

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confidence: 99%

“…The limited evidence available suggests that participation in clinical trials is motivated by altruism, with carers of patients seeking enrollment t o benefit other people (Karlawish et al, 2001) and to help future patients and science in general (Elad et al, 2000;Madsen et al, 2000;Terenius, 2000). Madsen and colleagues (1999) found that one third of trial participants felt a moral obligation to participate.…”

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confidence: 99%

“…In addition, most would have done "absolutely anything t o improve the plight of their loved one" (Karlawish et al, 2001). Carers also hoped to ease their own burden of care through improving the quality of life of the patient (Karlawish et al, Other reasons given for enrolling in clinical trials were trust in the physician (Karlawish et al, 2001), access to new drugs (Karlawish et al, 2001;Madsen et al, 2000), the wish to be closely monitored (Madsen et al, 2000), family pressure, and a sense of responsibility for the patient (Elad et a]., 2000).…”

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confidence: 99%

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Carer Impressions of Participation in Alzheimer's Disease Clinical Trials: What Are Their Hopes? And Is It Worth It?

Mastwyk

Ritchie

LoGiudice

et al. 2002

Int. Psychogeriatr.

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Background: We aimed to assess why carers seek participation for their relatives in clinical trials of Alzheimer's disease (AD) medications, and to assess carer impressions of the value of trial participation. Method: A retrospective questionnaire was sent to 31 carers of participants in clinical trials for AD conducted at the Mental Health Research Institute and the National Aging Research Institute between January 1997 and December 1999. Results: Twenty-five questionnaires (81%) were returned, completed to an extent to permit analysis. Helping a relative feel better, contributing to medical science, and hoping for a cure were the main reasons for trial participation. In general, carers found the regular consultation with research staff supportive and would recommend trial participation to others. Conclusion: A greater understanding of the motivations of carers may aid the recruitment and retention of participants in clinical trials.

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confidence: 99%

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confidence: 99%

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confidence: 99%

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Carer Impressions of Participation in Alzheimer's Disease Clinical Trials: What Are Their Hopes? And Is It Worth It?

Mastwyk

Ritchie

LoGiudice

et al. 2002

Int. Psychogeriatr.

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“…Caregivers expect the patients to benefit directly from involvement in such studies, although they also acknowledge that help to others and advancement of science in general are also important outcomes [8]. Interestingly, a recent study showed that past participation in a drug study led caregivers to refrain from agreeing to participate in a new one [9].…”

Section: The Caregivermentioning

confidence: 99%

Drug Trials in Dementia: Challenging Ethical Dilemmas

Korczyn

2007

CAR

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Advances in the treatment of demented individuals is critically dependent upon experimental administration of new drugs to such people, who, by definition, frequently cannot provide informed consent. Ethical problems associated with studies on demented individuals are therefore of great importance. While there is some similarity to other groups (children, psychotic individuals and patients in coma) there also exist several differences. Obtaining an informed consent from a dementing individual is always problematic. Advance directives are helpful to caregivers and patients should be encouraged, at early stages of the disease, to provide them. Participation in drug studies carries inherent benefits to patients, but at the same time exposes them to risks and discomforts which should be monitored and reviewed more intensively than in studies on cognitively intact individuals. The vulnerability of demented people and their dependence requires special attention by the institutional review board (IRB), unique items to be included in the study protocols and consent forms, etc. Representatives of patients' advocacy groups can make important contributions to the IRB, to serve the best interests of the patient and prevent exploitation by the industry as well as by researchers, and honoring the autonomy of the patients. It would be helpful and justified to enable subjects to continue in the study in an open-label design in this situation, once they sign a suitable informed consent. A no-fault insurance could be provided to the patient in this situation.

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“…The decisionmaking process involving those with impaired cognitive skills is particularly important, for example in discussions of consent (e.g. High, 1992;Elad et al, 2000) and the aggressiveness of medical care in relation to end-of-life decisions (e.g. Luchins and Hanrahan, 1993;Dautzenberg et al, 1996;Mitchell et al, 2000).…”

Section: Excluding Dementiamentioning

confidence: 99%

Cognitive Citizenship: Access to Hip Surgery for People with Dementia

Graham

2004

Health (London)

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Dementia and chronic hip disease are both more prevalent with advancing age. Given this, the number of people with both dementia and hip disease is likely to increase in an ageing population such as the UK. This article raises questions about how people with dementia and chronic hip disease are conceptualized in the context of evidence-based medicine, and whether this conceptualization may limit unfairly their access to surgical services. The published clinical research discourse at the interface of hip disease and dementia is taken as an 'evidence-base', and is evaluated in terms of its suitability for informing professional decisions about viability for surgery. The analysis suggests that the outcomes criteria used to determine patient viability serve to discriminate unfairly against people with dementia. If such discrimination exists, it necessarily militates against the promotion of health-related citizenship rights of the cognitively impaired, creating an evidence-based culture that encourages a problematic model of cognitive citizenship.

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Demented patients' participation in a clinical trial: factors affecting the caregivers' decision

Cited by 23 publications

References 13 publications

Carer Impressions of Participation in Alzheimer's Disease Clinical Trials: What Are Their Hopes? And Is It Worth It?

Carer Impressions of Participation in Alzheimer's Disease Clinical Trials: What Are Their Hopes? And Is It Worth It?

Drug Trials in Dementia: Challenging Ethical Dilemmas

Cognitive Citizenship: Access to Hip Surgery for People with Dementia

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