The Views of Alzheimer Disease Patients and Their Study Partners on Proxy Consent for Clinical Trial Enrollment

Department of Medicine, Alzheimer's Disease Center, Leonard Davis Institute for Health Economics, University of Pennsylvania, School of Medicine, Philadelphia, PA 19104, USA.
American Journal of Geriatric Psychiatry (Impact Factor: 4.24). 04/2008; 16(3):240-7. DOI: 10.1097/JGP.0b013e318162992d
Source: PubMed


To examine the views of Alzheimer disease (AD) patients and their study partners on the ethics of proxy consent for clinical research.
Cross-sectional interview.
At the 13 study sites of a randomized and placebo controlled study of simvastatin for the treatment of AD.
Patients with mild-to-moderate AD and their study partners enrolled in an Alzheimer's Disease Cooperative Study trial of simvastatin.
Interviews to assess how participants made the decision to enroll in a randomized controlled trial and their attitudes on proxy consent.
Study partners of patients judged not capable of providing informed consent reported the same degree of patient involvement in the decision to enroll as the study partners of patients capable of providing informed consent. Most study partners and patients supported proxy consent for this clinical trial and nearly all patients chose their study partner as their proxy. Study partners generally made research enrollment decisions based on what they thought would maximize the patient's well-being as opposed to a substituted judgment.
Patients and their study partners who were enrolled in a clinical trial supported proxy consent both for themselves and as a matter of policy. Our findings suggest that policies that require substituted judgments may not accord with the views of the people currently participating in AD clinical trials.

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    • "Since all persons participating had moderate to severe AD, a next of kin as well as the caregivers at the ward were informed both in writing and verbally of the aim of the study and the function of the Actiwatch®. The person's next of kin was also given written information about the study and then asked to sign a proxy consent [33] "
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    ABSTRACT: Background Persons with Alzheimer's disease (AD) sometimes express themselves through behaviours that are difficult to manage for themselves and their caregivers, and to minimise these symptoms alternative methods are recommended. For some time now, animals have been introduced in different ways into the environment of persons with dementia. Animal-Assisted Therapy (AAT) includes prescribed therapy dogs visiting the person with dementia for a specific purpose.AimThis study aims to illuminate the meaning of the lived experience of encounters with a therapy dog for persons with Alzheimer's disease.Method Video recorded sessions were conducted for each visit of the dog and its handler to a person with AD (10 times/person). The observations have a life-world approach and were transcribed and analysed using a phenomenological hermeneutical approach.ResultsThe result shows a main theme ‘Being aware of one's past and present existence’, meaning to connect with one's senses and memories and to reflect upon these with the dog. The time spent with the dog shows the person recounting memories and feelings, and enables an opportunity to reach the person on a cognitive level.Conclusions The present study may contribute to health care research and provide knowledge about the use of trained therapy dogs in the care of older persons with AD in a way that might increase quality of life and well-being in persons with dementia.Implications for practiceThe study might be useful for caregivers and dog handlers in the care of older persons with dementia.
    International Journal of Older People Nursing 05/2014; 10(2). DOI:10.1111/opn.12053

  • The Lancet 07/2008; 372(9634):183-5. DOI:10.1016/S0140-6736(08)61049-1 · 45.22 Impact Factor
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    ABSTRACT: Research that seeks to enroll noncompetent patients with Alzheimer's disease without presenting any potential benefit to participants is the source of substantial ethical controversy. The authors used hypothetical Alzheimer's disease studies that included either a blood draw or a blood draw and lumbar puncture to explore older persons' attitudes on this question. Face-to-face interviews were conducted with 538 persons age 65 and older. Questions explored participants' understanding of research concepts, their views on enrolling persons with Alzheimer's disease in research, and their preferences regarding having a proxy decision maker, granting advance consent, and granting their proxy leeway to override the participant's decision. Additional questions assessed altruism, trust, value for research, and perceptions of Alzheimer's disease. The majority (83%) were willing to grant advance consent to a blood draw study, and nearly half (48%) to a blood draw plus lumbar puncture study. Most (96%) were willing to identify a proxy for research decision making, and most were willing to grant their proxy leeway over their advance consent: 81% for the blood draw study and 70% for the blood draw plus lumbar puncture study. Combining the preferences for advance consent and leeway, the proportion who would permit being enrolled in the blood draw and lumbar puncture studies, respectively, were 92% and 75%. Multivariate models showed that willingness to be enrolled in research was most strongly associated with a favorable attitude toward biomedical research. Older adults generally support enrolling noncompetent persons with Alzheimer's disease into research that does not present a benefit to subjects. Willingness to grant their proxy leeway over advance consent and a favorable attitude about biomedical research substantially explain this willingness.
    American Journal of Psychiatry 11/2008; 166(2):182-8. DOI:10.1176/appi.ajp.2008.08050645 · 12.30 Impact Factor
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