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Titolo:
Addressing the ethical challenges of clinical trials that involve patientswith dementia
Autore:
Karlawish, JHT; Casarett, D;
Indirizzi:
Ctr Bioeth, Philadelphia, PA USA Ctr Bioeth Philadelphia PA USACtr Bioeth, Philadelphia, PA USA Rush Alzheimers Dis Ctr, Philadelphia, PA USA Rush Alzheimers Dis Ctr Philadelphia PA USA is Ctr, Philadelphia, PA USA Univ Penn, Philadelphia Vet Affairs Med Ctr, Dept Med, Div Geriatr, Philadelphia, PA 19104 USA Univ Penn Philadelphia PA USA 19104 v Geriatr, Philadelphia, PA 19104 USA
Titolo Testata:
JOURNAL OF GERIATRIC PSYCHIATRY AND NEUROLOGY
fascicolo: 4, volume: 14, anno: 2001,
pagine: 222 - 228
SICI:
0891-9887(200124)14:4<222:ATECOC>2.0.ZU;2-C
Fonte:
ISI
Lingua:
ENG
Soggetto:
ALZHEIMERS-DISEASE; DEPRESSED-PATIENTS; INFORMED CONSENT; ELDERLY PATIENTS; DRUGS; PREFERENCES; COMPETENCE; EQUIPOISE; OUTCOMES; PROXY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
40
Recensione:
Indirizzi per estratti:
Indirizzo: Karlawish, JHT 3815 Chestnut St,Room 215, Philadelphia, PA 19104 USA 3815Chestnut St,Room 215 Philadelphia PA USA 19104 04 USA
Citazione:
J.H.T. Karlawish e D. Casarett, "Addressing the ethical challenges of clinical trials that involve patientswith dementia", J GER PSY N, 14(4), 2001, pp. 222-228

Abstract

Research subjects face uncertainties, risks, burdens, and indignities, andresearch protocol requirements inhibit the physician's ability to make individualized treatment decisions. To address these problems, investigators and Institutional Review Boards (IRBs) should justify research risks using informed consent and the judgment that the risks of research are reasonable with respect to the potential benefits, if any, to subjects and to the expectation that the research will produce important knowledge. But clinical research in Alzheimer's disease (AD) presents investigators and IRBs with significant challenges to achieve these two requirements. Broadly, these challenges are the result of the impact of patients' cognitive impairment and the caregiving experience on decision making and the indeterminacy of defining clinically meaningful treatment benefits. In this article, we review the data that begin to answer whether and how patients' cognitive impairments and the caregiving experience impact on their decision making and what kindsof research results justify research risks. We will use these data to suggest changes to the design and conduct of clinical research in AD that can meet the challenge of justifying research risks.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 25/01/20 alle ore 07:02:56