TY - JOUR
T1 - Understanding information on clinical trials by persons with Alzheimer's dementia. A pilot study
AU - Porteri, Corinna
AU - Andreatta, Chiara
AU - Anglani, Livio
AU - Pucci, Eugenio
AU - Frisoni, Giovanni B.
PY - 2009/4
Y1 - 2009/4
N2 - Background: Because of the growing value attributed to informed consent, competence assessment has become an important task for physicians and researchers, particularly when treatment and research involve persons who may be cognitively impaired, such as those with Alzheimer's dementia. Methods: We developed and validated a 12-item questionnaire to assess the understanding of information about clinical trials by research subjects (score 0 to 24). The 12 questions were selected from a larger pool of 16 through internal consistency validity testing. We used the instrument in a pilot study involving 42 patients with mild to moderate Alzheimer's disease who had been asked to take part in two randomized clinical trials, and 21 caregivers. Results: Patients with Alzheimer's disease had poor understanding (mean global score on questionnaire: 6.1±3.5). Unlike patients, caregivers understand the key elements of the clinical trials (questionnaire mean global score: 21.5±2.3; p for difference with patients
AB - Background: Because of the growing value attributed to informed consent, competence assessment has become an important task for physicians and researchers, particularly when treatment and research involve persons who may be cognitively impaired, such as those with Alzheimer's dementia. Methods: We developed and validated a 12-item questionnaire to assess the understanding of information about clinical trials by research subjects (score 0 to 24). The 12 questions were selected from a larger pool of 16 through internal consistency validity testing. We used the instrument in a pilot study involving 42 patients with mild to moderate Alzheimer's disease who had been asked to take part in two randomized clinical trials, and 21 caregivers. Results: Patients with Alzheimer's disease had poor understanding (mean global score on questionnaire: 6.1±3.5). Unlike patients, caregivers understand the key elements of the clinical trials (questionnaire mean global score: 21.5±2.3; p for difference with patients
KW - Alzheimer's disease
KW - Clinical trials understanding
KW - Informed consent
KW - Research ethics
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M3 - Article
C2 - 19448388
AN - SCOPUS:66849087510
VL - 21
SP - 158
EP - 166
JO - Aging clinical and experimental research
JF - Aging clinical and experimental research
SN - 1594-0667
IS - 2
ER -