Authors: Corinna Porteri Chiara Andreatta Livio Anglani Eugenio Pucci Giovanni B Frisoni
Publish Date: 2013/07/31
Volume: 21, Issue: 2, Pages: 158-166
Abstract
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 12item 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 61±35 Unlike patients caregivers understand the key elements of the clinical trials questionnaire mean global score 215±23 p for difference with patients 00001 In the group of patients the score on the questionnaire correlated weakly with the Mini Mental State Exam r=0351 p=0023 but more strongly with years of education in the group of caregivers r=0548 p=0010 and age r=0540 p=0011 Conclusions Patients with Alzheimer’s disease of mild to moderate severity show poor understanding of the design risks and benefits of clinical trials Enrolment of these patients in clinical trials must be accompanied by adequate measures for patient protection
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