EXPERIENCED CONSENT IN GERIATRICS RESEARCH - A NEW METHOD TO OPTIMIZETHE CAPACITY TO CONSENT IN FRAIL ELDERLY SUBJECTS

Objectives - Cognitive and sensory difficulties frequently jeopardize informed consent of frail elderly patients This study is the first to test whether preliminary research experience could enhance geriatric p atients' capacity to consent. Design/setting - A step-wise consent pro cedure was introduced in a study on fluid balance in geriatric patient s. Eligible patients providing verbal consent participated in a try-ou t of a week, during which bioelectrical impedance and weight measureme nts were performed daily. Afterwards, written informed consent was req uested. Comprehension, risk and inconvenience scores (ranges: 0-10) we re obtained before and after the try-out by asking ten questions about the study's essentials and by asking for a risk and inconvenience ass essment on a ten-points rating scab. Subjects and results - Seventy of the 78 eligible subjects started the try-out and 53 (68% provided wri tten consent. The comprehension score increased from 5.0 (+/-2.3) to 7 .0 (+/-1.9) following the try-out (P<0.001). The number of subjects ca pable of weighing risks and inconveniences increased from 32 to 48 (P< 0.001). Conclusions - Research experience improved the capacity to con sent, still enabling an acceptable participation rate. Therefore, expe rienced consent seems a promising tool to optimize informed consent in frail elderly subjects.