Rikkert M G, van den Bercken J H, ten Have H A, Hoefnagels W H
University of Nijmegen, The Netherlands.
J Med Ethics. 1997 Oct;23(5):271-6. doi: 10.1136/jme.23.5.271.
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 patients' capacity to consent.
DESIGN/SETTING: A step-wise consent procedure was introduced in a study on fluid balance in geriatric patients. Eligible patients providing verbal consent participated in a try-out of a week, during which bioelectrical impedance and weight measurements were performed daily. Afterwards, written informed consent was requested. Comprehension, risk and inconvenience scores (ranges: 0-10) were obtained before and after the try-out by asking ten questions about the study's essentials and by asking for a risk and inconvenience assessment on a ten-points rating scale.
Seventy of the 78 eligible subjects started the try-out and 53 (68%) provided written 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 capable of weighing risks and inconveniences increased from 32 to 48 (P < 0.001).
Research experience improved the capacity to consent, still enabling an acceptable participation rate. Therefore, experienced consent seems a promising tool to optimize informed consent in frail elderly subjects.
认知和感觉方面的困难常常会危及体弱老年患者的知情同意权。本研究首次测试初步研究体验是否能增强老年患者的同意能力。
设计/背景：在一项关于老年患者液体平衡的研究中引入了逐步同意程序。符合条件且提供口头同意的患者参加为期一周的试验，在此期间每天进行生物电阻抗和体重测量。之后，要求提供书面知情同意书。通过询问关于研究要点的十个问题，并要求在十分制评分量表上对风险和不便进行评估，在试验前后获得理解、风险和不便评分（范围：0至10）。
78名符合条件的研究对象中有70人开始了试验，53人（68%）提供了书面同意书。试验后理解评分从5.0（±2.3）提高到7.0（±1.9）（P<0.001）。能够权衡风险和不便的研究对象数量从32人增加到48人（P<0.001）。
研究体验提高了同意能力，同时仍能保持可接受的参与率。因此，有经验的同意似乎是优化体弱老年受试者知情同意的一个有前景的工具。
