Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, Michigan, USA.
PLoS One. 2013;8(1):e54790. doi: 10.1371/journal.pone.0054790. Epub 2013 Jan 31.
There is a longstanding concern about the accuracy of surrogate consent in representing the health care and research preferences of those who lose their ability to decide for themselves. We sought informed, deliberative views of the older general public (≥50 years old) regarding their willingness to participate in dementia research and to grant leeway to future surrogates to choose an option contrary to their stated wishes.
METHODOLOGY/PRINCIPAL FINDINGS: 503 persons aged 50+ recruited by random digit dialing were randomly assigned to one of three groups: deliberation, education, or control. The deliberation group attended an all-day education/peer deliberation session; the education group received written information only. Participants were surveyed at baseline, after the deliberation session (or equivalent time), and one month after the session, regarding their willingness to participate in dementia research and to give leeway to surrogates, regarding studies of varying risk-benefit profiles (a lumbar puncture study, a drug randomized controlled trial, a vaccine randomized controlled trial, and an early phase gene transfer trial). At baseline, 48% (gene transfer scenario) to 92% (drug RCT) were willing to participate in future dementia research. A majority of respondents (57-71% depending on scenario) were willing to give leeway to future surrogate decision-makers. Democratic deliberation increased willingness to participate in all scenarios, to grant leeway in 3 of 4 scenarios (lumbar puncture, vaccine, and gene transfer), and to enroll loved ones in research in all scenarios. On average, respondents were more willing to volunteer themselves for research than to enroll their loved ones.
CONCLUSIONS/SIGNIFICANCE: Most people were willing to grant leeway to their surrogates, and this willingness was either sustained or increased after democratic deliberation, suggesting that the attitude toward leeway is a reliable opinion. Eliciting a person's current preferences about future research participation should also involve eliciting his or her leeway preferences.
人们长期以来一直担心替代同意在代表那些丧失自我决策能力的人的医疗保健和研究偏好方面的准确性。我们征求了年龄在 50 岁及以上的普通公众的知情、深思熟虑的意见，了解他们是否愿意参与痴呆症研究，并给予未来的代理人一定的回旋余地，让他们选择与自己意愿相反的方案。
方法/主要发现：通过随机拨号招募了 503 名年龄在 50 岁及以上的人，将他们随机分配到三个组之一：讨论组、教育组或对照组。讨论组参加了一整天的教育/同伴讨论会议；教育组仅收到书面信息。在基线、讨论会议（或同等时间）后以及会议一个月后，对参与者进行调查，了解他们是否愿意参与痴呆症研究以及是否给予代理人一定的回旋余地，涉及不同风险效益特征的研究（腰椎穿刺研究、药物随机对照试验、疫苗随机对照试验和早期基因转移试验）。在基线时，48%（基因转移方案）至 92%（药物 RCT）的人愿意参与未来的痴呆症研究。大多数受访者（取决于方案，57-71%）愿意给予未来代理人决策者一定的回旋余地。民主讨论增加了对所有方案的参与意愿，在 4 个方案中的 3 个方案（腰椎穿刺、疫苗和基因转移）中给予了回旋余地，并在所有方案中让亲人参与研究。平均而言，受访者更愿意自愿参加研究，而不是让亲人参加。
结论/意义：大多数人愿意给予代理人一定的回旋余地，而且这种意愿在民主讨论后得到了维持或增加，这表明对回旋余地的态度是一种可靠的意见。在征求一个人对未来研究参与的当前偏好时，也应该征求他或她对回旋余地的偏好。
