Diabetes Research Center, Massachusetts General Hospital, Boston, MA 02114, USA.
Clin Trials. 2013 Feb;10(1):93-6. doi: 10.1177/1740774512464727. Epub 2012 Nov 20.
Obtaining surrogate consent for clinical research studies conducted in the intensive care unit (ICU) setting is logistically challenging.
To determine whether differences in proportions consenting to trial enrollment existed among patients eligible to consent directly versus those requiring surrogate decision makers in a minimal-risk study to evaluate the accuracy of continuous glucose monitoring in the ICU setting.
Low initial enrollment rates prompted a detailed tracking of the screening and consent process. We analyzed the subset of eligible patients identified during a single year to document whether they were approached about trial enrollment, whether they consented or declined, the reasons for declining, and the method of consent (self or surrogate). The proportion of participants who consented and the reasons for declining were compared for self-consenting and surrogate-consenting participants.
Of the 3041 patients screened, one-third (n = 982) were eligible; 119 of the 982 were approached regarding enrollment. Absence of a surrogate accounted for the majority of eligible patients (726; 84%) not approached. The most common reasons for refusal in the self versus surrogate groups included feeling overwhelmed (13% vs 24%), fear of discomfort (22% vs 12%), and fear of risk (7% vs 4%). Of the 57 eligible patients capable of consenting directly, 11 (19%) enrolled versus 12 (19%) of the 62 who required surrogate consent. When recruitment hours were expanded to include evening time, more eligible patients or their surrogates could be approached than during the day-shift hours alone. Consent was obtained for a larger proportion of potential participants with a history of diabetes (40%) than for those without a history of diabetes (14%).
The findings are from a subset of the entire study sample; data were available only for participants who could be approached, who may have differed from those who could not be approached.
Surrogate and self-consent rates were similar. Surrogate unavailability was a major barrier to enrollment; overlap of staffing with usual visiting hours should be considered when planning trials in the ICU.
在重症监护病房（ICU）进行的临床研究中，获得替代同意具有挑战性。
确定在一项评估 ICU 环境中连续血糖监测准确性的低风险研究中，直接符合条件的患者与需要替代决策者的患者在同意参加试验方面的比例是否存在差异。
低初始入组率促使我们详细跟踪筛选和同意过程。我们分析了在一年内确定的符合条件患者的子集，以记录他们是否被征求参加试验的意见，他们是否同意或拒绝，拒绝的原因以及同意的方式（自行或替代）。比较了自行同意和替代同意参与者的同意比例和拒绝原因。
在筛查的 3041 名患者中，有三分之一（n = 982）符合条件；982 人中的 119 人被征求了入组意见。替代决策者的缺失是大多数未被征求意见的符合条件患者（726；84%）的主要原因。自我与替代组中拒绝的最常见原因包括感到不知所措（13%对 24%）、担心不适（22%对 12%）和担心风险（7%对 4%）。在能够直接同意的 57 名符合条件的患者中，有 11 名（19%）入组，而需要替代同意的 62 名患者中有 12 名（19%）入组。当扩大招募时间包括晚上时，与仅在白天班次相比，可以接触到更多符合条件的患者或其替代决策者。有糖尿病病史的潜在参与者获得同意的比例（40%）大于无糖尿病病史的参与者（14%）。
研究结果来自整个研究样本的一部分；仅对可以接触到的参与者有数据，这些参与者可能与无法接触到的参与者不同。
替代同意和自行同意的比例相似。替代决策者的缺失是入组的主要障碍；在 ICU 中计划试验时，应考虑与常规探视时间重叠的人员配备。
