Inclusion of older adults and reporting of consent processes in randomized controlled trials in the emergency department: A scoping review.
Inclusion of older adults and reporting of consent processes in randomized controlled trials in the emergency department: A scoping review.
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DOI：
10.1002/emp2.12774
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发表时间：
2022-08
影响因子：
2.3
通讯作者：
中科院分区：
文献类型：
--
作者：
在急诊科（艾德）进行研究通常会因患者的急性和慢性疾病而变得复杂，这会对认知和随后同意研究的能力产生不利影响，特别是在老年人中。目前已存在经验证的筛选工具来评估同意研究的能力，但使用频率和用于艾德研究的工具均未知。我们使用标准审查技术进行了范围审查。入选标准包括（1）2014-2019年发表的随机对照试验（RCT），（2）仅在艾德招募受试者，（3）纳入65岁以上的患者，（4）完全以英文发表。文章来源于Embase，并使用Covidence进行筛选。从3130个检索结果中，269个研究通过了标题/摘要和全文筛选。平均或中位年龄的平均值为55.7岁（SD 14.2）。研究参与者的平均数量为311.9 [范围8- 10，807名参与者]。少数（n = 13，4.8%）患者放弃或例外知情同意。在256项需要知情同意的研究中，四分之一（26.5%，n = 68）因知情同意能力受损而专门排除了患者。只有11例（4.3%）记录了正式的能力筛选工具，只有13例（5.1%）报告了法定授权代表（LAR）的同意。大多数招募ED老年人的RCT没有报告对同意或使用LARs的能力的评估。知情同意程序的这一快照可能令人担忧，并表明老年患者的研究同意过程和/或同意过程的报告需要改进。
Conducting research in the emergency department (ED) is often complicated by patients’ acute and chronic illnesses, which can adversely affect cognition and subsequently capacity to consent for research, especially in older adults. Validated screening tools to assess capacity to consent for research exist, but neither the frequency of use nor which ones are used for ED research are known. We conducted a scoping review using standard review techniques. Inclusion criteria included (1) randomized controlled trials (RCTs) from publication years 2014–2019 that (2) enrolled participants only in the ED, (3) included patients aged 65+ years, and (4) were fully published in English. Articles were sourced from Embase and screened using Covidence. From 3130 search results, 269 studies passed title/abstract and full text screening. Average of the mean or median ages was 55.7 years (SD 14.2). The mean number of study participants was 311.9 [range 8–10,807 participants]. A few (n = 13, 4.8%) waived or had exception from informed consent. Of the 256 studies requiring consent, a fourth (26.5%, n = 68) specifically excluded patients due to impaired capacity to consent. Only 11 (4.3%) documented a formal capacity screening tool and only 13 (5.1%) reported consent by legally authorized representative (LAR). Most RCTs enrolling older adults in EDs did not report assessment of capacity to consent or use of LARs. This snapshot of informed consent procedures is potentially concerning and suggests that either research consent processes for older patients and/or reporting of consent processes require improvement.
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影响因子：
6.3
作者：
Kennedy M;Enander RA;Tadiri SP;Wolfe RE;Shapiro NI;Marcantonio ER
通讯作者：
Marcantonio ER
影响因子：
3.7
作者：
Hohl CM;Partovi N;Ghement I;Wickham ME;McGrail K;Reddekopp LN;Sobolev B
通讯作者：
Sobolev B
影响因子：
2.5
作者：
Ahn, Shin;Kim, Youn-Jung;Kim, Won Young
通讯作者：
Kim, Won Young
影响因子：
6.2
作者：
Atkinson, Paul R.;Milne, James;Lewis, David A.
通讯作者：
Lewis, David A.
影响因子：
6.2
作者：
Hustey, FM;Meldon, SW
通讯作者：
Meldon, SW