Departments of Critical Care Services and Emergency Medicine, Maine Medical Center, Portland, ME, USA.
Division of Cardiology, University of Arizona, Sarver Heart Center, Tucson, AZ, USA.
Resuscitation. 2018 Sep;130:81-87. doi: 10.1016/j.resuscitation.2018.06.031. Epub 2018 Jun 28.
Community consultation (CC) is fundamental to the Exception from Informed Consent (EFIC) process for emergency research, designed to inform and receive feedback from the target study population about potential risks and benefits. To better understand the effectiveness of different techniques for CC, we evaluated EFIC processes at two centers participating in a trial of early cardiac catheterization following out-of-hospital cardiac arrest.
We studied the Institutional Review Board-approved CC activities at Maine Medical Center (MMC) and University of Arizona (AZ) in support of NCT02387398. In Maine, the public was consulted by survey at a professional basketball game and in the emergency department waiting room (in-person group), by multimedia direction to an online website (online group), and by mail (mailing group). Arizona respondents were either approached at a county fair (in-person group) or were directed to an online survey (online group) via social media advertising.
Among 2185 survey respondents, approval rates were high for community involvement and personal participation without individual consent. Community consultation using in-person, online, and mailed surveys offered slightly different approval rates, and the rate of responses by modality differed by age and education level but not ethnicity. Print advertising was the least cost effective at $442 per completed survey.
Canvassing at public events was the most efficient mode of performing CC, with approval rates similar to mailings, online surveys, and canvassing in other locations. Print advertisements in local papers had a low yield and cost more than other approaches.
社区咨询（CC）是紧急研究豁免知情同意（EFIC）过程的基础，旨在向目标研究人群告知并征求他们对潜在风险和益处的反馈。为了更好地了解 CC 不同技术的有效性，我们评估了参与院外心脏骤停后早期心脏导管插入术试验的两个中心的 EFIC 流程。
我们研究了缅因州医疗中心（MMC）和亚利桑那大学（AZ）经机构审查委员会批准的 CC 活动，以支持 NCT02387398。在缅因州，通过在职业篮球赛和急诊室候诊室进行调查（现场组）、通过多媒体引导至在线网站（在线组）以及通过邮件（邮寄组）向公众进行咨询。亚利桑那州的受访者要么在县集市上被接触（现场组），要么通过社交媒体广告被引导至在线调查（在线组）。
在 2185 名调查受访者中，社区参与和无需个人同意的个人参与的批准率很高。通过现场、在线和邮寄调查进行的社区咨询提供了略有不同的批准率，并且通过模式进行回复的比例因年龄和教育水平而异，但与种族无关。平面广告的每完成一份调查的成本效益最低，为 442 美元。
在公共活动中进行民意调查是进行 CC 的最有效模式，其批准率与邮寄、在线调查和在其他地点进行民意调查相似。当地报纸上的平面广告效果不佳，成本高于其他方法。
