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Community consultation for prehospital research: Experiences of study coordinators and principal investigators

机译：院前研究的社区咨询：研究协调员和主要研究者的经验

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Objective. To assess principal investigators' and study coordinators' views and experiences regarding community consultation in a multicenter trial of prehospital treatment for status epilepticus conducted under an exception from informed consent for research in emergency settings. Methods. Principal investigators and study coordinators at all 17 hubs for the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) were invited to complete a web-based survey regarding community consultation at their site for RAMPART. Major domains included 1) perceived goals of community consultation, 2) experiences with and views of community consultation methods used, 3) interactions with IRB regarding community consultation, and 4) general satisfaction and lessons learned. Descriptive statistics were tabulated for Likert scale data; relevant themes were reported for text-based data. Results. Twenty-eight individuals (16 coordinators and 12 investigators) representing all 17 RAMPART hubs completed the survey. Respondents considered multiple community consultation goals to be important, with least support for the role of community consultation in altering study design. All sites used multiple methods (median = 5). The most widely used, and generally favored, method was attending previously scheduled meetings of existing groups. Respondents expressed frustration with low attendance and responsiveness at open public meetings. Conclusions. Coordinators and investigators in this trial viewed community consultation efforts as successful but reported real challenges generating public interest. Individuals with the condition under study were found to be more engaged and supportive of the trial. Respondents endorsed numerous potential goals of the community consultation process and often combined methods to achieve these goals.
机译：目的。在知情同意下进行的院外治疗癫痫持续状态的多中心试验中，评估主要研究者的意见，并研究协调者关于社区咨询的观点和经验，该研究在知情同意下进行，用于紧急情况下的研究。方法。邀请了所有17个中心的快速抗惊厥药物抵达前快速试验（RAMPART）的首席研究人员和研究协调员在其RAMPART网站上完成有关社区咨询的网络调查。主要领域包括1）社区咨询的预期目标，2）使用社区咨询方法的经验和观点，3）与IRB在社区咨询方面的互动以及4）总体满意度和经验教训。表述了李克特量表数据的描述性统计量;报告了相关主题以获取基于文本的数据。结果。代表所有17个RAMPART中心的28个人（16位协调员和12位调查员）完成了调查。受访者认为多个社区咨询目标很重要，而对社区咨询在改变研究设计中的作用的支持却最少。所有站点都使用多种方法（中位数= 5）。最广泛使用且最受欢迎的方法是参加现有小组先前安排的会议。受访者对公开会议的出席率和响应度低感到沮丧。结论。该试验的协调员和调查员认为社区咨询工作是成功的，但报告了引起公众关注的实际挑战。发现处于研究状态的个体更加参与并支持该试验。受访者认可了社区咨询过程中的许多潜在目标，并经常结合使用多种方法来实现这些目标。

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