Galbraith Kyle L, Keck Anna-Sigrid, Little Charletta
Prehosp Emerg Care. 2014 Jul-Sep;18(3):328-34. doi: 10.3109/10903127.2014.882998. Epub 2014 Mar 26.
The purpose of this study was to evaluate community member feedback from community consultation and public disclosure activities performed for a clinical investigation involving a device designed to treat traumatic brain injury in prehospital contexts. The clinical investigation of that device was to be performed under the federal regulations providing an exception from prospective informed consent requirements in emergency settings. Secondarily, we sought to assess the community consultation process by measuring the levels of outreach provided by the different communication methods used in these activities, with special attention to the effectiveness of social media for community outreach.
The medical device investigation consists of a single-site pilot study based at a 345-bed community hospital in east central Illinois, which also serves as the area's only level I trauma center. Investigators, in collaboration with the local institutional review board, fulfilled community consultation and public disclosure requirements through four public town hall meetings, seven targeted focus groups, targeted mailings to 884 community leaders and researchers, a press conference and press release, internal and external websites, and multiple postings to the hospital's Facebook and Twitter accounts. Community members provided feedback by completing paper or electronic comment cards.
A total of 428 community members attended the four town hall meetings and seven focus group sessions. Attendance at each meeting ranged from 4 to 20 attendees for the town hall meetings and 8 to 140 attendees for the focus groups. The investigation's external website received 626 unique visitors and the intranet website received 528 unique visits. Social media postings on Facebook and Twitter received six comments and eight "likes" to indicate that an individual read the posting. In total, attendees completed 175 comment cards to provide their feedback. Community member attitudes regarding the research were very positive, with 173 (98.8%) comment card respondents viewing the research as beneficial and 162 (92.6%) indicating that they would allow themselves or their family members to participate in the research.
The internal and external websites provided the most effective means for sharing research-related information to community members. While cost-effective, social media outreach was very limited and did not foster communication with community members.
本研究旨在评估社区成员对为一项临床研究开展的社区咨询和信息公开活动的反馈,该临床研究涉及一种用于院前治疗创伤性脑损伤的设备。该设备的临床研究将依据联邦法规进行,该法规规定在紧急情况下可免除前瞻性知情同意要求。其次,我们试图通过衡量这些活动中使用的不同沟通方式的推广程度来评估社区咨询过程,特别关注社交媒体在社区推广方面的有效性。
该医疗器械研究包括一项在伊利诺伊州中东部一家拥有345张床位的社区医院开展的单中心试点研究,该医院也是该地区唯一的一级创伤中心。研究人员与当地机构审查委员会合作,通过四场公开市政厅会议、七场有针对性的焦点小组讨论、向884名社区领袖和研究人员进行有针对性的邮寄、一场新闻发布会和新闻稿、内部和外部网站,以及在医院的Facebook和Twitter账户上多次发布信息,来满足社区咨询和信息公开的要求。社区成员通过填写纸质或电子意见卡提供反馈。
共有428名社区成员参加了四场市政厅会议和七场焦点小组会议。每场市政厅会议的参会人数为4至20人,焦点小组会议的参会人数为8至140人。该研究的外部网站有626名独立访客,内部网站有528次独立访问。在Facebook和Twitter上发布的社交媒体信息收到了6条评论和8个“赞”,表明有人阅读了该信息。总共有175名参会者填写了意见卡以提供反馈。社区成员对该研究的态度非常积极,173名(98.8%)意见卡受访者认为该研究有益,162名(92.6%)表示他们会允许自己或家人参与该研究。
内部和外部网站为向社区成员分享研究相关信息提供了最有效的方式。虽然社交媒体推广成本效益高,但非常有限,并未促进与社区成员的沟通。