• Kyle L Galbraith, Anna-Sigrid Keck, and Charletta Little.
• Prehosp Emerg Care. 2014 Jul 1;18(3):328-34.

ObjectivesThe 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.Methods And SettingThe 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.ResultsA 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.ConclusionsThe 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.

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