Integration of social media with targeted emails and in‐person outreach for exception from informed consent community consultation

Abstract

Background: Exception from informed consent (EFIC) enables the enrollment of research subjects with emergent conditions to clinical trials without prior consent. EFIC study approval requires community consultation and public disclosure. We hypothesized that the integration of social media with targeted emails and in-person outreach is an effective community consultation strategy. Methods:We utilized social media with targeted emails and in-person outreach for the community consultation of the ACCESS cardiac arrest trial. Study advertisements were disseminated using Facebook and Instagram, and targeted emails were sent to emergency medicine, prehospital, and cardiology providers. We also interviewed atrisk individuals with cardiac conditions, their caretakers, and patient advocacy groups.Participants were asked to complete a survey about their opinions about the study. Results:We collected 559 surveys over an 8-week period, and 70.5% of the surveys were obtained using social media. The median (IQR) age of survey respondents was 44 (33-57) years; 89.9% were White and 60.1% were women. A total of 91.3% believed ACCESS was an important study. Compared to the in-person group, more from social media (81.8% vs. 63.3%, p < 0.05) and targeted email (77.4% vs. 63.3%, p < 0.05) groups said they would include their loved ones in the study. More from the in-person group believed that their opinion would be considered seriously compared to the social media (75.9% vs. 62.6%, p < 0.05) and targeted email (75.9% vs. 54.5%, p < 0.05) groups. The incorporation of social media and targeted emails for community consultation reduced the cost per survey by fourfold compared to an in-persononly strategy. Conclusions:The integration of social media with targeted emails and in-person outreach was a feasible and cost-saving approach for EFIC community consultation.Future work is necessary to determine the perception and best utilization of social media for community consultation.

Community consultation for Exception from Informed consent (EFIC) before and during the COVID-19 pandemic

“… 15 Community meetings and individual interviews are generally associated with higher rates of acceptance than remote surveys, 15 but may include a different demographic group relative to age, sex, educational level, and familiarity with electronic technology. 8 Our PROTECT in-patient interviews yielded lower acceptance rates and higher opt-out rates than our remote surveys, perhaps reflecting hospitalization for a medical problem or demographic differences between the groups. Hsu et al found a similar lower acceptance rate with individuals in cardiology clinic waiting rooms before the pandemic compared to surveys returned electronically.…”

“…Hsu et al found a similar lower acceptance rate with individuals in cardiology clinic waiting rooms before the pandemic compared to surveys returned electronically. 8 Though commonly reported as part of the community consultation process, closed-ended surveys designed to provide a percent “acceptance” may fail to capture and explore distinct views of sub-groups within the population; opportunities for open-ended comments and two-way communication should also be included.…”

“…3 Community consultation methods have varied, with differing approaches to define the community of interest. [4] , [5] , [6] , [7] , [8] Several studies have surveyed crowds (e.g. at state fairs) as a less expensive and more time-efficient method of community consultation.…”

Interactive media-based community consultation for exception from informed consent trials: How representative should (and can) it be?

“…Recently, social media-based CC campaigns have become more commonplace, 2,6,8,9 not only for trauma trials but also other conditions. These campaigns can take advantage of the interactive components of the ability of social media to: (1) provide information to a large number of individuals, provide an efficient mechanism for obtaining feedback; (2) accomplish outreach including accruing granular metrics about the search and review functions of viewers (e.g., number of people reached, time individuals spent reviewing various aspects of clinical trial information); and (3) seek feedback through online surveys (both linked and unlinked to social media).…”