Impact of Social Media on Community Consultation in Exception From Informed Consent Clinical Trials

Background‘Community consultation’ (CC) is a key step when conducting Exception From Informed Consent research. Social-media-based CC has been shown to reach more people than traditional methods, but it is unclear whether those reached are representative of the community as a whole.MethodsThis is a retrospective analysis of the CC performed in preparation for the PHOXSTAT trial. Social media advertisement campaigns were conducted in the catchment areas of the three participating trauma centers and evaluated by examining Facebook user statistics. We compared these data to georeferenced population data obtained from the U.S. Census Bureau. We examined variations in the proportion of each age group reached, by gender.ResultsOur social media advertisements reached a total of 332 081 individuals in Los Angeles, Birmingham, and Nashville. Although there were differences in the proportion of individuals reached within each age group and gender groups, compared with the population in each area, these were small (within 5%). In Birmingham, participants 55 to 64 years old, 25 to 34 years old, and females 18 to 24 years old were slightly over-represented (a larger proportion of individuals in this age group were reached by the social media campaign, compared with the population resident in this area). In contrast, in Nashville, female participants 45 to 64 years old, and males 25 to 64 years old were over-represented. In Los Angeles, females 45 to 64 years old, and males 25 to 64 years and over were over-represented.DiscussionIn conclusion, this study demonstrates that social media CC campaigns can be used to reach a sample of the community broadly representative of the population as a whole, in terms of age and gender. This finding is helpful to IRBs and investigators, as it lends further support to the use of social media to conduct CC. Further work is needed to analyze how representative community samples are in terms of other characteristics, such as race, ethnicity, and socioeconomic status.Level III evidenceEconomic & Value-based Evaluations.

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Using Social Media to Facilitate Community Consultation for Trials Using Exception from Informed Consent

Annals of Emergency Medicine ◽

10.1016/j.annemergmed.2013.07.241 ◽

2013 ◽

Vol 62 (4) ◽

pp. S150

Author(s):

J.R. Miner ◽

J.C. Moore ◽

N. Maddy ◽

M.H. Biros

Keyword(s):

Social Media ◽

Informed Consent ◽

Community Consultation

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Getting Started: A Social Media Primer

Clinics in Colon and Rectal Surgery ◽

10.1055/s-0037-1604249 ◽

2017 ◽

Vol 30 (04) ◽

pp. 227-232 ◽

Cited By ~ 4

Author(s):

Dalya Ferguson ◽

Lillian Kao

Keyword(s):

Social Media ◽

Clinical Trials ◽

Education Research ◽

Information Exchange ◽

General Public ◽

Media Use ◽

Community Consultation ◽

Social Media Use ◽

Research Recruitment ◽

Social Media Platforms

AbstractSocial media use has increased both in the general public and in the surgical profession. A variety of social media platforms have been used, with Twitter being one of the most common and interactive platforms. Common uses by surgeons and scientists for social media include dissemination of information, information exchange, education, research recruitment, community consultation for clinical trials, and hospital or surgeon ratings. As social media use increases, a new language as well as metrics has been developed to track impact and reach of research incorporating social media platforms. All surgeons should be encouraged to familiarize themselves with social media, regardless of whether or not they choose to actively engage in it.

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Improving Informed Consent for Novel Vaccine Research in a Pediatric Hospital Setting Using a Blended Research-Design Approach

Frontiers in Pediatrics ◽

10.3389/fped.2020.520803 ◽

2021 ◽

Vol 8 ◽

Author(s):

Sally M. Jackson ◽

Margherita Daverio ◽

Silvia Lorenzo Perez ◽

Francesco Gesualdo ◽

Alberto E. Tozzi

Keyword(s):

Social Media ◽

Clinical Trials ◽

Informed Consent ◽

Research Design ◽

Participatory Design ◽

Hospital Setting ◽

Media Analysis ◽

Design Approach ◽

Original Text ◽

The Impact

It is necessary to conduct Clinical Trials in children, including for novel vaccines. Children cannot legally provide valid consent, but can assent to research participation. Informed consent and assent communications are frequently criticized for their lack of comprehensibility and often, researchers do not involve patients in informed consent design. We tested a blended research-design approach to co-design multimedia informed consent prototypes for experimental vaccine studies targeted at the pediatric population. We report details on the methodology utilized, and the insights, ideas, and prototype solutions we generated using social media data analysis, a survey, and workshops. A survey of clinical trial researchers indicated that while the most did not use technology for informed consent, they considered its utilization favorable. Social media analysis enabled researchers to quickly understand where community perspectives were concordant and discordant and build their understanding of the types of topics that they may want to focus on during the design workshops. Participatory design workshops for children and their families reaped insights, ideas, and prototypes for a range of tools including apps and websites. Participants felt that the prototypes were better able to communicate necessary content than the original text document format. We propose using a participatory, mixed-methods approach to design informed consent so that it is better adapted to patients' needs. Such an approach would be helpful in better addressing the needs of different segments of the populations involved in clinical trials. Further evidence should be gained about the impact of this strategy in improving recruitment, decreasing withdrawals and litigations, and improving patient satisfaction during clinical trials.

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Abstract TMP5: Social Media Campaign with Traditional Community Consultation for Successful Exception from Informed Consent Approval - the SEGA Trial Experience

Stroke ◽

10.1161/str.50.suppl_1.tmp5 ◽

2019 ◽

Vol 50 (Suppl_1) ◽

Author(s):

Peng R Chen ◽

Aditya R Sanzgiri ◽

Sunil A Sheth ◽

Sean I Savitz ◽

Sujatha Sridhar ◽

...

Keyword(s):

Social Media ◽

Informed Consent ◽

Media Campaign ◽

Community Consultation ◽

Trial Experience

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Evidence‐Based Communication in Clinical, Mass Media, and Social Media Contexts to Enhance Informed Consent for Participation in Clinical Trials and Precision Medicine Initiatives

The Handbook of Applied Communication Research ◽

10.1002/9781119399926.ch49 ◽

2020 ◽

pp. 897-915

Author(s):

Susan E. Morgan ◽

Aurora Occa ◽

Wei Peng ◽

Soroya J. McFarlane

Keyword(s):

Social Media ◽

Clinical Trials ◽

Informed Consent ◽

Mass Media ◽

Precision Medicine ◽

Evidence Based

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Abstract 135: Integration of Social Media With Targeted Emails and interviews for Exception From Informed Consent Community Consultation

Circulation ◽

10.1161/circ.138.suppl_2.135 ◽

2018 ◽

Vol 138 (Suppl_2) ◽

Author(s):

Cindy H Hsu ◽

Jennifer Fowler ◽

James A Cranford ◽

Michael P Thomas ◽

Robert W Neumar

Keyword(s):

At Risk ◽

Social Media ◽

Cardiac Arrest ◽

Informed Consent ◽

Small Sample Size ◽

Small Sample ◽

Community Consultation ◽

Cardiac Catheterization Laboratory ◽

The Social ◽

Interview Group

Introduction: Exception from informed consent (EFIC) enables the enrollment of subjects with emergent conditions for clinical trials without prior consent. All EFIC studies are required to include community consultation (CC). However, CC implementation is often challenged by significant cost and scarce community engagement. Hypothesis: We hypothesize that the utilization of social media, targeted emails, and interviews of at-risk individuals and their caretakers can lead to more effective EFIC CC. Methods: We utilized social media and targeted emails/interviews for the EFIC CC of the ACCESS to the Cardiac Catheterization Laboratory in Patients Without ST-Segment Elevation Myocardial Infarction Resuscitated From Out-of-hospital Ventricular Fibrillation Cardiac Arrest Trial. We disseminated study advertisements with survey links and opt-out option using Facebook/Instagram to our communities and targeted emails to prehospital and cardiology providers. We also interviewed at-risk individuals with cardiac conditions, their caretakers, and patient advocacy groups. Between-group comparisons of proportions were tested using modified chi-squared tests for small sample size. Results: We collected 559 fully or partially completed surveys over an eight-week period. The majority of the surveys (70.5%) were obtained using social media. The mean age was 45 years; 90% were white and 61% were female. Overall, 91.3% believed ACCESS is an important study. The interview group had significantly more loved ones with cardiac arrest than the social media (50% vs 36.7%, p < 0.05) or targeted email (50% vs 23.6%, p < 0.005) group. Compared to the interview 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 interview 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. No one opted out from the study. Conclusions: The integration of social media with targeted emails and interviews is an effective approach for EFIC CC. Future work is necessary to determine the perception and best utilization of these strategies for EFIC studies.

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Multicenter Social Media Community Consultation for an Exception From Informed Consent Trial of the XStat device (PhoXstat Trial)

Journal of Trauma and Acute Care Surgery ◽

10.1097/ta.0000000000003425 ◽

2021 ◽

Vol Publish Ahead of Print ◽

Author(s):

Shannon W. Stephens ◽

Paige Farley ◽

Sean P. Collins ◽

Monica D. Wong ◽

Ashley B. Panas ◽

...

Keyword(s):

Social Media ◽

Informed Consent ◽

Community Consultation

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