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J Surg Res. 2019 Feb;234:65-71. doi: 10.1016/j.jss.2018.09.007. Epub 2018 Oct 4.

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

Author information

1
The University of Texas McGovern Medical School at Houston, Houston, Texas. Electronic address: john.harvin@uth.tmc.edu.
2
The University of Texas McGovern Medical School at Houston, Houston, Texas.

Abstract

BACKGROUND:

Exception from informed consent (EFIC) allows clinician scientists to perform much needed emergency research. Obtaining this exception, however, requires many meetings with community groups for consultation, which can make the process time-consuming and expensive. We aim to determine the impact of using social media in lieu of some community meetings in an effort to obtain an EFIC.

MATERIALS AND METHODS:

An economic analysis of four randomized clinical trials was performed. Costs were conservatively estimated using personnel costs, social media costs, and adjusted to 2016 US dollars. People were considered reached if they attended a community meeting or were directed to the study website by social media and spent ≥1 min.

RESULTS:

The Early Whole Blood study required 14 meetings, reached 272 people, and cost $8260 ($30/person reached). The Pragmatic, Randomized Optimal Platelet and Plasma Ratios study required 14 meetings, reached 260 people, and cost $7479 overall ($29/person reached). The Prehospital Tranexamic Acid Use for Traumatic Brain Injury study required 12 meetings, reached 198 people, and cost $6340 ($32/person reached). Only the damage control laparotomy trial utilized social media in lieu of some community meetings. The damage control laparotomy trial required six meetings at which 137 people were reached. The $1000 social media campaign reached 229 people. The cost was $3977 overall and $11/person reached.

CONCLUSIONS:

Including a social media campaign during the EFIC process increased the number of potential patients reached and reduced total and per person costs reached costs. Obtaining an EFIC for future emergency clinical trials may be facilitated by the inclusion of a social media campaign.

KEYWORDS:

Community consultation; Emergency research; Exception from informed consent; Informed consent; Trauma

PMID:
30527501
PMCID:
PMC6291833
[Available on 2020-02-01]
DOI:
10.1016/j.jss.2018.09.007

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