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

Abstract

Exception from informed consent Emergency researchInformed consent Community consultation a b s t r a c t 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 timeconsuming 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. ª

Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke

“…63 Although some reports are positive and participants satisfied, 64,65 community consultation and public disclosure are also challenging, time consuming, and costly. 66,67 A study 68 reviewed 28 completed and published acute care studies between 1996 and 2018, that used exception from informed consent or waiver of informed consent. 68 Only 359 (0•6%) of 63 947 study enrolments were withdrawn or did not provide consent for continued study participation.…”

Patient and surrogate attitudes via an interviewer-administered survey on exception from informed consent enrollment in the Prehospital Air Medical Plasma (PAMPer) trial

“…We found that while most (81.7%) participants believed community consultation was important, none of the patients or surrogates could recall being informed of PAMPer via community consultation, and none were aware of opt out procedures. Social media has also been reported to be a cost-effective and efficient means of notifying the public [15,24]. Accordingly, social media has become one of the primary avenues for community consultation for EFIC since the PAMPer study [31].…”

“…Very few studies have examined patients' and surrogates' opinions regarding EFIC procedures and emergency research after they had participated in the clinical trial [23][24][25][26][27][28]. This is the first of these studies involving trial participants with uncontrolled traumatic hemorrhage.…”

“…The US Food and Drug Administration also requires a public disclosure and community consultation phase prior to beginning the trial to inform communities of the proposed study and provide ways in which individuals wishing to opt out may be excluded. It is known that the general population is largely accepting of EFIC enrollment [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20], and community consultation practices have been associated with increased acceptance [9,[21][22][23][24]. However, there is a paucity of studies that have characterized the experiences of patients or surrogates enrolled in the actual EFIC studies [25][26][27][28][29][30], and none have been conducted following interventions that focus on traumatic hemorrhage.…”

Damage control laparotomy in trauma: a pilot randomized controlled trial. The DCL trial

“…An EFIC was obtained from the Institutional Review Board to randomize patients into the trial during emergency trauma laparotomy. 12 Patients were only included if they or their legally authorized representative consented to further participation. Patients were enrolled at the Red Duke Trauma Institute at Memorial Hermann Hospital-Texas Medical Center, which admits >6000 adult trauma patients per year and is one of two American College of Surgeons verified level 1 trauma centers in Houston, Texas, USA.…”