Multicenter social media community consultation for an exception from informed consent trial of the XStat device (PhoXStat trial)

Abstract

INTRODUCTION:Community consultation (CC) is a key step for exception from informed consent research. Using social media to conduct CC is becoming more widely accepted but has largely been conducted by single sites. We describe our experience of a social mediabased CC for a multicenter clinical trial, coordinated by the lead clinical site. METHODS:Multicenter CC was administered by the lead site and conducted in preparation for a three-site prehospital randomized clinical trial.We used Facebook and Instagram advertisements targeted to the population of interest. When "clicked," the advertisements directed individuals to study-specific websites, providing additional information and the opportunity to opt out. The lead institution and one other hospital relied on a single website, whereas the third center set up their own website. Site views were evaluated using Google analytics. RESULTS:The CC took 8 weeks to complete for each site. The advertisements were displayed 9.8 million times, reaching 332,081 individuals, of whom 1,576 viewed one of the study-specific websites. There were no requests to opt out.

Interactive Media-Based Approach for an Exception From Informed Consent Trial Involving Patients With Trauma

“…The eFigure in Supplement 1 shows the number of views that the main landing pages, FAQ pages, EFIC description pages, and opt-out information pages received by site. The main landing pages were viewed most frequently (median [IQR] viewings, 2936 [1250-3924]), followed by the community meeting pages (median [IQR] viewings, 13 ), opt-out information pages (median [IQR] viewings, 12 [7][8][9][10][11][12][13][14][15][16][17][18][19]), FAQ pages (median [IQR] viewings, 10 [5-20]), and EFIC description pages (median [IQR] viewings, 9 [4][5][6][7][8][9][10][11][12][13][14][15][16]). There was a discernible temporal pattern, in that websites that have been active and able to be accessed for longer were viewed by more people.…”

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

“…The demographic profile of trauma patients differs from that of the general population, and minorities are usually overrepresented. We have recently conducted a three-center CC, in preparation for the PHOXSTAT trial, a prehospital EFIC trial of the XSTAT hemostatic device 10 . We evaluated the racial and ethnic composition of the resident adult community (obtained from the U.S. Census Bureau), and the trauma community (obtained from trauma registries) in each of the three proposed trial sites.…”

“…We have recently conducted a three-center CC, in preparation for the PHOXSTAT trial, a prehospital EFIC trial of the XSTAT hemostatic device. 10 We evaluated the racial and ethnic composition of the resident adult community (obtained from the U.S. Census Bureau), and the trauma community (obtained from trauma registries) in each of the three proposed trial sites. The results are shown in Table 1 and Figure 2 and confirm that there are important demographic differences between the resident and trauma communities, and between locations.…”

“…We have successfully used this concept for a number of cardiac arrest and trauma trials. 2,9,10 Social media advertisements can similarly be used to disseminate study results. This highlights that, although conceptually different, CC and PD can both be facilitated by social media.…”

“…The reach of social media is best leveraged by using advertisements, which are seen by individuals as part of their “feeds.” When “clicked,” the advertisements redirect interested users to a study website, which contains information on the trial, how to engage with investigators (by a variety of means), and a mechanism for leaving feedback. We have successfully used this concept for a number of cardiac arrest and trauma trials 2,9,10 . Social media advertisements can similarly be used to disseminate study results.…”