知情同意(EFIC)的例外允许临床医生科学家进行急需的紧急研究。获得此异常,然而,需要与社区团体举行多次会议进行协商,这可能会使该过程耗时且昂贵。我们的目标是确定使用社交媒体代替某些社区会议以获得EFIC的影响。
对四个随机临床试验进行了经济分析。成本是使用人员成本保守估计的,社交媒体成本,并调整至2016年美元。如果人们参加了社区会议或通过社交媒体被引导到研究网站并花费≥1分钟,则认为他们已经达到。
早期全血研究需要14次会议,272人费用为8260美元(每人达到30美元)。务实,随机最佳血小板和血浆比率研究需要14次会议,达到260人,整体费用为7479美元(每人29美元)。院前氨甲环酸用于创伤性脑损伤研究需要12次会议,达到198人,费用为6340美元(每人达到32美元)。只有损害控制剖腹手术试验利用社交媒体代替一些社区会议。损害控制剖腹手术试验需要六次会议,有137人参加。这项价值1000美元的社交媒体活动吸引了229人。总体费用为3977美元,每人达到11美元。
在EFIC过程中包括社交媒体活动,增加了潜在患者的数量,并减少了总和每人成本达到的成本。通过纳入社交媒体活动可以促进获得用于未来紧急临床试验的EFIC。
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.
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.
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.
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.