Impact of individual clinical outcomes on trial participants’ perspectives on enrollment in emergency research without consent

Background:Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions.Methods:Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients’ Experiences in Emergency Research–Progesterone for the Treatment of Traumatic Brain Injury study. Answers to three key questions from Patients’ Experiences in Emergency Research–Progesterone for the Treatment of Traumatic Brain Injury study were analyzed in the context of enrolled patients’ initial injury severity (initial Glasgow Coma Scale and Injury Severity Score) and principal clinical outcomes (Extended Glasgow Outcome Scale and Extended Glasgow Outcome Scale relative to in...