Alternative end points for trauma studies: A survey of academic trauma surgeons.

ABSTRACT

INTRODUCTION: Changing the epidemiology of trauma makes traditional end points like 30-day mortality less than ideal. Many alternative end points have been suggested; however, they are not yet accepted by the trauma community or regulatory bodies. This study characterizes opinions about the adequacy of accepted end points of studies of trauma and the appropriateness of several novel end points. METHODS: An electronic survey was administered to all members of the American Association for the Surgery of Trauma. Questions involved demographics, research experience, appropriateness of proposed study end points, and the role of nontraditional, surrogate, and composite end points. RESULTS: Response rate was 16% (141 of 873) with 74% of respondents practicing at Level 1 Trauma Centers. The respondents were very experienced, with 81% reporting >10 years of practice at the attending level and 87% actively involved in research. The majority of respondents rated the following end points favorably 24-hour survival, 30-day survival, and time to control of acute hemorrhage with approval rates of 82%, 78%, and 76%, respectively. Six-hour survival, intensive care unit-free survival, and days free of multiorgan failure were rated as appropriate or very appropriate less than 66% of the time. Only 45% of respondents judged the currently used end points of trauma to be appropriate. More than 80% respondents disagreed or strongly disagreed that there was no role for of surrogate or composite endpoints in research of trauma resuscitation. CONCLUSION: There is strong interest in finding efficient end points in trauma research that are both specific and reflect the changing epidemiology of trauma death. The alternative end points of 24-hour survival and time to control of acute hemorrhage had similar approval rates to 30-day mortality.