title: Alternative end points for trauma studies: A survey of academic trauma surgeons.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Surgery, University of Texas Medical School, Houston, TX; University of Texas Health Science Center at Houston Center for Surgical Trials and Evidence-based Practice (C-STEP), Houston, TX. Electronic address: Zeinab.alawadi@uth.tmc.edu.
authors.forename: Zeinab M
authors.initials: ZM
authors.lastname: Alawadi
authors.affiliation: Department of Emergency Medicine, University of Texas Medical School, Houston, TX.
authors.forename: Eric
authors.initials: E
authors.lastname: LeFebvre
authors.affiliation: University of Texas Health Science Center at Houston Center for Translational Injury Research (CeTIR), Houston, TX.
authors.forename: Erin E
authors.initials: EE
authors.lastname: Fox
authors.affiliation: University of Texas Health Science Center at Houston Center for Translational Injury Research (CeTIR), Houston, TX.
authors.forename: Deborah J
authors.initials: DJ
authors.lastname: Del Junco
authors.affiliation: Department of Surgery, University of Texas Medical School, Houston, TX; University of Texas Health Science Center at Houston Center for Translational Injury Research (CeTIR), Houston, TX.
authors.forename: Bryan A
authors.initials: BA
authors.lastname: Cotton
authors.affiliation: Department of Surgery, University of Texas Medical School, Houston, TX; University of Texas Health Science Center at Houston Center for Translational Injury Research (CeTIR), Houston, TX.
authors.forename: Charles E
authors.initials: CE
authors.lastname: Wade
authors.affiliation: Department of Surgery, University of Texas Medical School, Houston, TX; University of Texas Health Science Center at Houston Center for Translational Injury Research (CeTIR), Houston, TX.
authors.forename: John B
authors.initials: JB
authors.lastname: Holcomb
mesh_terms: D001291:Attitude of Health Personnel; D003422:Critical Care; D003430:Cross-Sectional Studies; D006470:Hemorrhage / Q000517:prevention & control; D006801:Humans; D017063:Outcome Assessment, Health Care; D012107:Research Design; D012151:Resuscitation; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D014193:Trauma Centers; D014194:Traumatology