Alawadi Zeinab M, LeFebvre Eric, Fox Erin E, Del Junco Deborah J, Cotton Bryan A, Wade Charles E, Holcomb John B
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.
Department of Emergency Medicine, University of Texas Medical School, Houston, TX.
Surgery. 2015 Nov;158(5):1291-6. doi: 10.1016/j.surg.2015.03.030. Epub 2015 May 7.
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.
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.
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.
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.
创伤流行病学的变化使得诸如30天死亡率等传统终点指标不太理想。已经提出了许多替代终点指标；然而，它们尚未被创伤学界或监管机构所接受。本研究描述了关于创伤研究公认终点指标的充分性以及几个新终点指标的适宜性的观点。
对美国创伤外科协会的所有成员进行了电子调查。问题涉及人口统计学、研究经验、拟议研究终点指标的适宜性以及非传统、替代和复合终点指标的作用。
回复率为16%（873人中141人），74%的受访者在一级创伤中心工作。受访者经验丰富，81%报告在主治医生级别有超过10年的工作经验，87%积极参与研究。大多数受访者对以下终点指标评价良好：24小时生存率、30天生存率以及控制急性出血的时间，批准率分别为82%、78%和76%。6小时生存率、无重症监护病房生存率以及无多器官功能衰竭天数被评为适宜或非常适宜的比例不到66%。只有45%的受访者认为目前使用的创伤终点指标是适宜的。超过80%的受访者不同意或强烈不同意替代或复合终点指标在创伤复苏研究中没有作用。
在创伤研究中寻找既具体又能反映创伤死亡流行病学变化的有效终点指标有着浓厚的兴趣。24小时生存率和控制急性出血时间的替代终点指标与30天死亡率的批准率相似。
