Feasibility of Informed Consent for Computed Tomography in Acute Trauma Patients.
Feasibility of Informed Consent for Computed Tomography in Acute Trauma Patients.
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急性创伤患者进行计算机断层扫描知情同意的可行性。
DOI：
10.1111/acem.13164
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发表时间：
2017
期刊：
影响因子：
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通讯作者：
Rodriguez,RobertM
中科院分区：
文献类型：
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作者：
Moore,Nicole;Patel,Bhavesh;Zuabi,Nadia;Langdorf,MarkI;Rodriguez,RobertM
背景计算机断层扫描（CT）对于创伤受害者来说很常见，但通常在没有告知患者潜在风险或获得知情同意的情况下进行。目的本研究的目的是确定成年创伤患者知情同意 CT 所需的两个要素（时间和正常警觉水平）的可行性。方法我们在两个城市一级创伤中心进行了这项前瞻性观察性、两阶段队列研究。在第一阶段，我们通过对每个地点的 11 名受伤患者进行假同意，确定了获得 CT 知情同意所需的中位时间。在第二阶段，我们观察了在指定时间段内出现的所有成人创伤激活病例，并记录了格拉斯哥昏迷量表（GCS）评分和 CT 同意时间（TAC）——定义为二次创伤调查结束与患者离开复苏室去做 CT 之间的时间。我们将先验的可行同意病例定义为患者的 GCS 为 15 且 TAC 大于该部位的中位假同意时间。结果两个部位的假 CT 同意时间中位时间分别为 3:36 和 2:09 分:秒（范围 = 1:12–4:54）。在 II 期入组的 729 名创伤患者中，646 名 (89%) 进行了 CT 扫描，在这 646 名患者中，461 名 (71.4% [95% 置信区间 = 67.8%–74.7%]) 符合可行的同意标准。在 185 名未能满足可行同意标准的患者中，171 名 (92.4%) 的 GCS < 15，1 名 (0.5%) 的 TAC 短于假同意时间，13 名 (7.0%) 两者兼而有之。结论我们发现，在超过三分之二的急性成人创伤患者中，CT 知情同意可能是可行的。
BackgroundComputed tomography (CT) is common for trauma victims, but is usually done without informing patients of potential risks or obtaining informed consent.ObjectiveThe objective of this study was to determine the feasibility of two elements (time and normal level of alertness) necessary for informed consent for CT in adult trauma patients.MethodsWe conducted this prospective observational, two‐phase cohort study at two urban, Level I trauma centers. In the first phase, we determined the median time needed to obtain informed consent for CT by performing sham consent on 11 injured patients at each site. In the second phase, we observed all adult trauma activation cases that presented during specified time blocks and recorded Glasgow Coma Scale (GCS) scores and the time available for consent (TAC) for CT—defined as the time between the end of the secondary trauma survey and when the patient left the resuscitation room to go to CT. We defined, a priori, feasible consent cases as those in which the patient had a GCS of 15 and a TAC greater than the median sham consent time at that site.ResultsThe median times for sham CT consent at the two sites were 3:36 and 2:09 minutes:seconds (range = 1:12–4:54). Of the 729 trauma patients enrolled during phase II, 646 (89%) had a CT scan, and of these 646 patients, 461 (71.4% [95% confidence interval = 67.8%– 74.7%]) met feasible consent criteria. Of the 185 patients who failed to meet feasible consent criteria, 171 (92.4%) had a GCS < 15, one (0.5%) had a TAC less than the sham consent time, and 13 (7.0%) had both.ConclusionWe found that informed consent for CT was likely feasible in over two‐thirds of acute, adult trauma patients.