Department of Emergency Medicine, Emory University School of Medicine, Atlanta, GA, USA.
Acad Emerg Med. 2011 Sep;18(9):972-6. doi: 10.1111/j.1553-2712.2011.01153.x. Epub 2011 Aug 19.
The objective was to determine if geospatial techniques can be used to inform targeted community consultation (CC) and public disclosure (PD) for a clinical trial requiring emergency exception from informed consent (EFIC).
Data from January 2007 to December 2009 were extracted from a Level I trauma center's trauma database using the National Trauma Registry of the American College of Surgeon (NTRACS). Injury details, demographics, geographic codes, and clinical data necessary to match core elements of the clinical trial inclusion criteria (Glasgow Coma Scale [GCS] 3-12 and blunt head injury) were collected on all patients. Patients' home zip codes were geocoded to compare with population density and clustering analysis.
Over a 2-year period, 179 patients presented with moderate to severe traumatic brain injury (TBI). Mapping the rate and frequency of TBI patients presenting to the trauma center delineated at-risk populations for moderate to severe head injury. Four zip codes had higher incidences of TBI than the rest, with one zip code having a very high rate of 80 per 100,000 population.
Geospatial techniques and hospital data records can be used to characterize potential subjects and delineate a high-risk population to inform directed CC and public disclosure strategies.
确定地理空间技术是否可用于为临床试验提供信息,该临床试验需要紧急豁免知情同意(EFIC)。
从 2007 年 1 月至 2009 年 12 月,从一级创伤中心的创伤数据库中使用美国外科医师学院国家创伤登记处(NTRACS)提取数据。收集所有患者的受伤详细信息、人口统计学信息、地理代码和临床数据,这些数据是匹配临床试验纳入标准(格拉斯哥昏迷量表[GCS] 3-12 和钝性头部损伤)的核心要素所必需的。患者的家庭邮政编码进行地理编码,以与人口密度和聚类分析进行比较。
在 2 年期间,有 179 名患者出现中度至重度创伤性脑损伤(TBI)。绘制创伤中心就诊的中度至重度头部损伤患者的比率和频率图,划定了中度至重度头部损伤的高危人群。有四个邮政编码的 TBI 发生率高于其他地区,其中一个邮政编码的发生率非常高,为每 10 万人 80 人。
地理空间技术和医院数据记录可用于描述潜在受试者,并划定高危人群,以告知有针对性的社区咨询和公开披露策略。