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循证社区咨询用于创伤性脑损伤。

Evidence-based community consultation for traumatic brain injury.

机构信息

Department of Emergency Medicine, Emory University School of Medicine, Atlanta, GA, USA.

出版信息

Acad Emerg Med. 2011 Sep;18(9):972-6. doi: 10.1111/j.1553-2712.2011.01153.x. Epub 2011 Aug 19.

DOI:10.1111/j.1553-2712.2011.01153.x
PMID:21854486
Abstract

OBJECTIVES

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).

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

摘要

目的

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)。

方法

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。

结果

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。

结论

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。

相似文献

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Evidence-based community consultation for traumatic brain injury.循证社区咨询用于创伤性脑损伤。
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引用本文的文献

1
Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent.满足特殊需求:在紧急情况下使用免除知情同意的例外情况下进行研究的社区咨询和公开披露。
Acad Emerg Med. 2021 Oct;28(10):1183-1194. doi: 10.1111/acem.14264. Epub 2021 May 26.
2
Impact of individual clinical outcomes on trial participants' perspectives on enrollment in emergency research without consent.个体临床结果对试验参与者在未经同意情况下参与紧急研究的招募观点的影响。
Clin Trials. 2017 Apr;14(2):180-186. doi: 10.1177/1740774516677276. Epub 2016 Nov 15.
3
Exceptions to the rule of informed consent for research with an intervention.
针对有干预措施的研究的知情同意规则的例外情况。
BMC Med Ethics. 2016 Feb 6;17:9. doi: 10.1186/s12910-016-0092-6.
4
Variation of community consultation and public disclosure for a pediatric multi-centered "Exception from Informed Consent" trial.一项儿科多中心“知情同意豁免”试验中社区咨询与公众披露的变化
Clin Trials. 2015 Feb;12(1):67-76. doi: 10.1177/1740774514555586. Epub 2014 Nov 4.
5
Exception from informed consent for emergency research: consulting the trauma community.紧急研究的知情同意例外:咨询创伤界。
J Trauma Acute Care Surg. 2013 Jan;74(1):157-65; discussion 165-6. doi: 10.1097/TA.0b013e318278908a.