Exploring ethical conflicts in emergency trauma research: the COMBAT (Control of Major Bleeding after Trauma) study experience.
Exploring ethical conflicts in emergency trauma research: the COMBAT (Control of Major Bleeding after Trauma) study experience.
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DOI：
10.1016/j.surg.2014.05.021
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发表时间：
2015-01
期刊：
影响因子：
3.8
通讯作者：
Sauaia A
中科院分区：
文献类型：
--
作者：
Chin TL;Moore EE;Coors ME;Chandler JG;Ghasabyan A;Harr JN;Stringham JR;Ramos CR;Ammons S;Banerjee A;Sauaia A
高达25%的严重受伤患者发展为外伤性凝血功能障碍。为了研究针对这些不易获得同意的弱势群体的干预措施，美国食品和药物管理局（FDA）发布了紧急研究条例，但知情同意除外（ER-EIC）。我们描述了准备ER-EIC研究即创伤后大出血控制（COMBAT）研究的社区咨询和公众披露（CCPD）过程。CCPD以四项生物伦理原则为指导。我们采用了多媒体方法，包括单向传播（报纸广告、小册子、电视、广播和网络）和双向传播（社区会议上的互动面对面演讲、印刷和在线反馈表格），以达到试验集水区（丹佛县人口：64.3万，通勤者居住的丹佛大都会区：290万）。可在现场演示期间或通过COMBAT网站获得退出材料。联系了227个社区组织。向11个诊所和3个无家可归者收容所分发了小册子。多媒体宣传活动有可能接触到丹佛大都会地区约150万人的听众，其中大多数人通过单向通信，1900人通过双向通信。这一资源密集型过程的成本超过84 000美元。CCPC过程是资源密集型的、昂贵的和复杂的。虽然多媒体的中央电脑吸引了大量的观众，但这一过程的有效性仍然难以捉摸。这些模板可以为类似的ER-EIC研究提供帮助。
Up to 25% of severely injured patients develop trauma-induced coagulopathy. To study interventions for this vulnerable population for whom consent cannot be obtained easily, the Food and Drug Administration (FDA) issued regulations for emergency research with an exception from informed consent (ER-EIC). We describe the community consultation and public disclosure (CCPD) process in preparation an ER-EIC study namely the Control of Major Bleeding after Trauma (COMBAT) study. The CCPD was guided by the four bioethical principles. We employed a multimedia approach including one-way communications (newspaper ads, brochures, television, radio, and web) and two-way communications (interactive in-person presentations at community meetings, printed and online feedback forms) to reach the trials catchment area (Denver County’s population: 643,000 and the Denver larger metro area where commuters reside: 2.9 million). Particular attention was given to special-interests groups (e.g., Jehovah Witnesses, homeless) and to Spanish-speaking communities (brochures and presentations in Spanish). Opt-out materials were available during on-site presentations or via the COMBAT website. 227 community organizations were contacted. Brochures were distributed to 11 medical clinics and 3 homeless shelters. The multimedia campaign had the potential to reach an estimated audience of 1.5 million individuals in large metro Denver area, the majority via one-way communication and 1900 in two-way communications. This resource intensive process cost over $84,000. The CCPC process is resource-intensive, costly, and complex. While the multimedia CCPC reached a large audience, the effectiveness of this process remains elusive. The templates can be helpful to similar ER-EIC studies.
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影响因子：
8.8
作者：
Dickert, Neal W.;Mah, Victoria A.;Pentz, Rebecca D.
通讯作者：
Pentz, Rebecca D.
影响因子：
6.2
作者：
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通讯作者：
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影响因子：
3.8
作者：
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通讯作者：
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影响因子：
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作者：
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影响因子：
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作者：
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