Does experience matter? Implications for community consultation for research in emergency settings.
Does experience matter? Implications for community consultation for research in emergency settings.
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DOI：
10.1080/23294515.2017.1308978
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发表时间：
2017-04-01
影响因子：
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通讯作者：
Dickert, Neal W
中科院分区：
文献类型：
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作者：
Scicluna, Victoria M;Ali, Mohammed K;Dickert, Neal W
背景技术背景：在美国，使用知情同意例外（EFIC）的紧急情况下的研究需要社区协商（CC），但关于最佳CC实践的不确定性仍然存在。关于谁应该包括在CC中，特别是，是否优先考虑地理定义的社区或与条件有关的个人，正在进行辩论。了解EFIC研究的个人疾病经验的影响是很重要的设计CC和解释其results.METHODS：本研究是一个二次分析的调查，2612名参与者在12个地点进行CC事件的ProTECT III：预后创伤性脑损伤，第三阶段，随机试验进行EFIC。主要调查领域包括个人创伤性脑损伤（TBI）的经验，人口统计学信息，并接受两个假设的个人入组EFIC和使用EFIC一般在ProTECT III。描述性统计和多元回归模型用于探讨关键领域之间的关系。TBI患者、家人/亲人患有TBI的患者以及认识其他TBI患者的患者稍微更容易接受EFIC下的假设个人入组（调整后的比值比[OR]分别为1.14 [0.78-1.67]、1.54 [1.17-2.02]和1.51 [1.19-1.92]）和一般EFIC的使用（调整后OR分别为1.17 [0.83-1.64]、1.39 [1.08-1.77]和1.06 [0.86-1.31]）。在基于种族的亚组分析中，有任何疾病经历的白色参与者对EFIC的接受程度更高，正如预期的那样。然而，有数值较低的接受个人和一般EFIC招生黑人参与者之间的TBI connects.CONCLUSIONS：个人TBI的经验与接受EFIC研究的条件增加，除了黑人参与者。个人疾病经历对EFIC观点影响的异质性进一步支持将具有相关疾病经历的个人纳入CC，并强调了吸引少数参与者的重要性。
BACKGROUND: Community consultation (CC) is required for research in emergency settings using an exception from informed consent (EFIC) in the United States, but uncertainty persists regarding best CC practices. There is ongoing debate about whom to include in CC, specifically, whether to prioritize geographically defined communities or individuals with connections to the condition. Understanding the impact of personal disease experience on views of EFIC research is important for designing CC and interpreting its results.METHODS: This study was a secondary analysis of surveys administered to 2612 participants at 12 sites in CC events conducted for ProTECT III: Progesterone for Traumatic Brain Injury, a Phase III, randomized trial conducted using EFIC. Key survey domains included personal traumatic brain injury (TBI) experience, demographic information, and acceptance of both hypothetical personal enrollment under EFIC and the use of EFIC in general in ProTECT III. Descriptive statistics and multivariable regression models were used to explore relationships between key domains.RESULTS: TBI patients, those with family members/loved ones with TBI, and those who knew someone else with TBI were slightly more accepting of hypothetical personal enrollment under EFIC (adjusted odds ratio [OR] 1.14 [0.78-1.67], 1.54 [1.17-2.02], and 1.51 [1.19-1.92], respectively) and use of EFIC in general (adjusted OR 1.17 [0.83-1.64], 1.39 [1.08-1.77], and 1.06 [0.86-1.31], respectively) than those without this. In a subgroup analysis based on race, white participants with any disease experience had higher levels of acceptance of EFIC, as expected. However, there was numerically lower acceptance of personal and general EFIC enrollment among black participants with closer TBI connections.CONCLUSIONS: Personal TBI experience was associated with increased acceptance of EFIC research for that condition, except among black participants. Heterogeneity of the effect of personal disease experience on EFIC views further supports inclusion of individuals with relevant disease experience in CC and highlights the importance of engaging minority participants.