Nelson Maria J, Warden Craig, Griffiths Denise, Zive Dana, Schmidt Terri, Hedges Jerris R, Daya Mohamud, Newgard Craig D
Oregon Health & Science University School of Medicine, Portland, OR, USA.
Resuscitation. 2009 Jan;80(1):89-95. doi: 10.1016/j.resuscitation.2008.10.003. Epub 2008 Nov 17.
For trials involving exception from informed consent, some IRBs require that community members be allowed to "opt out" prior to enrollment. We tested for geospatial clustering of opt-out requests and the associated census tract characteristics in one study region.
This was a retrospective study at a single site of a multicenter exception from informed consent resuscitation trial. We collected and geocoded mailing addresses for persons requesting opt-out bracelets over 16 months, then tested for geospatial clustering using geographic information systems (GIS) analysis. Characteristics for tracts with and without bracelet clustering were compared using univariate tests, multivariable regression, and classification and regression tree (CART) analysis.
We received 395 phone calls requesting 718 bracelets, of which 673 were analyzable. Of 397 census tracts in the region, 208 (52%) had at least one request and 38 (10%) demonstrated clustering. In multivariable models, an increasing proportion of family households (OR .90, 95%CI .85-.93), veterans (OR .91, 95%CI .81-1.02), and renters (OR .96, 95%CI .92-.99) were associated with lower odds of requesting an opt-out bracelet, while census tracts with higher income had higher odds of opting-out (OR 1.07, 95%CI 1.02-1.11). Using CART, the proportion of family households and graduate education identified the majority of opt-out requests by census tracts (cross-validation sensitivity 92%, specificity 56%).
Opt-out requests for an exception from informed consent trial at one study site were geographically clustered and associated with certain population demographics. These findings may help identify key target groups for community consultation in future trials.
对于涉及知情同意豁免的试验，一些机构审查委员会要求在招募前允许社区成员“选择退出”。我们在一个研究区域测试了选择退出请求的地理空间聚集情况以及相关普查区的特征。
这是一项针对多中心知情同意豁免复苏试验单个站点的回顾性研究。我们收集了16个月内请求退出手环者的邮寄地址并进行地理编码，然后使用地理信息系统（GIS）分析测试地理空间聚集情况。使用单变量检验、多变量回归以及分类与回归树（CART）分析比较有和没有手环聚集的普查区特征。
我们接到395个索要718个手环的电话，其中673个可用于分析。该区域的397个普查区中，208个（52%）至少有一项请求，38个（10%）显示出聚集。在多变量模型中，家庭户比例增加（比值比0.90，95%置信区间0.85 - 0.93）、退伍军人（比值比0.91，95%置信区间0.81 - 1.02）以及租户（比值比0.96，95%置信区间0.92 - 0.99）与索要退出手环的较低几率相关，而收入较高的普查区选择退出的几率更高（比值比1.07，95%置信区间1.02 - 1.11）。使用CART分析，家庭户比例和研究生教育程度可识别出普查区中大部分的选择退出请求（交叉验证敏感性92%，特异性56%）。
在一个研究站点，针对知情同意试验豁免的选择退出请求在地理上呈聚集状态，并且与特定的人口统计学特征相关。这些发现可能有助于在未来试验中确定社区咨询的关键目标群体。
