Shoaibi Azza, Obeid Jihad S, Oates Jim C, Habrat Melissa L, Lenert Leslie A
Biomedical Informatics Center, Medical University of South Carolina, Charleston, South Carolina, USA.
Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.
JAMIA Open. 2018 Oct;1(2):195-201. doi: 10.1093/jamiaopen/ooy038. Epub 2018 Sep 24.
Obtaining patient permissions for research contact and for surplus tissue use as part of routine clinical practice can improve research participation. This study aims to investigate the difference in patient permissions for use of surplus tissues, and for direct contact for research, using 2 different methods of solicitation.
An opt-in, population-based approach for gathering research permissions was implemented in 2 methods. The first method, applied a 2-item patient questionnaire delivered through the electronic health record patient portal. The questionnaire composed of 2 questions (1) whether de-identified surplus specimens may be used for research and (2) whether patients could be contacted about research. In the second method, the same questionnaire was physically presented in clinic within the clinical workflow. We used 1 to 1 propensity score matching and multivariate logistic regression to estimate the odds of obtaining permission and the difference between the 2 methods of solicitation.
The propensity score model matched 8044 observations (4114 submissions in each group). Among the in-clinic submission group, 70.13% provided permission for surplus tissue compared with 66.65% in the patient portal submission group (odds ratio [OR] = 1.20; 95% confidence interval [CI] 1.09-1.32; < 0.001). Permission for future research contact was similar among in-clinic (65.07%) and patient portal submission (66.65%) groups (OR = 0.94; 95% CI 0.85-1.03; = 0.175). These trends were consistent among European Americans and African American patients. However, among patients of other race, higher permission for both future contact (OR = 0.58; 95% CI 0.39-0.86; < 0.007) and surplus tissue use (OR = 0.65; 95% CI 0.43-0.97; = 0.036) was observed among patient portal submission.
Our findings suggest that in-clinic solicitation of patient permissions may provide the same opportunity to patients who do not use patient portals and may be associated with higher permission rate for surplus tissue. However, this was primary true for European American and African Americans patients. Patients of other race minorities might respond better to online approaches.
Adopting a patient-centric approach that combines in-clinic and portal-based administration may be feasible and promising. Further research is required in this area.
在常规临床实践中获取患者对研究接触及剩余组织使用的许可能够提高研究参与度。本研究旨在调查使用两种不同征求方法时，患者对剩余组织使用及研究直接接触的许可差异。
采用两种方法实施基于人群的选择加入式研究许可收集方式。第一种方法是通过电子健康记录患者门户发放一份包含两个项目的患者问卷。该问卷由两个问题组成：（1）去标识化的剩余标本是否可用于研究；（2）是否可就研究联系患者。第二种方法是在临床工作流程中于诊所实际发放相同问卷。我们使用一对一倾向得分匹配和多变量逻辑回归来估计获得许可的几率以及两种征求方法之间的差异。
倾向得分模型匹配了8044例观察对象（每组4114份提交）。在诊所提交组中，70.13%的患者允许使用剩余组织，而患者门户提交组中这一比例为66.65%（比值比[OR]=1.20；95%置信区间[CI]1.09 - 1.32；P<0.001）。诊所提交组（65.07%）和患者门户提交组（66.65%）中未来研究接触的许可情况相似（OR = 0.94；95% CI 0.85 - 1.03；P = 0.175）。这些趋势在欧裔美国人和非裔美国患者中是一致的。然而，在其他种族的患者中，患者门户提交组在未来接触（OR = 0.58；95% CI 0.39 - 0.86；P<0.007）和剩余组织使用（OR = 0.65；95% CI 0.43 - 0.97；P = 0.036）方面的许可率更高。
我们的研究结果表明，在诊所征求患者许可可能为不使用患者门户的患者提供相同机会，并且可能与剩余组织的更高许可率相关。然而，这主要适用于欧裔美国人和非裔美国患者。其他种族少数群体的患者可能对在线方式反应更好。
采用结合诊所和基于门户管理的以患者为中心的方法可能是可行且有前景的。该领域需要进一步研究。
