Cheah Stefanie, O'Donoghue Sheila, Daudt Helena, Dee Simon, LeBlanc Jodi, Braun Lauren, Barnes Rebecca, Vercauteren Suzanne, Boone Robert H, Watson Peter H
1 University of British Columbia, Office of Biobank Education and Research , Vancouver, British Columbia, Canada .
Biopreserv Biobank. 2013 Aug;11(4):245-52. doi: 10.1089/bio.2013.0023.
Improving patient recruitment and consent to participate in clinical studies is an important issue. The process of consent involves three steps: patient referral for contact, the preliminary interview to determine patient interest, and the informed consent discussion. We hypothesized that putting the first step of the consent process into a 'Permission to Contact' (PTC) platform would improve patient engagement, would improve the efficiency of the other steps of the process, and would be acceptable to diverse patient groups.
To test this hypothesis, four PTC platforms were established in three types of outpatient health clinics (cancer, cardiac, maternal health) in different British Columbia health centers. Each began as a research project where clinic personnel were engaged, clinic flow processes were mapped, and a design for each PTC was derived by consensus. All patients at these clinics were asked for 'permission to be contacted for future research purposes.' Patient approach and permission response rates were assessed and operational costs were estimated.
Overall permission rates were high for all projects, but ranged from 94% of 'cancer' patients to 80% of 'congenital heart' patients who were approached (p<0.0001). Sustainability was demonstrated by stable enrollment levels after several years, and ongoing costs averaged $25 (range $12-$39) for each 'permission' across all four platforms.
A PTC platform is a feasible mechanism to engage patients in research programs such as biobanking. It is well supported by clinic staff and receives high engagement and acceptance from patients. Patient-approach rates vary in different clinics, likely due to both clinic and PTC process factors, but this strategy provides an efficient means of engaging patients in research and sets the stage for enhanced enrollment into translational research programs.
改善患者招募情况以及提高患者参与临床研究的同意率是一个重要问题。同意过程包括三个步骤：将患者转介以进行联系、进行初步访谈以确定患者兴趣以及进行知情同意讨论。我们假设将同意过程的第一步纳入“联系许可”（PTC）平台将提高患者参与度，提高该过程其他步骤的效率，并且能为不同患者群体所接受。
为了验证这一假设，在不列颠哥伦比亚省不同的健康中心的三种门诊健康诊所（癌症、心脏、孕产妇健康）中建立了四个PTC平台。每个平台最初都是一个研究项目，在此过程中诊所工作人员参与其中，绘制诊所流程，并通过协商得出每个PTC的设计方案。这些诊所的所有患者都被询问是否“允许为未来研究目的而被联系”。评估了患者的接触率和许可回复率，并估算了运营成本。
所有项目的总体许可率都很高，但范围从被接触的“癌症”患者中的94%到“先天性心脏病”患者中的80%（p<0.0001）。几年后稳定的入组水平证明了其可持续性，并且所有四个平台上每个“许可”的持续成本平均为25美元（范围为12 - 39美元）。
PTC平台是让患者参与生物样本库等研究项目的可行机制。它得到了诊所工作人员的大力支持，并获得了患者的高度参与和接受。不同诊所的患者接触率有所不同，这可能是由于诊所和PTC流程因素共同导致的，但该策略为让患者参与研究提供了一种有效方式，并为增加转化研究项目的入组奠定了基础。
