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利用结构化研究站点指导模型促进临床研究网络中的站点表现。

Utilization of a structured research site mentorship model to facilitate site performance in a clinical research network.

作者信息

Johnson Marcus R, Beck Danielle, Sueiro Melyssa, Decker Makaila, Newcomb Jeff, Tiktin Margaret, Kiliveros Amelia, Asghar Aliya

机构信息

Durham VA Health Care System, USA.

VA San Diego Healthcare System, USA.

出版信息

Contemp Clin Trials Commun. 2024 Dec 31;44:101423. doi: 10.1016/j.conctc.2024.101423. eCollection 2025 Apr.

Abstract

BACKGROUND

Research site mentorship has a positive impact on study enrollment. The VA Cooperative Studies Program's (CSP) Network of Dedicated Enrollment Sites (NODES) utilized an existing site mentorship model to onboard 13 new expansion sites. We describe the successes, challenges, and lessons learned during the development and implementation of this model in this paper.

METHODS

NODES established a "Site Mentorship/Expansion Workgroup (SWG)" in October 2020 to plan and guide the consortium on providing mentorship and services to other clinical research networks, non-Node CSP study sites, and NODES expansion sites. In 2021, the SWG developed a 12-month implementation plan to onboard 13 new sites by pairing original Node (mentor) sites with expansion Node (mentee) sites. Mentors offered prompt guidance and solutions to mentees on site-level challenges by working with them closely. Implementation of the plan occurred from February 2022 through September 2023.

RESULTS

Data from the implementation of this mentorship plan demonstrated a 32.7 % increase (from 54.8 % in 2022 to 87.5 % in 2023) in the expansion sites' achievement of their Objectives & Key Results (OKRs). From October 2020-September 2021, prior to mentorship assignments, the original sites (mentors) achieved an average of 88 % of their OKRs and attained an average of 86.7 % and 80.9 % of those OKRs in October-September of 2022 and 2023 respectively during the mentorship implementation phase.

CONCLUSIONS

The results demonstrate that developing and implementing a research site mentorship model to facilitate onboarding and performance of research sites into an established network was feasible and contributed to the success of those sites.

摘要

背景

研究站点指导对研究入组有积极影响。退伍军人事务部合作研究项目(CSP)的专用入组站点网络(NODES)利用现有的站点指导模式接纳了13个新的扩展站点。在本文中,我们描述了该模式开发和实施过程中的成功经验、挑战及教训。

方法

NODES于2020年10月成立了“站点指导/扩展工作组(SWG)”,以规划并指导该联盟为其他临床研究网络、非节点CSP研究站点和NODES扩展站点提供指导和服务。2021年,SWG制定了一项为期12个月的实施计划,通过将原始节点(导师)站点与扩展节点(学员)站点配对来接纳13个新站点。导师通过与学员密切合作,就站点层面的挑战为其提供及时的指导和解决方案。该计划于2022年2月至2023年9月实施。

结果

该指导计划实施数据显示,扩展站点的目标与关键成果(OKR)达成率提高了32.7%(从2022年的54.8%提高到2023年的87.5%)。在2020年10月至2021年9月,即指导任务分配之前,原始站点(导师)的OKR平均达成率为88%,在2022年10月至2023年9月的指导实施阶段,分别平均达成了这些OKR的86.7%和80.9%。

结论

结果表明,开发并实施研究站点指导模式以促进研究站点融入既定网络并提高其绩效是可行的,且有助于这些站点取得成功。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/32bd/11782873/040f2e2755eb/gr1.jpg

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