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基层医疗对临床试验招募实施的看法。

Primary care perspectives on implementation of clinical trial recruitment.

作者信息

Taft Teresa, Weir Charlene, Kramer Heidi, Facelli Julio C

机构信息

Department of Biomedical Informatics, University of Utah, Salt Lake City, UT, USA.

Center for Clinical and Translational Science, University of Utah, Salt Lake City, UT, USA.

出版信息

J Clin Transl Sci. 2019 Dec 26;4(1):61-68. doi: 10.1017/cts.2019.435. eCollection 2020 Feb.

Abstract

INTRODUCTION

Poor clinical trial (CT) recruitment is a significant barrier to translating basic science discoveries into medical practice. Improving support for primary care provider (PCP) referral of patients to CTs may be an important part of the solution. However, implementing CT referral support in primary care is not only technically challenging, but also presents challenges at the person and organization levels.

METHODS

The objectives of this study were (1) to characterize provider and clinical supervisor attitudes and perceptions regarding CT research, recruitment, and referrals in primary care and (2) to identify perceived workflow strategies and facilitators relevant to designing a technology-supported primary care CT referral program. Focus groups were conducted with PCPs, directors, and supervisors.

RESULTS

Analysis indicated widespread support for the intrinsic scientific value of CTs, while at the same time deep concerns regarding protecting patient well-being, perceived loss of control when patients participate in trials, concern about the impact of point-of-care referrals on clinic workflow, the need for standard processes, and the need for CT information that enables referring providers to quickly confirm that the burdens are justified by the benefits at both patient and provider levels. PCP suggestions pertinent to implementing a CT referral decision support system are reported.

CONCLUSION

The results from this work contribute to developing an implementation approach to support increased referral of patients to CTs.

摘要

引言

临床试验招募困难是将基础科学发现转化为医学实践的重大障碍。加强对初级保健提供者(PCP)将患者转诊至临床试验的支持可能是解决问题的重要一环。然而,在初级保健中实施临床试验转诊支持不仅在技术上具有挑战性,而且在个人和组织层面也存在挑战。

方法

本研究的目的是:(1)描述初级保健提供者和临床主管对临床试验研究、招募及转诊的态度和看法;(2)确定与设计一项技术支持的初级保健临床试验转诊计划相关的工作流程策略及促进因素。我们对初级保健提供者、主任及主管进行了焦点小组访谈。

结果

分析表明,大家普遍支持临床试验的内在科学价值,与此同时,也深切关注如何保护患者福祉、患者参与试验时感觉失去控制权、担心即时护理转诊对诊所工作流程的影响、对标准流程的需求,以及对临床试验信息的需求,以便转诊提供者能够迅速确认,在患者和提供者层面,试验带来的负担能被其益处所抵消。本文报告了初级保健提供者对实施临床试验转诊决策支持系统的相关建议。

结论

本研究结果有助于制定一种实施方法,以支持增加将患者转诊至临床试验的比例。

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