利用电子健康记录招募临床试验参与者：对“和谐结局电子健康记录辅助研究”的混合方法分析。

The use of electronic health records for recruitment in clinical trials: a mixed methods analysis of the Harmony Outcomes Electronic Health Record Ancillary Study.

机构信息

Duke Clinical Research Institute, Durham, NC, USA.

Department of Population Health Sciences, Duke University School of Medicine, 215 Morris Street, Suite 210, Durham, NC, 27701, USA.

出版信息

Trials. 2021 Jul 19;22(1):465. doi: 10.1186/s13063-021-05397-0.

DOI:10.1186/s13063-021-05397-0

PMID:34281607

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8287813/

Abstract

BACKGROUND

The electronic health record (EHR) contains a wealth of clinical data that may be used to streamline the identification of potential clinical trial participants. However, there is little empirical information on site-level facilitators of and barriers to optimal use of EHR systems with respect to trial recruitment.

METHODS

We conducted qualitative focus groups and quantitative surveys as part of the EHR Ancillary Study, which is being conducted alongside the multicenter, global, Harmony Outcomes Trial comparing albiglutide to standard care for the prevention of cardiovascular events in type 2 diabetes. Subject matter experts used findings from focus groups to draft a 20-question survey examining the use of the EHR for participant identification, common site recruitment strategies, and variation in perceived barriers to optimal use of the EHR. The final survey was fielded with 446 site investigators actively enrolling participants in the main trial.

RESULTS

Nearly two-thirds of respondents were study coordinators (63.2%), 23.1% were principal investigators, and 13.7% held other research roles. Approximately half of the respondents reported using the EHR to find potential trial participants. Of these, 79.4% reported using EHR searches in conjunction with other recruitment methods, including reviewing of upcoming clinic schedules (75.3%) and contacting past trial participants (71.2%). Important barriers to optimal use of the EHR included the lack of availability of certain research-focused EHR modules and limitations on the ability to contact patients cared for by other providers. Of survey respondents who did not use the EHR to find potential participants, one-quarter reported that the EHR was not accessible in their country; this finding varied from 2.6% of respondents in North America to 50% of respondents in the Asia Pacific.

CONCLUSIONS

While EHR screening was commonly used for recruitment in a cardiovascular outcomes trial, important technical, governance, and regulatory barriers persist. Multifaceted, scalable, and customizable strategies are needed to support the optimal use of the EHR for trial participant identification.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02465515. Registered on 8 June 2015.

摘要

背景

电子健康记录（EHR）包含丰富的临床数据，可用于简化潜在临床试验参与者的识别。然而，关于站点层面促进和阻碍 EHR 系统在试验招募中最佳使用的经验信息很少。

方法

我们开展了定性焦点小组和定量调查，作为正在进行的多中心、全球 Harmony Outcomes 试验的一部分，该试验比较了阿必鲁肽与标准治疗在 2 型糖尿病患者心血管事件预防方面的效果。主题专家利用焦点小组的发现起草了一份 20 个问题的调查，调查了 EHR 在参与者识别、常见站点招募策略以及对 EHR 最佳使用的感知障碍方面的使用情况。最终的调查在 446 个积极参与主要试验的现场调查员中进行。

结果

近三分之二的受访者是研究协调员（63.2%），23.1%是主要研究者，13.7%担任其他研究角色。约一半的受访者报告使用 EHR 寻找潜在的试验参与者。其中，79.4%报告说他们使用 EHR 搜索与其他招募方法相结合，包括查看即将到来的诊所日程（75.3%）和联系过去的试验参与者（71.2%）。EHR 最佳使用的重要障碍包括某些专注于研究的 EHR 模块不可用，以及联系其他提供者照顾的患者的能力受限。在未使用 EHR 寻找潜在参与者的调查受访者中，四分之一的人报告说 EHR 在其所在国家/地区不可用；这一发现从北美 2.6%的受访者到亚太地区 50%的受访者各不相同。