TransFAIR study: a European multicentre experimental comparison of EHR2EDC technology to the usual manual method for eCRF data collection.

IF 4.1 Q1 HEALTH CARE SCIENCES & SERVICES
Nadir Ammour, Nicolas Griffon, Juliette Djadi-Prat, Gilles Chatellier, Martine Lewi, Marija Todorovic, Augustín Gómez de la Cámara, Maria Teresa García Morales, Sara Testoni, Oriana Nanni, Christoph Schindler, Mats Sundgren, Almenia Garvey, Tomothy Victor, Manon Cariou, Christel Daniel
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Abstract

Purpose: Regulatory authorities including the Food and Drug Administration and the European Medicines Agency are encouraging to conduct clinical trials using routinely collected data. The aim of the TransFAIR experimental comparison was to evaluate, within real-life conditions, the ability of the Electronic Health Records to Electronic Data Capture (EHR2EDC) module to accurately transfer from EHRs to EDC systems patients' data of clinical studies in various therapeutic areas.

Methods: A prospective study including six clinical trials from three different sponsors running in three hospitals across Europe has been conducted. The same data from the six studies were collected using both traditional manual data entry and the EHR2EDC module. The outcome variable was the percentage of data accurately transferred using the EHR2EDC technology. This percentage was calculated considering all collected data and the data in four domains: demographics (DM), vital signs (VS), laboratories (LB) and concomitant medications (CM).

Results: Overall, 6143 data points (39.6% of the data in the scope of the TransFAIR study and 16.9% when considering all data) were accurately transferred using the platform. LB data represented 65.4% of the data transferred; VS data, 30.8%; DM data, 0.7% and CM data, 3.1%.

Conclusions: The objective of accurately transferring at least 15% of the manually entered trial datapoints using the EHR2EDC module was achieved. Collaboration and codesign by hospitals, industry, technology company, supported by the Institute of Innovation through Health Data was a success factor in accomplishing these results. Further work should focus on the harmonisation of data standards and improved interoperability to extend the scope of transferable EHR data.

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TransFAIR 研究:欧洲多中心实验比较 EHR2EDC 技术和通常的手工方法收集电子病历资料。
目的:食品药品管理局和欧洲药品管理局等监管机构鼓励利用日常收集的数据开展临床试验。TransFAIR 实验对比的目的是在现实条件下评估电子健康记录到电子数据采集(EHR2EDC)模块从电子健康记录到电子数据采集系统准确传输不同治疗领域临床研究患者数据的能力:方法:进行了一项前瞻性研究,包括在欧洲三家医院进行的来自三个不同赞助商的六项临床试验。使用传统的人工数据录入和 EHR2EDC 模块收集了六项研究的相同数据。结果变量是使用 EHR2EDC 技术准确传输数据的百分比。该百分比的计算考虑了所有收集的数据和四个领域的数据:人口统计学(DM)、生命体征(VS)、实验室(LB)和伴随药物(CM):总体而言,该平台准确传输了 6143 个数据点(占 TransFAIR 研究范围内数据的 39.6%,占所有数据的 16.9%)。LB数据占传输数据的65.4%;VS数据占30.8%;DM数据占0.7%;CM数据占3.1%:使用 EHR2EDC 模块准确传输至少 15%的人工输入试验数据点的目标已经实现。在健康数据创新研究所的支持下,医院、行业、技术公司之间的合作和代码设计是取得这些成果的成功因素。今后的工作重点应放在统一数据标准和提高互操作性上,以扩大可转移电子病历数据的范围。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
6.10
自引率
4.90%
发文量
40
审稿时长
18 weeks
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