Tabriz Health Services Management Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
Department of Health Information Technology, School of Management and Medical Informatics, Tabriz University of Medical Sciences, Tabriz, Iran.
BMC Med Res Methodol. 2024 Mar 18;24(1):70. doi: 10.1186/s12874-024-02177-7.
Clinical trials are of high importance for medical progress. This study conducted a systematic review to identify the applications of EHRs in supporting and enhancing clinical trials.
A systematic search of PubMed was conducted on 12/3/2023 to identify relevant studies on the use of EHRs in clinical trials. Studies were included if they (1) were full-text journal articles, (2) were written in English, (3) examined applications of EHR data to support clinical trial processes (e.g. recruitment, screening, data collection). A standardized form was used by two reviewers to extract data on: study design, EHR-enabled process(es), related outcomes, and limitations.
Following full-text review, 19 studies met the predefined eligibility criteria and were included. Overall, included studies consistently demonstrated that EHR data integration improves clinical trial feasibility and efficiency in recruitment, screening, data collection, and trial design.
According to the results of the present study, the use of Electronic Health Records in conducting clinical trials is very helpful. Therefore, it is better for researchers to use EHR in their studies for easy access to more accurate and comprehensive data. EHRs collects all individual data, including demographic, clinical, diagnostic, and therapeutic data. Moreover, all data is available seamlessly in EHR. In future studies, it is better to consider the cost-effectiveness of using EHR in clinical trials.
临床试验对于医学进展至关重要。本研究进行了系统评价，以确定电子健康记录（EHR）在支持和增强临床试验方面的应用。
于 2023 年 12 月 3 日在 PubMed 上进行了系统检索，以确定有关 EHR 在临床试验中应用的相关研究。如果研究符合以下标准，则被纳入：（1）全文期刊文章，（2）用英语撰写，（3）考察 EHR 数据在支持临床试验流程（如招募、筛选、数据收集）方面的应用。两位评审员使用标准化表格提取以下数据：研究设计、EHR 支持的流程、相关结果和局限性。
经过全文审查，有 19 项研究符合预先设定的纳入标准，并被纳入。总体而言，纳入的研究一致表明，EHR 数据集成可提高临床试验在招募、筛选、数据收集和试验设计方面的可行性和效率。
根据本研究的结果，在进行临床试验时使用电子健康记录非常有帮助。因此，研究人员最好在研究中使用 EHR，以便更轻松地获得更准确和全面的数据。EHR 收集所有个体数据，包括人口统计学、临床、诊断和治疗数据。此外，所有数据在 EHR 中都可无缝获取。在未来的研究中，最好考虑在临床试验中使用 EHR 的成本效益。
