Ye Jiancheng, Xiong Shangzhi, Wang Tengyi, Li Jingyi, Cheng Nan, Tian Maoyi, Yang Yang
Weill Cornell Medicine, New York, NY, United States.
Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
JMIR Med Inform. 2023 Nov 22;11:e47052. doi: 10.2196/47052.
Clinical trials are a crucial element in advancing medical knowledge and developing new treatments by establishing the evidence base for safety and therapeutic efficacy. However, the success of these trials depends on various factors, including trial design, project planning, research staff training, and adequate sample size. It is also crucial to recruit participants efficiently and retain them throughout the trial to ensure timely completion.
There is an increasing interest in using electronic health records (EHRs)-a widely adopted tool in clinical practice-for clinical trials. This scoping review aims to understand the use of EHR in supporting the conduct of clinical trials in low- and middle-income countries (LMICs) and to identify its strengths and limitations.
A comprehensive search was performed using 5 databases: MEDLINE, Embase, Scopus, Cochrane Library, and the Cumulative Index to Nursing and Allied Health Literature. We followed the latest version of the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guideline to conduct this review. We included clinical trials that used EHR at any step, conducted a narrative synthesis of the included studies, and mapped the roles of EHRs into the life cycle of a clinical trial.
A total of 30 studies met the inclusion criteria: 13 were randomized controlled trials, 3 were cluster randomized controlled trials, 12 were quasi-experimental studies, and 2 were feasibility pilot studies. Most of the studies addressed infectious diseases (15/30, 50%), with 80% (12/15) of them about HIV or AIDS and another 40% (12/30) focused on noncommunicable diseases. Our synthesis divided the roles of EHRs into 7 major categories: participant identification and recruitment (12/30, 40%), baseline information collection (6/30, 20%), intervention (8/30, 27%), fidelity assessment (2/30, 7%), primary outcome assessment (24/30, 80%), nonprimary outcome assessment (13/30, 43%), and extended follow-up (2/30, 7%). None of the studies used EHR for participant consent and randomization.
Despite the enormous potential of EHRs to increase the effectiveness and efficiency of conducting clinical trials in LMICs, challenges remain. Continued exploration of the appropriate uses of EHRs by navigating their strengths and limitations to ensure fitness for use is necessary to better understand the most optimal uses of EHRs for conducting clinical trials in LMICs.
临床试验是通过建立安全性和治疗效果的证据基础来推进医学知识和开发新疗法的关键要素。然而，这些试验的成功取决于多种因素，包括试验设计、项目规划、研究人员培训以及足够的样本量。在整个试验过程中高效招募参与者并留住他们以确保按时完成试验也至关重要。
人们越来越有兴趣将电子健康记录（EHR）——临床实践中广泛采用的工具——用于临床试验。本范围综述旨在了解EHR在支持低收入和中等收入国家（LMIC）开展临床试验方面的应用，并确定其优势和局限性。
使用5个数据库进行了全面检索：MEDLINE、Embase、Scopus、Cochrane图书馆和护理及相关健康文献累积索引。我们遵循PRISMA-ScR（系统评价和Meta分析扩展版的首选报告项目，用于范围综述）的最新版本指南进行本次综述。我们纳入了在任何步骤中使用EHR的临床试验，对纳入研究进行了叙述性综合分析，并将EHR的作用映射到临床试验的生命周期中。
共有30项研究符合纳入标准：13项为随机对照试验，3项为整群随机对照试验，12项为准实验研究，2项为可行性预试验。大多数研究涉及传染病（15/30，50%），其中80%（12/15）是关于艾滋病毒或艾滋病，另外40%（12/30）关注非传染性疾病。我们的综合分析将EHR的作用分为7大类：参与者识别和招募（12/30，40%）、基线信息收集（6/30，20%）、干预（8/30，27%）、保真度评估（2/30，7%）、主要结局评估（24/30，80%）、非主要结局评估（13/30，43%）和延长随访（2/30，7%）。没有研究使用EHR进行参与者同意和随机分组。
尽管EHR在提高LMIC开展临床试验的有效性和效率方面具有巨大潜力，但挑战依然存在。有必要通过权衡其优势和局限性来持续探索EHR的适当用途，以确保适用性，从而更好地理解EHR在LMIC开展临床试验的最佳用途。
