The Roles of Electronic Health Records for Clinical Trials in Low- and Middle-Income Countries: Scoping Review.

Abstract

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.