JMIR Publications

ABSTRACT

Background:

real-world data (RWD) relating to patient health status and/or the delivery of healthcare can be broadly defined as data collected outside of conventional clinical trials in the context of databases, treatment and disease registries, electronic medical records, insurance claims, and information directly contributed by healthcare professionals and/or the patients themselves. RWD is used to generate real-world evidence, which is increasingly relevant to policymakers in Asia to support decision-making from several perspectives, including public health policy, regulatory, health technology assessments, and reimbursement, and to set priorities or inform (clinical) practice.

Objective:

To support the purpose of achieving the benefits of RWE in Asian healthcare strategy and policy, we sought to identify linked contemporary databases used in real-world studies in three representative countries (India, Thailand, and Taiwan) to reflect the diversity in Asia by performing a systematic scoping review. In this article, we describe the protocol and preliminary literature search for the scoping review.

Methods:

The PubMed search strategy covered three concepts. Concept 1 was designed to identify potential RWE/RWD studies by applying a variety of MeSH terms (“Treatment Outcome”, “Evidence-Based Medicine”, “Retrospective Studies”, “Time Factors”) and related keywords (e.g. “real-world”, “actual life”, “actual practice”). Concept 2 introduced the three countries (India, Taiwan, and Thailand). Concept 3 focused on data types, by using a combination of MeSH terms (“Electronic Health Records”, “Insurance, Health”, “Registries”, “Databases, Pharmaceutical”, “Pharmaceutical Services”) and related keywords (e.g., electronic medical record, electronic healthcare record, EMR, EHR, administrative database, registry). These searches were combined with filters for the English language and publications in the last 5 years before the search. In the next step, the retrieved articles will undergo two screening phases (phase 1: review of the title and abstract; phase 2: review of full text) in order to identify relevant and eligible articles for data extraction. Data to be extracted from eligible studies will include characteristics of the database itself, region(s) covered, and the patient population.

Results:

The literature search was conducted on Sep 27, 2022 and retrieved 3,172,434 (concept 1), 1,094,125 (concept 2), and 672,794 (concept 3) articles. After applying all three concepts together with the language and publication date filters, 2,277 articles were identified. These articles will be further screened to identify eligible studies. Based on phase 1 screening to date, we estimate that approximately 20% (~450) of the articles will require full-text review to judge their eligibility, and that 100–200 studies will be used for data extraction.

Conclusions:

We believe that this research will be crucial in nurturing advancement in RWD generation in Asia by identifying linked clinical RWD databases and identifying new avenues for public-private partnerships and multiple collaborations to expand the scope and spectrum of high-quality, robust RWE generation in Asia. Clinical Trial: NA