Contemporary Databases in Real-world Studies Regarding the Diverse Health Care Systems of India, Thailand, and Taiwan: Protocol for a Scoping Review

Abstract

Background Real-world data (RWD) related to patient health status or health care delivery can be broadly defined as data collected outside of conventional clinical trials, including those from databases, treatment and disease registries, electronic medical records, insurance claims, and information directly contributed by health care professionals or patients. RWD are used to generate real-world evidence (RWE), which is increasingly relevant to policy makers in Asia, who use RWE to support decision-making in several areas, including public health policy, regulatory health technology assessment, and reimbursement; set priorities; or inform clinical practice. Objective To support the achievement of the benefits of RWE in Asian health care strategies and policies, we sought to identify the linked contemporary databases used in real-world studies from three representative countries—India, Thailand, and Taiwan—and explore variations in results based on these countries’ economies and health care reimbursement systems by performing a systematic scoping review. Herein, we describe the protocol and preliminary findings of our scoping review. Methods The PubMed search strategy covered 3 concepts. Concept 1 was designed to identify potential RWE and RWD studies by applying various Medical Subject Headings (MeSH) terms (“Treatment Outcome,” “Evidence-Based Medicine,” “Retrospective Studies,” and “Time Factors”) and related keywords (eg, “real-world,” “actual life,” and “actual practice”). Concept 2 introduced the three countries—India, Taiwan, and Thailand. Concept 3 focused on data types, using a combination of MeSH terms (“Electronic Health Records,” “Insurance, Health,” “Registries,” “Databases, Pharmaceutical,” and “Pharmaceutical Services”) and related keywords (eg, “electronic medical record,” “electronic healthcare record,” “EMR,” “EHR,” “administrative database,” and “registry”). These searches were conducted with filters for language (English) and publication date (publications in the last 5 years before the search). The retrieved articles will undergo 2 screening phases (phase 1: review of titles and abstracts; phase 2: review of full texts) to identify relevant and eligible articles for data extraction. The data to be extracted from eligible studies will include the characteristics of databases, the regions covered, and the patient populations. Results The literature search was conducted on September 27, 2022. We retrieved 3,172,434, 1,094,125, and 672,794 articles for concepts 1, 2, and 3, respectively. After applying all 3 concepts and the language and publication date filters, 2277 articles were identified. These will be further screened to identify eligible studies. Based on phase 1 screening and our progress to date, approximately 44% (1003/2277) of articles have undergone phase 2 screening to judge their eligibility. Around 800 studies will be used for data extraction. Conclusions Our research will be crucial for nurturing advancement in RWD generation within Asia by identifying linked clinical RWD databases and new avenues for public-private partnerships and multiple collaborations for expanding the scope and spectrum of high-quality, robust RWE generation in Asia. International Registered Report Identifier (IRRID) DERR1-10.2196/43741

Integrated Real-World Study Databases in 3 Diverse Asian Health Care Systems in Taiwan, India, and Thailand: Scoping Review

“…The study methodology adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines [ 17 ]. The complete protocol has been published before [ 15 ] and is summarized infographically in Multimedia Appendix 1 (pages 6-8).…”

“…We performed a comprehensive literature search to identify RWE/RWD studies in India, Thailand, and Taiwan by incorporating 3 combined concepts in PubMed [ 15 ]. Concept 1 was designed to identify published studies that used RWE or RWD in the absence of specific Medical Subject Heading (MeSH) terms in PubMed.…”

“…The next phase involved screening of the retrieved studies against eligibility criteria ( Multimedia Appendix 1 , page 8) [ 15 ]. These eligibility criteria were chosen to help us identify relevant studies reporting RWE and RWD.…”

“…To achieve the benefits of RWE in Asian health care strategy and policy, we performed a scoping review to identify and characterize the databases used for RWE generation in Asia. The complete protocol for this scoping review is described in our previous publication [ 15 ] and illustrated in Multimedia Appendix 1 (pages 2-8). As a pilot, we chose 3 countries (Taiwan, India, Thailand) with diverse health care systems and income levels defined according to World Bank data [ 16 ].…”

“…As a pilot, we chose 3 countries (Taiwan, India, Thailand) with diverse health care systems and income levels defined according to World Bank data [ 16 ]. Taiwan is a high-income economy with health insurance that provides UHC and a single social health insurance scheme [ 15 ]. India is considered a lower-middle-income economy that largely relies on a self-pay health care system.…”