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

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          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

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          Most cited references22

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          PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation

          Scoping reviews, a type of knowledge synthesis, follow a systematic approach to map evidence on a topic and identify main concepts, theories, sources, and knowledge gaps. Although more scoping reviews are being done, their methodological and reporting quality need improvement. This document presents the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) checklist and explanation. The checklist was developed by a 24-member expert panel and 2 research leads following published guidance from the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network. The final checklist contains 20 essential reporting items and 2 optional items. The authors provide a rationale and an example of good reporting for each item. The intent of the PRISMA-ScR is to help readers (including researchers, publishers, commissioners, policymakers, health care providers, guideline developers, and patients or consumers) develop a greater understanding of relevant terminology, core concepts, and key items to report for scoping reviews.
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            Pragmatic Trials.

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              Good practices for real‐world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR‐ISPE Special Task Force on real‐world evidence in health care decision making

              Abstract Purpose Real‐world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. Methods The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus‐building iterative process for the topics and framing of recommendations. Results The ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making. Conclusion The focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                December 2022
                13 December 2022
                : 11
                : 12
                : e43741
                Affiliations
                [1 ] Regional Medical Affairs Pfizer Corporation Hong Kong Limited Hong Kong Hong Kong
                [2 ] Executive Office Transform Medical Communications Limited Wanganui New Zealand
                Author notes
                Corresponding Author: Sajita Setia sajita.setia@ 123456transform-medcomms.com
                Author information
                https://orcid.org/0000-0003-3977-1729
                https://orcid.org/0000-0002-7423-3742
                https://orcid.org/0000-0003-3657-0454
                https://orcid.org/0000-0003-4209-7632
                https://orcid.org/0000-0002-5912-6439
                Article
                v11i12e43741
                10.2196/43741
                9795390
                36512386
                a3f34fbf-83e2-4805-8610-1dee8f6b71dc
                ©Wen-Yi Shau, Sajita Setia, Salil Prakash Shinde, Handoko Santoso, Daniel Furtner. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.12.2022.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 22 October 2022
                : 16 November 2022
                : 30 November 2022
                : 1 December 2022
                Categories
                Protocol
                Protocol

                asia,health care databases,real-world data,real-world evidence,scoping review

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