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

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. 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. 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. 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. 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. DERR1-10.2196/43741.

Shau WY ，Setia S ，Shinde SP ，Santoso H ，Furtner D ... -  《JMIR Research Protocols》

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

The use of real-world data (RWD) warehouses for research in Asia is on the rise, but current trends remain largely unexplored. Given the varied economic and health care landscapes in different Asian countries, understanding these trends can offer valuable insights. We sought to discern the contemporary landscape of linked RWD warehouses and explore their trends and patterns in 3 Asian countries with contrasting economies and health care systems: Taiwan, India, and Thailand. Using a systematic scoping review methodology, we conducted an exhaustive literature search on PubMed with filters for the English language and the past 5 years. The search combined Medical Subject Heading terms and specific keywords. Studies were screened against strict eligibility criteria to identify eligible studies using RWD databases from more than one health care facility in at least 1 of the 3 target countries. Our search yielded 2277 studies, of which 833 (36.6%) met our criteria. Overall, single-country studies (SCS) dominated at 89.4% (n=745), with cross-country collaboration studies (CCCS) being at 10.6% (n=88). However, the country-wise breakdown showed that of all the SCS, 623 (83.6%) were from Taiwan, 81 (10.9%) from India, and 41 (5.5%) from Thailand. Among the total studies conducted in each country, India at 39.1% (n=133) and Thailand at 43.1% (n=72) had a significantly higher percentage of CCCS compared to Taiwan at 7.6% (n=51). Over a 5-year span from 2017 to 2022, India and Thailand experienced an annual increase in RWD studies by approximately 18.2% and 13.8%, respectively, while Taiwan's contributions remained consistent. Comparative effectiveness research (CER) was predominant in Taiwan (n=410, or 65.8% of SCS) but less common in India (n=12, or 14.8% of SCS) and Thailand (n=11, or 26.8% of SCS). CER percentages in CCCS were similar across the 3 countries, ranging from 19.2% (n=10) to 29% (n=9). The type of RWD source also varied significantly across countries, with India demonstrating a high reliance on electronic medical records or electronic health records at 55.6% (n=45) of SCS and Taiwan showing an increasing trend in their use over the period. Registries were used in 26 (83.9%) CCCS and 31 (75.6%) SCS from Thailand but in <50% of SCS from Taiwan and India. Health insurance/administrative claims data were used in most of the SCS from Taiwan (n=458, 73.5%). There was a consistent predominant focus on cardiology/metabolic disorders in all studies, with a noticeable increase in oncology and infectious disease research from 2017 to 2022. This review provides a comprehensive understanding of the evolving landscape of RWD research in Taiwan, India, and Thailand. The observed differences and trends emphasize the unique economic, clinical, and research settings in each country, advocating for tailored strategies for leveraging RWD for future health care research and decision-making. RR2-10.2196/43741.

Shau WY ，Setia S ，Chen YJ ，Ho TY ，Prakash Shinde S ，Santoso H ，Furtner D ... -  《JOURNAL OF MEDICAL INTERNET RESEARCH》

Ethics of Procuring and Using Organs or Tissue from Infants and Newborns for Transplantation, Research, or Commercial Purposes: Protocol for a Bioethics Scoping Review.

Since the inception of transplantation, it has been crucial to ensure that organ or tissue donations are made with valid informed consent to avoid concerns about coercion or exploitation. This issue is particularly challenging when it comes to infants and younger children, insofar as they are unable to provide consent. Despite their vulnerability, infants' organs and tissues are considered valuable for biomedical purposes due to their size and unique properties. This raises questions about the conditions under which it is permissible to remove and use these body parts for transplantation, research, or commercial purposes. The aim of this protocol is to establish a foundation for a scoping review that will identify, clarify, and categorise the main ethical arguments regarding the permissibility of removing and using organs or tissues from infants. The scoping review will follow the methodology outlined by the Joanna Briggs Institute (JBI), consisting of five stages: (1) identifying the research question, (2) developing the search strategy, (3) setting inclusion criteria, (4) extracting data, and (5) presenting and analysing the results. We will include both published and unpublished materials that explicitly discuss the ethical arguments related to the procurement and use of infant organs or tissues in the biomedical context. The search will cover various databases, including the National Library of Medicine, Web of Science, EBSCO, and others, as well as grey literature sources. Two raters will independently assess the eligibility of articles, and data from eligible studies will be extracted using a standardised form. The extracted data will then be analysed descriptively through qualitative content analysis. There has been debate about how to respect the rights and interests of organ and tissue donors since the beginning of transplantation practice, given the moral risks involved in procuring parts of their bodies and using them for transplantation or research. A major concern has been to ensure that, at a minimum, donation of organs or other bodily tissues for transplantation or research is done under conditions of valid informed consent, so as to avoid coercion or exploitation among other moral harms. In the case of infants and younger children, however, this concern poses special difficulties insofar as infants and younger children are deemed incapable of providing valid consent. Due to their diminutive size and other distinctive properties, infants' organs and tissues are seen as valuable for biomedical purposes. Yet, the heightened vulnerability of infants raises questions about when and whether it is ever permissible to remove these body parts or use them in research or for other purposes. The aim of this protocol is to form the basis of a systematic scoping review to identify, clarify, and systematise the main ethical arguments for and against the permissibility of removing and using infant or newborn (hereafter, "infant") organs or tissues in the biomedical context (i.e. for transplantation, research, or commercial purposes). Our scoping review will broadly follow the well-established methodology outlined by the Joanna Briggs Institute ( Peters et al., 2020). We will follow a five-stage review process: (1) identification of the research question, (2) development of the search strategy, (3) inclusion criteria, (4) data extraction, and (5) presentation and analysis of the results. Published and unpublished bibliographic material (including reports, dissertations, book chapters, etc.) will be considered based on the following inclusion criteria: the presence of explicit (bio)ethical arguments or reasons (concept) for or against the procurement and use of organs or tissues from infants, defined as a child from birth until 1 year old (population), in the biomedical domain, including transplantation, research, and commercial development (context). We will search for relevant studies in the National Library of Medicine (including PubMed and MEDLINE), Virtual Health Library, Web of Science, Google Scholar, EBSCO, Google Scholar, PhilPapers, The Bioethics Literature Database (BELIT), EthxWeb as well as grey literature sources (e.g., Google, BASE, OpenGrey, and WorldCat) and the reference lists of key studies to identify studies suitable for inclusion. A three-stage search strategy will be used to determine the eligibility of articles, as recommended by the JBI methodological guidelines. We will exclude sources if (a) the full text is not accessible, (b) the main text is in a language other than English, or (c) the focus is exclusively on scientific, legal, or religious/theological arguments. All articles will be independently assessed for eligibility between two raters (MB & XL); data from eligible articles will be extracted and charted using a standardised data extraction form. The extracted data will be analysed descriptively using basic qualitative content analysis. Ethical review is not required as scoping reviews are a form of secondary data analysis that synthesise data from publicly available sources. Our dissemination strategy includes peer review publication, presentation at conferences, and outreach to relevant stakeholders. The results will be reported according to the PRISMA-ScR guidelines. An overview of the general data from the included studies will be presented in the form of graphs or tables showing the distribution of studies by year or period of publication, country of origin, and key ethical arguments. These results will be accompanied by a narrative summary describing how each included study or article relates to the aims of this review. Research gaps will be identified and limitations of the review will also be highlighted. A paper summarising the findings from this review will be published in a peer-reviewed journal. In addition, a synthesis of the key findings will be disseminated to biomedical settings (e.g., conferences or workshops, potentially including ones linked to university hospitals) in the UK, USA, Türkiye, and Singapore. They will also be shared with the academic community and policy makers involved in the organ procurement organisations (OPO), which will potentially consider our recommendations in their decision-making processes regarding infant tissue/organ donation practice in these countries. The use of a rigorous, well-established methodological framework will ensure the production of a high-quality scoping review that will contribute to the bioethics literature.A comprehensive search of disciplinary and cross-disciplinary databases will be undertaken to ensure coverage of all possible sources that meet the inclusion criteria for the review.This review will focus exclusively on infant tissue/organ procurement/use in biomedical contexts, providing a comprehensive and reliable source of ethical arguments for future debates on this sensitive topic.The review will be limited to articles published in English, which increases the risk of missing relevant sources published in other languages.The review will be limited to articles for which the full text is available, which increases the risk of missing relevant sources that otherwise may have been included in the scoping review had the full text been accessible.

Barış M ，Lim X ，T Almonte M ，Shaw D ，Brierley J ，Porsdam Mann S ，Nguyen T ，Menikoff J ，Wilkinson D ，Savulescu J ，Earp BD ... -  《-》

Integrated Real-World Data Warehouses Across 7 Evolving Asian Health Care Systems: Scoping Review.

Asia consists of diverse nations with extremely variable health care systems. Integrated real-world data (RWD) research warehouses provide vast interconnected data sets that uphold statistical rigor. Yet, their intricate details remain underexplored, restricting their broader applications. Building on our previous research that analyzed integrated RWD warehouses in India, Thailand, and Taiwan, this study extends the research to 7 distinct health care systems: Hong Kong, Indonesia, Malaysia, Pakistan, the Philippines, Singapore, and Vietnam. We aimed to map the evolving landscape of RWD, preferences for methodologies, and database use and archetype the health systems based on existing intrinsic capability for RWD generation. A systematic scoping review methodology was used, centering on contemporary English literature on PubMed (search date: May 9, 2023). Rigorous screening as defined by eligibility criteria identified RWD studies from multiple health care facilities in at least 1 of the 7 target Asian nations. Point estimates and their associated errors were determined for the data collected from eligible studies. Of the 1483 real-world evidence citations identified on May 9, 2023, a total of 369 (24.9%) fulfilled the requirements for data extraction and subsequent analysis. Singapore, Hong Kong, and Malaysia contributed to ≥100 publications, with each country marked by a higher proportion of single-country studies at 51% (80/157), 66.2% (86/130), and 50% (50/100), respectively, and were classified as solo scholars. Indonesia, Pakistan, Vietnam, and the Philippines had fewer publications and a higher proportion of cross-country collaboration studies (CCCSs) at 79% (26/33), 58% (18/31), 74% (20/27), and 86% (19/22), respectively, and were classified as global collaborators. Collaboration with countries outside the 7 target nations appeared in 84.2% to 97.7% of the CCCSs of each nation. Among target nations, Singapore and Malaysia emerged as preferred research partners for other nations. From 2018 to 2023, most nations showed an increasing trend in study numbers, with Vietnam (24.5%) and Pakistan (21.2%) leading the growth; the only exception was the Philippines, which declined by -14.5%. Clinical registry databases were predominant across all CCCSs from every target nation. For single-country studies, Indonesia, Malaysia, and the Philippines favored clinical registries; Singapore had a balanced use of clinical registries and electronic medical or health records, whereas Hong Kong, Pakistan, and Vietnam leaned toward electronic medical or health records. Overall, 89.9% (310/345) of the studies took >2 years from completion to publication. The observed variations in contemporary RWD publications across the 7 nations in Asia exemplify distinct research landscapes across nations that are partially explained by their diverse economic, clinical, and research settings. Nevertheless, recognizing these variations is pivotal for fostering tailored, synergistic strategies that amplify RWD's potential in guiding future health care research and policy decisions. RR2-10.2196/43741.

Shau WY ，Santoso H ，Jip V ，Setia S ... -  《JOURNAL OF MEDICAL INTERNET RESEARCH》

Effectiveness of interventions for improving educational outcomes for people with disabilities in low- and middle-income countries: A systematic review.

People with disabilities are consistently falling behind in educational outcomes compared to their peers without disabilities, whether measured in terms of school enrolment, school completion, mean years of schooling, or literacy levels. These inequalities in education contribute to people with disabilities being less likely to achieve employment, or earn as much if they are employed, as people without disabilities. Evidence suggests that the gap in educational attainment for people with and without disabilities is greatest in low- and middle-income countries (LMICs). Exclusion of people with disabilities from mainstream education, and low rates of participation in education of any kind, are important issues for global equity. Interventions which might have a positive impact include those that improve educational outcomes for people with disabilities, whether delivered in specialist or inclusive education settings. Such interventions involve a wide range of initiatives, from those focused on the individual level - such as teaching assistance to make mainstream classes more accessible to children with specific learning needs - to those which address policy or advocacy. The objectives of this review were to answer the following research questions: (1) What is the nature of the interventions used to support education for people with disabilities in LMICs? (2) What is the size and quality of the evidence base of the effectiveness of interventions to improve educational outcomes for people with disabilities in LMICs? (3) What works to improve educational outcomes for people with disabilities in LMICs? (4) Which interventions appear to be most effective for different types of disability? (5) What are the barriers and facilitators to the improvement of educational outcomes for people with disabilities? (6) Is there evidence of cumulative effects of interventions? The search for studies followed two steps. Firstly, we conducted an electronic search of databases and sector-specific websites. Then, after initial screening, we examined the reference lists of all identified reviews and screened the cited studies for inclusion. We also conducted a forward search and an ancestral search. No restrictions in terms of date or format were placed on the search, but only English-language publications were eligible for inclusion. In our review, we included studies on the basis that they were able to detect intervention impact. Descriptive studies of various designs and methodologies were not included. We also excluded any study with a sample size of fewer than five participants. We included studies which examined the impact of interventions for people with disabilities living in LMICs. There were no restrictions on comparators/comparison groups in included studies. However, to be eligible for inclusion, a study needed to have both an eligible intervention and an eligible outcome. Any duration of follow-up was eligible for inclusion. We used EppiReviewer for bibliographic management, screening, coding, and data synthesis. Eligibility was assessed using a predesigned form based on the inclusion criteria developed by the authors. We piloted all coding sheets with at least five studies before use. The form allowed for coding of multiple intervention domains and multiple outcomes domains. The entire screening process was reported using a PRISMA flow chart. We screened all unique references from our search title and abstract, with two independent reviewers determining relevance, and repeated this process for full texts. Data was extracted from studies according to a coding sheet. Coding included: (1) extraction of basic study characteristics, (2) a narrative summary of procedures and findings (including recording of iatrogenic effects), (3) a summary of findings/results table, (4) an assessment of confidence in study findings, and (5) creation of a forest plot of effect sizes. A third data collector, a research associate, checked the results of this process. Confidence in study findings was assessed using a standardised tool. All coding categories were not mutually exclusive and so multiple coding was done where an intervention covered more than one category of intervention. Twenty-eight studies were included in this review. Most studies (n = 25) targeted children with disabilities. Only two studies directly targeted family members, and the remaining three focused on service providers. Individuals with intellectual or learning and developmental impairments were most frequently targeted by interventions (n = 17). The category of interventions most represented across studies was 'Educational attainment support', for instance, a reading comprehension intervention that combined strategy instruction (graphic organisers, visual displays, mnemonic illustrations, computer exercises, predicting, inference, text structure awareness, main idea identification, summarisation, and questioning) for children with dyslexia. The second most common category of intervention was 'Accessible learning environments', for instance, programmes which aimed to improve social skills or to reduce rates of victimisation of children with disabilities in schools. Regarding intervention effects, included studies concerned with 'Conditions for inclusion of people with disabilities in education' showed a moderately significant effect, and one study concerned with teacher knowledge showed a significant effect size. Among the 18 studies included in the analysis of intervention effects on 'Skills for learning', 12 interventions had a significant effect. When considering the effect of interventions on different outcomes, we see that the effect on literacy, cognitive skills, handwriting, and numeracy are significant. All these effects are large but are based on a low number of studies. The studies concerned with speech and school behaviour show no significant effect of intervention. Across studies, heterogeneity is high, and risk of publication bias varies but was frequently high. All but one study received an overall rating of low confidence in study findings. However, this lack of confidence across studies was largely due to the use of low-rigour study designs and was not always reflective of multiple points of weakness within a given study. Children with disabilities fall behind in educational outcomes as the current school systems are not set up to teach children with different impairment types. There is no one 'magic bullet' intervention which can equalise health outcomes for this group. A twin-track approach is needed, which both addresses the specific needs of children with disabilities but also ensures that they are included in mainstream activities (e.g., through improving the skills of teachers and accessibility of the classroom). However, currently most interventions included in this systematic review targeted individual children with disabilities in an attempt to improve their functioning, skills, and competencies, but did not focus on mainstreaming these children into the school by system-level or school-level changes. Consequently, a focus on evaluation of interventions which target not just the individual with a disability but also their broader environment, are needed.

Hunt X ，Saran A ，White H ，Kuper H ... -  《-》