Health Research Policy and Systems最新文献

Background: Regulatory barriers present significant challenges to clinical trial approval during both "peacetime" and pandemics, particularly for multi-country clinical trials sponsored by academic institutions and low- and middle-income countries (LMICs). While such barriers have been depicted as a "python's embrace", analyses of trial approval efficiency and ethical frameworks have largely overlooked clinical trial insurance.

Methods: I interrogate the evolution of clinical trial indemnification mechanisms, rationales, and operationalisation over the past fifty years through a structured literature review. I then consider the procedural barriers faced by academic institutions conducting multi-country clinical research during the COVID-19 pandemic using a case study of the University of Oxford's "COPCOV" trial, which was led by the Mahidol Oxford Tropical Medicine Research Unit in Bangkok, Thailand. This includes thematic analysis of more than 65 semi-structured interviews with trial stakeholders and analysis of insurance documents from the Trial Master File and hundreds of stakeholder emails.

Results: Supplementary reinsurance policies cost over £110,000 during the COPCOV trial, delayed trial approvals by up to nine months in some countries, and were largely justified by sponsors based on concerns about reputational damage. I argue that risk frameworks grounded in financial risk management and the commercial sector have expanded within academic institutions and, when coupled with an expansion of national requirements for "local paper" insurance policies, create serious barriers to initiating trial sites in many LMICs.

Conclusions: Two potential reform pathways, which are grounded in procedural or systemic reforms and should be led by LMIC-based policymakers, could help to de-barrier clinical trial insurance procedures and ensure that evidence of efficacious (and affordable) countermeasures are available during future global health emergencies.

Health research among forcibly displaced populations presents distinct and multifaceted challenges, including limited healthcare access, heightened exposure to environmental hazards and insufficient research infrastructure. In December 2024, a multidisciplinary workshop convened in Kampala, Uganda, bringing together researchers, healthcare professionals, representatives from humanitarian non-governmental organizations and a global health funding body. The workshop aimed to identify key barriers and co-develop actionable strategies for conducting ethical and equitable research in contexts of displacement, with a specific focus on infectious disease. Across the 20 workshop participants, several critical challenges were identified: the misalignment between global health funding priorities and those of low- and middle-income countries; structural and methodological barriers in research design, such as restricted data access and the perpetuation of epistemic biases; and the ethical complexities of working with vulnerable and highly mobile populations. Discussants emphasized the essential role of sustained community engagement, transparent and bidirectional communication and targeted capacity-building as prerequisites for addressing these barriers. Proposed solutions highlighted the importance of long-term, sustainable research models supported by contextually adaptive methodologies, participatory approaches that centre community co-creation and the strengthening of regional research networks to improve access to funding and resources. These findings provide a basis for developing future frameworks aimed at improving health outcomes among forcibly displaced populations, and underscoring the need for a paradigmatic shift towards more inclusive, context-sensitive health research.

Background: Governmental action in Mexico has sought to understand and address the health situation of Indigenous Peoples (IPs) primarily through an intercultural perspective. However, intercultural approaches focused mainly on cultural aspects may obscure the historical and structural origins of health inequalities. Since the 1980s and during the early years of the new millennium, a series of political and institutional processes shaped a context that was central to incorporating IPs into the national health agenda.

Objective: The aim of this article is to conduct a critical analysis of health initiatives targeting IPs developed within this context (2000-2012).

Methodology: We carried out a qualitative critical analysis on the basis of a multi-source documentary review to analyse four specific initiatives, selected because they sought to include the participation of Indigenous leaders and explicitly incorporated an intercultural perspective.

Results: The government-led initiatives APV, PROSANI and EEM reproduced cultural essentialisms through a functional and relational intercultural approach and did not contribute to improving the situation of traditional medicine actors, such as midwives. In contrast the CAMIA initiatives have a community-based origin and, for more than two decades, have been a fundamental space for the health and rights of Indigenous women.

Discussion and conclusions: The incorporation of interculturality in most initiatives appears to respond to a State discourse strategy embedded in narratives of what is considered "politically correct," aimed at legitimizing programs and actions. The perspective from which health initiatives targeting Indigenous Peoples are designed, developed and implemented, as well as the actors involved in these processes and the degree of power and control exercised by both governmental actors and potential users/beneficiaries, determine their transformative potential. Initiatives built upon critical interculturality and with strong community foundations have had a significant impact on health and on other areas of Indigenous women's lives. There is an urgent need to rethink healthcare approaches for Indigenous Peoples in Mexico by adopting more critical intercultural frameworks that enable Indigenous self-determination and decolonial health perspectives.

Background: Effective collaboration between public health researchers and policymakers is critical for translating evidence into actionable policies. However, such collaboration is often undermined by misaligned priorities, structural barriers, and fragmented systems. This scoping review synthesizes global evidence on the strategies, facilitators and barriers shaping these collaborations, with a focus on how they enhance the uptake and use of research in policymaking.

Methods: A scoping review was conducted using a systematic search across four electronic databases (SCOPUS, Embase, Web of Science and Medline via PubMed), targeting studies published between 2019 and 2024. Eligible studies discussed strategies, barriers and facilitators for collaboration between researchers and policymakers in public health. Data were extracted on study context, collaboration mechanisms, enabling conditions and reported impacts.

Results: A total of 24 studies were included, revealing four interdependent strategies for effective collaboration. Most notably, co-production of knowledge emerged in two distinct forms: as a deliberately structured intervention and as an emergent outcome of sustained engagement over time. This dual nature of co-production offers a critical lens for understanding how collaboration evolves in practice. Other key strategies included capacity building at both individual and organizational levels, the use of structured communication and feedback mechanisms to align research with policy needs, and the establishment of governance frameworks to institutionalize research-policy partnerships. Collaborations that were formalized, embedded within institutions, and maintained through iterative engagement were more likely to result in increased research uptake and enduring policy impact.

Conclusions: These findings underscore that structured collaboration, particularly when supported by institutional mechanisms, ongoing capacity building and iterative engagement, plays a critical role in increasing the use of research in public health policymaking. By distinguishing co-production as both a deliberate strategy and an emergent outcome, this review offers new insight into how collaborative models can be designed or evolved to strengthen evidence-informed decision-making.

Introduction: Evidence on safety, clinical and cost-effectiveness forms a key part of Health Technology Assessment (HTA) value appraisal for new health technologies and is often used to inform reimbursement and market access decisions. However, value may depreciate over the lifecycle of technologies, requiring reassessment to inform disinvestment decisions. This scoping review aimed to synthesise the evidence on tools that address Health Technology Reassessment (HTR) and disinvestment decision-making processes, with a view to identifying the key elements of an appropriate HTR and disinvestment model.

Methods: The scoping review was guided by the Joanna Briggs Institute (JBI) methodology for scoping reviews and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. Using the keywords "tool" "disinvestment" and "health technology reassessment", studies published in the English language were identified from the following databases: EMBASE, Medline, CINAHL, Web of Science Core Collections, and Google Scholar. Additional sources of unpublished studies and grey literature included websites and databases of Health Technology Assessment International (HTAi), International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and members of the International Network of Agencies for Health Technology Assessment (INAHTA). The studies were screened, and the data extracted from the included studies were mapped to our predefined conceptual framework and synthesised narratively.

Results: Nineteen studies conducted in nine different countries were included in the scoping review. Most of the studies were conducted in high-income countries with formal HTA processes and nine studies conducted in or by researchers in Canada. The studies proposed different frameworks to guide the HTR and disinvestment process, only four of which have been validated in a real-world setting. There was generally underreporting of the sustainability component in proposed models as only three studies considered sustainability.

Conclusion: This scoping review synthesised available evidence on HTR and mapped the attributes of tools in the included studies to our predefined conceptual framework. Our results suggest that a stronger focus on sustainability and a consistent stakeholder engagement process may improve implementation of disinvestment frameworks and tools. Further work on contextualising models to the local setting and beyond HTA-related processes would be required.

Background: People from ethnically diverse backgrounds are underrepresented in clinical trials, reinforcing healthcare inequity. Co-production involves users of research (knowledge users) as partners in the research process. A premise of co-production is that it enhances ethicality of research by responding to the needs and preferences of those it is designed for while facilitating adoption and impact. Research reporting co-production in ethnically diverse communities is emerging; however, reporting of specific strategies to support effective co-production remains sparse, particularly when designing interventions for clinical trials. We draw on our experience of co-production with ethnically diverse communities to address this gap in the research literature using the exemplar, MOVE Together: Reduce falls, a co-produced intervention to support people aged over 65 years from ethnically diverse communities to develop exercise habits and reduce their risk of falls.

Methods: Utilizing an integrated knowledge translation (IKT) approach to co-production, our team of 24 partners, including people aged over 65 years from ethnically diverse communities, representatives from ethnically diverse community groups and service providers developed our intervention over five stages. Two stages engaged 75 participants including 63 (84%) people aged over 65 years from three ethnically diverse communities (Chinese, Italian and Arabic-speaking) and 12 service providers. The remaining three stages involved the co-production research team.

Results: Strong participant satisfaction (96%) and co-production team consensus regarding the readiness of our intervention for progression to clinical trial (100%) support the success of our approach. Strategies to optimize communication and uphold the principles of co-production were identified by our team as important to the process. Drawing on research evidence and our experience we highlight potential strategies to support alignment with the principles of co-production when co-producing with people from ethnically diverse communities. These include additional time and financial resources, tailored approaches to information provision and a culturally responsive approach.

Conclusions: When co-producing interventions for clinical trials with ethnically diverse communities, co-production teams must be prepared for the additional resources necessary to ensure genuine partnership. In this exemplar, we describe an iterative approach to health research co-production that may inform future health research involving under-served populations.

Background: Area-level socioeconomic deprivation is a key determinant of health disparities and quality of life. This study aimed to develop and validate the Thailand district-level Socioeconomic Deprivation Index (TSDI)-a nationwide, district-level index to identify deprived areas and their specific deprivation dimensions using national census data.

Methods: In this methodological cross-sectional study, we constructed the TSDI from a 20% stratified random sample of the 2010 Thai national census (63 478 990 individuals across 928 districts). Domains and indicators were selected on the basis of a scoping review and theoretical frameworks of relative deprivation. Principal component analysis (PCA) was used to create a composite index, which was visualized through choropleth mapping.

Results: The TSDI comprises six principal components encompassing 29 indicators, explaining 73.82% of the total variance. The components represent: (1) overall socioeconomic deprivation, (2) housing and assets, (3) demography and family composition, (4) foreign and elementary workers, (5) household crowding and (6) access to tap water. Spatial analysis revealed severe deprivation clusters in the northern, lower northeastern and southern regions, while central (including Bangkok) and eastern coastal areas were less deprived.

Conclusions: The TSDI is a novel, validated tool that provides a comprehensive and spatially explicit measure of socioeconomic deprivation in Thailand. It offers critical data for targeting public health interventions, informing resource allocation and investigating the pathways linking social inequality to health and development outcomes.

Background: Although dementia research agendas increasingly prioritize dissemination and implementation (D&I) of research findings, there is still limited understanding of the role and activities of dementia research funders. Implementation science literature offers theories, frameworks and tools to integrate diverse stakeholder perspectives, supporting the translation of research evidence into practice and policy. This study identifies and categorizes the D&I strategies and related challenges, faced by public and private dementia research funders in the Netherlands. This study aims to provide evidence that clarifies the roles of public and private dementia research funders and offers guidance for planning and executing dementia research D&I. This study contributed to evidence and perspectives generated outside the traditional clinical settings, which are essential to advance implementation science.

Methods: Semi-structured qualitative interviews were conducted with 20 individuals, selected through purposive snowball sampling. Respondents involved representatives of three public and four private funding agencies in the Netherlands. Interviews were conducted in-person or virtually, audio-recorded and transcribed verbatim. Data extraction and data analysis were conducted using an iterative abductive thematic coding approach on the basis of the methodology of Timmermans and Tavory.

Results: The strategies and related challenges of public and private funders of dementia research were clustered into three themes: "dissemination", "implementation support" and "research ecosystem capacity-building". Strategies for dissemination and implementation support were facilitated through brokering knowledge and providing financial incentives, procedural guidance and action mandates. Public and private funders contributed significantly to research ecosystem capacity-building through strategies such as establishing research consortium models, implementation training programs and professional connective networks. Results suggested that both types of funders are guided by distinct value systems and contribute different resources and expertise to the D&I process. Collaborative capacity between public and private funders was hindered by D&I role ambiguity and conflicting value systems, which emphasizes the lack of insights in how and when to engage each type of funder in D&I.

Conclusions: This study provides contextual insight into the opportunities to invest in developing D&I professional competencies and leveraging strategic public-private partnerships to optimize D&I processes. Future research could develop this research ecosystem concept to overcome persistent contextual D&I challenges.

Background: Research funders, such as the UK National Institute for Health and Care Research, are committed to capacity-building for the health and social care workforce in addition to that provided for doctors and dentists. Programmes designed to build capacity offer research training and collaborations with academia. This paper reports findings from a process evaluation of capacity-building research internships and predoctoral fellowships provided through a research-practice partnership in one region in England. The aim of the study was to explore experiences from multiple perspectives and ascertain factors influencing the development of research capacity and impact of the schemes.

Methods: A total of 29 individual qualitative, semistructured interviews were undertaken with (i) interns and predoctoral fellows (health, social care or quality improvement professionals based in the regional health and social care system), (ii) health and social care managers (mostly line managers of the interns and predoctoral fellows) and (iii) supervisors (university academics). Data analysis followed a thematic approach, informed by Cooke's framework for the evaluation of research capacity-building.

Results: Our analytical framework was based on Cooke's framework for research capacity-building; all six principles were relevant. (i) The schemes facilitated the building of skills and confidence and exposure to the academic research environment. (ii) The research facilitated was close to practice; trainees pursued their research interests sparked by their practice experience. (iii) The schemes fostered linkages, collaborations and partnerships by bringing together practitioners from the regional health and social care system with researchers at the university; many effective and enduring collaborations were forged. (iv) Trainees achieved dissemination and impact via publishing research and leveraging funding, generating outputs traditionally recognized as metrics of capacity-building success; they also created impact in practice. (v) In terms of continuity and sustainability, the schemes provided a first step in research for some and a next step for others. Trainees shared and cascaded newly acquired skills, coaching and encouraged practice colleagues to get involved in research. Programme infrastructure, including organizing staff cover and support from managers in practice, were necessary.

Conclusions: Our findings aligned with all of Cooke's principles. Individual managerial support, infrastructure and research culture were crucial for the development of research capacity. Subsequent research should develop theories of change and apply them in evaluations of research capacity-building.

Background: India conducts all three tiers of the Field Epidemiology Training Program (FETP). During the coronavirus disease 2019 (COVID-19) pandemic, the country committed to rapid scale-up of its frontline public health workforce capacity through the 3-month in-service Frontline FETP.

Implementation, achievements, challenges and lessons learned: Between January 2021 and May 2023, 300 district-level public health workers and 73 mentors were trained across 124 districts in eight states. Frontline FETP officers successfully completed 236 field assignments, nearly half of which were surveillance systems evaluations or surveillance data analyses and another half of which were case, cluster or outbreak investigations. Acute diarrhoeal disease (ADD) was the most frequently assessed or investigated condition and was one of many diseases exemplifying how FETP officers may need to work across multiple sectors (for example, health, water and sanitation) to help mitigate the public health impact of disease on the affected communities. Challenges (for example, time-consuming process of tailoring learning content, attrition, identification of qualified mentors and task-shifting) and lessons learned (for example, pivoting to a self-paced learning model, using case studies with real-world examples, and a blended learning approach) are described.

Conclusion: This paper portrays the feasibility of not only implementing a 3-month FETP in India's diverse context but, given the complexity of health challenges in an increasingly interconnected environment, its flexibility to be naturally transitioned towards One Health FETP (named SectorConnect in India). It highlights a milestone in India's journey towards realizing the goals set under the One India FETP Roadmap for having at least one trained field epidemiologist per district.