Tracking global resources and capacity for health research: time to reassess strategies and investment decisions.

The COVID-19 pandemic and more recently the Monkeypox outbreak emphasize the urgency and importance of improving the availability and equitable distribution of resources for health research across rich and poor countries. Discussions about the persistent imbalances in resource allocation for health research between rich and poor countries are not new, but little or no progress has been made in redressing these imbalances over the years. This is critical not only for emergency preparedness, but for the worlds' ability to improve population health in an equitable manner. Concerned with the lack of progress in this area, Member States of the World Health Organization requested the establishment of a Global Observatory on Health Research and Development, with the aim of consolidating, monitoring and analyzing relevant information on health research and development, with a view to informing the coordination and prioritization of new investments. In this commentary, we highlight some of the striking disparities from the Observatory's analysis over the 5 years since its establishment and reflect on what is needed to overturn stagnant progress.

From private incentives to public health need: rethinking research and development for pandemic preparedness.

Pandemic preparedness and response have relied primarily on market dynamics to drive development and availability of new health products. Building on calls for transformation, we propose a new value proposition that instead prioritises equity from the research and development (R&D) stage and that strengthens capacity to control outbreaks when and where they occur. Key elements include regional R&D hubs free to adapt well established technology platforms, and independent clinical trials networks working with researchers, regulators, and health authorities to better study questions of comparative benefit and real-world efficacy. Realising these changes requires a shift in emphasis: from pandemic response to outbreak control, from one-size-fits-all economies of scale to R&D and manufacture for local need, from de novo product development to last-mile innovation through adaptation of existing technologies, and from proprietary, competitive R&D to open science and financing for the common good that supports collective management and sharing of technology and know-how.

Increasing Effectiveness and Equity in Strengthening Health Research Capacity Using Data and Metrics: Recent Advances of the ESSENCE Mechanism.

Background: The ESSENCE on Health Research initiative established a Working Group on Review of Investments in 2018 to improve coordination and collaboration among funders of health research capacity strengthening. The Working Group comprises more than a dozen ESSENCE members, including diverse representation by geography, country income level, the public sector, and philanthropy. Objective: The overall goal of the Working Group is increased research on national health priorities as well as improved pandemic preparedness, and, ultimately, fewer countries with very limited research capacity. Methods: We developed a basic set of metrics for national health research capacity, assessed different models of coordination and collaboration, took a deeper dive into eight countries to characterize their national research capacity, and began to identify opportunities to better coordinate our investments. In this article, we summarize the presentations, discussions, and outcomes of our second annual (virtual) meeting, which had more than 100 participants representing funders, researchers, and other stakeholders from higher- and lower-income countries worldwide. Findings and conclusions: Presentations on the first day included the keynote speaker, Dr. Soumya Swaminathan, chief scientist of the World Health Organization (WHO), and updates on data and metrics for research capacity, which are critical to establish targets, road maps, and budgets. The second day focused on improving collaboration and coordination among funders and other stakeholders, the potential return on investment for health research, ongoing work to increase coordination at the country level, and examples of research capacity strengthening efforts in diverse health research areas from around the world. We concluded that an intentional data- and metric-driven approach to health research capacity strengthening, emphasizing coordination among funders, local leadership, and equitable partnerships and allocation of resources, will enhance the health systems of resource-poor countries as well as the world's pandemic preparedness.

Organizational Formation for Priority Setting: Historical Perspectives and Thematic Analysis of India's Health Technology Assessment Agency.

Countries pursuing universal health coverage must set priorities to determine which benefits to add to a national health program, but the roles that organizations play are less understood. This article investigates the case of the formation of an organization with a mandate for choice of technology for public health interventions and priorities, the Health Technology Assessment India. First, we narrate a chronology of agenda setting and adoption of national policy for organizational formation drawing on historical documentation, publicly available literature, and lived experiences from coauthors. Next, we conduct a thematic analysis that examines windows of opportunity, enabling factors, barriers and conditions, roles of stakeholders, messaging and framing, and specific administrative and bureaucratic tools that facilitated organization formation. This case study shows that organizational formation relied on the identification of multiple champions with sufficient seniority and political authority across a wide group of organizations, forming a coalition of broad base support, who were keen to advance health technology assessment policy development and organizational placement or formation. The champions in turn could use their roles for policy decisions that used private and public events to raise priority and commitment to the decisions, carefully considered organizational placement and formation, and developed the network of organizations for the generation of technical evidence and capacity building for health technology assessment, strengthened by international networks and organizations with financing, expertise, and policymaker relationships.

Creating equity in health research to drive more and better evidence.

Health research is rapidly changing with evidence being gathered through new agile methods. This evolution is critical but must be globally equitable so the poorest nations do not lose out. We must harness this change to better tackle the daily burden of diseases that affect the most impoverished populations and bring research capabilities to every corner of the world so that rapid and fair responses to new pathogen are possible; anywhere they appear. We must seize this opportunity to make research easier, better and more equitable. Currently too many nations are unable to generate the evidence or translate it to directly change health outcomes in their own communities. It is essential to act and harness this emerging change in how research data can be generated and shared, so that all nations sustainably gain from this development. There are positive examples to draw on from COVID-19, but we now need to act. Here we present an initiative to develop a new framework that can guide researchers in the design and execution of their studies. This highly agile system will work by adapting to risk and complexity in any given study, whilst generating quality, safe and ethical data.

Assistive technology as a pillar of universal health coverage: qualitative analysis of stakeholder responses to the world health assembly resolution on assistive technology.

Purpose: The importance of assistive technology (AT) as a pillar of universal health coverage was recognized at the 71st World Health Assembly (WHA) through the passing of Resolution 71.8 on improving access to AT (May 2018). A systematic analysis was conducted on the responses made to the Resolution by Member States and non-state actors, in order to provide a snapshot of global intent.Methods: Qualitative content analysis was conducted on over 40 written "Statements" made by Member States and non-state actors in response to Resolution 71.8.Results: The Resolution provides tangible guidance to the World Health Organisation (WHO) and its member states in order for them to meet commitments within the Convention on the Rights of Persons with Disabilities (CRPD). Statements made in response to the Resolution offer a unique plethora of multi-stakeholder views from differing global perspectives. Analysis identified a range of themes within two overarching themes: intersection of health, human rights and sustainable development; and international collaboration and support within an international agenda framework.Conclusion: The content analysis synthesises complex global data and identifies directions to positively influence national and regional AT policy and delivery. The complexity of factors demonstrates the importance of an AT systems-thinking approach; that is, the development and application of organised knowledge, skills, procedures and policies related to assistive products. AT systems thinking will be essential for AT to be effectively deployed as a pillar of universal health coverage.IMPLICATIONS FOR REHABILITATIONAssistive technology is a key facilitator of health and well-being, playing a critical role in global efforts to improve population health outcomes and strengthening health systemsAccess to assistive technology is a public health priority and is an essential health product to be covered under Universal Health CoverageEffective action on access to assistive technology must encompass the reality of diverse contexts yet common purposes expressed by global actorsThis analysis demonstrates the intersection of the health, human rights and sustainable development agendas, and the importance of international collaboration and support in achieving effective access.

Catastrophic costs due to tuberculosis in South India: comparison between active and passive case finding.

BACKGROUND: To measure and compare economic burden at the household level for tuberculosis (TB) patients who were detected through active case finding (ACF) and passive case finding (PCF) in rural areas. METHODS: This study was conducted in the Thiruvallur district from October 2016 to March 2018. TB patients diagnosed through ACF were included in this study. For the comparison, patients diagnosed through ACF were recruited in the ratio of 1:2 from the same study area during the same period. Costs between the groups were compared and a multiple regression model was used to identify factors associated with catastrophic costs due to TB. RESULTS: Of the 336 individuals, 110 were diagnosed through ACF and 226 through PCF. A total of 29% of patients diagnosed through PCF and 9% of patients diagnosed through ACF experienced catastrophic costs due to TB. The multiple logistic model shows that catastrophic costs due to TB had a significant association with higher income status (adjusted odds ratio [aOR] 4.91 [confidence interval {CI} 2.39 to 10.08]; p<0.001), alcohol use (aOR 2.78 [CI 1.33 to 5.81]; p=0.007), private as a first point of care (aOR 3.91 [CI 2.01 to 7.60]; p<0.001) and PCF (aOR 3.68 [CI 1.62 to 8.33]; p=0.002). CONCLUSIONS: Findings highlight that ACF significantly averted catastrophic costs due to TB among patients. ACF as a strategy could ensure financial protection of TB patients and limit their risk of poverty.

Clinical Benefits and Cost-Effectiveness of Laboratory Monitoring Strategies to Guide Antiretroviral Treatment Switching in India.

Current Indian guidelines recommend twice-annual CD4 testing to monitor first-line antiretroviral therapy (ART), with a plasma HIV RNA test to confirm failure if CD4 declines, which would prompt a switch to second-line ART. We used a mathematical model to assess the clinical benefits and cost-effectiveness of alternative laboratory monitoring strategies in India. We simulated a cohort of HIV-infected patients initiating first-line ART and compared 11 strategies with combinations of CD4 and HIV RNA testing at varying frequencies. We included adaptive strategies that reduce the frequency of tests after 1 year from 6 to 12 months for virologically suppressed patients. We projected life expectancy, time on failed first-line ART, cumulative 10-year HIV transmissions, lifetime cost (2014 US dollars), and incremental cost-effectiveness ratios (ICERs). We defined strategies as cost-effective if their ICER was <1 × the Indian per capita gross domestic product (GDP, $1,600). We found that the current Indian guidelines resulted in a per person life expectancy (from mean age 37) of 150.2 months and a per person cost of $2,680. Adding annual HIV RNA testing increased survival by ∼8 months; adaptive strategies were less expensive than similar nonadaptive strategies with similar life expectancy. The most effective strategy with an ICER <1 × GDP was the adaptive HIV RNA strategy (ICER $840/year). Cumulative 10-year transmissions decreased from 27.2/1,000 person-years with standard-of-care to 20.9/1,000 person-years with adaptive HIV RNA testing. In India, routine HIV RNA monitoring of patients on first-line ART would increase life expectancy, decrease transmissions, be cost-effective, and should be implemented.

Accelerating access to quality TB care for pediatric TB cases through better diagnostic strategy in four major cities of India.

BACKGROUND: Diagnosis of TB in children is challenging, and is largely based on positive history of contact with a TB case, clinical and radiological findings, often without microbiological confirmation. Diagnostic efforts are also undermined by challenges in specimen collection and the limited availability of high sensitivity, rapid diagnostic tests that can be applied with a quick turnaround time. The current project was undertaken in four major cities of India to address TB diagnostic challenges in pediatric population, by offering free of cost Xpert testing to pediatric presumptive TB cases, thereby paving the way for better TB care. METHODS: A high throughput lab was established in each of the four project cities, and linked to various health care providers across the city through rapid specimen transportation and electronic reporting linkages. Free Xpert testing was offered to all pediatric (0-14 years) presumptive TB cases (both pulmonary and extra-pulmonary) seeking care at public and private health facilities. RESULTS: The current project enrolled 42,238 pediatric presumptive TB cases from April, 2014 to June, 2016. A total of 3,340 (7.91%, CI 7.65-8.17) bacteriologically confirmed TB cases were detected, of which 295 (8.83%, CI 7.9-9.86) were rifampicin-resistant. The level of rifampicin resistance in the project cohort was high. Overall Xpert yielded a high proportion of valid results and TB detection rates were more than three-fold higher than smear microscopy. The project provided same-day testing and early availability of results led to rapid treatment initiation and success rates and very low rates of treatment failure and loss to follow-up. CONCLUSION: The current project demonstrated the feasibility of rolling out rapid and upfront Xpert testing for pediatric presumptive TB cases through a single Xpert lab per city in an efficient manner. Rapid turnaround testing time facilitated prompt and appropriate treatment initiation. These results suggest that the upfront Xpert assay is a promising solution to address TB diagnosis in children. The high levels of rifampicin resistance detected in presumptive pediatric TB patients tested under the project are a major cause of concern from a public health perspective which underscores the need to further prioritize upfront Xpert access to this vulnerable population.