Scaling malaria interventions: bottlenecks to malaria elimination.

The slow progress in malaria control efforts and increasing challenges have prompted a need to accelerate the research and development (R&D), launch and scaling of effective interventions for malaria elimination. This research, including desk research and key informant interviews, identified the following challenges along the end-to-end scale-up pathway of malaria interventions. Underinvestment in malaria R&D persists, and developers from low-resource settings are not commonly included in the R&D process. Unpredictable or unclear regulatory and policy pathways have been a hurdle. The private sector has not been fully engaged, which results in a less competitive market with few manufacturers, and consequently, a low supply of products. Persistent challenges also exist in the scaling of malaria interventions, such as the fragmentation of malaria programmes. Further efforts are needed to: (1) Strengthen coordination among stakeholders and especially the private sector to inform decisions and mobilise resources. (2) Increase engagement of national stakeholders, particularly those in low-income and middle-income countries, in planning for and implementing R&D, launching and scaling proven malaria interventions. (3) Use financial incentives and other market-shaping strategies to encourage R&D for innovative malaria products and improve existing interventions. (4) Streamline and improve transparency of WHO's prequalification and guidelines processes to provide timely technical advice and strategies for different settings. (5) Increase effort to integrate malaria services into the broader primary healthcare system. (6) Generate evidence to inform policies on improving access to malaria interventions.

Comparing research and development, launch, and scale up timelines of 18 vaccines: lessons learnt from COVID-19 and implications for other infectious diseases.

Over the next decade, millions of deaths could be prevented by increasing access to vaccines in low-income and middle-income countries (LMICs). The COVID-19 pandemic has demonstrated that the research and development (R&D), launch and scale up timelines of vaccines can be drastically shortened. This study compares such timelines for eighteen vaccines and identifies lessons and implications for accelerating the R&D, launch and scale up process for other vaccine candidates. To replicate the rapid R&D process of the COVID-19 vaccines, future vaccine R&D should capitalise on public-private knowledge sharing partnerships to promote technology innovation, establish regional clinical trial centres and data sharing networks to optimise clinical trial efficiency, and create a funding mechanism to support research into novel vaccine platforms that may prove valuable to quickly developing vaccine candidates in future global health emergencies. To accelerate the launch timeline, future efforts to bring safe and efficacious vaccines to market should include LMICs in the decision-making processes of global procurement and delivery alliances to optimise launch in these countries, strengthen the WHO prequalification and Emergency Use Listing programs to ensure LMICs have a robust and transparent regulatory system to rely on, and invest in LMIC regulatory and manufacturing capacity to ensure these countries are vaccine self-sufficient. Lastly, efforts to accelerate scale up of vaccines should include the creation of regional pooled procurement mechanisms between LMICs to increase purchasing power among these countries and an open line of clear communication with the public regarding pertinent vaccine information to combat misinformation and vaccine hesitancy.

Experiences, Enablers, and Challenges in Service Delivery and Integration of COVID-19 Vaccines: A Rapid Systematic Review.

The COVID-19 vaccination is a crucial public health intervention for controlling the spread and severity of the SARS-CoV2 virus. COVID-19 vaccines have been developed in record time, but their deployment has varied across countries, owing to differences in health system capacity, demand for the vaccine, and purchasing power of countries. The aim of this rapid review is to summarize and synthesize experiences on COVID-19 vaccine service delivery and integration to inform future COVID-19 vaccination programming and contribute to the knowledge base for future pandemic management. A systematic search was conducted in PubMed, Scopus, and Global Index Medicus databases. Twenty-five studies were included in the analysis. Included studies spanned nine countries where COVID-19 vaccines were delivered through mass, mobile, and fixed-post vaccination service delivery models. There was limited evidence of integrating COVID-19 vaccines into routine services for pregnant women, people who inject drugs, and leveraging existing health programs to deliver COVID-19 vaccines to the general population. Common challenges reported were vaccine skepticism, lack of adequate health workers, and linguistic barriers to access. Partnerships with a variety of stakeholders and the involvement of volunteers were vital in overcoming barriers and contributed to the efficient functioning of COVID-19 vaccination programs.

The Health Innovation Impact Checklist: a tool to improve the development and reporting of impact models for global health innovations.

Donor financing is increasingly relying on performance-based measures that demonstrate impact. As new technologies and interventions enter the innovation space to address global health challenges, innovators often need to model their potential impact prior to obtaining solid effectiveness data. Diverse stakeholders rely on impact modeling data to make key funding and scaling decisions. With a lack of standardized methodology to model impact and various stakeholders using different modeling strategies, we propose that a universal innovation impact checklist be used to aid in transparent and aligned modeling efforts. This article describes a new Health Innovation Impact Checklist (HIIC) - a tool developed while evaluating the impact of health innovations funded under the Saving Lives at Birth (SL@B) program. SL@B, a global health Grand Challenge initiative, funded 116 unique maternal and newborn health innovations, four of which were selected for cost-effectiveness analyses (CEAs) within our evaluation. A key data source needed to complete a CEA was the lives saved estimate. HIIC was developed to help validate draft impact models from the SL@B donors and our own team's additional modeling efforts, to ensure the inclusion of standardized elements and to pressure test assumptions for modeling impact. This article describes the core components of HIIC including its strengths and limitations. It also serves as an open call for further reviewing and tailoring of this checklist for applicability across global efforts to model the impact of health innovations.

Improving global maternal and newborn survival via innovation: Stakeholder perspectives on the Saving Lives at Birth Grand Challenge.

The Saving Lives at Birth (SL@B) funding partners joined in 2011 to source, support, and scale maternal and newborn health (MNH) innovations to improve maternal and newborn survival by focusing on the 24 hours around the time of birth. A multi-methods, retrospective portfolio evaluation was conducted to determine SL@B's impact. Forty semi-structured, key informant interviews (KIIs) were conducted with experts in global MNH based in low- and middle-income and in high-income countries to assess the SL@B program. KIIs were conducted with global MNH technical experts, innovators, government officials in low- and middle-income countries, donors, private investors, and implementing partners to include the full spectrum of voices involved in identifying and scaling innovations. Data were analyzed using thematic analysis. Stakeholders believe the SL@B program has been successful in changing the way maternal and newborn health programs are delivered with a focus on doing things differently through innovation. The open approach to sourcing innovation was seen as positive to the extent that it brought more interdisciplinary stakeholders to think about the problem of maternal and newborn survival. However, a demand-driven approach that aims to source innovations that address MNH priority needs and takes into account the needs of end users (e.g. individuals and governments) was suggested as a strategy for ensuring that more innovations go to scale.

Improving Care And Lowering Costs: Evidence And Lessons From A Global Analysis Of Accountable Care Reforms.

Policy makers and providers are under increasing pressure to find innovative approaches to achieving better health outcomes as efficiently as possible. Accountable care, which holds providers accountable for results rather than specific services, is emerging in many countries to support such care innovations. However, these reforms are challenging and complex to implement, requiring significant policy and delivery changes. Despite global interest, the evidence on how to implement accountable care successfully remains limited. To improve the evidence base and increase the likelihood of success, we applied a comprehensive framework for assessing accountable care implementation to three promising reforms outside the United States. The framework relates accountable care policy reforms to the competencies of health care organizations and their health policy environments to facilitate qualitative comparisons of innovations and factors that influence success. We present emerging lessons to guide future implementation and evaluation of accountable care reforms to improve access to and the quality and affordability of care.

Global Lessons In Frugal Innovation To Improve Health Care Delivery In The United States.

In a 2015 global study of low-cost or frugal innovations, we identified five leading innovations that scaled successfully in their original contexts and that may provide insights for scaling such innovations in the United States. We describe common themes among these diverse innovations, critical factors for their translation to the United States to improve the efficiency and quality of health care, and lessons for the implementation and scaling of other innovations. We highlight promising trends in the United States that support adapting these innovations, including growing interest in moving care out of health care facilities and into community and home settings; the growth of alternative payment models and incentives to experiment with new approaches to population health and care delivery; and the increasing use of diverse health professionals, such as community health workers and advanced practice providers. Our findings should inspire policy makers and health care professionals and inform them about the potential for globally sourced frugal innovations to benefit US health care.

Accountable Care Reforms Improve Women's And Children's Health In Nepal.

Over the past decade the Ministry of Health of Nepal and the nonprofit Possible have partnered to deliver primary and secondary health care via a public-private partnership. We applied an accountable care framework that we previously developed to describe the delivery of their integrated reproductive, maternal, newborn, and child health services in the Achham district in rural Nepal. In a prospective pre-post study, examining pregnancies at baseline and 541 pregnancies in follow-up over the course of eighteen months, we found an improvement in population-level indicators linked to reducing maternal and infant mortality: receipt of four antenatal care visits (83 percent to 90 percent), institutional birth rate (81 percent to 93 percent), and the prevalence of postpartum contraception (19 percent to 47 percent). The intervention cost $3.40 per capita (at the population level) and $185 total per pregnant woman who received services. This study provides new analysis and evidence on the implementation of innovative care and financing models in resource-limited settings.

Innovations In Diabetes Care Around the World: Case Studies Of Care Transformation Through Accountable Care Reforms.

The rising prevalence, health burden, and cost of chronic diseases such as diabetes have accelerated global interest in innovative care models that use approaches such as community-based care and information technology to improve or transform disease prevention, diagnosis, and treatment. Although evidence on the effectiveness of innovative care models is emerging, scaling up or extending these models beyond their original setting has been difficult. We developed a framework to highlight policy barriers-institutional, regulatory, and financial-to the diffusion of transformative innovations in diabetes care. The framework builds on accountable care principles that support higher-value care, or better patient-level outcomes at lower cost. We applied this framework to three case studies from the United States, Mexico, and India to describe how innovators and policy leaders have addressed barriers, with a focus on important financing barriers to provider and consumer payment. The lessons have implications for policy reform to promote innovation through new funding approaches, institutional reforms, and performance measures with the goal of addressing the growing burdens of diabetes and other chronic diseases.

Translation of acute coronary syndrome therapies: from evidence to routine clinical practice.

BACKGROUND: The use of evidence-based therapies has improved the outcome of patients with acute coronary syndrome (ACS), but there is a time lag between the generation of clinical evidence and its application in routine clinical practice. We sought to quantify temporal lags in the lifecycle of American College of Cardiology (ACC)/American Heart Association (AHA) class IA ACS therapies. METHODS: Using current and historical ACC/AHA guideline publications, we retrieved publication dates of pivotal clinical trials (PCTs) and class IA guideline-recommended therapies for patients with ST-elevation myocardial infarction (STEMI) and unstable angina (UA)/non-STEMI (NSTEMI). Clinical practice uptake data for each therapy were retrieved from the National Registry for Myocardial Infarction, Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines, and Acute Coronary Treatment and Intervention Outcomes Network Registry-Get with the Guidelines, which are registries containing publicly available peer-reviewed data. Descriptive data were calculated and compared for each phase of the evidence lifecycle for both STEMI and UA/NSTEMI drug classifications. RESULTS: We identified 11 class IA- and 4 class IB/IC-recommended therapies for acute, inhospital, and discharge use for patients with STEMI or UA/NSTEMI. The median time lags were 2 years (interquartile range [IQR], 1-4 years) from PCT to practice guideline recommendation, 14 years (IQR, 11-15 years) from guideline recommendation to 90% practice uptake, and overall, a 16-year median (IQR, 13-19 years) from PCT to 90% practice uptake. CONCLUSIONS: The time of PCT publication to meaningful uptake of class IA ACS therapies into clinical practice took a median of 16 years. This significant time lag indicates systemic barriers to the translation of therapeutics into routine clinical practice.

The MURDOCK Study: a long-term initiative for disease reclassification through advanced biomarker discovery and integration with electronic health records.

BACKGROUND: Facing critically low return per dollar invested on clinical research and clinical care, the American biomedical enterprise is in need of a significant transformation. A confluence of high-throughput "omic" technologies and increasing adoption of the electronic health record has fueled excitement for a new paradigm for biomedical research and practice. The ability to simultaneously measure thousands of molecular variables and assess their relationships with clinical data collected during the course of care could enable reclassification of disease not only by gross phenotypic observation but according to underlying molecular mechanism and influence of social determinants.In turn, this reclassification could enable development of targeted therapeutic interventions as well as disease prevention strategies at the individual and population levels. METHODS/DESIGN: The MURDOCK Study consists of distinct project "horizons" or stages. Horizon 1 entailed the generation and analysis of molecular data for existing large,clinically well-annotated cohorts in four disease areas. Horizon 1.5 involves creating and maintaining a 50,000-person,community volunteer registry for biomarker signature validation and prospective studies, including integration of environmental and social data. Horizon 2 leverages and prospectively recruits Horizon 1.5 volunteers, and extends the study to additional disease areas of interest. Horizon 3 will expand the study through regional, national,and international partnerships. DISCUSSION: The MURDOCK Study embodies a new model of team science investigation and represents a significant resource for translational research. The study team invites inquiries to form new collaborations to exploit the rich resources provided by these biospecimens and associated study data.

The need for transformative innovation in hypertension management.

Despite multiple available effective therapies for hypertension, many patients with high blood pressure in the United States are not adequately controlled. This inability to effectively manage hypertension can be attributed to patient, provider, and system failures. To create an effective model for hypertension management, current care delivery systems must be reorganized around the following principles: improved patient engagement and patient-provider communication, increased use of nonphysician providers, better performance monitoring and feedback systems, and better aligned reimbursement models. Transformation of care around these principles would lead to marked improvements in cost, quality, and access to care.

Perspective: global medicine: opportunities and challenges for academic health science systems.

Globalization is having a growing impact on health and health care, presenting challenges as well as opportunities for the U.S. health care industry in general and for academic health science systems (AHSSs) in particular. The authors believe that AHSSs must develop long-term strategies that address their future role in global medicine. AHSSs should meet global challenges through planning, engagement, and innovation that combine traditional academic activities with entrepreneurial approaches to health care delivery, research, and education, including international public-private partnerships. The opportunities for U.S.-based AHSSs to be global health care leaders and establish partnerships that improve health locally and globally more than offset the potential financial, organizational, politico-legal, and reputational risks that exist in the global health care arena. By examining recent international activities of leading AHSSs, the authors review the risks and the critical factors for success and discuss external policy shifts in workforce development and accreditation that would further support the growth of global medicine.

Training the next generation of physician-executives: an innovative residency pathway in management and leadership.

The rapidly changing field of medicine demands that future physician-leaders excel not only in clinical medicine but also in the management of complex health care enterprises. However, many physicians have become leaders "by accident," and the active cultivation of future leaders is required. Addressing this need will require multiple approaches, targeting trainees at various stages of their careers, such as degree-granting programs, residency and fellowship training, and career and leadership development programs. Here, the authors describe a first-of-its-kind graduate medical education pathway at Duke Medicine, the Management and Leadership Pathway for Residents (MLPR). This program was developed for residents with both a medical degree and management training. Created in 2009, with its first cohort enrolled in the summer of 2010, the MLPR is intended to help catalyze the emergence of a new generation of physician-leaders. The program will provide physicians-in-training with rigorous clinical exposure along with mentorship and rotational opportunities in management to accelerate the development of critical leadership and management skills in all facets of medicine, including care delivery, research, and education. To achieve this, the MLPR includes 15 to 18 months of project-based rotations under the guidance of senior leaders in many disciplines including finance, patient safety, health system operations, strategy, and others. Developing both clinical and management skill sets during graduate medical education holds the promise of engaging future leaders of health care at an early career stage, keeping more MD-MBA graduates within health care, and creating a bench of talented future physician-executives.

Lessons from India in organizational innovation: a tale of two heart hospitals.

Recent discussions in health reform circles have pinned great hopes on the prospect of innovation as the solution to the high-cost, inadequate-quality U.S. health system. But U.S. health care institutions-insurers, providers, and specialists-have ceded leadership in innovation to Indian hospitals such as Care Hospital in Hyderabad and the Fortis Hospitals around New Delhi, which have U.S.-trained doctors and can perform open heart surgery for $6,000 (compared to $100,000 in the United States). The Indian success is a window into America's stalemate with inflating costs and stagnant innovation.

Economic effects of prolonged clopidogrel therapy after percutaneous coronary intervention.

OBJECTIVES: This study examined the incremental cost-effectiveness of extending clopidogrel therapy from one month to one year after percutaneous coronary intervention (PCI) in an unselected, heterogeneous patient population. BACKGROUND: Clinical trials suggest that prolonging clopidogrel therapy for up to one year after PCI reduces downstream cardiac events. However, clopidogrel therapy is costly and may increase bleeding risk. METHODS: Using decision analysis, we compared the outcomes and cost of prolonging clopidogrel treatment from one month to one year after PCI with the alternative strategy of discontinuing therapy one month after the procedure. Event rates were based on 3,976 PCI patients who were treated between January 1999 and December 2001 at the Duke Medical Center and received no more than one month of clopidogrel after the procedure. Baseline characteristics and event rates were obtained from Duke clinical information systems. The effect of prolonged clopidogrel therapy on event rates was based on the Clopidogrel for the Reduction of Events During Observation (CREDO) trial per-protocol data. Unit costs and the effect of myocardial infarction (MI) on life expectancy were based on published sources. RESULTS: Extending clopidogrel therapy from one month to one year after PCI cost USD 879 per patient and reduced the risk of MI by 2.6%. Assuming MI decreases life expectancy by two years, prolonged therapy would cost USD 15,696 per year of life saved. Economic attractiveness of therapy varied with baseline risk, the effect of prolonged therapy on MI risk, and the price of clopidogrel. CONCLUSIONS: Prolonging clopidogrel therapy for one year after PCI is economically attractive, particularly in high-risk patients.