The launch of the EU Health Emergency Preparedness and Response Authority (HERA): Improving global pandemic preparedness?

The crowded global health landscape has been joined by the European Union Health Emergency Preparedness and Response Authority (HERA). HERA will assume four broad areas of responsibility: horizon scanning for major health threats; research and development; support for capacity to manufacture drugs, vaccines, and equipment; and procuring and stockpiling key medical countermeasures. In this Health Reform Monitor article, we outline the reform process and describe HERA's structure and responsibilities, explore issues that arise from the creation of this new organisation, and suggest options for collaboration with existing bodies in Europe and beyond. The COVID-19 pandemic and other infectious disease outbreaks have shown the need to treat health as a cross-border issue, and there is now a broad consensus that greater direction and coordination at the European level is needed. This ambition has been matched with a considerable increase in EU funding to tackle cross-border health threats, and HERA can be used to deploy this funding in an effective manner. Yet this is contingent upon clearly defining its role and responsibilities vis-à-vis existing agencies to reduce redundancies.

Evaluation of the NHS England evidence-based interventions programme: a difference-in-difference analysis.

BACKGROUND: The NHS England evidence-based interventions programme (EBI), launched in April 2019, is a novel nationally led initiative to encourage disinvestment in low value care. METHOD: We sought to evaluate the effectiveness of this policy by using a difference-in-difference approach to compare changes in volume between January 2016 and February 2020 in a treatment group of low value procedures against a control group unaffected by the EBI programme during our period of analysis but subsequently identified as candidates for disinvestment. RESULTS: We found only small differences between the treatment and control group after implementation, with reductions in volumes in the treatment group 0.10% (95% CI 0.09% to 0.11%) smaller than in the control group (equivalent to 16 low value procedures per month). During the month of implementation, reductions in volumes in the treatment group were 0.05% (95% CI 0.03% to 0.06%) smaller than in the control group (equivalent to 7 low value procedures). Using triple difference estimators, we found that reductions in volumes were 0.35% (95% CI 0.26% to 0.44%) larger in NHS hospitals than independent sector providers (equivalent to 47 low value procedures per month). We found no significant differences between clinical commissioning groups that did or did not volunteer to be part of a demonstrator community to trial EBI guidance, but found reductions in volume were 0.06% (95% CI 0.04% to 0.08%) larger in clinical commissioning groups that posted a deficit in the financial year 2018/19 before implementation (equivalent to 4 low value procedures per month). CONCLUSIONS: Our analysis shows that the EBI programme did not accelerate disinvestment for procedures under its remit during our period of analysis. However, we find that financial and organisational factors may have had some influence on the degree of responsiveness to the EBI programme.

Virtual Care in Canada as of the Sixth Wave of the COVID-19 Pandemic: Finding the Right Balance - An Indigenous Perspective.

The constraints of the COVID-19 pandemic accelerated the adoption of virtual care. The role of virtual care in the mix of healthcare services is being re-examined as the pandemic evolves. For many diverse Indigenous communities (rural, remote, urban), virtual care has the potential to increase access to healthcare and improv health outcomes, or to worsen existing inequities. Thoughtful co-design of virtual care programs, attention to user experience and enabling policy decisions can unlock the potential of virtual care for Indigenous individuals and communities.

Evaluation of strategies to modify Anti-SARS-CoV-2 monoclonal antibodies for optimal functionality as therapeutics.

The current global COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in a public health crisis with more than 168 million cases reported globally and more than 4.5 million deaths at the time of writing. In addition to the direct impact of the disease, the economic impact has been significant as public health measures to contain or reduce the spread have led to country wide lockdowns resulting in near closure of many sectors of the economy. Antibodies are a principal determinant of the humoral immune response to COVID-19 infections and may have the potential to reduce disease and spread of the virus. The development of monoclonal antibodies (mAbs) represents a therapeutic option that can be produced at large quantity and high quality. In the present study, a mAb combination mixture therapy was investigated for its capability to specifically neutralize SARS-CoV-2. We demonstrate that each of the antibodies bind the spike protein and neutralize the virus, preventing it from infecting cells in an in vitro cell-based assay, including multiple viral variants that are currently circulating in the human population. In addition, we investigated the effects of two different mutations in the Fc portion (YTE and LALA) of the antibody on Fc effector function and the ability to alleviate potential antibody-dependent enhancement of disease. These data demonstrate the potential of a combination of two mAbs that target two different epitopes on the SARS-CoV2 spike protein to provide protection against SARS-CoV-2 infection in humans while extending serum half-life and preventing antibody-dependent enhancement of disease.

COVID-19 in Children.

Coronavirus disease 2019 (COVID-19) is an ongoing pandemic caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus. More than 5 million children have been infected in the United States. Risk factors for more severe disease progression include obesity, pulmonary disease, gastrointestinal disorders, and neurologic comorbidities. Children with COVID-19 are admitted to the pediatric intensive care unit because of severe acute COVID-19 illness or COVID-19-associated multisystem inflammatory syndrome in children. The delta surge of 2021 was responsible for an increased disease burden in children and points to the key role of vaccinating children against this sometimes-deadly disease.

Emergency contracting and the delivery of elective care services across the English National Health Service and independent sector during COVID-19: a descriptive analysis.

BACKGROUND: Following a virtual standstill in the delivery of elective procedures in England, a national block contract between the NHS and the independent sector aimed to help restart surgical care. This study aims to describe subsequent changes in trends in elective care service delivery following implementation of the initial iteration of this contract. METHODS: Population-based retrospective cohort study, assessing the delivery of all publicly funded and privately funded elective care delivered in England between 1 April 2020 and 31 July 2020 compared with the same period in 2019. Discharge data from the Hospital Episode Statistics and private healthcare data from the Private Health Information Network was stratified by specialty, procedure, length of stay and patient complexity in terms of age and Charlson Comorbidity Index. RESULTS: COVID-19 significantly reduced publicly funded elective care activity, though changes were more pronounced in the independent sector (-65.1%) compared with the NHS (-52.7%), whereas reductions in privately funded elective care activity were similar in both independent sector hospitals (-74.2%) and NHS hospitals (-72.9%). Patient complexity increased in the independent sector compared with the previous year, with mixed findings in NHS hospitals. Most specialties, irrespective of sector or funding mechanisms, experienced a reduction in hospital admissions. However, some specialities, including medical oncology, clinical oncology, clinical haematology and cardiology, experienced an increase in publicly-funded elective care activity in the independent sector. CONCLUSION: Elective care delivered by the independent sector remained significantly below historic levels, although this overlooks significant variation between regions and specialities. There may be opportunities to learn from regions which achieved more significant increases in publicly funded elective care in independent sector providers as a strategy to address the growing backlog of elective care.

United Kingdom: Health System Review.

This analysis provides a review of developments in financing, governance, organisation and delivery, health reforms and performance of the health systems in the United Kingdom. The United Kingdom has enjoyed a national health service with access based on clinical need, and not ability to pay for over 70 years. This has provided several important benefits including protection against the financial consequences of ill-health, redistribution of wealth from rich to poor, and relatively low administrative costs. Despite this, the United Kingdom continues to lag behind many other comparable high-income countries in key measures including life expectancy, infant mortality and cancer survival. Total health spending in the United Kingdom is slightly above the average for Europe, but it is below many other comparable high-income countries such as Germany, France and Canada. The United Kingdom also has relatively lower levels of doctors, nurses, hospital beds and equipment than many other comparable high-income countries. Wider social determinants of health also contribute to poor outcomes, and the United Kingdom has one of the highest levels of income inequality in Europe. Devolution of responsibility for health care services since the late 1990s to Scotland, Wales and Northern Ireland has resulted in divergence in policies between countries, including in prescription charges, and eligibility for publicly funded social care services. However, more commonalities than differences remain between these health care systems. The United Kingdom initially experienced one of the highest death rates associated with COVID-19; however, the success and speed of the United Kingdom's vaccination programme has since improved the United Kingdom's performance in this respect. Principal health reforms in each country are focusing on facilitating cross-sectoral partnerships and promoting integration of services in a manner that improves the health and well-being of local populations. These include the establishment of integrated care systems in England, integrated joint boards in Scotland, regional partnership boards in Wales and integrated partnership boards in Northern Ireland. Policies are also being developed to align the social care funding model closer to the National Health Service funding model. These include a cap on costs over an individual's lifetime in England, and a national care service free at the point of need in Scotland and Wales. Currently, and for the future, significant investment is needed to address major challenges including a growing backlog of elective care, and staffing shortfalls exacerbated by Brexit.

Infrastructure for rapid open knowledge network development

The past decade has witnessed a growth in the use of knowledge graph technologies for advanced data search, data integration, and query-answering applications. The leading example of a public, general-purpose open knowledge network (aka knowledge graph) is Wikidata, which has demonstrated remarkable advances in quality and coverage over this time. Proprietary knowledge graphs drive some of the leading applications of the day including, for example, Google Search, Alexa, Siri, and Cortana. Open Knowledge Networks are exciting: they promise the power of structured database-like queries with the potential for the wide coverage that is today only provided by the Web. With the current state of the art, building, using, and scaling large knowledge networks can still be frustratingly slow. This article describes a National Science Foundation Convergence Accelerator project to build a set of Knowledge Network Programming Infrastructure systems to address this issue.

Digital Health Paradox: International Policy Perspectives to Address Increased Health Inequalities for People Living With Disabilities.

The COVID-19 pandemic accelerated the uptake of digital health worldwide and highlighted many benefits of these innovations. However, it also stressed the magnitude of inequalities regarding accessing digital health. Using a scoping review, this article explores the potential benefits of digital technologies for the global population, with particular reference to people living with disabilities, using the autism community as a case study. We ultimately explore policies in Sweden, Australia, Canada, Estonia, the United Kingdom, and the United States to learn how policies can lay an inclusive foundation for digital health systems. We conclude that digital health ecosystems should be designed with health equity at the forefront to avoid deepening existing health inequalities. We call for a more sophisticated understanding of digital health literacy to better assess the readiness to adopt digital health innovations. Finally, people living with disabilities should be positioned at the center of digital health policy and innovations to ensure they are not left behind.

Making Room for Zoom in Focus Group Methods: Opportunities and Challenges for Novice Researchers (During and Beyond COVID-19)

Als die COVID-19-Pandemie über die Welt hereinbrach, waren viele Menschen gezwungen, sich auf online-basierte Routinen einzustellen, darunter auch qualitative Forscher*innen, die nach alternativen Möglichkeiten zur Erhebung aussagekräftiger Daten suchten. Während Fokusgruppen traditionell Face to Face durchgeführt werden, bieten Fortschritte bei Online-Videokonferenzanwendungen neue Methoden zur Datenerhebung, die jedoch bisher nur selten untersucht wurden. In diesem Artikel berichten wir über die Erfahrungen von 12 Doktorand*innen mit der Durchführung von Fokusgruppen unter Verwendung von Zoom im Rahmen eines Kurses zu qualitativen Interviewmethoden. Wir reflektieren Chancen und Herausforderungen, die wir als Moderator*innen und Teilnehmer*innen bei der Nutzung von Zoom erlebten z.B. bei der Vorbereitung oder in Bezug auf Rapport, die Einbindung anderer digitaler Tools und von Internetverbindungen. Zusammenfassend lässt sich sagen, dass die Durchführung von Online-Fokusgruppen unter Verwendung von Zoom insgesamt eine positive Erfahrung war und mit Face-to-Face-Fokusgruppen vergleichbar ist. Möglichkeiten der Teilnehmer*innenrekrutierung, die Sicherheitsmerkmale von Zoom und die Nutzung von Zoom und allgemeiner neuen Technologien sollten auch jenseits der Pandemie weiter erforscht werden.Alternate :As the COVID-19 pandemic swept through the world, it forced many people to adapt to an online-based routine, including qualitative researchers looking for alternative ways to collect meaningful data. While focus groups are traditionally conducted in-person, advances with online videoconferencing applications present a new method to collect data, however, few studies have explored this. In this article we present 12 doctoral students' experiences with conducting focus groups using the videoconferencing application Zoom during a qualitative methods course on interviewing methods. Through this self-study qualitative analysis, participants reflected on the opportunities and challenges experienced as both moderators and participants using Zoom including: preparation, rapport, incorporating other digital tools, and internet connectivity. In conclusion, doing focus groups online using Zoom was a positive experience overall and comparable to in-person focus groups for collecting qualitative data, despite the introduction of technology. More research on participant recruitment, new technology, Zoom's security features, and Zoom's use outside of a pandemic should be further explored.

Implementation of SARS-CoV-2 monoclonal antibody infusion sites at three medical centers in the United States: Strengths and challenges assessment to inform COVID-19 pandemic and future public health emergency use.

Monoclonal antibody therapeutics to treat COVID-19 have been authorized by the U.S. Food and Drug Administration under Emergency Use Authorization (EUA). Many barriers exist when deploying a novel therapeutic during an ongoing pandemic, and it is critical to assess the needs of incorporating monoclonal antibody infusions into pandemic response activities. We examined the monoclonal antibody infusion site process during the COVID-19 pandemic and conducted a descriptive analysis using data from three sites at medical centers in the U.S. supported by the National Disaster Medical System. Monoclonal antibody implementation success factors included engagement with local medical providers, therapy batch preparation, placing the infusion center in proximity to emergency services, and creating procedures resilient to EUA changes. Infusion process challenges included confirming patient SARS-CoV-2 positivity, strained staff, scheduling, and pharmacy coordination. Infusion sites are effective when integrated into pre-existing pandemic response ecosystems and can be implemented with limited staff and physical resources.

Tocilizumab as a Therapeutic Agent for Critically Ill Patients Infected with SARS-CoV-2.

Tocilizumab is an IL-6 receptor antagonist with the ability to suppress the cytokine storm in critically ill patients infected with severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2). We evaluated patients treated with tocilizumab for a SARS-CoV-2 infection who were admitted between March 13, 2020, and April 16, 2020. This was a multicenter study with data collected by chart review both retrospectively and concurrently. Parameters evaluated included age, sex, race, use of mechanical ventilation (MV), usage of steroids and vasopressors, inflammatory markers, and comorbidities. Early dosing was defined as a tocilizumab dose administered prior to or within 1 day of intubation. Late dosing was defined as a dose administered > 1 day after intubation. In the absence of MV, the timing of the dose was related to the patient's date of admission only. We evaluated 145 patients. The average age was 58.1 years, 64% were men, 68.3% had comorbidities, and 60% received steroid therapy. Disposition of patients was 48.3% discharged and 29.3% died, of which 43.9% were African American. MV was required in 55.9%, of which 34.5% died. Avoidance of MV (P = 0.002) and increased survival (P < 0.001) was statistically associated with early dosing. Tocilizumab therapy was effective at decreasing mortality and should be instituted early in the management of critically ill patients with coronavirus disease 2019) COVID-19).

Real-world Effect of Monoclonal Antibody Treatment in COVID-19 Patients in a Diverse Population in the United States.

BACKGROUND: Monoclonal antibodies (mAbs) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are a promising treatment for limiting the progression of coronavirus disease 2019 (COVID-19) and decreasing strain on hospitals. Their use, however, remains limited, particularly in disadvantaged populations. METHODS: Electronic health records were reviewed from SARS-CoV-2 patients at a single medical center in the United States that initiated mAb infusions in January 2021 with the support of the US Department of Health and Human Services' National Disaster Medical System. Patients who received mAbs were compared with untreated patients from the time period before mAb availability who met eligibility criteria for mAb treatment. We used logistic regression to measure the effect of mAb treatment on the risk of hospitalization or emergency department (ED) visit within 30 days of laboratory-confirmed COVID-19. RESULTS: Of 598 COVID-19 patients, 270 (45%) received bamlanivimab and 328 (55%) were untreated. Two hundred thirty-one patients (39%) were Hispanic. Among treated patients, 5/270 (1.9%) presented to the ED or required hospitalization within 30 days of a positive SARS-CoV-2 test, compared with 39/328 (12%) untreated patients (P < .001). After adjusting for age, gender, and comorbidities, the risk of ED visit or hospitalization was 82% lower in mAb-treated patients compared with untreated patients (95% CI, 56%-94%). CONCLUSIONS: In this diverse, real-world COVID-19 patient population, mAb treatment significantly decreased the risk of subsequent ED visit or hospitalization. Broader treatment with mAbs, including in disadvantaged patient populations, can decrease the burden on hospitals and should be facilitated in all populations in the United States to ensure health equity.

Referrals for Cryptorchidism: Analyzing for Quality from a Pre-COVID Dataset.

OBJECTIVE: To identify risk factors associated with an inaccurate diagnosis, delayed referral, and/or inappropriate ultrasound in consecutive referrals for an undescended testicle (UDT). METHODS: This study was approved by the institutional review board. Data was prospectively collected for all children referred to University of Oklahoma's pediatric urology service from August 2019 to February 2020. The data was imported into SAS vs 9.4 for analysis. We categorized the "quality" of referral by a point system using 3 factors (no previous ultrasound, ≤18 months, correct location). An optimal referral had an accurate testicular examination, was referred by 18 months of age, and no diagnostic ultrasound. RESULTS: We collected 75 referrals. Thirty-nine (52.0%) had confirmed UDT, requiring surgery. Twenty-seven (69.2%) had an accurate initial examination. Forty-one (54.7%) were outside the optimal age. Thirty-four were considered low quality (0-1 qualities) and 41 were high quality (2-3 qualities). Seven (9.3%) were optimal (3/3 qualities). Referrals that needed intervention were statistically more likely to be higher quality. CONCLUSION: Increased quality of UDT referrals directly correlated with the likelihood for treatment. This study reveals a need for more education on UDT referral in the community. By improving referring provider knowledge and skills, we can minimize unnecessary referrals.

Health information technology and digital innovation for national learning health and care systems.

Health information technology can support the development of national learning health and care systems, which can be defined as health and care systems that continuously use data-enabled infrastructure to support policy and planning, public health, and personalisation of care. The COVID-19 pandemic has offered an opportunity to assess how well equipped the UK is to leverage health information technology and apply the principles of a national learning health and care system in response to a major public health shock. With the experience acquired during the pandemic, each country within the UK should now re-evaluate their digital health and care strategies. After leaving the EU, UK countries now need to decide to what extent they wish to engage with European efforts to promote interoperability between electronic health records. Major priorities for strengthening health information technology in the UK include achieving the optimal balance between top-down and bottom-up implementation, improving usability and interoperability, developing capacity for handling, processing, and analysing data, addressing privacy and security concerns, and encouraging digital inclusivity. Current and future opportunities include integrating electronic health records across health and care providers, investing in health data science research, generating real-world data, developing artificial intelligence and robotics, and facilitating public-private partnerships. Many ethical challenges and unintended consequences of implementation of health information technology exist. To address these, there is a need to develop regulatory frameworks for the development, management, and procurement of artificial intelligence and health information technology systems, create public-private partnerships, and ethically and safely apply artificial intelligence in the National Health Service.

The changing health needs of the UK population.

The demographics of the UK population are changing and so is the need for health care. In this Health Policy, we explore the current health of the population, the changing health needs, and future threats to health. Relative to other high-income countries, the UK is lagging on many health outcomes, such as life expectancy and infant mortality, and there is a growing burden of mental illness. Successes exist, such as the striking improvements in oral health, but inequalities in health persist as well. The growth of the ageing population relative to the working-age population, the rise of multimorbidity, and persistent health inequalities, particularly for preventable illness, are all issues that the National Health Service (NHS) will face in the years to come. Meeting the challenges of the future will require an increased focus on health promotion and disease prevention, involving a more concerted effort to understand and tackle the multiple social, environmental, and economic factors that lie at the heart of health inequalities. The immediate priority of the NHS will be to mitigate the wider and long-term health consequences of the COVID-19 pandemic, but it must also strengthen its resilience to reduce the impact of other threats to health, such as the UK leaving the EU, climate change, and antimicrobial resistance.

What is the right level of spending needed for health and care in the UK?

The health and care sector plays a valuable role in improving population health and societal wellbeing, protecting people from the financial consequences of illness, reducing health and income inequalities, and supporting economic growth. However, there is much debate regarding the appropriate level of funding for health and care in the UK. In this Health Policy paper, we look at the economic impact of the COVID-19 pandemic and historical spending in the UK and comparable countries, assess the role of private spending, and review spending projections to estimate future needs. Public spending on health has increased by 3·7% a year on average since the National Health Service (NHS) was founded in 1948 and, since then, has continued to assume a larger share of both the economy and government expenditure. In the decade before the ongoing pandemic started, the rate of growth of government spending for the health and care sector slowed. We argue that without average growth in public spending on health of at least 4% per year in real terms, there is a real risk of degradation of the NHS, reductions in coverage of benefits, increased inequalities, and increased reliance on private financing. A similar, if not higher, level of growth in public spending on social care is needed to provide high standards of care and decent terms and conditions for social care staff, alongside an immediate uplift in public spending to implement long-overdue reforms recommended by the Dilnot Commission to improve financial protection. COVID-19 has highlighted major issues in the capacity and resilience of the health and care system. We recommend an independent review to examine the precise amount of additional funds that are required to better equip the UK to withstand further acute shocks and major threats to health.