Patient outcomes, efficiency, and adverse events for elective hip and knee replacement in private and NHS hospitals: a population-based cohort study in England.

Background: Since the early 2000s, the National Health Service (NHS) in England has expanded provision of publicly funded care in private hospitals as a strategy to meet growing demand for elective care. This study aims to compare patient outcomes, efficiency and adverse events in private and NHS hospitals when providing elective hip and knee replacement. Methods: We conducted a population-based cohort study including patients ≥18 years, undergoing a publicly funded elective hip or knee replacement in private and NHS hospitals in England between January 1st 2016 and March 31st 2019. Comparative probability was estimated for three patient outcome measures (in-hospital mortality, emergency readmissions with 28 days, hospital transfers), two efficiency measures (pre-operative length of stay (LOS) >0 day and post-operative LOS >2 days), and four adverse events (hospital-associated infection, adverse drug reactions, pressure ulcers, venous thromboembolism). Probit regression was used to adjust for observable confounding followed by instrumental variable (IV) analyses to also account for unobserved confounding at the patient-level. Propensity score matching was then used as a robustness check. Findings: Our study sample included 169,232 patients in private hospitals, and 262,659 patients in NHS hospitals. Estimates from probit regression indicated that treatment in private hospital was associated with reduced probability of in-hospital mortality (-0.0009, 95% CI -0.0010, -0.0007), emergency readmissions (-0.0181, 95% CI -0.0191, -0.0172), hospital transfers (-0.0076, 95% CI -0.0084, -0.0068), prolonged post-operative LOS (-0.1174, 95% CI -0.1547, -0.0801), hospital-associated infection (-0.0115, 95% CI -0.0123, -0.0107), adverse drug reactions (-0.0051, 95% CI -0.0056, -0.0046), pressure ulcers (-0.0017, 95% CI -0.0019, -0.0014), and venous thromboembolism (-0.0027, 95% CI -0.0031, -0.0022). IV analyses produced no significant differences between private and NHS hospitals, except for lower probability in private hospitals of hospital-associated infection (-0.0057, 95% CI -0.0081, -0.0032), and greater probability in private hospitals of prolonged post-operative LOS (0.2653, 95% CI 0.1833, 0.3472). Propensity score matching produced similar results to probit regression. Interpretation: Our findings indicate there is potentially important unobservable confounding at the patient-level between private and NHS hospitals not adjusted for when using probit regression or propensity score matching. Funding: This research did not receive any dedicated funding.

How to Use Quasi-Experimental Methods in Cardiovascular Research: A Review of Current Practice.

BACKGROUND: Quasi-experimental methods (QEMs) are a family of techniques used to estimate causal relationships when randomized controlled trials are unfeasible or unethical. They offer a powerful alternative to observational studies by introducing random assignment of individuals or groups into their design, thereby offering stronger means of establishing causation. The use of QEMs in cardiovascular research has not been systematically examined to determine steps toward improving and expanding their use. METHODS: We identified 4 main techniques using a systematic search strategy from 2016 to 2021: instrumental variable analysis, interrupted time series analysis, difference-in-differences analysis, and regression discontinuity designs. QEMs are examined as alternatives to randomized controlled trials and traditional observational studies; as more observational data becomes available to researchers, there are more opportunities to apply these techniques. Eligible articles were selected based on publication in high-ranked journals. The quality of eligible articles was appraised using the Joanna Briggs Institute checklist for quasi-experimental studies. RESULTS: Data from 380 studies were extracted based on our inclusion criteria. Forty-two of these studies were published in the top 10 medical or top 20 cardiovascular disease journals, and 25 studies were included after quality appraisal. The review identifies the main features and limitations associated with each technique, providing readers with practical guidance on how to apply these to their research. A graphical decision aid was developed to facilitate the routine use of QEMs. CONCLUSIONS: The use of QEMs in cardiovascular research published in contemporary, high-impact articles was examined. Findings are biased toward this segment of literature, which represents the latest developments in this growing area of cardiovascular research. The decision aid is a novel schematic that researchers can adopt into practice.

Unfavorable social determinants of health and risk of mortality in adults with diabetes: findings from the National Health Interview Survey.

INTRODUCTION: Understanding the role of social determinants of health as predictors of mortality in adults with diabetes may help improve health outcomes in this high-risk population. Using population-based, nationally representative data, this study investigated the cumulative effect of unfavorable social determinants on all-cause mortality in adults with diabetes. RESEARCH DESIGN AND METHODS: We used data from the 2013-2018 National Health Interview Survey, linked to the National Death Index through 2019, for mortality ascertainment. A total of 47 individual social determinants of health were used to categorize participants in quartiles denoting increasing levels of social disadvantage. Poisson regression was used to report age-adjusted mortality rates across increasing social burden. Multivariable Cox proportional hazards models were used to assess the association between cumulative social disadvantage and all-cause mortality in adults with diabetes, adjusting for traditional risk factors. RESULTS: The final sample comprised 182 445 adults, of whom 20 079 had diabetes. In the diabetes population, mortality rate increased from 1052.7 per 100 000 person-years in the first quartile (Q1) to 2073.1 in the fourth quartile (Q4). In multivariable models, individuals in Q4 experienced up to twofold higher mortality risk relative to those in Q1. This effect was observed similarly across gender and racial/ethnic subgroups, although with a relatively stronger association for non-Hispanic white participants compared with non-Hispanic black and Hispanic subpopulations. CONCLUSIONS: Cumulative social disadvantage in individuals with diabetes is associated with over twofold higher risk of mortality, independent of established risk factors. Our findings call for action to screen for unfavorable social determinants and design novel interventions to mitigate the risk of mortality in this high-risk population.

Race, Social Determinants of Health, and Risk of All-Cause and Cardiovascular Mortality in the United States.

OBJECTIVE: To examine the independent and interdependent effects of race and social determinants of health (SDoH) and risk of all-cause and cardiovascular disease (CVD) mortality in the US. DATA SOURCE/STUDY DESIGN: Secondary analysis of pooled data for 252,218 participants of the 2006-2018 National Health Interview Survey, linked to the National Death Index. METHODS: Age-adjusted mortality rates (AAMR) were reported for non-Hispanic White (NHW) and non-Hispanic Black (NHB) individuals overall, and by quintiles of SDoH burden, with higher quintiles representing higher cumulative social disadvantage (SDoH-Qx). Survival analysis was used to examine the association between race, SDoH-Qx, and all-cause and CVD mortality. FINDINGS: AAMRs for all-cause and CVD mortality were higher for NHB and considerably higher at higher levels of SDoH-Qx, however, with similar mortality rates at any given level of SDoH-Qx. In multivariable models, NHB experienced 20-25% higher mortality risk relative to NHW (aHR = 1.20-1.26); however, no association was observed after adjusting for SDoH. In contrast, higher SDoH burden was associated with up to nearly threefold increased risk of all-cause (aHR, Q5 vs Q1 = 2.81) and CVD mortality (aHR, Q5 vs Q1 = 2.90); the SDoH effect was observed similarly for NHB (aHR, Q5:all-cause mortality = 2.38; CVD mortality = 2.58) and NHW (aHR, Q5:all-cause mortality = 2.87; CVD mortality = 2.93) subgroups. SDoH burden mediated 40-60% of the association between NHB race and mortality. CONCLUSIONS: These findings highlight the critical role of SDoH as upstream drivers of racial inequities in all-cause and CVD mortality. Population level interventions focused on addressing adverse SDoH experienced by NHB individuals may help mitigate persistent disparities in mortality in the US.

A prospective study on the prevalence of MASLD in people with type-2 diabetes in the community. Cost effectiveness of screening strategies.

BACKGROUND AND AIMS: As screening for the liver disease and risk-stratification pathways are not established in patients with type-2 diabetes mellitus (T2DM), we evaluated the diagnostic performance and the cost-utility of different screening strategies for MASLD in the community. METHODS: Consecutive patients with T2DM from primary care underwent screening for liver diseases, ultrasound, ELF score and transient elastography (TE). Five strategies were compared to the standard of care: ultrasound plus abnormal liver function tests (LFTs), Fibrosis score-4 (FIB-4), NAFLD fibrosis score, Enhanced liver fibrosis test (ELF) and TE. Standard of care was defined as abnormal LFTs prompting referral to hospital. A Markov model was built based on the fibrosis stage, defined by TE. We generated the cost per quality-adjusted life year (QALY) gained and calculated the incremental cost-effectiveness ratio (ICER) over a lifetime horizon. RESULTS: Of 300 patients, 287 were included: 64% (186) had MASLD and 10% (28) had other causes of liver disease. Patients with significant fibrosis, advanced fibrosis, and cirrhosis due to MASLD were 17% (50/287), 11% (31/287) and 3% (8/287), respectively. Among those with significant fibrosis classified by LSM≥8.1 kPa, false negatives were 54% from ELF and 38% from FIB-4. On multivariate analysis, waist circumference, BMI, AST levels and education rank were independent predictors of significant and advanced fibrosis. All the screening strategies were associated with QALY gains, with TE (148.73 years) having the most substantial gains, followed by FIB-4 (134.07 years), ELF (131.68 years) and NAFLD fibrosis score (121.25 years). In the cost-utility analysis, ICER was £2480/QALY for TE, £2541.24/QALY for ELF and £2059.98/QALY for FIB-4. CONCLUSION: Screening for MASLD in the diabetic population in primary care is cost-effective and should become part of a holistic assessment. However, traditional screening strategies, including FIB-4 and ELF, underestimate the presence of significant liver disease in this setting.

Provenance and Clinical Benefit of Medicines Introduced to the French Market, 2008 to 2018.

Importance: Both the commercial sector and academia play a vital role in medicine development. Ongoing debates exist on their contribution and the value of medicinal products entering the market. Objective: To identify the provenance and clinical benefit of medicines that entered the French market between 2008 and 2018. Design and Setting: In this cross-sectional study, the provenance of each medicine in the French market was established via a review of multiple sources documenting at least 2 matching findings per product. The clinical benefit was assigned using the matched scale developed from the Prescrire and Haute Autorité de Santé (HAS) gradings. The χ2 test was used to analyze the proportions and frequencies of medicines graded by Prescrire and HAS by origin, therapeutic category, and clinical benefit. Main outcomes and measures: The origins and therapeutic categories of medicines. Clinical benefit based on Prescrire and HAS grading. Concordance of Prescrire and HAS grading. Results: Of the 632 medicines that entered the French market between 2008 and 2018, 464 originated (73%) in the commercial sector, and 168 originated (27%) in the academic setting or in collaboration with commercial enterprises. Prescrire graded psychotropic agents (13/14 [93%]), whereas HAS graded respiratory agents (24/25 [96%]) as the highest percentage of medicines that provided no added benefit. Prescrire graded 360 medicines (77.6%) that originated in the industry and 108 medicines (64.3%) that originated in the academic setting (P = .001) to have no added clinical benefit. HAS assigned such grading to 331 ([71.3%] industry) vs 104 ([61.9%] academia) (P = .02). Based on the Prescrire grading, academia invented more medicines delivering some added benefit 57 (33.9%) vs 98 (21.1%) invented by industry (P = .001). HAS grading on some added benefit 51 ([30.4%] academia) vs 121 ([26.1%] industry) did not reach statistical significance (P = .29). However, HAS grading on substantial added clinical benefit reached statistical significance in favor of academia (13 [7.7%] vs 12 [2.6%] in the industry; P = .003), whereas Prescrire grading did not (1.8% academia vs 1.3% industry; P = .64). Conclusions and Relevance: More than 70% of medicines that entered the French market during the 10-year period originated in the commercial sector. Although most medicines were not graded as providing clinical benefit, medicines originating in the academic setting were more likely to be graded as conferring clinical benefit than those originating in the commercial setting.

The Origin of First-in-Class Drugs: Innovation Versus Clinical Benefit.

First-in-class (FIC) designation became a hallmark of innovation, however, even at the marketing authorization stage, little is known about the clinical benefits these products deliver. We identified the provenance of the FIC drugs that entered the French market from 2008 to 2018 and matched these medicines to the clinical benefit grading by Haute Autorité de Santé (HAS) and Prescrire. Analyses were performed using descriptive statistics to present our findings by drug origin and therapeutic area and to establish the degree of concordance between HAS and Prescrire. Of the 135 FIC drugs identified, 71.1% (n = 96) originated from the industry, 16.3% (n = 22) from academia, and 12.6% (n = 17) from joint partnerships. Three therapeutic areas accounted for most FIC medications: antineoplastic (25.9%, N = 35), anti-infective (14.1%, N = 19), and metabolic (11.1%, N = 15) agents. HAS and Prescrire agreed on 60.74% of clinical benefit gradings. According to HAS, only 5% of all FIC drugs had substantial added benefit, and only 3%, according to Prescrire. HAS and Prescrire graded 45.9% and 68.2%, respectively, of FIC drugs as no clinical benefit and 48.9% and 28.9%, respectively, as some clinical benefit. FIC-designated drugs are primarily of industry (> 70%) rather than academic origin. We found that 55% of FIC medicines that entered the French market over the 10-year period deliver no additional clinical benefit. Whereas FIC medicines may represent important scientific advancements in drug development, in > 50% of cases, the new mode of action does not translate into additional clinical benefits for patients.

Unfavorable social determinants of health and mortality risk by cardiovascular disease status: Findings from a National Study of United States Adults.

BACKGROUND: The association between cumulative burden of unfavorable social determinants of health (SDoH) and all-cause mortality has not been assessed by atherosclerotic cardiovascular disease (ASCVD) status on a population level in the United States. METHODS: We assessed the association between cumulative social disadvantage and all-cause mortality by ASCVD status in the National Health Interview Survey, linked to the National Death Index. RESULTS: In models adjusted for established clinical risk factors, individuals experiencing the highest level of social disadvantage (SDoH-Q4) had over 1.5 (aHR = 1.55; 95%CI = 1.22, 1.96) and 2-fold (aHR = 2.21; 95% CI = 1.91, 2.56) fold increased risk of mortality relative to those with the most favorable social profile (SDoH-Q1), respectively for adults with and without ASCVD; those experiencing co-occurring ASCVD and high social disadvantage had up to four-fold higher risk of mortality (aHR = 3.81; 95%CI = 3.36, 4.32). CONCLUSIONS: These findings emphasize the importance of a healthcare model that prioritizes efforts to identify and address key social and environmental barriers to health and wellbeing, particularly in individuals experiencing the double jeopardy of clinical and social risk.

Enhancing global insight into AMR spread and generation: prospects and limitations of the WHO and quadripartite research agendas.

In Summer 2023, the World Health Organisation (WHO) and the Food and Agriculture Organization of the United Nations (FAO)-United Nations Environment Programme (UNEP) WHO-World Organisation for Animal Health (OIE) Quadripartite published two separate research agendas on antimicrobial resistance (AMR). While the publication of these research agendas on AMR creates a significant opportunity to align research priorities internationally, we emphasize a number of limitations. Firstly, the production of two separate AMR research agendas, in human health and One Health, rather than one integrated research agenda, risks the continued deprioritization of the One Health agenda. Furthermore, neither research agenda addressed the need to study the relationship between climate change and AMR despite growing evidence to suggest this may be significant. Finally, there are also missed opportunities in directing the study of appropriate treatment regimens and in clarifying the overall most resource-efficient path to combatting AMR. Moving forward, the international research agenda for AMR needs to be continually redefined in an inclusive, transparent and independent manner. This could be the task of the proposed, but so far not realized, Independent Panel on Evidence for Action against AMR.

The impact of collaborative organisational models and general practice size on patient safety and quality of care in the English National Health Service: A systematic review.

Collaborative primary care has become an increasingly popular strategy to manage existing pressures on general practice. In England, the recent changes taking place in the primary care sector have included the formation of collaborative organisational models and a steady increase in practice size. The aim of this review was to summarise the available evidence on the impact of collaborative models and general practice size on patient safety and quality of care in England. We searched for quantitative and qualitative studies on the topic published between January 2010 and July 2023. The quality of articles was assessed using the Newcastle-Ottawa Scale and the Critical Appraisal Skills Programme checklist. We screened 6533 abstracts, with full-text screening performed on 76 records. A total of 29 articles were included in the review. 19 met the inclusion criteria following full-text screening, with seven identified through reverse citation searching and three through expert consultation. All studies were found to be of moderate or high quality. A predominantly positive impact on service delivery measures and patient-level outcomes was identified. Meanwhile, the evidence on the effect on pay-for-performance outcomes and hospital admissions is mixed, with continuity of care and access identified as a concern. While this review is limited to evidence from England, the findings provide insights for all health systems undergoing a transition towards collaborative primary care.

A Framework for Digital Health Policy: Insights from Virtual Primary Care Systems Across Five Nations.

Digital health technologies used in primary care, referred to as, virtual primary care, allow patients to interact with primary healthcare professionals remotely though the current iteration of virtual primary care may also come with several unintended consequences, such as accessibility barriers and cream skimming. The World Health Organization (WHO) has a well-established framework to understand the functional components of health systems. However, the existing building blocks framework does not sufficiently account for the disruptive and multi-modal impact of digital transformations. In this review, we aimed to develop the first iteration of this updated framework by reviewing the deployment of virtual primary care systems in five leading countries: Canada, Finland, Germany and Sweden and the United Kingdom (England). We found that all five countries have taken different approaches with the deployment of virtual primary care, yet seven common themes were highlighted across countries: (1) stated policy objectives, (2) regulation and governance, (3) financing and reimbursement, (4) delivery and integration, (5) workforce training and support, (6) IT systems and data sharing, and (7) the extent of patient involvement in the virtual primary care system. The conceptual framework that was derived from these findings offers a set of guiding principles that can facilitate the assessment of virtual primary care in health system settings.

Digital Health Reimbursement Strategies of 8 European Countries and Israel: Scoping Review and Policy Mapping.

BACKGROUND: The adoption of digital health care within health systems is determined by various factors, including pricing and reimbursement. The reimbursement landscape for digital health in Europe remains underresearched. Although various emergency reimbursement decisions were made during the COVID-19 pandemic to enable health care delivery through videoconferencing and asynchronous care (eg, digital apps), research so far has primarily focused on the policy innovations that facilitated this outside of Europe. OBJECTIVE: This study examines the digital health reimbursement strategies in 8 European countries (Belgium, France, Germany, Italy, the Netherlands, Poland, Sweden, and the United Kingdom) and Israel. METHODS: We mapped available digital health reimbursement strategies using a scoping review and policy mapping framework. We reviewed the literature on the MEDLINE, Embase, Global Health, and Web of Science databases. Supplementary records were identified through Google Scholar and country experts. RESULTS: Our search strategy yielded a total of 1559 records, of which 40 (2.57%) were ultimately included in this study. As of August 2023, digital health solutions are reimbursable to some extent in all studied countries except Poland, although the mechanism of reimbursement differs significantly across countries. At the time of writing, the pricing of digital health solutions was mostly determined through discussions between national or regional committees and the manufacturers of digital health solutions in the absence of value-based assessment mechanisms. Financing digital health solutions outside traditional reimbursement schemes was possible in all studied countries except Poland and typically occurs via health innovation or digital health-specific funding schemes. European countries have value-based pricing frameworks that range from nonexistent to embryonic. CONCLUSIONS: Studied countries show divergent approaches to the reimbursement of digital health solutions. These differences may complicate the ability of patients to seek cross-country health care in another country, even if a digital health app is available in both countries. Furthermore, the fragmented environment will present challenges for developers of such solutions, as they look to expand their impact across countries and health systems. An increased emphasis on developing a clear conceptualization of digital health, as well as value-based pricing and reimbursement mechanisms, is needed for the sustainable integration of digital health. This study can therein serve as a basis for further, more detailed research as the field of digital health reimbursement evolves.

Generic cardiology drug prices: the potential benefits of the Marc Cuban cost plus drug company model.

Introduction: Generic pharmaceuticals account for the majority of the $359 billion US pharmaceutical market, including for cardiology drugs. Amidst a lack of price transparency and administrative inefficiencies, generic drug prices are high, causing an undue burden on patients. Methods: We identified the 50 most used generic cardiology drugs by volume per the 2020 Medicare Part D spending data. We extracted cost per dose of each drug from the Marc Cuban Cost Plus Drug Company (MCCPDC) website and estimated the aggregate cost savings if MCCPDC were employed on a national scale by calculating the difference between this cost and Medicare spending. Results: Medicare spent $7.7 billion on the 50 most used generic cardiology drugs by volume in 2020 according to Medicare Part D data. Pharmacy and shipping costs accounted for a substantial portion of expenditures. Per our most conservative estimate, $1.3 billion (17% of total) savings were available on 16 of 50 drugs. A slightly less conservative estimate suggested $2.9 billion (38%) savings for 35 of 50 drugs. Discussion: There is enormous potential for cost savings in the US market for generic cardiology drugs. By encouraging increased competition, decreasing administrative costs, and advocating for our patients to compare prices between the MCCPDC and other generic pharmaceutical dispensers, we have the potential to improve access to care and corresponding outcomes for cardiology patients.

Cumulative social disadvantage and health-related quality of life: national health interview survey 2013-2017.

BACKGROUND: Evidence for the association between social determinants of health (SDoH) and health-related quality of life (HRQoL) is largely based on single SDoH measures, with limited evaluation of cumulative social disadvantage. We examined the association between cumulative social disadvantage and the Health and Activity Limitation Index (HALex). METHODS: Using adult data from the National Health Interview Survey (2013-2017), we created a cumulative disadvantage index by aggregating 47 deprivations across 6 SDoH domains. Respondents were ranked using cumulative SDoH index quartiles (SDoH-Q1 to Q4), with higher quartile groups being more disadvantaged. We used two-part models for continuous HALex scores and logistic regression for poor HALex (< 20th percentile score) to examine HALex differences associated with cumulative disadvantage. Lower HALex scores implied poorer HRQoL performance. RESULTS: The study sample included 156,182 respondents, representing 232.8 million adults in the United States (mean age 46 years; 51.7% women). The mean HALex score was 0.85 and 17.7% had poor HALex. Higher SDoH quartile groups had poorer HALex performance (lower scores and increased prevalence of poor HALex). A unit increase in SDoH index was associated with - 0.010 (95% CI [-0.011, -0.010]) difference in HALex score and 20% higher odds of poor HALex (odds ratio, OR = 1.20; 95% CI [1.19, 1.21]). Relative to SDoH-Q1, SDoH-Q4 was associated with HALex score difference of -0.086 (95% CI [-0.089, -0.083]) and OR = 5.32 (95% CI [4.97, 5.70]) for poor HALex. Despite a higher burden of cumulative social disadvantage, Hispanics had a weaker SDoH-HALex association than their non-Hispanic White counterparts. CONCLUSIONS: Cumulative social disadvantage was associated with poorer HALex performance in an incremental fashion. Innovations to incorporate SDoH-screening tools into clinical decision systems must continue in order to accurately identify socially vulnerable groups in need of both clinical risk mitigation and social support. To maximize health returns, policies can be tailored through community partnerships to address systemic barriers that exist within distinct sociodemographic groups, as well as demographic differences in health perception and healthcare experience.

Real-world Effectiveness of Molnupiravir and Nirmatrelvir/Ritonavir as Treatments for COVID-19 in Patients at High Risk.

BACKGROUND: Using a retrospective cohort study design, we aimed to evaluate the effectiveness of molnupiravir and nirmatrelvir/ritonavir in patients with SARS-CoV-2 who were highly vulnerable. METHODS: The impact of each drug was determined via comparisons with age-matched control groups of patients positive for SARS-CoV-2 who did not receive oral antiviral therapy. RESULTS: Administration of molnupiravir significantly reduced the risk of hospitalization (odds ratio [OR], 0.40; P < .001) and death (OR, 0.31; P < .001) among these patients based on data adjusted for age, previous SARS-CoV-2 infection, vaccination status, and time elapsed since the most recent vaccination. The reductions in risk were most profound among elderly patients (≥75 years old) and among those with high levels of drug adherence. Administration of nirmatrelvir/ritonavir also resulted in significant reductions in the risk of hospitalization (OR, 0.31; P < .001) and death (OR, 0.28; P < .001). Similar to molnupiravir, the impact of nirmatrelvir/ritonavir was more substantial among elderly patients and in those with high levels of drug adherence. CONCLUSIONS: Collectively, these real-world findings suggest that although the risks of hospitalization and death due to COVID-19 have been reduced, antivirals can provide additional benefits to members of highly vulnerable patient populations.

Strengthening Cybersecurity for Patient Data Protection in Europe.

The health care sector experiences 76% of cybersecurity breaches due to basic web application attacks, miscellaneous errors, and system intrusions, resulting in compromised health data or disrupted health services. The European Commission proposed the European Health Data Space (EHDS) in 2022 to enhance care delivery and improve patients' lives by offering all European Union (EU) citizens control over their personal health data in a private and secure environment. The EU has taken an important step in homogenizing the health data environment of the European health ecosystem, although more attention needs to be paid to keeping the health data of EU citizens safe and secure within the EHDS. The pooling of health data across countries can have tremendous benefits, but it may also become a target for cybercriminals or state-sponsored hackers. State-of-the-art security measures are essential, and the current EHDS proposal lacks sufficient measures to warrant a cybersecure and resilient environment.

Challenges and opportunities for incentivising antibiotic research and development in Europe.

Antimicrobial, and particularly antibiotic resistance are one of the world's biggest challenges today, and urgent action is needed to reinvigorate the antibiotic development pipeline. To inform policy discussions during and after the 2023 Swedish Presidency of the Council of the European Union, we critically appraise incentive options recently proposed by the European Commission, and member states, and consider what has been achieved over the last two decades in relation to antibiotic research and development. While several new antibiotics have achieved regulatory approval in recent years, almost none have innovative characteristics such as new chemical classes or novel mechanisms of action. We consider four incentive options to incentivise research and development of new antibiotics, including subscription payments, market entry rewards, transferable exclusivity extensions, and milestone payments. While each option has advantages and drawbacks, a combination of incentives may be required and continued investment is needed by the EU in push incentives, such as direct funding and grants, to incentivise drug discovery and preclinical stages of development. The EU must also coordinate with international initiatives and support access to new and pre-existing antibiotics in LMICs through platforms such as the WHO, and G7 and G20 group of countries.

Mapping Factors That Affect the Uptake of Digital Therapeutics Within Health Systems: Scoping Review.

BACKGROUND: Digital therapeutics are patient-facing digital health interventions that can significantly alter the health care landscape. Despite digital therapeutics being used to successfully treat a range of conditions, their uptake in health systems remains limited. Understanding the full spectrum of uptake factors is essential to identify ways in which policy makers and providers can facilitate the adoption of effective digital therapeutics within a health system, as well as the steps developers can take to assist in the deployment of products. OBJECTIVE: In this review, we aimed to map the most frequently discussed factors that determine the integration of digital therapeutics into health systems and practical use of digital therapeutics by patients and professionals. METHODS: A scoping review was conducted in MEDLINE, Web of Science, Cochrane Database of Systematic Reviews, and Google Scholar. Relevant data were extracted and synthesized using a thematic analysis. RESULTS: We identified 35,541 academic and 221 gray literature reports, with 244 (0.69%) included in the review, covering 35 countries. Overall, 85 factors that can impact the uptake of digital therapeutics were extracted and pooled into 5 categories: policy and system, patient characteristics, properties of digital therapeutics, characteristics of health professionals, and outcomes. The need for a regulatory framework for digital therapeutics was the most stated factor at the policy level. Demographic characteristics formed the most iterated patient-related factor, whereas digital literacy was considered the most important factor for health professionals. Among the properties of digital therapeutics, their interoperability across the broader health system was most emphasized. Finally, the ability to expand access to health care was the most frequently stated outcome measure. CONCLUSIONS: The map of factors developed in this review offers a multistakeholder approach to recognizing the uptake factors of digital therapeutics in the health care pathway and provides an analytical tool for policy makers to assess their health system's readiness for digital therapeutics.