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In this article, we transform thoughts from classical strategy and insights from modern complexity science into a novel concept of intervention. In doing so, we pursue two goals: First, to improve the prediction of outcomes, and second, to refine the design of interventions. For the first purpose, we outline approaches to modeling the natural behavior of systems and the effect of interventions. For the second purpose, we propose an idea for the design of interventions. We call the concepts that relate to modeling system behaviors system dynamics, and those that relate to predicting outcomes of interventions intervention dynamics, and we call the concepts that relate to the design of interventions intervention design.

Since 72% of rare diseases are genetic in origin and mostly paediatrics, genetic newborn screening represents a diagnostic "window of opportunity". Therefore, many gNBS initiatives started in different European countries. Screen4Care is a research project, which resulted of a joint effort between the European Union Commission and the European Federation of Pharmaceutical Industries and Associations. It focuses on genetic newborn screening and artificial intelligence-based tools which will be applied to a large European population of about 25.000 infants. The neonatal screening strategy will be based on targeted sequencing, while whole genome sequencing will be offered to all enrolled infants who may show early symptoms but have resulted negative at the targeted sequencing-based newborn screening. We will leverage artificial intelligence-based algorithms to identify patients using Electronic Health Records (EHR) and to build a repository "symptom checkers" for patients and healthcare providers. S4C will design an equitable, ethical, and sustainable framework for genetic newborn screening and new digital tools, corroborated by a large workout where legal, ethical, and social complexities will be addressed with the intent of making the framework highly and flexibly translatable into the diverse European health systems.

Health economists have written extensively on the design and implementation of coverage with evidence development (CED) schemes and have proposed theoretical frameworks based on cost-effectiveness modeling and value of information analysis. CED may aid decision-makers when there is uncertainty about the (cost-)effectiveness of a new health technology at the time of reimbursement. Medical devices are potential candidates for CED schemes, as regulatory regimes do not usually require the same level of efficacy and safety data normally needed for pharmaceuticals. The purpose of this research is to assess whether the actual practice of CED for medical devices in Europe meets the theoretical principles proposed by health economists and whether theory and practice can be more closely aligned. Based on decision-makers' perceptions of the challenges associated with CED schemes, plus examples from the schemes themselves, we discuss a series of proposals for assessing the desirability of schemes, their design, implementation, and evaluation. These proposals, while reflecting the practical challenges with developing CED programs, embody many of the principles suggested by economists and should support decision-makers in dealing with uncertainty about the real-world performance of devices.

Objectives: Methodological challenges in the evaluation of medical devices (MDs) may be different for early and late technology adopter countries, as well as the potential health technology assessment (HTA) solutions to tackle them. This study aims to provide guidance to Central and Eastern European (CEE) countries on how to address key challenges of HTA for MDs with special focus on the transferability of scientific evidence. Methods:As part of the COMED Horizon 2020 project, a comprehensive list of issues related to MD HTA were identified based on a targeted literature review. Health technology assessment issues which pose a greater challenge or require different solutions in late technology adopter countries were selected. Draught recommendations to address these issues were developed and discussed in a focus group. The recommendations were then validated with a wider group of experts, including HTA and reimbursement decision makers from CEE countries in May and June 2020. Results: A consolidated list of 11 recommendations were developed in 3 major areas: (1) clinical value assessment, focusing on the use of joint EU work, relying on real-world evidence, use of coverage with evidence development schemes, transferring evidence from foreign countries and addressing the challenges of learning curve and centre effect; (2) economic value assessment, covering cost calculation of complex medical devices and transferability of economic evaluations of MDs; (3) HTA processes, related to the frequent product modifications and various indications of MDs. Conclusions: Central and Eastern European countries with limited resources for conducting HTA, can benefit from HTA methods and evidence generated in early technology adopter countries. Considering the appropriate reuse of international HTA materials, late technology adopter countries can still implement HTA, even for MDs, which have a more limit

Introduction: Specific guidance and examples for health technology assessment (HTA) of medical devices are scarce in medical device development. A more intense dialogue of competent authorities, HTA agencies, and manufactures may improve evidence base on clinical and cost-effectiveness. Especially as the new Medical Device Regulation requires more clinical evidence. Methods: We explore the perceptions of manufacturers, competent authorities, and HTA agencies towards such dialogues and investigate how they should be designed to accelerate the translational process from development to patient access using semi-structured interviews. We synthesized the evidence from manufacturers, competent authorities, and HTA agencies from 14 different jurisdictions across Europe. Results: Eleven HTA agencies, four competent authorities, and eight manufacturers of high-risk devices expressed perceptions on the current situation and the expected development of three types of early dialogues. Discussion: The MDR has to be taken into account when designing the early dialogue processes. Transferring insights from medicinal product regulation is limited as the regulatory pathways differ substantially. Conclusion: Early dialogues promise to accelerate the translational process and to provide faster access to innovative medical devices. However, health policy-makers should promote and fully establish regulatory and HTA early dialogues before introducing parallel early dialogues of regulatory, HTA agencies, and manufacturers. For initiating change, the legislator must create the legal basis and set the appropriate incentives for manufacturers.

One of the most pressing challenges facing most health care systems is rising costs. As the population ages and the demand for health care services grows, there is a growing need to understand the drivers of these costs across systems. This paper attempts to address this gap by examining utilization and spending of the course of a year for two specific high-need high-cost patient types: a frail older person with a hip fracture and an older person with congestive heart failure and diabetes. Data on utilization and expenditure is collected across five health care settings (hospital, post-acute rehabilitation, primary care, outpatient specialty and drugs), in six countries (Canada (Ontario), France, Germany, Spain (Aragon), Sweden and the United States (fee for service Medicare) and used to construct treatment episode Purchasing Power Parities (PPPs) that compare prices using baskets of goods from the different care settings. The treatment episode PPPs suggest other countries have more similar volumes of care to the US as compared to other standardization approaches, suggesting that US prices account for more of the differential in US health care expenditures. The US also differs with regards to the share of expenditures across care settings, with post-acute rehab and outpatient speciality expenditures accounting for a larger share of the total relative to comparators.

Objective: To establish a methodological approach to compare two high-need, high-cost (HNHC) patient personas internationally. Data sources: Linked individual-level administrative data from the inpatient and outpatient sectors compiled by the International Collaborative on Costs, Outcomes, and Needs in Care (ICCONIC) across 11 countries: Australia, Canada, England, France, Germany, the Netherlands, New Zealand, Spain, Sweden, Switzerland, and the United States. Study design: We outline a methodological approach to identify HNHC patient types for international comparisons that reflect complex, priority populations defined by the National Academy of Medicine. We define two patient profiles using accessible patient-level datasets linked across different domains of care—hospital care, primary care, outpatient specialty care, post-acute rehabilitative care, long-term care, home-health care, and outpatient drugs. The personas include a frail older adult with a hip fracture with subsequent hip replacement and an older person with complex multimorbidity, including heart failure and diabetes. We demonstrate their comparability by examining the characteristics and clinical diagnoses captured across countries. Data collection/extraction methods: Data collected by ICCONIC partners. Principal findings: Across 11 countries, the identification of HNHC patient personas was feasible to examine variations in healthcare utilization, spending, and patient outcomes. The ability of countries to examine linked, individual-level data varied, with the Netherlands, Canada, and Germany able to comprehensively examine care across all seven domains, whereas other countries such as England, Switzerland, and New Zealand were more limited. All countries were able to identify a hip fracture persona and a heart failure persona. Patient characteristics were reassuringly similar across countries. Conclusion: Although there are cross-country differences in the availability and structure of data sources

Objective This study explores variations in outcomes of care for two types of patient personas—an older frail person recovering from a hip fracture and a multimorbid older patient with congestive heart failure (CHF) and diabetes. Data Sources We used individual-level patient data from 11 health systems. Study Design We compared inpatient mortality, mortality, and readmission rates at 30, 90, and 365 days. For the hip fracture persona, we also calculated time to surgery. Outcomes were standardized by age and sex. Data Collection/Extraction Methods Data was compiled by the International Collaborative on Costs, Outcomes and Needs in Care across 11 countries for the years 2016–2017 (or nearest): Australia, Canada, England, France, Germany, the Netherlands, New Zealand, Spain, Sweden, Switzerland, and the United States. Principal Findings The hip sample across ranged from 1859 patients in Aragon, Spain, to 42,849 in France. Mean age ranged from 81.2 in Switzerland to 84.7 in Australia, and the majority of hip patients across countries were female. The congestive heart failure (CHF) sample ranged from 742 patients in England to 21,803 in the United States. Mean age ranged from 77.2 in the United States to 80.3 in Sweden, and the majority of CHF patients were males. Average in-hospital mortality across countries was 4.1%. for the hip persona and 6.3% for the CHF persona. At the year mark, the mean mortality across all countries was 25.3% for the hip persona and 32.7% for CHF persona. Across both patient types, England reported the highest mortality at 1 year followed by the United States. Readmission rates for all periods were higher for the CHF persona than the hip persona. At 30 days, the average readmission rate for the hip persona was 13.8% and 27.6% for the CHF persona. Conclusion Across 11 countries, there are meaningful differences in health system outcomes for two types of patients.

Objective: The objective of this study was to explore cross-country differences in spending and utilization across different domains of care for a multimorbid persona with heart failure and diabetes. Data Sources: We used individual-level administrative claims or registry data from inpatient and outpatient health care sectors compiled by the International Collaborative on Costs, Outcomes, and Needs in Care (ICCONIC) across 11 countries: Australia, Canada, England, France, Germany, the Netherlands, New Zealand, Spain, Sweden, Switzerland, and the United States (US). Data Collection/Extraction Methods: Data collected by ICCONIC partners. Study Design: We retrospectively analyzed age–sex standardized utilization and spending of an older person (65–90 years) hospitalized with a heart failure exacerbation and a secondary diagnosis of diabetes across five domains of care: hospital care, primary care, outpatient specialty care, post–acute rehabilitative care, and outpatient drugs. Principal Findings: Sample sizes ranged from n = 1270 in Spain to n = 21,803 in the United States. Mean age (standard deviation [SD]) ranged from 76.2 (5.6) in the Netherlands to 80.3 (6.8) in Sweden. We observed substantial variation in spending and utilization across care settings. On average, England spent $10,956 per person in hospital care while the United States spent $30,877. The United States had a shorter length of stay over the year (18.9 days) compared to France (32.9) and Germany (33.4). The United States spent more days in facility-based rehabilitative care than other countries. Australia spent $421 per person in primary care, while Spain (Aragon) spent $1557. The United States and Canada had proportionately more visits to specialist providers than primary care providers. Across almost all sectors, the United States spent more than other countries, suggesting higher prices per unit. Conclusion: Across 11 countries, there is substantial variation in health care spending and utilizatio

Objective To identify and explore differences in spending and utilization of key health services at the end of life among hip fracture patients across seven developed countries. Data Sources Individual-level claims data from the inpatient and outpatient health care sectors compiled by the International Collaborative on Costs, Outcomes, and Needs in Care (ICCONIC). Study Design We retrospectively analyzed utilization and spending from acute hospital care, emergency department, outpatient primary care and specialty physician visits, and outpatient drugs. Patterns of spending and utilization were compared in the last 30, 90, and 180 days across Australia, Canada, England, Germany, New Zealand, Spain, and the United States. We employed linear regression models to measure age- and sex-specific effects within and across countries. In addition, we analyzed hospital-centricity, that is, the days spent in hospital and site of death. Data Collection/Extraction Methods We identified patients who sustained a hip fracture in 2016 and died within 12 months from date of admission. Principal Findings Resource use, costs, and the proportion of deaths in hospital showed large variability being high in England and Spain, while low in New Zealand. Days in hospital significantly decreased with increasing age in Canada, Germany, Spain, and the United States. Hospital spending near date of death was significantly lower for women in Canada, Germany, and the United States. The age gradient and the sex effect were less pronounced in utilization and spending of emergency care, outpatient care, and drugs. Conclusions Across seven countries, we find important variations in end-of-life care for patients who sustained a hip fracture, with some differences explained by sex and age. Our work sheds important insights that may help ongoing health policy discussions on equity, efficiency, and reimbursement in health care systems.

Objective To compare within-country variation of health care utilization and spending of patients with chronic heart failure (CHF) and diabetes across countries. Data Sources Patient-level linked data sources compiled by the International Collaborative on Costs, Outcomes, and Needs in Care across nine countries: Australia, Canada, England, France, Germany, New Zealand, Spain, Switzerland, and the United States. Data Collection Methods Patients were identified in routine hospital data with a primary diagnosis of CHF and a secondary diagnosis of diabetes in 2015/2016. Study Design We calculated the care consumption of patients after a hospital admission over a year across the care pathway—ranging from primary care to home health nursing care. To compare the distribution of care consumption in each country, we use Gini coefficients, Lorenz curves, and female–male ratios for eight utilization and spending measures. Principal Findings In all countries, rehabilitation and home nursing care were highly concentrated in the top decile of patients, while the number of drug prescriptions were more uniformly distributed. On average, the Gini coefficient for drug consumption is about 0.30 (95% confidence interval (CI): 0.27–0.36), while it is, 0.50 (0.45–0.56) for primary care visits, and more than 0.75 (0.81–0.92) for rehabilitation use and nurse visits at home (0.78; 0.62–0.9). Variations in spending were more pronounced than in utilization. Compared to men, women spend more days at initial hospital admission (+5%, 1.01–1.06), have a higher number of prescriptions (+7%, 1.05–1.09), and substantially more rehabilitation and home care (+20% to 35%, 0.79–1.6, 0.99–1.64), but have fewer visits to specialists (−10%; 0.84–0.97). Conclusions Distribution of health care consumption in different settings varies within countries, but there are also some common treatment patterns across all countries. Clinicians and policy makers need to look into these differences in care utilization by

Objective This study explores differences in spending and utilization of health care services for an older person with frailty before and after a hip fracture. Data Sources We used individual-level patient data from five care settings. Study Design We compared utilization and spending of an older person aged older than 65 years for 365 days before and after a hip fracture across 11 countries and five domains of care as follows: acute hospital care, primary care, outpatient specialty care, post–acute rehabilitative care, and outpatient drugs. Utilization and spending were age and sex standardized.. Data Collection/Extraction Methods The data were compiled by the International Collaborative on Costs, Outcomes, and Needs in Care (ICCONIC) across 11 countries as follows: Australia, Canada, England, France, Germany, the Netherlands, New Zealand, Spain, Sweden, Switzerland, and the United States. Principal Findings The sample ranged from 1859 patients in Spain to 42,849 in France. Mean age ranged from 81.2 in Switzerland to 84.7 in Australia. The majority of patients across countries were female. Relative to other countries, the United States had the lowest inpatient length of stay (11.3), but the highest number of days were spent in post–acute care rehab (100.7) and, on average, had more visits to specialist providers (6.8 per year) than primary care providers (4.0 per year). Across almost all sectors, the United States spent more per person than other countries per unit ($13,622 per hospitalization, $233 per primary care visit, $386 per MD specialist visit). Patients also had high expenditures in the year prior to the hip fracture, mostly concentrated in the inpatient setting. Conclusion Across 11 high-income countries, there is substantial variation in health care spending and utilization for an older person with frailty, both before and after a hip fracture. The United States is the most expensive country due to high prices and above average utilization of post–acute

Objective The objectives of this study are to compare the relative use of different postacute care settings in different countries and to compare three important outcomes as follows: total expenditure, total days of care in different care settings, and overall longevity over a 1-year period following a hip fracture. Data Sources We used administrative data from hospitals, institutional and home-based long-term care (LTC), physician visits, and medications compiled by the International Collaborative on Costs, Outcomes, and Needs in Care (ICCONIC) from five countries as follows: Canada, France, Germany, the Netherlands, and Sweden. Data Extraction Methods Data were extracted from existing administrative data systems in each participating country. Study Design This is a retrospective cohort study of all individuals admitted to acute care for hip fracture. Descriptive comparisons were used to examine aggregate institutional and home-based postacute care. Care trajectories were created to track sequential care settings after acute-care discharge through institutional and community-based care in three countries where detailed information allowed. Comparisons in patient characteristics, utilization, and costs were made across these trajectories and countries. Principal Findings Across five countries with complete LTC data, we found notable variations with Germany having the highest days of home-based services with relatively low costs, while Sweden incurred the highest overall expenditures. Comparisons of trajectories found that France had the highest use of inpatient rehabilitation. Germany was most likely to discharge hip fracture patients to home. Over 365 days, France averaged the highest number of days in institution with 104, Canada followed at 94, and Germany had just 87 days of institutional care on average. Conclusion In this comparison of LTC services following a hip fracture, we found international differences in total use of institutional and noninstitutional c