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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., Competing Interests: Declarations of Competing Interest None., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)

Following a series of major scandals over the past two decades, the medical device industry is now undergoing a major regulatory change: the implementation of the European Union Medical Device Regulation (MDR) of 2017. After a transitional period of four years, the MDR became fully binding in May 2021. Although the medium- and long-term impacts of the MDR are still unclear, a range of scholars, health care professionals, and industry representatives have begun to publish early evidence and publicize their views on how the new regulation may impact free trade and patient safety. Even a cursory view of their output reveals hypotheses and opinions that could hardly be more divergent. The reasons for this disagreement are unclear and may extend beyond the different interests of the various stakeholder groups. To find out why this might be the case, we examine the MDR and seek to improve scholarly understanding of this most extensive regulation of medical devices since the early 1990s. We offer policymakers suggestions to help them improve future regulation. Based on theoretical considerations, we conclude that while the MDR is highly likely to strengthen the internal market of the EU, its impact on patient safety will remain unclear as long as there are no comprehensive studies on this topic that are based on empirical data., Competing Interests: Declaration of Competing Interest None declared., (Copyright © 2022. Published by Elsevier B.V.)

Vaccinations are crucial to fighting SARS-CoV-2, and high coverage rates can in most countries probably only be achieved with the involvement of primary care physicians (PCPs). We aimed to explore how SARS-CoV-2 vaccination payment schemes in 43 countries differ with regard to the (i) type of payment scheme, (ii) amount paid, (iii) degree of bundling, and (iv) use of pay-for-performance elements. We collected information on payments and health system characteristics, such as PCP income and employment status, in all EU and OECD countries over time. We regressed the payment amount on the income of PCPs for countries with activity-dependent schemes using a linear regression (OLS), and we interpreted the residuals of this regression as a vaccination payment index. The majority of countries (30/43) had chosen payment schemes that reward PCPs for the activity they perform. Seventeen countries paid less per vaccination than the income-adjusted average, whereas 13 countries paid more. Twelve countries used pay-for-performance elements., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)

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 rehab care., (© 2021 The Authors. Health Services Research published by Wiley Periodicals LLC on behalf of Health Research and Educational Trust.)

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 sex and care setting to determine whether they are justified or indicate suboptimal care., (© 2021 Health Research and Educational Trust.)

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, countries had the ability to effectively identify comparable HNHC personas for international study. This work serves as the methodological paper for six accompanying papers examining differences in spending, utilization, and outcomes for these personas across countries., (© 2021 The Authors. Health Services Research published by Wiley Periodicals LLC on behalf of Health Research and Educational Trust.)

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., (© 2021 The Authors. Health Services Research published by Wiley Periodicals LLC on behalf of Health Research and Educational Trust.)

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., (© 2021 The Authors. Health Services Research published by Wiley Periodicals LLC on behalf of Health Research and Educational Trust.)

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 utilization for a complex multimorbid persona with heart failure and diabetes. Drivers of spending vary across countries, with the United States being the most expensive country due to high prices and higher use of facility-based rehabilitative care., (© 2021 The Authors. Health Services Research published by Wiley Periodicals LLC on behalf of Health Research and Educational Trust.)

Objectives: Medical devices are potentially good candidates for coverage with evidence development (CED) schemes, as clinical data at market entry are often sparse and (cost-)effectiveness depends on real-world use. The objective of this research was to explore the diffusion of CED schemes for devices in Europe, and the factors that favour or hamper their utilization., Methods: We conducted structured interviews with 25 decision-makers from 22 European countries to explore the characteristics of existing CED programmes for devices, and how decision makers perceived 13 pre-identified challenges associated with initiating and operating CED schemes for devices. We also collected data on individual schemes that were either initiated or still ongoing in the last 5 years., Results: We identified seven countries with CED programmes for devices and 78 ongoing schemes. The characteristics of CED programmes varied across countries, including eligibility criteria, roles and responsibilities of stakeholders, funding arrangements, and type of decisions being contemplated at the outset of each scheme. We observed a high variability in how decision makers perceived CED-related challenges possibly reflecting country-specific arrangements and different experiences with CED. One general finding across all countries was that relatively little attention was paid to the evaluation of schemes, both during and at their completion., Conclusions: CED programmes for devices with different characteristics exist in Europe. Decision-makers' perceptions differ on the challenges associated with these schemes. More exchange of knowledge and experience will help decision makers anticipate the likely challenges in CED schemes for devices, and to learn from good practices existing elsewhere., (© 2021. The Author(s).)

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., Competing Interests: Declaration of Competing Interest The authors declare that they have no financial/personal interest or belief that could affect their objectivity other than the stated funding source., (Copyright © 2021 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: Kaizen-a management technique increasingly employed in health care-enables employees, regardless of their hierarchy level, to contribute to the improvement of their organization. The approach puts special emphasis on frontline employees because it represents one of their main opportunities to participate directly in decision making. In this study, we aimed to (1) understand the experiences of nurses in two hospitals that had recently implemented kaizen, and (2) identify factors affecting the implementation of the technique., Methods: By means of purposeful sampling, we selected 30 nurses from different units in two private acute care hospitals in Switzerland in May 2018. We used the Organizational Transformation Model to conduct semi-structured interviews and perform qualitative content analysis. Lastly, originating from Herzberg's motivation theory, we suggest two types of factor influencing the implementation of kaizen-hygiene factors that may prevent nurses from getting demotivated, and motivational factors that may boost their motivation., Results: Nurses generally experienced kaizen as a positive practice that enabled them to discuss work-related activities in a more comprehensive manner. In some cases, however, a lack of visible improvement in the workplace lowered nurses' motivation to make suggestions. Nurses' attitudes towards kaizen differed across both hospitals depending on the available managerial support, resources such as infrastructure and staffing levels., Conclusions: From our findings, we derived several coping strategies to help health practitioners implement kaizen for the benefit of their organization and employees: Strong managerial support, appropriate use of kaizen tools, and a greater sense of team cohesion, among other factors, can influence how effectively hospital teams implement kaizen. To reap the benefits of kaizen, hospital managers should promote the exchange of opinions across hierarchy levels, allocate the necessary resources in terms of personnel and infrastructure, and show nurses how the technique can help them improve their workplace., Competing Interests: All authors of this manuscript have read the journal’s policy and have the following competing interests: KS, CP and RB declare that they have no conflicts of interest. KH, BT, and AG are employed by Hislanden AG, the hospital organization that was examined in this study. The commercial affiliation of the authors KH, BT, and AG does not alter our adherence to PLOS ONE policies on sharing data and materials. Hislanden AG does not profit financially or otherwise from the study results. All authors declare that no other competing interests exist.

In the drive towards faster patient access to treatments, health technology assessment (HTA) agencies are increasingly faced with reliance on evidence from surrogate endpoints, leading to increased decision uncertainty. This study undertook an updated survey of methodological guidance for using surrogate endpoints across international HTA agencies. We reviewed HTA and economic evaluation methods guidance from European, Australian and Canadian HTA agencies. We considered how guidelines addressed the methods for handling surrogate endpoints, including (1) level of evidence, (2) methods of validation, and (3) thresholds of acceptability. Across the 73 HTA agencies surveyed, 29 (40%) had methodological guidelines that made specific reference to consideration of surrogate outcomes. Of the 45 methods documents analysed, the majority [27 (60%)] were non-technology specific, 15 (33%) focused on pharmaceuticals and three (7%) on medical devices. The principles of the European network for Health Technology Assessment (EUnetHTA) guidelines published in 2015 on the handling of surrogate endpoints appear to have been adopted by many European HTA agencies, i.e. preference for final patient-relevant outcomes and reliance on surrogate endpoints with biological plausibility and epidemiological evidence of the association between the surrogate and final endpoint. Only a small number of HTA agencies (UK National Institute for Care and Excellence; the German Institute for Medical Documentation and Information and Institute for Quality and Efficiency in Health Care; the Australian Pharmaceutical Benefits Advisory Committee; and the Canadian Agency for Drugs and Technologies in Health) have developed more detailed prescriptive criteria for the acceptance of surrogate endpoints, e.g. meta-analyses of randomised controlled trials showing strong association between the treatment effect on the surrogate and final outcomes. As the decision uncertainty associated with reliance on surrogate endpoints carries a risk to patients and society, there is a need for HTA agencies to develop more detailed methodological guidance for consistent selection and evaluation of health technologies that lack definitive final patient-relevant outcome evidence at the time of the assessment.