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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of partisan political control on financial performance, structure, and outcomes of for-profit and not-for-profit US nursing homes.Data Sources/study Setting: Nineteen-year panel (1996-2014) of state election outcomes, financial performance data from nursing home cost reports, operational and aggregate resident characteristics from OSCAR of 13 737 nursing homes.Study Design: A linear panel model was estimated to identify the effect of Democratic and Republican political control on next year's outcomes. Nursing home outcomes were defined as yearly facility revenues, expenses, and profits; the number of Medicaid, Medicare, and private-pay residents; staffing levels; and selected resident outcomes.Principal Findings: Democratic political control leads to an increase in financial flows to for-profit nursing homes, boosting profits without producing observable improvements in resident outcomes. Republican political control leads to lower revenues and profits of for-profit nursing homes. A shift from Medicaid to more profitable private-pay residents following Republican political control is observed for all nursing homes. Financial performance of not-for-profit nursing homes is not significantly affected by changes in political control.Conclusion: Political control of the two legislative chambers-but not of the governorship-shapes the structure of the nursing home industry as seen in provider behavior. [ABSTRACT FROM AUTHOR]

Background Marfan syndrome is a rare disease of the connective tissues, affecting multiple organ systems. Elevated morbidity and mortality in these patients raises the issue of costs for sickness funds and society. To date, there has been no study analysing the costs of Marfan syndrome from a sickness fund and societal perspective. Objective To estimate excess health resource utilisation, direct (non-)medical and indirect costs attributable to Marfan syndrome from a healthcare payer and a societal perspective in Germany in 2008. Methods A retrospective matched cohort study design is applied, using claims data. For isolating the causal effect of Marfan syndrome on excess costs, a genetic matching algorithm was used to reduce differences in observable characteristics between Marfan syndrome patients and the control group. 892 patients diagnosed with Marfan syndrome (ICD-10 Q87.4) were matched from a pool of 26,645 control individuals. After matching, we compared health resource utilisation and costs. Results From the sickness fund perspective, an average Marfan syndrome patient generates excess annual costs of €2496 compared with a control individual. From the societal perpective, excess annual costs amount to €15,728. For the sickness fund, the strongest cost drives are inpatient treatment and care by non-physicians. From the sickness fund perspective, the third (25-41 years) and first (0-16 years) age quartiles reveal the greatest surplus in total costs. Marfan syndrome patients have 39% more physician contacts, a 153% longer average length of hospital stay, 119% more inpatient stays, 33% more prescriptions, 236% more medical imaging and 20% higher average prescription costs than control individuals. Depending on the prevalence, the economic impact from the sickness fund perspective ranges between €24.0 million and €61.4 million, where the societal econimic impact extendes from €151.3 million to € million. Conclusions Relative to its low frequency, Marfan syndrome requires high healthcare expenditure. Not only the high costs of Marfan syndrome but also its burden on patients' lives call for more awareness from policy-makers, physicians and clinical researchers. Consequently, the diagnosis and treatment of Marfan syndrome should begin as soon as possible in order to prevent disease complications, early mortality and substantial healthcare expenditure. [ABSTRACT FROM AUTHOR]

Background: Chronic lymphocytic leukemia (CLL) is a slowly progressing but fatal disease that imposes a high economic burden on sickness funds and society. The objective of this study was to analyze and compare the direct and indirect costs of CLL in Germany from the perspective of the sickness funds and society and analyze the burden of the disease. Methods: Using a database of 7.6 million enrolled individuals, we identified 4198 CLL patients in 2007 and 2008. The costs attributable to CLL were estimated using a case-control design with a randomly selected control group of 150 individuals per combination of age and sex. We used the bootstrap approach to estimate uncertainties in costs estimated. We employed generalized estimating equation regression models and count data models to test for differences in costs and healthcare utilization. Results: The cost attributable to CLL for each prevalent case amounts to €4946 from the payer's perspective and €7910 from a societal perspective. Inpatient hospital stays and pharmaceuticals are the main cost drivers of the disease. The economic burden of disease in Germany was estimated to be approximately €201 million per year for the sickness funds and €322 million for society. Conclusions: Compared with common diseases, such as diabetes or COPD, the economic burden of CLL is considerably lower. However, the cost of treatment per case is about twice as high as the cost per case for these common diseases, even though treatment is only performed in the later stages of CLL. With new healthcare technologies, the aging population, and the increasing incidence of the disease, it is likely that the economic burden of the disease will continue to grow. [ABSTRACT FROM AUTHOR]

Background: Market authorization does not guarantee patient access to any given drug. This is particularly true for costly orphan drugs because access depends primarily on co-payments, reimbursement policies and prices. The objective of this article is to identify differences in the availability of orphan drugs and in patient access to them in 11 pharmaceutical markets: Australia, Canada, England, France, Germany, Hungary, the Netherlands, Poland, Slovakia, Switzerland and the US. Methods: Four rare diseases were selected for analysis: pulmonary arterial hypertension (PAH), Fabry disease (FD), hereditary angioedema (HAE) and chronic myeloid leukaemia (CML). Indicators for availability were defined as (i) the indications for which orphan drugs had been authorized in the treatment of these diseases; (ii) the application date; and (iii) the date upon which these drugs received market authorization in each country. Indicators of patient access were defined as (i) the outcomes of technology appraisals; (ii) the extent of coverage provided by healthcare payers; and (iii) the price of the drugs in each country. For PAH we analysed bosentan, iloprost, sildenafil, treprostinil (intravenous and inhaled) as well as sitaxentan and ambrisentan; for FD we analysed agalsidase alfa and agalsidase beta; for HAE we analysed icatibant, ecallantide and two complement C1s inhibitors; for CML we analysed imatinib, dasatinib and nilotinib. Results: Most drugs included in this study had received market authorization in all countries, but the range of indications for which they had been authorized differed by country. The broadest range of indications was found in Australia, and the largest variations in indications were found for PAH drugs. Authorization process speed (the time between application and market authorization) was fastest in the US, with an average of 362 days, followed by the EU (394 days). The highest prices for the included drugs were found in Germany and the US, and the lowest in Canada, Australia and England. Although the prices of all of the included drugs were high compared with those of most non-orphan drugs, most of the insurance plans in our country sample provided coverage for authorized drugs after a certain threshold. Conclusions: Availability of and access to orphan drugs play a key role in determining whether patients will receive adequate and efficient treatment. Although the present study showed some variations between countries in selected indicators of availability and access to orphan drugs, virtually all of the drugs in question were available and accessible in our sample. However, substantial co-payments in the US and Canada represent important barriers to patient access, especially in the case of expensive treatments such as those analysed in this study. Market exclusivity is a strong instrument for fostering orphan drug development and drug availability. However, despite the positive effect of this instrument, the conditions under which market exclusivity is granted should be reconsidered in cases where the costs of developing an orphan drug have already been amortized through the use of the drug’s active ingredient for the treatment of a common indication. [ABSTRACT FROM AUTHOR]

Background: Market authorization does not guarantee patient access to any given drug. This is particularly true for costly orphan drugs because access depends primarily on co-payments, reimbursement policies and prices. The objective of this article is to identify differences in the availability of orphan drugs and in patient access to them in 11 pharmaceutical markets: Australia, Canada, England, France, Germany, Hungary, the Netherlands, Poland, Slovakia, Switzerland and the US. Methods: Four rare diseases were selected for analysis: pulmonary arterial hypertension (PAH), Fabry disease (FD), hereditary angioedema (HAE) and chronic myeloid leukaemia (CML). Indicators for availability were defined as (i) the indications for which orphan drugs had been authorized in the treatment of these diseases; (ii) the application date; and (iii) the date upon which these drugs received market authorization in each country. Indicators of patient access were defined as (i) the outcomes of technology appraisals; (ii) the extent of coverage provided by healthcare payers; and (iii) the price of the drugs in each country. For PAH we analysed bosentan, iloprost, sildenafil, treprostinil (intravenous and inhaled) as well as sitaxentan and ambrisentan; for FD we analysed agalsidase alfa and agalsidase beta; for HAE we analysed icatibant, ecallantide and two complement C1s inhibitors; for CML we analysed imatinib, dasatinib and nilotinib. Results: Most drugs included in this study had received market authorization in all countries, but the range of indications for which they had been authorized differed by country. The broadest range of indications was found in Australia, and the largest variations in indications were found for PAH drugs. Authorization process speed (the time between application and market authorization) was fastest in the US, with an average of 362 days, followed by the EU (394 days). The highest prices for the included drugs were found in Germany and the US, and the lowest in Canada, Australia and England. Although the prices of all of the included drugs were high compared with those of most non-orphan drugs, most of the insurance plans in our country sample provided coverage for authorized drugs after a certain threshold. Conclusions: Availability of and access to orphan drugs play a key role in determining whether patients will receive adequate and efficient treatment. Although the present study showed some variations between countries in selected indicators of availability and access to orphan drugs, virtually all of the drugs in question were available and accessible in our sample. However, substantial co-payments in the US and Canada represent important barriers to patient access, especially in the case of expensive treatments such as those analysed in this study. Market exclusivity is a strong instrument for fostering orphan drug development and drug availability. However, despite the positive effect of this instrument, the conditions under which market exclusivity is granted should be reconsidered in cases where the costs of developing an orphan drug have already been amortized through the use of the drug's active ingredient for the treatment of a common indication. [ABSTRACT FROM AUTHOR]

Objective Data Sources and Study Setting Study Design Principal Findings Conclusion What is known on this topic What this study adds To explore variation in rates of acute care utilization for mental health conditions, including hospitalizations and emergency department (ED) visits, across high‐income countries before and during the COVID‐19 pandemic.Administrative patient‐level data between 2017 and 2020 of eight high‐income countries: Canada, England, Finland, France, New Zealand, Spain, Switzerland, and the United States (US).Multi‐country retrospective observational study using a federated data approach that evaluated age‐sex standardized rates of hospitalizations and ED visits for mental health conditions.There was significant variation in rates of acute mental health care utilization across countries. Among the subset of four countries with both hospitalization and ED data, the US had the highest pre‐COVID‐19 combined average annual acute care rate of 1613 episodes/100,000 people (95% CI: 1428, 1797). Finland had the lowest rate of 776 (686, 866). When examining hospitalization rates only, France had the highest rate of inpatient hospitalizations of 988/100,000 (95% CI 858, 1118) while Spain had the lowest at 87/100,000 (95% CI 76, 99). For ED rates for mental health conditions, the US had the highest rate of 958/100,000 (95% CI 861, 1055) while France had the lowest rate with 241/100,000 (95% CI 216, 265). Notable shifts coinciding with the onset of the COVID‐19 pandemic were observed including a substitution of care setting in the US from ED to inpatient care, and overall declines in acute care utilization in Canada and France.The study underscores the importance of understanding and addressing variation in acute care utilization for mental health conditions, including the differential effect of COVID‐19, across different health care systems. Further research is needed to elucidate the extent to which factors such as workforce capacity, access barriers, financial incentives, COVID‐19 preparedness, and community‐based care may contribute to these variations. Approximately one billion people globally live with a mental health condition, with significant consequences for individuals and societies. Rates of mental health diagnoses vary across high‐income countries, with substantial differences in access to effective care. The COVID‐19 pandemic has exacerbated mental health challenges globally, with varying impacts across countries. This study provides a comprehensive international comparison of hospitalization and emergency department visit rates for mental health conditions across eight high‐income countries. It highlights significant variations in acute care utilization patterns, particularly in countries that are more likely to care for people with mental health conditions in emergency departments rather than inpatient facilities The study identifies temporal and cross‐country differences in acute care management of mental health conditions coinciding with the onset of the COVID‐19 pandemic. [ABSTRACT FROM AUTHOR]

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 care, longevity, and total expenditures. There exist opportunities to organize postacute care differently to maximize independence and mitigate costs. [ABSTRACT FROM AUTHOR]

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 care, longevity, and total expenditures. There exist opportunities to organize postacute care differently to maximize independence and mitigate costs. [ABSTRACT FROM AUTHOR]

Background: The delay in diagnosis for rare disease (RD) patients is often longer than for patients with common diseases. Machine learning (ML) technologies have the potential to speed up and increase the precision of diagnosis in this population group. We aim to explore the expectations and experiences of the members of the European Reference Networks (ERNs) for RDs with those technologies and their potential for application. Methods: We used a mixed-methods approach with an online survey followed by a focus group discussion. Our study targeted primarily medical professionals but also other individuals affiliated with any of the 24 ERNs. Results: The online survey yielded 423 responses from ERN members. Participants reported a limited degree of knowledge of and experience with ML technologies. They considered improved diagnostic accuracy the most important potential benefit, closely followed by the synthesis of clinical information, and indicated the lack of training in these new technologies, which hinders adoption and implementation in routine care. Most respondents supported the option that ML should be an optional but recommended part of the diagnostic process for RDs. Most ERN members saw the use of ML limited to specialised units only in the next 5 years, where those technologies should be funded by public sources. Focus group discussions concluded that the potential of ML technologies is substantial and confirmed that the technologies will have an important impact on healthcare and RDs in particular. As ML technologies are not the core competency of health care professionals, participants deemed a close collaboration with developers necessary to ensure that results are valid and reliable. However, based on our results, we call for more research to understand other stakeholders' opinions and expectations, including the views of patient organisations. Conclusions: We found enthusiasm to implement and apply ML technologies, especially diagnostic tools in the field of RDs, despite the perceived lack of experience. Early dialogue and collaboration between health care professionals, developers, industry, policymakers, and patient associations seem to be crucial to building trust, improving performance, and ultimately increasing the willingness to accept diagnostics based on ML technologies. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

A response by Carl Rudolf Blankart, Ezekiel J. Emanuel, and Justin E. Bekelman to a letter to the editor about their article on a cross-national study on the place of death, health care utilization, and hospital costs for patients dying with cancer in a 2016 issue is presented.

Following the reverse genetics strategy developed in the 1980s to pioneer the identification of disease genes, genome(s) sequencing has opened the era of genomics medicine. The human genome project has led to an innumerable series of applications of omics sciences on global health, from which rare diseases (RDs) have greatly benefited. This has propelled the scientific community towards major breakthroughs in disease genes discovery, in technical innovations in bioinformatics, and in the development of patients' data registries and omics repositories where sequencing data are stored. Rare diseases were the first diseases where nucleic acid-based therapies have been applied. Gene therapy, molecular therapy using RNA constructs, and medicines modulating transcription or translation mechanisms have been developed for RD patients and started a new era of medical science breakthroughs. These achievements together with optimization of highly scalable next generation sequencing strategies now allow movement towards genetic newborn screening. Its applications in human health will be challenging, while expected to positively impact the RD diagnostic journey. Genetic newborn screening brings many complexities to be solved, technical, strategic, ethical, and legal, which the RD community is committed to address. Genetic newborn screening initiatives are therefore blossoming worldwide, and the EU-IMI framework has funded the project Screen4Care. This large Consortium will apply a dual genetic and digital strategy to design a comprehensive genetic newborn screening framework to be possibly translated into the future health care. [ABSTRACT FROM AUTHOR]

Background: Marfan syndrome is a rare disease of the connective tissues, affecting multiple organ systems. Elevated morbidity and mortality in these patients raises the issue of costs for sickness funds and society. To date, there has been no study analysing the costs of Marfan syndrome from a sickness fund and societal perspective.Objective: To estimate excess health resource utilisation, direct (non-)medical and indirect costs attributable to Marfan syndrome from a healthcare payer and a societal perspective in Germany in 2008.Methods: A retrospective matched cohort study design is applied, using claims data. For isolating the causal effect of Marfan syndrome on excess costs, a genetic matching algorithm was used to reduce differences in observable characteristics between Marfan syndrome patients and the control group. 892 patients diagnosed with Marfan syndrome (ICD-10 Q87.4) were matched from a pool of 26,645 control individuals. After matching, we compared health resource utilisation and costs.Results: From the sickness fund perspective, an average Marfan syndrome patient generates excess annual costs of €2496 compared with a control individual. From the societal perspective, excess annual costs amount to €15,728. For the sickness fund, the strongest cost drivers are inpatient treatment and care by non-physicians. From the sickness fund perspective, the third (25-41 years) and first (0-16 years) age quartiles reveal the greatest surplus in total costs. Marfan syndrome patients have 39% more physician contacts, a 153% longer average length of hospital stay, 119% more inpatient stays, 33% more prescriptions, 236% more medical imaging and 20% higher average prescription costs than control individuals. Depending on the prevalence, the economic impact from the sickness fund perspective ranges between €24.0 million and €61.4 million, whereas the societal economic impact extends from €151.3 million to €386.9 million.Conclusions: Relative to its low frequency, Marfan syndrome requires high healthcare expenditure. Not only the high costs of Marfan syndrome but also its burden on patients' lives call for more awareness from policy-makers, physicians and clinical researchers. Consequently, the diagnosis and treatment of Marfan syndrome should begin as soon as possible in order to prevent disease complications, early mortality and substantial healthcare expenditure. [ABSTRACT FROM AUTHOR]

Background: Chronic lymphocytic leukemia (CLL) is a slowly progressing but fatal disease that imposes a high economic burden on sickness funds and society. The objective of this study was to analyze and compare the direct and indirect costs of CLL in Germany from the perspective of the sickness funds and society and analyze the burden of the disease.Methods: Using a database of 7.6 million enrolled individuals, we identified 4198 CLL patients in 2007 and 2008. The costs attributable to CLL were estimated using a case-control design with a randomly selected control group of 150 individuals per combination of age and sex. We used the bootstrap approach to estimate uncertainties in costs estimated. We employed generalized estimating equation regression models and count data models to test for differences in costs and healthcare utilization.Results: The cost attributable to CLL for each prevalent case amounts to €4946 from the payer's perspective and €7910 from a societal perspective. Inpatient hospital stays and pharmaceuticals are the main cost drivers of the disease. The economic burden of disease in Germany was estimated to be approximately €201 million per year for the sickness funds and €322 million for society.Conclusions: Compared with common diseases, such as diabetes or COPD, the economic burden of CLL is considerably lower. However, the cost of treatment per case is about twice as high as the cost per case for these common diseases, even though treatment is only performed in the later stages of CLL. With new healthcare technologies, the aging population, and the increasing incidence of the disease, it is likely that the economic burden of the disease will continue to grow. [ABSTRACT FROM AUTHOR]

Background Studies have often stated that individual-level determinants are important drivers for the adoption of medical devices. Empirical evidence supporting this claim is, however, scarce. At the individual level, physicians’ adoption motivation was often considered important in the context of adoption decisions, but a clear notion of its dimensions and corresponding measurement scales is not available. Objectives To develop and subsequently validate a scale to measure the motivation to adopt medical devices of hospital-based physicians. Methods The development and validation of the physician-motivation-adoption (PMA) scale were based on a literature search, internal expert meetings, a pilot study with physicians, and a three-stage online survey. The data collected in the online survey were analyzed using exploratory factor analysis (EFA), and the PMA scale was revised according to the results. Confirmatory factor analysis (CFA) was conducted to test the results from the EFA in the third stage. Reliability and validity tests and subgroup analyses were also conducted. Results Overall, 457 questionnaires were completed by medical personnel of the National Health Service England. The EFA favored a six-factor solution to appropriately describe physicians’ motivation. The CFA confirmed the results from the EFA. Our tests indicated good reliability and validity of the PMA scale. Conclusions This is the first reliable and valid scale to measure physicians’ adoption motivation. Future adoption studies assessing the individual level should include the PMA scale to obtain more information about the role of physicians’ motivation in the broader adoption context. [ABSTRACT FROM AUTHOR]

Importance: Differences in utilization and costs of end-of-life care among developed countries are of considerable policy interest.Objective: To compare site of death, health care utilization, and hospital expenditures in 7 countries: Belgium, Canada, England, Germany, the Netherlands, Norway, and the United States.Design, Setting, and Participants: Retrospective cohort study using administrative and registry data from 2010. Participants were decedents older than 65 years who died with cancer. Secondary analyses included decedents of any age, decedents older than 65 years with lung cancer, and decedents older than 65 years in the United States and Germany from 2012.Main Outcomes and Measures: Deaths in acute care hospitals, 3 inpatient measures (hospitalizations in acute care hospitals, admissions to intensive care units, and emergency department visits), 1 outpatient measure (chemotherapy episodes), and hospital expenditures paid by insurers (commercial or governmental) during the 180-day and 30-day periods before death. Expenditures were derived from country-specific methods for costing inpatient services.Results: The United States (cohort of decedents aged >65 years, N = 211,816) and the Netherlands (N = 7216) had the lowest proportion of decedents die in acute care hospitals (22.2.% and 29.4%, respectively). A higher proportion of decedents died in acute care hospitals in Belgium (N = 21,054; 51.2%), Canada (N = 20,818; 52.1%), England (N = 97,099; 41.7%), Germany (N = 24,434; 38.3%), and Norway (N = 6636; 44.7%). In the last 180 days of life, 40.3% of US decedents had an intensive care unit admission compared with less than 18% in other reporting nations. In the last 180 days of life, mean per capita hospital expenditures were higher in Canada (US $21,840), Norway (US $19,783), and the United States (US $18,500), intermediate in Germany (US $16,221) and Belgium (US $15,699), and lower in the Netherlands (US $10,936) and England (US $9342). Secondary analyses showed similar results.Conclusions and Relevance: Among patients older than 65 years who died with cancer in 7 developed countries in 2010, end-of-life care was more hospital-centric in Belgium, Canada, England, Germany, and Norway than in the Netherlands or the United States. Hospital expenditures near the end of life were higher in the United States, Norway, and Canada, intermediate in Germany and Belgium, and lower in the Netherlands and England. However, intensive care unit admissions were more than twice as common in the United States as in other countries. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: To compare countries' health care needs by segmenting populations into a set of needs‐based health states. Data sources: We used seven waves of the Survey of Health, Aging and Retirement in Europe (SHARE) panel survey data. Study design: We developed the Cross‐Country Simple Segmentation Tool (CCSST), a validated clinician‐administered instrument for categorizing older individuals by distinct, homogeneous health and related social service needs. Using clinical indicators, self‐reported physician diagnosis of chronic disease, and performance‐based tests conducted during the survey interview, individuals were assigned to 1–5 global impressions (GI) segments and assessed for having any of the four identifiable complicating factors (CFs). We used Cox proportional hazard models to estimate the risk of mortality by segment. First, we show the segmentation cross‐sectionally to assess cross‐country differences in the fraction of individuals with different levels of medical needs. Second, we compare the differences in the rate at which individuals transition between those levels and death. Data collection/extraction methods: We segmented 270,208 observations (from Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, the Netherlands, Poland, Spain, Sweden, and Switzerland) from 96,396 individuals into GI and CF categories. Principal findings: The CCSST is a valid tool for segmenting populations into needs‐based states, showing Switzerland with the lowest fraction of individuals in high medical needs segments, followed by Denmark and Sweden, and Poland with the highest fraction, followed by Italy and Israel. Comparing hazard ratios of transitioning between health states may help identify country‐specific areas for analysis of ecological and cultural risk factors. Conclusions: The CCSST is an innovative tool for aggregate cross‐country comparisons of both health needs and transitions between them. A cross‐country comparison gives policy makers an effective means of comparing national health system performance and provides targeted guidance on how to identify strategies for curbing the rise of high‐need, high‐cost patients. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: To compare countries' health care needs by segmenting populations into a set of needs-based health states.Data Sources: We used seven waves of the Survey of Health, Aging and Retirement in Europe (SHARE) panel survey data.Study Design: We developed the Cross-Country Simple Segmentation Tool (CCSST), a validated clinician-administered instrument for categorizing older individuals by distinct, homogeneous health and related social service needs. Using clinical indicators, self-reported physician diagnosis of chronic disease, and performance-based tests conducted during the survey interview, individuals were assigned to 1-5 global impressions (GI) segments and assessed for having any of the four identifiable complicating factors (CFs). We used Cox proportional hazard models to estimate the risk of mortality by segment. First, we show the segmentation cross-sectionally to assess cross-country differences in the fraction of individuals with different levels of medical needs. Second, we compare the differences in the rate at which individuals transition between those levels and death.Data Collection/extraction Methods: We segmented 270,208 observations (from Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, the Netherlands, Poland, Spain, Sweden, and Switzerland) from 96,396 individuals into GI and CF categories.Principal Findings: The CCSST is a valid tool for segmenting populations into needs-based states, showing Switzerland with the lowest fraction of individuals in high medical needs segments, followed by Denmark and Sweden, and Poland with the highest fraction, followed by Italy and Israel. Comparing hazard ratios of transitioning between health states may help identify country-specific areas for analysis of ecological and cultural risk factors.Conclusions: The CCSST is an innovative tool for aggregate cross-country comparisons of both health needs and transitions between them. A cross-country comparison gives policy makers an effective means of comparing national health system performance and provides targeted guidance on how to identify strategies for curbing the rise of high-need, high-cost patients. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Market authorization does not guarantee patient access to any given drug. This is particularly true for costly orphan drugs because access depends primarily on co-payments, reimbursement policies and prices. The objective of this article is to identify differences in the availability of orphan drugs and in patient access to them in 11 pharmaceutical markets: Australia, Canada, England, France, Germany, Hungary, the Netherlands, Poland, Slovakia, Switzerland and the US.Methods: Four rare diseases were selected for analysis: pulmonary arterial hypertension (PAH), Fabry disease (FD), hereditary angioedema (HAE) and chronic myeloid leukaemia (CML). Indicators for availability were defined as (i) the indications for which orphan drugs had been authorized in the treatment of these diseases; (ii) the application date; and (iii) the date upon which these drugs received market authorization in each country. Indicators of patient access were defined as (i) the outcomes of technology appraisals; (ii) the extent of coverage provided by healthcare payers; and (iii) the price of the drugs in each country. For PAH we analysed bosentan, iloprost, sildenafil, treprostinil (intravenous and inhaled) as well as sitaxentan and ambrisentan; for FD we analysed agalsidase alfa and agalsidase beta; for HAE we analysed icatibant, ecallantide and two complement C1s inhibitors; for CML we analysed imatinib, dasatinib and nilotinib.Results: Most drugs included in this study had received market authorization in all countries, but the range of indications for which they had been authorized differed by country. The broadest range of indications was found in Australia, and the largest variations in indications were found for PAH drugs. Authorization process speed (the time between application and market authorization) was fastest in the US, with an average of 362 days, followed by the EU (394 days). The highest prices for the included drugs were found in Germany and the US, and the lowest in Canada, Australia and England. Although the prices of all of the included drugs were high compared with those of most non-orphan drugs, most of the insurance plans in our country sample provided coverage for authorized drugs after a certain threshold.Conclusions: Availability of and access to orphan drugs play a key role in determining whether patients will receive adequate and efficient treatment. Although the present study showed some variations between countries in selected indicators of availability and access to orphan drugs, virtually all of the drugs in question were available and accessible in our sample. However, substantial co-payments in the US and Canada represent important barriers to patient access, especially in the case of expensive treatments such as those analysed in this study. Market exclusivity is a strong instrument for fostering orphan drug development and drug availability. However, despite the positive effect of this instrument, the conditions under which market exclusivity is granted should be reconsidered in cases where the costs of developing an orphan drug have already been amortized through the use of the drug's active ingredient for the treatment of a common indication. [ABSTRACT FROM AUTHOR]