A Potential Indicator for Assessing Patient Blood Management Standard Implementation.

(1) Background: Patient blood management (PBM) program as a multidisciplinary practice and a standard of care for the anemic surgical patient has an increasingly important role in reducing transfusions and optimizing both clinical outcomes and costs. Documented success of PBM implementation is not sufficient for implementation of recommendations and correct use at hospital level. The primary objective of our study was to define a composite patient blood management process safety index-Safety Index in PBM (SIPBM)-that measures the impact of screening and treating anemic patients on the efficiency and effectiveness of the patient care process undergoing elective surgery. (2) Methods: We conducted a retrospective comparative study in a tertiary hospital by collecting data and analyzing the Safety Index in PBM (SIPBM) in patients undergoing major elective surgical procedures. (3) Results: The percentage of patients from the total of 354 patients (178 in 2019 and 176 in 2022) included in the study who benefited from preoperative iron treatment increased in 2022 compared to 2019 from 27.40% to 36.71%. The median value of the SIPBM was 1.00 in both periods analyzed, although there is a significant difference between the two periods (p < 0.005), in favor of 2022. (4) Conclusions: Measuring the effectiveness of PBM implementation and providing ongoing feedback through the Safety Index in PBM (SIPBM) increases the degree to which opportunities to improve the PBM process are identified. The study represents a first step for future actions and baselines to develop tools to measure the safety and impact of the patient blood management process in the surgical field.

Recommendations for patient involvement in health technology assessment in Central and Eastern European countries.

Introduction: Meaningful patient involvement in health technology assessment (HTA) is essential in ensuring that the interests of the affected patient population, their families, and the general public are accurately reflected in coverage and reimbursement decisions. Central and Eastern European (CEE) countries are generally at less advanced stages of implementing HTA, which is particularly true for patient involvement activities. As part of the Horizon2020 HTx project, this research aimed to form recommendations for critical barriers to patient involvement in HTA in CEE countries. Methods: Built on previous research findings on potential barriers, a prioritisation survey was conducted online with CEE stakeholders. Recommendations for prioritised barriers were formed through a face-to-face workshop by CEE stakeholders and HTx experts. Results: A total of 105 stakeholders from 13 CEE countries completed the prioritisation survey and identified 12 of the 22 potential barriers as highly important. The workshop had 36 participants representing 9 CEE countries, and 5 Western European countries coming together to discuss solutions in order to form recommendations based on best practices, real-life experience, and transferability aspects. Stakeholder groups involved in both phases included HTA organisation representatives, payers, patients, caregivers, patient organisation representatives, patient experts, health care providers, academic and non-academic researchers, health care consultants and health technology manufacturers/providers. As a result, 12 recommendations were formed specified to the CEE region's context, but potentially useful for a broader geographic audience. Conclusion: In this paper, we present 12 recommendations for meaningful, systematic, and sustainable patient involvement in HTA in CEE countries. Our hope is that engaging more than a hundred CEE stakeholders in the study helped to spread awareness of the importance and potential of patient involvement and that the resulting recommendations provide tangible steps for the way forward. Future studies shall focus on country-specific case studies of the implemented recommendations.

Predictors of mortality for patients with hip fracture: a study of the nationwide 1-year records of 24,950 fractures in Romania.

We conducted a study evaluating incidence rates and influencing factors in Romanian hip fracture patients. Our results showed that the type of fracture and its respective surgical procedure as well as hospital characteristics correlate with mortality. Updated incidences can result in updated treatment guidelines. PURPOSE: The aim of our study was to assess incidence rates for a revision-calibration of the Romanian FRAX tool and to evaluate particularities of hip fracture cases to determine patient- and hospital-related variables affecting mortality. METHODS: We conducted a retrospective study using hospital reports of hip fracture codes to the National School of Statistics (NSS) from January 1, 2019, until December 31, 2019. The study population included 24,950 patients presenting to Romanian public hospitals in all 41 counties: ≥ the age of 40 with diagnostic ICD 10 codes: S72.0 femoral neck fracture, S72.1 pertrochanteric femoral fracture, and S72.2 subtrochanteric femoral fracture and procedure codes: O11104 (trochanteric/sub capital internal fixation), O12101 (hemiarthroplasty), O11808 (closed femoral reduction with internal fixation), O12103 (partial arthroplasty), O12104 (total arthroplasty). Hospital length of stay (LoS) was classified as follows: < 6, 6-9, 10-14, and ≥ 15 days. RESULTS: Incidence of hip fractures was 248/100,000 among those aged 50 + and 184/100,000 within the 40 + age category. Average age of the patients was 77 years (80 for females, 71 for males); 83.7% of the patients were 65 + with equivalent urban-rural distributions. Males had a 1.7 times higher mortality risk. Each year increase in age added a mortality risk of 6.9%. In-hospital mortality was 1.34 times higher among patients living in urban areas. Hemiarthroplasty and partial/total unilateral/bilateral arthroplasty had a lower risk of mortality than trochanteric/sub capital internal fixation (p < 0.02, p < 0.033). CONCLUSION: Gender, age, residence, and procedure type had significant impact on mortality. Updated incidence rates will allow the revision of Romania's FRAX model.

Recommendations to overcome barriers to the use of artificial intelligence-driven evidence in health technology assessment.

Background: Artificial intelligence (AI) has attracted much attention because of its enormous potential in healthcare, but uptake has been slow. There are substantial barriers that challenge health technology assessment (HTA) professionals to use AI-generated evidence for decision-making from large real-world databases (e.g., based on claims data). As part of the European Commission-funded HTx H2020 (Next Generation Health Technology Assessment) project, we aimed to put forward recommendations to support healthcare decision-makers in integrating AI into the HTA processes. The barriers, addressed by the paper, are particularly focusing on Central and Eastern European (CEE) countries, where the implementation of HTA and access to health databases lag behind Western European countries. Methods: We constructed a survey to rank the barriers to using AI for HTA purposes, completed by respondents from CEE jurisdictions with expertise in HTA. Using the results, two members of the HTx consortium from CEE developed recommendations on the most critical barriers. Then these recommendations were discussed in a workshop by a wider group of experts, including HTA and reimbursement decision-makers from both CEE countries and Western European countries, and summarized in a consensus report. Results: Recommendations have been developed to address the top 15 barriers in areas of (1) human factor-related barriers, focusing on educating HTA doers and users, establishing collaborations and best practice sharing; (2) regulatory and policy-related barriers, proposing increasing awareness and political commitment and improving the management of sensitive information for AI use; (3) data-related barriers, suggesting enhancing standardization and collaboration with data networks, managing missing and unstructured data, using analytical and statistical approaches to address bias, using quality assessment tools and quality standards, improving reporting, and developing better conditions for the use of data; and (4) technological barriers, suggesting sustainable development of AI infrastructure. Conclusion: In the field of HTA, the great potential of AI to support evidence generation and evaluation has not yet been sufficiently explored and realized. Raising awareness of the intended and unintended consequences of AI-based methods and encouraging political commitment from policymakers is necessary to upgrade the regulatory and infrastructural environment and knowledge base required to integrate AI into HTA-based decision-making processes better.

Guidance on using real-world evidence from Western Europe in Central and Eastern European health policy decision making.

Aim: Real-world data and real-world evidence (RWE) are becoming more important for healthcare decision making and health technology assessment. We aimed to propose solutions to overcome barriers preventing Central and Eastern European (CEE) countries from using RWE generated in Western Europe. Materials & methods: To achieve this, following a scoping review and a webinar, the most important barriers were selected through a survey. A workshop was held with CEE experts to discuss proposed solutions. Results: Based on survey results, we selected the nine most important barriers. Multiple solutions were proposed, for example, the need for a European consensus, and building trust in using RWE. Conclusion: Through collaboration with regional stakeholders, we proposed a list of solutions to overcome barriers on transferring RWE from Western Europe to CEE countries.

Systematic Literature Review of Economic Evaluations of Treatment Alternatives in Chronic Lymphocytic Leukemia.

BACKGROUND: Economic evaluations are widely used to predict the economic impact of new treatment alternatives. Comprehensive economic reviews in the field of chronic lymphocytic leukemia (CLL) are warranted to supplement the existing analyses focused on specific therapeutic areas. METHODS: A systematic literature review was conducted based on literature searches in Medline and EMBASE to summarize the published health economics models related to all types of CLL therapies. Narrative synthesis of relevant studies was performed focusing on compared treatments, patient populations, modelling approaches and key findings. RESULTS: We included 29 studies, the majority of which were published between 2016 and 2018, when data from large clinical trials in CLL became available. Treatment regimens were compared in 25 cases, while the remaining four studies considered treatment strategies with more complex patient pathways. Based on the review results, Markov modelling with a simple structure of three health states (progression-free, progressed, death) can be considered as the traditional basis to simulate cost effectiveness. However, more recent studies added further complexity, including additional health states for different therapies (e.g. best supportive care or stem cell transplantation), for progression-free state (e.g. by differentiating between with or without treatment), or for response status (i.e. partial response and complete response). CONCLUSIONS: As personalized medicine is increasingly gaining recognition, we expect that future economic evaluations will also incorporate new solutions, which are necessary to capture a larger number of genetic and molecular markers and more complex patient pathways with individual patient-level allocation of treatment options and thus economic assessments.

Is the criminalization of informal payment a good idea? The role of the free choice of physician in the elimination of the phenomenon / Jó ötlet-e a paraszolvencia kriminalizálása?

In Hungary, the new act on the employment status of health workers aims at the elimination of informal payments by the strict separation of public and private care, by a significant increase of the salary of medical doctors and with the criminalization of giving and accepting informal payments. In this study, which is based on our former research, an analysis of the Hungarian judicial practice and an internet research focused on obstetrics, we examine whether the chosen tools are appropriate to achieve this goal, and if not, how the provisions of law should be modified. Both the theoretical considerations and the empirical evidence suggest that the approach the act took is wrong, because the majority of patients are not paying to compensate the doctors for their low salary. Patients pay because they think that they will not get the necessary care without it. This fee-for-service type informal payment is not corruption and it originates from health system shortages, which is not addressed by the act. On the contrary, the full implementation of the provisions of the act might even increase these shortages, which paradoxically can lead to the amplification of the phenomenon. According to the international experiences, long-term measures aiming at the easing of shortages, in themselves, are not sufficient to roll back this undesirable phenomenon, if they are not coupled with a short-term quick fix intervention, which creates a formal substitution mechanism allowing patients to buy the services associated with informal payments legally. The free choice of doctor is perceived to be an additional service to be paid for by the majority of patients and doctors, despite that, according to the current regulations, it is part of the public benefit package and should be available free of charge. Hence, informal payments could be formalized in the frame of the free choice of doctor and health care provider by making it a chargeable service. Such an approach is not unfamiliar in the Hungarian health policy, judicial practice, and even private obstetric care. Moreover, there is a government-supported obstetric model program in the public system in Hungary, where an explicit goal is to replace informal payments with formal fees to be paid by the patients for the free choice of the obstetrician who attends the delivery. All of these seem to be realistic starting points to introduce a technically and politically feasible pilot project, but the detailed regulations should be designed so that the involved health workers have no financial interest to discriminate against non-paying patients. To achieve this, we recommend that the attending physicians are also paid a fee even if they care for a patient, who did not choose them and pay them out of pocket, but live in the catchment area of the health service delivery organization, which is obliged to care for the local residents. Obviously, the source of this fee, which is eventually a performance-based component of the income of physicians, in this case, has to be the social health insurance scheme.

Prioritization of implementation barriers related to integrated care models in Central and Eastern European countries.

The importance of integrated care will increase in future health systems due to aging populations and patients with chronic multimorbidity, however, such complex healthcare interventions are often developed and implemented in higher income countries. For Central and Eastern European (CEE) countries it is important to investigate which integrated care models are transferable to their setting and facilitate the implementation of relevant models by identifying barriers to their implementation. This study investigates the relative importance of integrated care models and the most critical barriers for their implementation in CEE countries. Experts from Croatia, Hungary, Poland, Romania and Serbia were invited to complete an online survey within the SELFIE H2020 project. 81 respondents completed the survey. Although experts indicated that some integrated care models were already being implemented in CEE countries, the survey revealed a great need for further improvement in the integration of care, especially the managed care of oncology patients, coordinated palliative care of terminally ill patients, and nursing care of elderly with multimorbidity. Lack of long-term financial sustainability as well as of dedicated financing schemes were seen the most critical implementation barriers, followed by the lack of integration between health and social care providers and insufficient availability of human resources. These insights can guide future policy making on integrated care in CEE countries.

Riding the Pandemic Waves-Lessons to Be Learned from the COVID-19 Crisis Management in Romania.

In our analysis, we assessed how Romania dealt with the numerous challenges presented by the COVID-19 pandemic during 2021. In that year, the government had to deal with two waves of COVID-19 pandemics caused by the new variants, the low vaccination rate of the population, the overload of the healthcare system and political instability at the same time. Based on publicly available databases and international literature, we evaluated government measures aimed at reducing the spread of the pandemic and ensure the operation of the healthcare workforce and infrastructure. In addition, we evaluated measures to provide health services effectively and the government's pandemic responses regarding excess mortality in 2021. In the absence of a complex monitoring system, limited information was available on the spread of the pandemic or the various risk factors at play. Due to incomplete and inadequate management systems, the government was unable to implement timely and adequate measures. Our analysis concludes that the management of a pandemic can only be successful if data are collected and evaluated using complex systems in a timely manner, and if members of society adhere to clearly communicated government measures due to high levels of trust in the government.

Burden of Chronic Heart Failure in Romania.

Chronic heart failure (CHF) affects millions of people across the world, with increasing trends in prevalence, putting ever increasing pressure on the healthcare system. The aim of this study was to assess the financial burden of CHF hospital care on the public healthcare sector in Romania by estimating the number of inpatient episodes and the associated costs. Additionally, societal costs associated with missed work and premature death of CHF patients were also estimated. The national claims database was analyzed to estimate the number of CHF patients. Cost data was extracted from a pool of nine public hospitals in Romania. In 2019, 375,037 CHF patient episodes were identified on specific wards at the national level. The average cost calculated for the selected nine hospitals was EUR 996. The calculated weighted national average cost per patient episode was EUR 1002, resulting in a total cost of EUR 376 million at the national level. The cost of workdays missed summed up to EUR 122 million, while the annual costs associated with the premature death of CHF patients was EUR 230 million. In conclusion, the prevalence of CHF in Romania is high, accounting for a large proportion of hospitalizations, which translates into large costs for the national payer.

Cost Assessment of Inpatient Care Episodes of Stroke in Romania.

Introduction: Stroke is the second leading cause of death worldwide and Romania is no exception. There is a high economic burden associated with the treatment of stroke patients, which puts pressure on the healthcare budget. This study aims to measure the inpatient treatment costs of stroke patients in Romania. Methods: Our retrospective analysis follows stroke patients in six Romanian hospitals at different progressivity level from different regions. Patients are identified from the official hospital databases, reported for reimbursement purposes. Mean inpatient costs incurred with the treatment of these stroke patient episodes are calculated using the gross costing method. The cost data are derived from the management control system of the study hospitals. Results: 3,155 patient episodes of stroke were identified in the study hospitals. The average cost per stroke inpatient care episode sums up to EUR 995.57 (95% CI: EUR 963.74-EUR 1 027.39) in 2017, while the overall yearly healthcare burden adds up to EUR 140 million, representing 2.18% of the total national health insurance budget and a cost of EUR 7.15 per capita. Conclusion: The hospital cost of stroke inpatient care episode in Romania is high and it represents a sizable part of the healthcare budget, but it is among the lowest in Europe, which can mainly be explained by the level of economic development of the country. As both the number of patients and the cost of acute care are expected to increase in the future, the economic burden of stroke is also expected to increase.

Identifying Patient Access Barriers for Tumor Necrosis Factor Alpha Inhibitor Treatments in Rheumatoid Arthritis in Five Central Eastern European Countries.

INTRODUCTION: Although there is a significant utilization gap of biologic medicines in the EU, many studies estimate equity in patient access to biopharmaceuticals only based on their availability on the national list of reimbursed medicines. Hidden access barriers may facilitate financial sustainability of pharmaceuticals in less affluent EU countries; however, they have rarely been documented in scientific publications. Our objective was to explore these access barriers for tumor necrosis factor (TNF) alpha inhibitors in rheumatoid arthritis (RA) in five Central and Eastern European countries. METHODS: A detailed interview guide was developed based on multi-stakeholder workshops and a targeted literature review. In each participant country 3-3-3-3 interviews with payers, rheumatologists, patients/patient representatives, and industry representatives were conducted. Responses were aggregated at a country level and validated by primary investigators in each country. RESULTS: Limited number of RA centers and consequently significant travelling time and cost for patients in distant geographical areas, uneven budget allocation among centers, limited capacity of nurses, narrowed patient population in national financial protocols compared to international clinical guidelines in initiating or continuing biologics, high administrative burden in prescribing biologics and limited health literacy of patients were the most relevant barriers to timely patient access in at least three participant countries. CONCLUSION: Assessing only the availability of TNF alpha inhibitors on the national list of reimbursed medicines provides limited information about real-world patient access to these medicines. Revealing hidden access barriers may contribute to initiate policy actions which could reduce inequity in patient access.

Quo Vadis HTA for Medical Devices in Central and Eastern Europe? Recommendations to Address Methodological Challenges.

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

Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts.

This policy research aims to map patient access barriers to biologic treatments, to explore how increased uptake of biosimilars may lower these hurdles and to identify factors limiting the increased utilisation of biosimilars. A policy survey was developed to review these questions in 10 Central and Eastern European (CEE) and Commonwealth of Independent States (CIS) countries. Two experts (one public and one private sector representative) from each country completed the survey. Questions were related to patient access, purchasing, clinical practice, and real-world data collection on both original biologics and biosimilars. Restrictions on the number of patients that can be treated and related waiting lists were reported as key patient access barriers. According to respondents, for both clinicians and payers the primary benefit of switching patients to biosimilars would be to treat more patients. However, concerns with therapeutic equivalence and fear of immunogenicity may reduce utilisation of biosimilars. Similar limitations in patient access to both original biologics and biosimilars raise concerns about the appropriateness and success of current biosimilar policies in CEE and CIS countries. The conceptual framework for additional real-world data collection exists in all countries which may provide a basis for future risk-management activities including vigorous pharmacovigilance data collection.