Impella versus VA-ECMO for the treatment of patients with cardiogenic shock: the Impella Network Project - observational study protocol for cost-effectiveness and budget impact analyses.

INTRODUCTION: The treatment of patients with cardiogenic shock (CS) encompasses several health technologies including Impella pumps and venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, while they are widely used in clinical practice, information on resource use and quality of life (QoL) associated with these devices is scarce. The aim of this study is, therefore, to collect and comparatively assess clinical and socioeconomic data of Impella versus VA-ECMO for the treatment of patients with severe CS, to ultimately conduct both a cost-effectiveness (CEA) and budget impact (BIA) analyses. METHODS AND ANALYSIS: This is a prospective plus retrospective, multicentre study conducted under the scientific coordination of the Center for Research on Health and Social Care Management of SDA Bocconi School of Management and clinical coordination of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute in Milan. The Impella Network stemmed for the purposes of this study and comprises 17 Italian clinical centres from Northern to Southern Regions in Italy. The Italian network qualifies as a subgroup of the international Impella Cardiac Surgery Registry. Patients with CS treated with Impella pumps (CP, 5.0 or 5.5) will be prospectively recruited, and information on clinical outcomes, resource use and QoL collected. Economic data will be retrospectively matched with data from comparable patients treated with VA-ECMO. Both CEA and BIA will be conducted adopting the societal perspective in Italy. This study will contribute to generate new socioeconomic evidence to inform future coverage decisions. ETHICS AND DISSEMINATION: As of May 2024, most of the clinical centres submitted the documentation to their ethical committee (N=13; 76%), six centres received ethical approval and two centres started to enrol patients. Study results will be published in peer-reviewed publications and disseminated through conference presentations.

Health managers' perspectives of community health committees' participation in the annual health sector planning and budgeting process in a devolved unit in Kenya: a cross-sectional study.

Introduction: health sector planning and budgeting are concerned with identifying priorities that guide budgetary allocation to improve health outcomes. Engaging the community in this process empowers them to manage their own health. Despite the benefits and the availability of legislation and structures to mainstream community participation, their involvement is minimal and marred with challenges. This study, therefore, aimed to examine the level and perspectives of health managers on community health committees´ (CHC) participation in health sector planning and budgeting. Methods: the study utilized a cross-sectional research design, incorporating both quantitative and qualitative research methods. Study participants were involved in planning and budgeting. Quantitative data were collected from 100% (n=170) of health managers, while qualitative data were gathered from 100% (n=3) of county department of health executives and 94% (n=83) of community health committee members. Descriptive statistics were utilized to analyze quantitative data, while qualitative data were analyzed thematically. Results: although 87% of the health managers agreed that community health committee participation is beneficial, only 11% of them were satisfied with their participation, and 54% rated CHC participation as low; furthermore, over 50% of health managers disagreed that Community Health Unit (CHUs) have the necessary skills to effectively participate in the process, that adequate budget and time are allocated for CHC participation, and that feedback about the process is provided to them. Conclusion: the county health department of health should allocate more funds and design sustained capacity-building programs to enhance CHC participation in health sector planning and budgeting.

Allocation of the household food budget among shopping basket items: How is it influenced by promotions?

Retailers have been using promotion as a differentiation strategy that influences consumers' expenditures and their shopping basket budgetary allocation. This study assessed the effect of retail promotions on total shopping basket expenditure and determined whether promotions provoke a reallocation of the shopping budget. The analysis was performed on a chain of supermarkets in Catalonia, Spain using a consumer scanner data set from Kantar Worldpanel for 2017. The methodological approach had two steps: prediction of the effect of promotion on household expenditures using an expenditure regression model and estimation of the promotion own- and cross-effect using the censored Exact Affine Stone Index. Promotion had a positive own-effect and mostly a negative asymmetric cross-effect, implying a small but significant budget reallocation.

Antenatal cardiotocography in primary midwife-led care: a budget impact analysis.

OBJECTIVES: In many countries, the healthcare sector is dealing with important challenges such as increased demand for healthcare services, capacity problems in hospitals and rising healthcare costs. Therefore, one of the aims of the Dutch government is to move care from in-hospital to out-of-hospital care settings. An example of an innovation where care is moved from a more specialised setting to a less specialised setting is the performance of an antenatal cardiotocography (aCTG) in primary midwife-led care. The aim of this study was to assess the budget impact of implementing aCTG for healthy pregnant women in midwife-led care compared with usual obstetrician-led care in the Netherlands. METHODS: A budget impact analysis was conducted to estimate the actual costs and reimbursement of aCTG performed in midwife-led care and obstetrician-led care (ie, base-case analysis) from the Dutch healthcare perspective. Epidemiological and healthcare utilisation data describing both care pathways were obtained from a prospective cohort, survey and national databases. Different implementation rates of aCTG in midwife-led care were explored. A probabilistic sensitivity analysis was conducted to estimate the uncertainty surrounding the budget impact estimates. RESULTS: Shifting aCTG from obstetrician-led care to midwife-led-care would increase actual costs with €311 763 (97.5% CI €188 574 to €426 072) and €1 247 052 (97.5% CI €754 296 to €1 704 290) for implementation rates of 25% and 100%, respectively, while it would decrease reimbursement with -€7 538 335 (97.5% CI -€10 302 306 to -€4 559 661) and -€30 153 342 (97.5% CI -€41 209 225 to -€18 238 645) for implementation rates of 25% and 100%, respectively. The sensitivity analysis results were consistent with those of the main analysis. CONCLUSIONS: From the Dutch healthcare perspective, we estimated that implementing aCTG in midwife-led care may increase the associated actual costs. At the same time, it might lower the healthcare reimbursement.

Cost-Effectiveness and Budget Impact Analysis of Apixaban and Rivaroxaban Versus Warfarin in the Prevention of Stroke in Patients With Non-Valvular Atrial Fibrillation (NVAF) in Iran.

INTRODUCTION: This study evaluates the cost-effectiveness of Apixaban and Rivaroxaban, compared to Warfarin, for stroke prevention in patients with non-valvular atrial fibrillation in Iran. METHOD: A Markov model with a 30-year time horizon was employed to simulate and assess different treatment strategies' cost-effectiveness. The study population comprised Iranian adults with NVAF, identified through specialist consultations, hospital visits, and archival record reviews. Direct medical costs, direct nonmedical, and indirect costs were included. Quality-adjusted life years (QALY) were assessed using an EQ-5D questionnaire. This study utilized a cost-effectiveness threshold of $11 134 per QALY. RESULTS: Apixaban demonstrated superior cost-effectiveness compared to Rivaroxaban and Warfarin. Over 30 years, total costs were lower in the Apixaban and Rivaroxaban groups compared to the Warfarin group ($126.18 and $109.99 vs. $150.49). However, Apixaban showed higher total QALYs gained compared to others (0.134 vs. 0.133 and 0.116). The incremental cost-effectiveness ratio for comparing Apixaban to Warfarin was calculated at -1332.83 cost per QALY, below the threshold of $11 134, indicating Apixaban's cost-effectiveness. Sensitivity analyses confirmed the robustness of the findings, with ICER consistently remaining below the threshold. Over 5 years (2024-2028) of Apixaban usage, the incremental cost starts at USD 70 250 296 in the first year and gradually rises to USD 71 770 662 in the fifth year. DSA and PSA were assessed to prove the robustness of the results. CONCLUSION: This study shows that Apixaban is a cost-effective option for stroke prevention in non-valvular atrial fibrillation patients in Iran compared to Warfarin.

Budgeting and Advocacy to Improve Water, Sanitation, and Hygiene in Health Care Facilities: A Case Study in Nepal.

Barriers to achieving and sustaining access to water, sanitation, hygiene, cleaning, and waste management (WASH) in health care facilities include a lack of supportive policy environment and adequate funding. While guidelines exist for assessing needs and making initial infrastructure improvements, there is little guidance on how to develop budgets and policies to sustain WASH services. We conducted costing and advocacy activities in Thakurbaba municipality, Nepal, to develop a budget and operations and maintenance policy for WASH in health care facilities in partnership with the municipal government. Our objectives for this study were to (1) describe the process and methods used for costing and advocacy, (2) report the costs to achieve and maintain basic WASH services in the 8 health care facilities of Thakurbaba municipality, and (3) report the outcomes of advocacy activities and policy development. We applied bottom-up costing to enumerate the resources necessary to achieve and maintain basic WASH services and their costs. The annual costs to achieve, operate, and maintain basic access to WASH services ranged from US$4881-US$9695 per facility. Cost findings were used to prepare annual budgets recommended to achieve, operate, and maintain basic services, which were presented to the municipal government and incorporated into an operations and maintenance policy. To date, the municipality has adopted the policy and established a recovery fund of US$3831 for repair and maintenance of infrastructure and an additional US$153 per facility for discretionary WASH spending, which were to be replenished as they were spent. Advocacy at the national level for WASH in health care facilities is currently being championed by the municipality, and findings from this project have informed the development of a nationally costed plan for universal access. This study is intended to provide a roadmap for how cost data can be collected and applied to inform policy.

Budget Impact Analysis of Circulating Tumor DNA Testing for Colon Cancer in Commercial Health and Medicare Advantage Plans.

Importance: In a randomized clinical trial, treatment guided by tumor-informed circulating tumor (ct)DNA testing reduced adjuvant chemotherapy use without compromising recurrence-free survival in patients with stage II colon cancer. The potential effects of adopting ctDNA testing into routine patient care is unknown. Objective: To compare the total cost of patient care scenarios with and without the adoption of ctDNA testing. Design, Setting, and Participants: This budget impact analysis was conducted from the perspectives of US commercial health and Medicare Advantage payers. A decision-analytical model was populated with age-specific incidence of colon cancer, use of adjuvant chemotherapy, and use of single-agent or multiagent regimens. Total cost was estimated with the costs of ctDNA testing, drug acquisition, administration, surveillance, and adverse events. The analysis was conducted from September 2023 to January 2024. Exposures: The adoption of ctDNA testing. Main Outcomes and Measures: The incremental cost in the first year following the adoption of ctDNA testing, where testing will affect patient treatment and costs. Results: In hypothetical plans with 1 million individuals covered, 35 commercial health plan members and 102 Medicare Advantage members aged 75 years and younger were eligible for ctDNA testing. In the base case with a 50% adoption rate, total cost savings were $221 684 (equivalent to $0.02 per member per month [PMPM]) for a commercial payer and $116 720 (equivalent to $0.01 PMPM) for a Medicare Advantage payer. Cost savings were robust to variations in assumptions of all parameters in the commercial population but sensitive to variations in assumptions of adjuvant chemotherapy use rates in the Medicare Advantage population. The number needed to test to avoid 1 patient receiving adjuvant chemotherapy was 4 in the commercial population and 10 in the Medicare Advantage population. The budget-neutral cost for ctDNA testing was $16 202 for a commercial payer and $5793 for a Medicare Advantage payer. Conclusions and Relevance: Use of tumor-informed ctDNA testing to guide adjuvant chemotherapy in postsurgery patients with stage II colon cancer was projected to result in cost savings for both commercial and Medicare Advantage payers. Adoption of ctDNA testing is therefore advantageous from a budgetary perspective.

Eight years into the horizon of aspirational maternal and newborn health pledges: a nationwide cross-sectional exploration of the Burundian EmONC network capacity and budget deficits.

OBJECTIVE: The Burundian emergency obstetric and neonatal care (EmONC) programme, which was initiated in 2017 and supported by a specific policy, does not appear to reverse maternal and newborn mortality trends. Our study examined the capacity challenges facing participating EmONC facilities and developed alternative investment proposals to improve their readiness paying particular attention to EmONC professionals, physical infrastructure, and capital equipment. DESIGN: Cross-sectional study. SETTING: Burundian EmONC facilities (n=112). PARTICIPANTS: We examined EmONC policy documents, consulted 12 maternal and newborn health experts and 23 stakeholders and policymakers, surveyed all EmONC facilities (n=112), and collected cost data from the Ministry of Health and local suppliers in Burundi. We developed three context-specific EmONC resource benchmark standards by facility type; the Burundian policy norms and the expert minimum and maximum suggested thresholds; and used these alternatives to estimate EmONC resource gaps. We forecasted three corresponding budget estimates needed to address prevailing deficits taking a government perspective for a 5-year EmONC investment strategy. Additionally, we explored relationships between EmONC professionals and selected measures of service delivery using bivariate analyses and graphically. RESULTS: The lowest EmONC resource benchmark revealed that 95% of basic EmONC and all comprehensive EmONC facilities lack corresponding sets of human resources and 90% of all facilities need additional physical infrastructure and capital equipment. Assessed against the highest benchmark which proposes the most progressive set of standards for the prevailing workloads, Burundi would require 162 more medical doctors, 1005 midwives and nurses, 132 delivery rooms, 191 delivery tables, 678 and 156 maternity and newborn care beds, and 395 incubators amounting to US$32.9 million additional budget for 5 years. CONCLUSION: We demonstrated that Burundian EmONC facilities face enormous capacity challenges equivalent to US$32.9 million funding gap for 5 years; averagely approximating to 5.96% total health budget increase annually.

Reconciling devolution with health financing and public financial management: challenges and policy options for the health sector.

The interplay between devolution, health financing and public financial management processes in health-or the lack of coherence between them-can have profound implications for a country's progress towards universal health coverage. This paper explores this relationship in seven Asian and African countries (Burkina Faso, Kenya, Mozambique, Nigeria, Uganda, Indonesia and the Philippines), highlighting challenges and suggesting policy solutions. First, subnational governments rely heavily on transfers from central governments, and most are not required to allocate a minimum share of their budget to health. Central governments channelling more funds to subnational governments through conditional grants is a promising way to increase public financing for health. Second, devolution makes it difficult to pool funding across populations by fragmenting them geographically. Greater fiscal equalisation through improved revenue sharing arrangements and, where applicable, using budgetary funds to subsidise the poor in government-financed health insurance schemes could bridge the gap. Third, weak budget planning across levels could be improved by aligning budget structures, building subnational budgeting capacity and strengthening coordination across levels. Fourth, delays in central transfers and complicated procedures for approvals and disbursements stymie expenditure management at subnational levels. Simplifying processes and enhancing visibility over funding flows, including through digitalised information systems, promise to improve expenditure management and oversight in health. Fifth, subnational governments purchase services primarily through line-item budgets. Shifting to practices that link financial allocations with population health needs and facility performance, combined with reforms to grant commensurate autonomy to facilities, has the potential to enable more strategic purchasing.

Health budget cuts will be paid for by the most vulnerable.

No abstract available.

Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions.

OBJECTIVE: International trials can be challenging to operationalise due to incompatibilities between country-specific policies and infrastructures. The aim of this systematic review was to identify the operational complexities of conducting international trials and identify potential solutions for overcoming them. DESIGN: Systematic review. DATA SOURCES: Medline, Embase and Health Management Information Consortium were searched from 2006 to 30 January 2023. ELIGIBILITY CRITERIA: All studies reporting operational challenges (eg, site selection, trial management, intervention management, data management) of conducting international trials were included. DATA EXTRACTION AND SYNTHESIS: Search results were independently screened by at least two reviewers and data were extracted into a proforma. RESULTS: 38 studies (35 RCTs, 2 reports and 1 qualitative study) fulfilled the inclusion criteria. The median sample size was 1202 (IQR 332-4056) and median number of sites was 40 (IQR 13-78). 88.6% of studies had an academic sponsor and 80% were funded through government sources. Operational complexities were particularly reported during trial set-up due to lack of harmonisation in regulatory approvals and in relation to sponsorship structure, with associated budgetary impacts. Additional challenges included site selection, staff training, lengthy contract negotiations, site monitoring, communication, trial oversight, recruitment, data management, drug procurement and distribution, pharmacy involvement and biospecimen processing and transport. CONCLUSIONS: International collaborative trials are valuable in cases where recruitment may be difficult, diversifying participation and applicability. However, multiple operational and regulatory challenges are encountered when implementing a trial in multiple countries. Careful planning and communication between trials units and investigators, with an emphasis on establishing adequately resourced cross-border sponsorship structures and regulatory approvals, may help to overcome these barriers and realise the benefits of the approach. OPEN SCIENCE FRAMEWORK REGISTRATION NUMBER: osf-registrations-yvtjb-v1.

Monetary valuation of one year in full capability and health based on demographics, health status, income and well-being.

BACKGROUND: Budget constraints in health-care systems have led to the popularity of Cost Effectiveness Thresholds (CET) to achieve efficient allocation of resources. The capability approach has been hailed for its potentially richer evaluative capabilities compared to the QALY in terms of thresholds. Extensive research, however, is still limited. RESEARCH DESIGN AND METHODS: This study estimated the monetary value of a year in full capability (YFC) and compared it to monetary value of a QALY for the Hungarian population. Data was collected from a large, cross sectional, representative online survey on the adult Hungarian population. Applying the wellbeing valuation method, health, capability, and income were then regressed against wellbeing to estimate 'shadow prices' for one QALY and YFC controlling for gender, age, employment, education, marital and social support. To examine 'core' regression coefficients, a robustness check was conducted. RESULTS: Health (VAS) and capability (ICECAP-A) had a positive and significant effect on Subjective Well-Being. The monetary values of one QALY and one YFC were 39 459 EUR and 58 148 EUR respectively. CONCLUSIONS: These tools provide a systematic approach to determining 'compensating income' for certain illnesses, disabilities and levels of pain. The capability approach shown to be broader than the QALY.

Sparsified federated learning with differential privacy for intrusion detection in VANETs based on Fisher Information Matrix.

With the continuous development of vehicular ad hoc networks (VANET) security, using federated learning (FL) to deploy intrusion detection models in VANET has attracted considerable attention. Compared to conventional centralized learning, FL retains local training private data, thus protecting privacy. However, sensitive information about the training data can still be inferred from the shared model parameters in FL. Differential privacy (DP) is sophisticated technique to mitigate such attacks. A key challenge of implementing DP in FL is that non-selectively adding DP noise can adversely affect model accuracy, while having many perturbed parameters also increases privacy budget consumption and communication costs for detection models. To address this challenge, we propose FFIDS, a FL algorithm integrating model parameter pruning with differential privacy. It employs a parameter pruning technique based on the Fisher Information Matrix to reduce the privacy budget consumption per iteration while ensuring no accuracy loss. Specifically, FFIDS evaluates parameter importance and prunes unimportant parameters to generate compact sub-models, while recording the positions of parameters in each sub-model. This not only reduces model size to lower communication costs, but also maintains accuracy stability. DP noise is then added to the sub-models. By not perturbing unimportant parameters, more budget can be reserved to retain important parameters for more iterations. Finally, the server can promptly recover the sub-models using the parameter position information and complete aggregation. Extensive experiments on two public datasets and two F2MD simulation datasets have validated the utility and superior performance of the FFIDS algorithm.

NIH's flat budget for 2024 will force 'very difficult decisions'.

Belated Senate and House compromise eliminates policy riders restricting certain studies.

Cybersecurity on a budget: Evaluating security and performance of open-source SIEM solutions for SMEs.

The proliferation of cyber threats necessitates robust security measures to safeguard critical assets and data in today's evolving digital landscape. Small and Medium Enterprises (SMEs), which are the backbone of the global economy are particularly vulnerable to these threats due to inadequate protection for critical and sensitive information, budgetary constraints, and lack of cybersecurity expertise and personnel. Security Information and Event Management (SIEM) systems have emerged as pivotal tools for monitoring, detecting, and responding to security incidents. While proprietary SIEM solutions have historically dominated the market, open-source SIEM systems have gained prominence for their accessibility and cost-effectiveness for SMEs. This article presents a comprehensive study focusing on the evaluation of open-source SIEM systems. The research investigates the capabilities of these open-source solutions in addressing modern security challenges and compliance with regulatory requirements. Performance aspects are explored through empirical testing in simulated enterprise-grade SME network environments to assess resource utilization, and real-time data processing capabilities. By providing a rigorous assessment of the security and performance features of open-source SIEM systems, this research offers valuable insights to cybersecurity practitioners, organizations seeking cost-effective security solutions, and the broader academic community. The findings shed light on the strengths and limitations of these systems, aiding decision-makers in selecting the most suitable SIEM solution for their specific requirements while enhancing the cybersecurity posture of SMEs.

Compact rover surveying and laser scanning for BIM development.

This paper presents a custom made small rover based surveying, mapping and building information modeling solution. Majority of the commercially available mobile surveying systems are larger in size which restricts their maneuverability in the targeted indoor vicinities. Furthermore their functional cost is unaffordable for low budget projects belonging to developing markets. Keeping in view these challenges, an economical indigenous rover based scanning and mapping system has developed using orthogonal integration of two low cost RPLidar A1 laser scanners. All the instrumentation of the rover has been interfaced with Robot Operating System (ROS) for online processing and recording of all sensorial data. The ROS based pose and map estimations of the rover have performed using Simultaneous Localization and Mapping (SLAM) technique. The perceived class 1 laser scans data belonging to distinct vicinities with variable reflective properties have been successfully tested and validated for required structural modeling. Systematically the recorded scans have been used in offline mode to generate the 3D point cloud map of the surveyed environment. Later the structural planes extraction from the point cloud data has been done using Random Sampling and Consensus (RANSAC) technique. Finally the 2D floor plan and 3D building model have been developed using point cloud processing in appropriate software. Multiple interiors of existing buildings and under construction indoor sites have been scanned, mapped and modelled as presented in this paper. In addition, the validation of the as-built models have been performed by comparing with the actual architecture design of the surveyed buildings. In comparison to available surveying solutions present in the local market, the developed system has been found faster, accurate and user friendly to produce more enhanced structural results with minute details.