National Healthcare Research Articles

Inside CKD: a microsimulation modelling study projects the clinical and economic burden of chronic kidney disease in Hungary

ObjectivesThe Inside CKD programme implemented a microsimulation modelling approach to project the clinical and economic burden of chronic kidney disease (CKD) between 2024 and 2027 in Hungary.MethodsUsing the peer-reviewed Inside CKD microsimulation, a virtual Hungarian population was generated that was derived from national records, local demographic data and published epidemiological data. These inputs defined the likelihood of a change in health state for each individual as they progressed through the model in annual increments. Individual CKD status, including disease progression, cardiorenal complications and associated costs, was tracked annually to generate the population-level projections of the clinical and economic burden of CKD.ResultsBy 2027, people with CKD were projected to constitute 13.3% of the Hungarian national population. The prevalence of heart failure, myocardial infarction and stroke in people with CKD were projected to remain consistently high, reaching 323 447, 69 188 and 120 118 by 2027, respectively. Kidney replacement therapy cases were predicted to remain high at 20 515 in 2024 and 22 325 in 2027, with associated costs increasing from 71.4 billion HUF in 2024 to 79.6 billion HUF in 2027. Total annual healthcare costs associated with treating CKD were projected to constitute 5.4% of the overall national healthcare budget in 2027.ConclusionsInside CKD demonstrates that the future burden of CKD in Hungary will be substantial unless current management strategies change. The high prevalence of undiagnosed CKD and associated cardiorenal complications highlight the urgent need for policy interventions focused on early diagnosis and timely intervention to mitigate the future burden of CKD.

Collaborative governance of an integrated system for collecting contributions for social health insurance, pension, and taxes from the informal sector: a synthesis of stakeholder perspectives

BackgroundMany low-and middle-income countries have adopted social health insurance schemes. However, the collection of contributions from the large informal sector of these economies poses a significant challenge. Employing an integrated system of contribution collection from all relevant institutions may be cost-effective. We used the integrative framework for collaborative governance, to explore and explain factors that may shape the governance of an integrated system for collecting contributions for social health insurance, pension, and taxes from the informal sector in Zambia.MethodsWe undertook a qualitative case study involving 25 key informants drawn from government ministries and institutions, cooperating partners, non-governmental organizations, and association representatives in the informal sector. Data were analyzed thematically using Emerson’s integrative framework for collaborative governance.ResultsThe main drivers of collaboration included a need for comprehensive policies and legislation to oversee the integrated system for contribution collection, prevent redundancy, reduce costs, and enhance organizational effectiveness. However, challenges such as leadership issues and coordination complexities were noted. Factors affecting principled engagement within the collaborative regime consisted of communication gaps, organizational structure disparities, and the adoption of appropriate strategies to engage the informal sector. Additionally, factors influencing shared motivation involved concerns about power dynamics, self-interests, trust issues, corruption, and a lack of common understanding of the informal sector.ConclusionThis study sheds light on a multitude of factors that may shape collaborative governance of an integrated system for contribution collection for social health insurance, pension, and taxes from the informal sector, providing valuable insights for policymakers and implementers alike. Expanding social health insurance coverage to the large but often excluded informal sector will require leveraging factors identified in this study to enhance collaboration with pension and tax subsystems.

Cost and resource comparison analysis for THA in Switzerland and Austria.

Total hip arthroplasty (THA) is an orthopedic intervention that generates substantial costs to national healthcare systems due to the number of interventions and the cost per intervention. We performed a cost comparison analysis in Austria and Switzerland. Data from the national joint arthroplasty register in Switzerland and internal information from the national healthcare services in Austria and Switzerland were compared for patient demographics, interventional characteristics, and costs adjusted for inflation and purchasing power from 2015 to 2021. The average age for primary THA in Austria was from 67.4 to 67.8years with 55.9-57.2 percent female patients and from 68.5 to 69.3years with 52.4-53.8 percent female patients in Switzerland. The annual incidence rate for primary THA rose from 210.28/100k to 216.6/100k in Austria and from 212/100k to 250/100k in Switzerland. After correction for inflation, costs were -1.91 percent lower in Austria in 2021 than in 2015 and -2.57 percent lower in Switzerland. After correction for purchasing power, costs were higher in Austria. The average hospital stay after THA in Austria was reduced by 20 percent (11.7days/2015 vs. 9.4days/2021) and 25 percent in Switzerland (8.4days/2015 vs. 6.4days/2021). Revision rate was 2.5-3.2 percent in Austria and 2.8-3.2 percent in Switzerland. The patient population was comparable while patients undergoing primary THA in Austria stay longer in hospital and have relatively higher costs when adjusted for currency, purchasing power, and inflation. The use of standardized registers would be helpful to compare outcomes and costs.

Cost-effectiveness of pembrolizumab as an adjuvant treatment of renal cell carcinoma post-nephrectomy in Switzerland

Aims Pembrolizumab has demonstrated significantly prolonged disease-free survival and overall survival (OS) among adult patients post-nephrectomy who have an intermediate-high risk, high-risk, or M1 stage with no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component. The aim of this study was to evaluate the cost-effectiveness of pembrolizumab for patients with RCC post-nephrectomy versus observation in Switzerland. Materials and methods A previously published Markov model was adapted for the Swiss setting to estimate the cost-effectiveness of adjuvant pembrolizumab versus observation from the Swiss statutory health insurance perspective. Transition probabilities between model states were estimated using survival curves from KEYNOTE-564 (data cut-off: June 14, 2021). Outcomes included costs (2022 Swiss francs [CHF]), quality-adjusted life-years (QALYs), and life-years (LYs), measured over a lifetime horizon. Costs included drug acquisition and administration for adjuvant and subsequent therapy. Both costs and effectiveness were discounted at 3.0% annually. Cost-effectiveness was evaluated at a hypothetical willingness-to-pay (WTP) threshold of CHF 100,000 Sensitivity was assessed through scenario analyses as well as deterministic and probabilistic sensitivity analyses. Results Over a lifetime horizon, the total incremental cost for pembrolizumab versus observation was CHF 59,089, providing incremental gains of 0.90 QALYs (1.07 LYs); the incremental cost-effectiveness ratio was CHF 65,299/QALY. Pembrolizumab was deemed cost-effective versus observation, with a 69.9% probability of cost-effectiveness. Limitations A more recent interim analysis data cut from KEYNOTE-564 with median follow up of 57.2 months has since been published; however, these were not available at the time of analysis. It would likely have minimal impact on transition probabilities from disease-free, and the current approach remains conservative for predicting OS for pembrolizumab. Conclusions As an adjuvant treatment of RCC post-nephrectomy, pembrolizumab was found to be cost-effective versus observation in Switzerland at a WTP threshold of CHF 100,000/QALY. Policy makers should consider pembrolizumab as an adjuvant treatment for patients with RCC post-nephrectomy when making decisions regarding resource allocation.

Impact of the COVID-19 pandemic on initiation of antihypertensive drugs in Sweden: an interrupted time series study

ObjectivesAntihypertensives reduce the risk of myocardial infarction and stroke. Restrictions during the COVID-19 pandemic limited access to healthcare, which may have had a negative impact on drug prescribing. This study...

Post-marketing quality evaluation of oxytocin injection and assessment of associated factors among selected health facilities in Addis Ababa, Ethiopia

Oxytocin is the principal drug and the primary choice for labor induction and postpartum hemorrhage prevention and treatment. The problems associated with oxytocin are not usually from its effectiveness, but they are from its compromised quality which may occur at the point of manufacturing, transportation, and storage. The main objective of this study was to assess the status of oxytocin injection quality and associated factors in the health facilities located in Addis Ababa city, Ethiopia. A laboratory based instrumental quality testing alongside a cross sectional study design was used to evaluate oxytocin injection quality in Addis Ababa city administration from January to June, 2022 according to United States Pharmacopeia (USP 20), and the World Health Organization guideline of post-market medicine quality assessment. Binary logistic regression and cross tabulation analysis were conducted using SPSS 26. Significance was considered at p ≤ 0.05. Out of 107 tested oxytocin injection samples, 92.5% met the limit for oxytocin content, 81.3% for sterility test, and 91.6% for pH value. Overall, quality failure rate was 23.4%, while sterility test failure rate was 18.7%. Lack of reliable refrigerated storage condition [(AOR = 5.62, 95% CI: (1.87, 16.88)], lack of effective cold chain system during distribution [(AOR = 5.5, 95% CI: (1.53, 19.74)], and weak national medicine regulatory system [(AOR = 3.23, 95% CI: (1.13, 9.23)] were among the significantly associated factors for the failure of some of the brands. The study demonstrated that oxytocin injection quality failure rate, failing to meet at least one quality test requirement, is demonstrated in the health facilities of Addis Ababa. The determinant factors for the reported failures are related to storage, distribution, and regulatory system. Hence, these should be addressed by strictly adhering in to the national regulation and providing a comprehensive health promotion on rational use of oxytocin injection should be implemented to assure its quality and safety.

National Medical Commission’s new rule on capping the number of undergraduate medical seats in high performing States: pragmatic or quixotic?

The article analyses the recent amendment by the National Medical Commission (NMC) in India, capping the number of undergraduate medical seats in high-performing states, which has sparked a debate. With a healthcare system catering to the diverse needs of 1.4 billion people, regional disparities in healthcare personnel distribution have emerged, especially among doctors. The advantages of the amendment include a focused approach on lagging states and the potential distribution of doctors to improve overall health indices. However, concerns arise over infringement of the autonomy of state governments, potential hindrance to high-performing states, and the impact on doctors' postgraduate choices. This commentary explores the complex factors influencing doctor distribution, including state policies, infrastructure and migration patterns. While emphasising the need for equitable healthcare access, and it also stresses the need for a balanced approach to address the challenges in doctor distribution to ensure both state and national healthcare needs are met effectively.

Transfusion reaction patterns by blood component

Abstract Introduction/Objective Blood transfusion is becoming safer by continuous improvement of donor screening, patient identification, blood management, and infectious disease screening. This study was conducted to examine the rate and characteristics of transfusion reactions in the setting of universal leukoreduction of cellular products as well as pathogen reduction and/or irradiation of apheresis platelets. Methods/Case Report Data from the blood bank database for a 5-year period from 1/1/2019 to 12/31/2023 was collected. Transfusion reaction data as reported to National Healthcare Safety Network (NHSN) was analyzed. Results (if a Case Study enter NA) A total of 134,552 transfusions and 491 transfusion reactions were reported over the study period, resulting in the overall transfusion reaction rate of 0.36%. Allergic reaction was the most common reaction (38%), followed by febrile non-hemolytic transfusion reaction (FNHTR, 30%), delayed serologic transfusion reaction (DSTR, 14%), transfusion-associated circulatory overload (TACO, 10%), and transfusion-associated dyspnea (TAD, 4%). Platelets had the highest rate of transfusion reaction at 0.61% (n=167 of 27,180), red blood cells (RBC) at 0.35% (n=289 of 82,963), plasma at 0.13% (n=24 of 19,114), and cryoprecipitate at 0.06% (n=3 of 5295). The most common reaction associated with platelet transfusion was allergic reaction (64%, n=107), while FNHTR was the most common reaction associated with RBC transfusion (37%, n=106). By severity, 9 (2%) reactions were life-threatening, 21 (4%) were severe, 374 (75%) were non-severe, and 87 (18%) were not determined. Of life-threatening reactions, allergic reactions were the most common (5 of 9), while TACO was the most common severe reaction (9 of 21). Platelets were the most commonly implicated component in life- threatening reactions (4 allergic and 2 TACO), and RBCs were more commonly implicated in severe reactions. Conclusion Platelet transfusions were associated with a higher rate of transfusion reactions and life-threatening allergic reactions compared to other blood components.

Feasibility of an environmental scan-based approach to collecting information about factors impacting cancer genetics services in Latin American countries.

Clinical cancer genetics services are expanding globally, but national policy and health care systems influence availability and implementation. Understanding the environmental factors within a country is required to appropriately implement, adapt, and evaluate cancer genetics service delivery models. An environmental scan (ES) is an approach used in business, public health, health care and other sectors to collect information about an environment or system for strategic decision making and program planning. An ES has been previously used to assess cancer genetics clinic-level factors to inform quality improvement efforts in the United States. We assessed the feasibility of using an ES to collect information about factors that may influence cancer genetics service delivery in the outer-most socio-ecological model environmental levels (policy, national agencies, healthcare systems, cultural considerations) in three Latin American countries. Oncology and Genetics care team members at three participating sites used publicly available sources and personal experiences to complete a data collection form (DCF) that included questions about subtopics: laws and policies, relevant agencies and regulations, health care systems and insurance, and cultural considerations. Time to complete the DCF and DCF completeness were used to measure ES feasibility. Participating sites completed the DCF in 3 months, and most questions (average, 87.0%) were answered. Questions in the cultural considerations subtopic had the fewest answers (average, 77.8%). Overall, the ES was feasible and identified a lack of published literature related to cultural considerations impacting health care and genetics services uptake in Latin America. Environmental factors impact cancer genetics services, and identification of these factors will facilitate future collaborative research and genetics service delivery dissemination efforts.

Regulatory Quality in the International Circulation of Medicinal Products

Since 2014, the World Health Organization has been implementing a large-scale project to strengthen and develop national regulatory systems, which is aimed at increasing the availability of safe, effective and high-quality medicines and medical devices for the population of all countries, but primarily low- and middle-income countries. The project analyzes the maturity of national regulatory systems using a global benchmarking tool developed based on various regulatory authority assessment systems and has undergone extensive discussion and pilot testing; the results of national authorities that have reached high levels of maturity are published. A WHO List of Regulatory Authorities is also being formed, replacing the previously used concept of "stringent regulatory authorities". This List is recommended for use in regulatory reliance procedures by national regulatory authorities, purchasing structures of various levels and status: commercial, public, state or international. The regulatory quality of drug regulation is one of the critical factors of any national healthcare system. At the global level, it is directly related to goals 1,3,8,9 and 11 of sustainable development defined by the UN. The WHO project under consideration to assess maturity) of the regulatory system of the pharmaceutical sector is fundamentally different from similarly focused projects carried out in the past. First of all, the project focuses not on legal and regulatory/methodological documents, but on institutional and procedural aspects, i.e. on the structure and functions of regulatory bodies. Along with this, the project can have a significant impact on global pharmaceutical markets.

Association of early follow-up visits with reduced hospital readmissions of newborns: a French population-based data-linkage study.

Newborn care guidelines recommend assessments within a week of discharge from maternity care. However, the optimal timing and effectiveness to prevent neonatal hospital readmission are debated. This study aimed to determine the association between early follow-up visits (EFVs) within threedays of postpartum discharge and hospital readmission of newborns up to 15days of life. This population-based data-linkage study used data from the French National Health Care Database. "Healthy" singleton term infants with a gestational age (GA) of ≥36weeks, born between January 1, 2017, and November 30, 2018, in Southern France, were included. A multivariate regression analysis was performed. Among the 67,359 included infants, 1519 (2.25%) were hospitalized. The principal causes of hospitalization were infectious diseases (42.4%) and jaundice or growth/nutrition disorders (36.1%). Hospitalized infants were more likely to be born to young and socioeconomically deprived mothers, to be male (54.4% vs. 50.6%, P < 0.001), or born early (GA < 38weeks; 28.5% vs. 20.5%, P < 0.001). They received 6% less EFVs than non-hospitalized infants (63.7% vs. 67.8%, P < 0.001). The multivariable regression logistic analysis revealed that infants who received EFVs had 13% lower odds of being hospitalized than infants without EFVs, with an adjusted odds ratio of 0.87 (95% confidence interval=0.78-0.96; P < 0.01). EFVs within threedays were associated with a 13% reduction in the rate of neonatal hospital readmission. Therefore, EFVs should be implemented to improve infant health and reduce healthcare costs.

Cardiovascular Health Among Young Men and Women in Puerto Rico as Assessed by the Life's Essential 8 Metrics.

Cardiovascular health (CVH) in young adulthood is associated with CVD in later life, yet CVH in young adults in the United States falls below ideal levels, with noticeable sex differences. Research on CVH in young adults in Puerto Rico is scarce. This study examined CVH and sex differences in CVH in a large cohort of young adults in Puerto Rico. Data from 2162 Puerto Rican young adults aged 18 to 29 residing in PR were obtained from the PR-OUTLOOK (Puerto Rico Young Adults' Stress, Contextual, Behavioral, and Cardiometabolic Risk) study (2020-2023). Participants were recruited through various media and community outreach. CVH scores, graded on a 0 (worst) to 100 (best) scale, were derived from survey responses, physical exams, and laboratory assays. Linear regression with the margins postestimation command was used to determine adjusted means (95% CIs) for CVH scores by sex, controlling for age, marital status, education, childhood material deprivation, subjective social status, health insurance, and depressive symptoms. CVH was less than ideal (score<80) in 72.6% of the cohort (70.5% of women, 75.9% of men, P<0.05). Men had a significantly lower adjusted mean overall CVH score than women (70.7 versus 73.0) and lower adjusted mean scores for nicotine exposure (78.3 versus 86.7), non-high-density lipoprotein cholesterol (80.6 versus 86.4), and blood pressure (79.5 versus 92.2). Women had a significantly lower adjusted mean physical activity score compared with men (50.4 versus 59.5). Less-than-ideal CVH is notable among young adults, with men having worse CVH than women. These identified sex differences warrant further investigation and the design of interventions to enhance and preserve CVH.

Bloodstream infections in a Brazilian Pediatric Tertiary Oncology Hospital: 30-month analysis regarding the classification of the infection, distribution of microorganisms and their resistance profile

Abstract Background Infections are a major cause of morbidity and mortality in pediatric oncology patients during their treatment. Bloodstream infections are the main site of infection in these patients. Bacteremia in these patients can be secondary to a primary infectious focus, result from central line associated bloodstream infections (CLABSIs) or mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI). Methods Descriptive study of bloodstream infections in pediatric patients undergoing oncological treatment and hematopoietic stem cell transplantation in a tertiary pediatric oncology hospital in Brazil from January 1st, 2021 to June 30th, 2023. Infections were classified according to the Centers for Disease Control and Prevention/ National Healthcare Safety Network (CDC/NHSN) criteria into CLABSIs, MBI-LCBIs and secondary bloodstream infections. Among the bloodstream infections that met CDC/NHSN criteria for CLABSI, were analyzed separately those who also met the criteria of catheter-related bloodstream infection (CRBSI) according to Infectious Diseases Society of America (IDSA). Results During this period were diagnosed 335 episodes of bloodstream infection (123 episodes in 2021, 150 in 2022 and 62 episodes in the first 6 months of 2023). There were 378 microorganisms isolated. These infections were classified into: 35% CLABSIs, 27% MBI-LCBIs, 23% CRBSIs, and 15% secondary bloodstream infections. Among the CLABSIs, the most common microorganisms were non-fermenting gram negative bacilli (NFGNB) 38%, enterobacteriaceae 35% and coagulase-negative staphylococcus (CoNS) 11%. Between CRBSIs, there were 31% enterobacteriaceae, 22% CoNS and 19% NFGNB. Among the MBI-LCBIs there were 66% enterobacteriaceae and 23% group viridans streptococci (VGS). Streptococcus pneumoniae (33%) was the most common microorganism in secondary infections followed by Staphylococcus aureus (17%). Assessing all infections together, the main enterobacteriaceae were Klebsiella spp. (40%) and only 50% of them were sensitive to cefepime while 10% were carbapenems resistant. Among NFGNB, 13% of Pseudomonas spp. and 5% of Acinetobacter spp. were carbapenems resistant. Between the gram-positive bacteria, 77% of the S. aureus were methicillin sensitive, the same percentage of the VGS were sensitive to cefepime. Conclusion Among bloodstream infections, there were a predominance of CLABSI followed by MBI-LCBIs. Antimicrobial resistance between gram-positive bacteria, is of little concern in our institution. In the case of gram-negative bacteria, resistance to cefepime is becoming worrying among enterobacteriaceae.

The influence of age, gender and pharmacogenetic profiles on the perspective on medicines in the German EMPAR study.

Pharmacogenetic testing in routine care could provide benefits for patients, doctors and statutory health insurances. Therefore, the aim of the retrospective, observational study Einfluss metabolischer Profile auf die Arzneimitteltherapiesicherheit in der Routineversorgung (EMPAR) was to analyze the relationship between pharmacogenetic profiles, the risk of adverse drug reactions, and patients' perceptions of drug therapy in 10748 adult (≥18 years) participants in Germany. A questionnaire was used to assess views and beliefs about medicines and participants individual perception of sensitivity to drug therapies. The questionnaire consisted of the Beliefs about Medicines Questionnaire (BMQ)-General scales (Overuse, Harm, Benefit), the Perceived Sensitivity to Medicines (PSM), Natural Remedy, and Gene Testing scales. The influence of gender, age, study collective, genotype and phenotype of relevant pharmacogenes on participant's perception were evaluated. Overuse, PSM and Benefit scores were significantly higher among patients of the collective International Classification of Diseases and Health Related Disorders (ICD)-10 Y57.9! diagnosis, which indicates complications related to drugs, compared to the anticoagulant/antiplatelet and cholesterol-lowering drug collective. Age and gender also played a significant role in patients' perceptions, with younger patients and female participants more likely to believe in medication overuse according to the Overuse scale score compared to older and male participants. Female participants compared to male participants and the old age group compared to the young and/or middle-age subgroup, scored higher in PSM and/or Harm scales, respectively. Only a tendency of increased Harm, Overuse and PSM scores was observed in the participant group with five or more relevant actionable variants compared to subgroups with 0 up to 4 variants. In conclusion, patients' beliefs about medicines and their drug sensitivity perceptions are influenced by various factors including age, gender, previous complications with medicines, and with some tendency also pharmacogenetic profiles. The higher association with more negative views related to treatment indicates that there is a need to target the underlying issues in affected patient groups in order to improve compliance to treatment and outcomes in routine care. Trial registration: EMPAR was registered in the German Clinical Trials Register (DRKS) on 06 July 2018 (DRKS00013909).

Social Capital, Social Health Insurance, and Health-related Quality of Life among People with Chronic Disease: Cultural and Ideational Perspectives

Social Capital, Social Health Insurance, and Health-related Quality of Life among People with Chronic Disease: Cultural and Ideational Perspectives

Components of the hr management process of a medical organization

Successful development of any sphere of human activity is unthinkable in modern society without management. The implementation of management goals and objectives is carried out through personnel policy, which is a strategic line of behavior in working with personnel. In the healthcare system, an important role is assigned to the mid-level medical worker, therefore, personnel development management is recognized throughout the world as a priorit y task of management in the field of nursing. Target. To study and analyze the process of professional selection, training and management of nursing personnel. Results. The aspects of selection of nursing personnel were studied, the level of quality of knowledge obtained by nursing personnel and the degree of their application in practical activities were determined, the features of the organizational activities of nursing service managers were identified. Conclusion. Trained medical personnel should take a place in accordance with the needs of national health care and taking into account the personal interests and needs of the medical workers themselves. This can be achieved with the appropriate organization of the personnel management process, when specialists will find adequate use for their qualifications in the system.

Navigating conflicting expectations in addressing healthcare scarcity: a q-methodology study on the Dutch National Health Care Institute.

In many European countries, semi-autonomous agencies have been created in health policy to safeguard general public interests. In executing their tasks, these agencies need to deal with conflicting expectations. Particularly avoiding the risk of regulatory capture and aligning with parent ministries are frequently studied challenges, even more so when complex issues such as scarcity are at stake. In this paper, we use q-methodology to provide a thorough overview of the debate regarding the role of an important agency in the Dutch healthcare system; the National Health Care Institute (Zorginstituut Nederland). We conducted 41 q-interviews with agency employees, evaluators, regulatees, ministry employees, health policy experts, members of its advisory committees, and peer agencies. We identify three viewpoints on what the agency should focus on. These are on societally relevant issues, strict package management, and efficient organisation of care. In doing so, our study shows how agencies are pulled in different directions by conflicting expectations. We show that this can be problematic because it complicates a clear role of the agency that allows addressing such issues. We thereby contribute to theories on agencies' complex relations with their external environment such as regulatory capture, tripartism, reflexive regulation, legal boundaries, and stewardship theory.

Real-World Evidence of Clinical Outcomes of the Use of the Adalimumab Biosimilar SB5 in Rheumatic and Gastrointestinal Immune-Mediated Inflammatory Diseases: 12-Month Data from the PERFUSE Study.

There is a need for published data on real-world use of SB5, an adalimumab (ADL) biosimilar approved in Europe in 2017, on the basis of evidence from pre-clinical and analytic data as well as phase I and III clinical studies demonstrating equivalent efficacy and comparable pharmacokinetics, safety and immunogenicity profiles as the reference ADL. The purpose of this study was to estimate patient persistence on SB5 at 12 months post-initiation using clinical and healthcare claims data from the French Système National des Données de Santé (national healthcare claims database, SNDS) in addressing data gaps. PERFUSE is a 12-month, observational, multi-centre cohort study of patients with rheumatic or gastrointestinal immune-mediated inflammatory diseases (IMIDs) who initiated routine SB5 treatment between October 2018 and October 2020, either as their first ADL (naïve) or transitioning from another ADL (switched). Clinical data, including disease activity scores, C-reactive protein levels, and dosing information, were collected as available from patient records captured during routine visits to specialist physicians. Persistence data were supplemented with data from the French national healthcare claims database (SNDS). Analyses of clinical data were descriptive, while persistence was assessed using a Kaplan-Meier survival analysis. Overall, 911 patients were included: 507 from rheumatology centres [116 with rheumatoid arthritis (RA), 78 psoriatic arthritis (PsA), and 313 ankylosing spondylitis (AS)] and 404 from gastroenterology centres [316 with Crohn's disease (CD) and 88 ulcerative colitis (UC)]. Among naïve patients, 12-month remission/low activity rates were 58% for RA, 66% for PsA, 59% for AS, 94% for CD, and 85% for UC, increasing significantly from baseline for all indications (p < 0.05). Switched patients' remission rates remained stable between baseline and month 12 (M12) for all indications (p > 0.05). Persistence (95% CI) at M12 among naïve patients was 59% (46.5, 68.8) for RA, 65% (49.7, 77.1) for PsA, 56% (48.3, 62.6) for AS, 70% (63.0, 75.7) for CD, and 42% (30.7, 53.1) for UC, compared to 60% (42.7, 73.7) for RA, 57% (37.3, 72.1) for PsA, 55% (45.8, 64.0) for AS, 63% (53.4, 71.7) for CD, and 56% (27.2, 77.6) for UC among switched patients. No significant differences were observed between naïve and switched patients (p > 0.05). SNDS pairing provided information on 68 of the 132 patients (52%) who were lost to follow-up in the clinical database, of whom 57 (84%) were confirmed persistent at M12 and 11 (16%) non-persistent. Primary treatment failure (naïve patients) and patient decision (switched patients) were the most common reasons stated for treatment discontinuation. SB5 provides clinically effective treatment of both gastrointestinal and rheumatic IMIDs for naïve and switched patients, with no loss of control observed when switching. Persistence was comparable between naïve and switched populations, though the reasons for non-persistence differed. Trial registration number: Clinical Trials identifier NCT03662919. Trial registration date: 10 September 2018.

Cost-effectiveness of a patient-reported outcome-based remote monitoring and alert intervention for early detection of critical recovery after joint replacement: A randomised controlled trial.

While the effectiveness of patient-reported outcome measures (PROMs) as an intervention to impact patient pathways has been established for cancer care, it is unknown for other indications. We assessed the cost-effectiveness of a PROM-based monitoring and alert intervention for early detection of critical recovery paths following hip and knee replacement. The cost-effectiveness analysis (CEA) is based on a multicentre randomised controlled trial encompassing 3,697 patients with hip replacement and 3,110 patients with knee replacement enrolled from 2019 to 2020 in 9 German hospitals. The analysis was conducted with a subset of 546 hip and 492 knee replacement cases with longitudinal cost data from 24 statutory health insurances. Patients were randomised 1:1 to a PROM-based remote monitoring and alert intervention or to a standard care group. All patients were assessed at 12-months post-surgery via digitally collected PROMs. Patients within the intervention group were additionally assessed at 1-, 3-, and 6-months post-surgery to be contacted in case of critical recovery paths. For the effect evaluation, a PROM-based composite measure (PRO-CM) was developed, combining changes across various PROMs in a single index ranging from 0 to 100. The PRO-CM included 6 PROMs focused on quality of life and various aspects of physical and mental health. The primary outcome was the incremental cost-effectiveness ratio (ICER). The intervention group showed incremental outcomes of 2.54 units PRO-CM (95% confidence interval (CI) [0.93, 4.14]; p = 0.002) for patients with hip and 0.87 (95% CI [-0.94, 2.67]; p = 0.347) for patients with knee replacement. Within the 12-months post-surgery period the intervention group had less costs of 376.43€ (95% CI [-639.74, -113.12]; p = 0.005) in patients with hip, and 375.50€ (95% CI [-767.40, 16.39]; p = 0.060) in patients with knee replacement, revealing a dominant ICER for both procedures. However, it remains unclear which step of the multistage intervention contributes most to the positive effect. The intervention significantly improved patient outcomes at lower costs in patients with hip replacements when compared with standard care. Further it showed a nonsignificant cost reduction in knee replacement patients. This reinforces the notion that PROMs can be utilised as a cost-effective instrument for remote monitoring in standard care settings. Registration: German Register for Clinical Studies (DRKS) under DRKS00019916.

European Respiratory Society International Congress 2024: attendance of the Ukrainian delegation

ABSTRACT. From September 7 to 14, 2024, the Congress of the European Respiratory Society was held in Vienna (Austria) and for the third time it was organized in hybrid format. This event attracts participants from more than 160 countries from all continents and provides a scientific forum with a broad multidisciplinary program. Every year, the Ukrainian delegation takes part in the congress, where it highlights the results of the investigations of Ukrainian scientists and doctors. In 2024, 48 abstracts of reviews from Ukraine were selected for the congress. The structure of their topics reflected the current problems of national health care. The largest number of works (16) were devoted to chronic obstructive pulmonary disease and bronchial asthma, the most common conditions among chronic pathologies of the respiratory system. The next important topic of the Ukrainian delegation was tuberculosis (9 reports), as an epidemic of this disease has been registered in Ukraine since 1995 and continue now. The third important group of questions (8 presentations) related to today’s global problem – the consequences of the COVID-19 pandemic. Two oral presentations of the Ukrainian researchers on the topic of artificial intelligence and digital technologies were associated to the main theme of the congress “Humans and machines: getting the balance right”.