The clinical trial activation process: a case study of an Italian public hospital.

BACKGROUND/AIMS: In order to make the centers more attractive to trial sponsors, in recent years, some research institutions around the world have pursued projects to reorganize the pathway of trial activation, developing new organizational models to improve the activation process and reduce its times. This study aims at analyzing and reorganizing the start-up phase of trials conducted at the Research and Innovation Department (DAIRI) of the Public Hospital of Alessandria (Italy). METHODS: A project was carried out to reorganize the trial authorization process at DAIRI by involving the three facilities responsible for this pathway: clinical trial center (CTC), ethics committee secretariat (ESC), and administrative coordination (AC). Lean Thinking methodology was used with the A3 report tool, and the analysis was carried out by monitoring specific key performance indicators, derived from variables representing highlights of the trials' activation pathway. The project involved phases of analysis, implementation of identified countermeasures, and monitoring of timelines in eight 4-month periods. The overall mean and median values of studies activation times were calculated as well as the average times for each facility involved in the process. RESULTS: In this study, 298 studies both sponsored by research associations and industry with both observational and interventional study design were monitored. The mean trial activation time was reduced from 218 days before the project to 56 days in the last period monitored. From the first to the last monitoring period, each facility involved achieved at least a halving of the average time required to carry out its activities in the clinical trials' activation pathway (CTC: 55 days vs 23, ECS: 25 days vs 8, AC 29 days vs 10). Average activation time for studies with agreement remains longer than those without agreement (100 days vs. 46). CONCLUSIONS: The reorganization project emphasized the importance of having clinical and administrative staff specifically trained on the trial activation process. This reorganization led to the development of a standard operating procedure and a tool to monitor the time (KPIs of the process) that can also be implemented in other clinical centers.

The Mountain Model for Evidence-Based Practice Quality Improvement Initiatives.

ABSTRACT: This article introduces the Mountain Model, the first conceptual model for evidence-based practice quality improvement (EBPQI) initiatives. The Mountain Model merges modern evidence-based practice (EBP) and quality improvement (QI) paradigm principles into a unified conceptual framework with the goal of disseminating and sustaining EBPQI projects across health care and related settings. The model was developed within the nursing discipline, but is designed for transdisciplinary implementation through interprofessional teams.

Comparison of major abdominal emergency surgery outcomes across organizational models of emergency surgical care: Analysis of the UK NELA national database.

BACKGROUND: Emergency general surgery (EGS) admissions account for a large proportion of surgical care and represent the majority of surgical patients who suffer in-hospital mortality. Health care systems continue to experience growing demand for emergency services: one way in which this is being increasingly addressed is dedicated subspecialty teams for emergency surgical admissions, most commonly termed "emergency general surgery" in the United Kingdom. This study aims to understand the impact of the emergency general surgery model of care on outcomes from emergency laparotomies. METHODS: Data was obtained from the National Emergency Laparotomy Audit database. Patients were dichotomized into EGS hospital or non-EGS hospital. Emergency general surgery hospital is defined as a hospital where >50% of in-hours emergency laparotomy operating is performed by an emergency general surgeon. The primary outcome was in-hospital mortality. Secondary outcomes were intensive therapy unit (ITU) length of stay and duration of hospital stay. A propensity score weighting approach was used to reduce confounding and selection bias. RESULTS: There were 115,509 patients from 175 hospitals included in the final analysis. The EGS hospital care group included 5,789 patients versus 109,720 patients in the non-EGS group. Following propensity score weighting, mean standardized mean difference reduced from 0.055 to <0.001. In-hospital mortality was similar (10.8% vs. 11.1%, p = 0.094), with mean length of stay (16.7 days vs. 16.1 days, p < 0.001) and ITU stay (2.8 days vs. 2.6 days, p < 0.001) persistently longer in patients treated in EGS systems. CONCLUSION: No significant association between the emergency surgery hospital model of care and in-hospital mortality in emergency laparotomy patients was seen. There is a significant association between the emergency surgery hospital model of care and an increased length of ITU stay and overall hospital stay. Further studies are required to examine the impact of changing models of EGS delivery in the United Kingdom. LEVEL OF EVIDENCE: Prognostic and Epidemiological; Level III.

Understanding clinical implementation coordinators' experiences in deploying evidence-based interventions.

PURPOSE: The fluoroquinolone restriction for the prevention of Clostridioides difficile infection (FIRST) trial is a multisite clinical study in which sites carry out a preauthorization process via electronic health record-based best-practice alert (BPA) to optimize the use of fluoroquinolone antibiotics in acute care settings. Our research team worked closely with clinical implementation coordinators to facilitate the dissemination and implementation of this evidence-based intervention. Clinical implementation coordinators within the antibiotic stewardship team (AST) played a pivotal role in the implementation process; however, considerable research is needed to further understand their role. In this study, we aimed to (1) describe the roles and responsibilities of clinical implementation coordinators within ASTs and (2) identify facilitators and barriers coordinators experienced within the implementation process. METHODS: We conducted a directed content analysis of semistructured interviews, implementation diaries, and check-in meetings utilizing the conceptual framework of middle managers' roles in innovation implementation in healthcare from Urquhart et al. RESULTS: Clinical implementation coordinators performed a variety of roles vital to the implementation's success, including gathering and compiling information for BPA design, preparing staff, organizing meetings, connecting relevant stakeholders, evaluating clinical efficacy, and participating in the innovation as clinicians. Coordinators identified organizational staffing models and COVID-19 interruptions as the main barriers. Facilitators included AST empowerment, positive relationships with staff and oversight/governance committees, and using diverse implementation strategies. CONCLUSION: When implementing healthcare innovations, clinical implementation coordinators facilitated the implementation process through their roles and responsibilities and acted as strategic partners in improving the adoption and sustainability of a fluoroquinolone preauthorization protocol.

CONCEPTUAL, FUNCTIONAL-ORGANISATIONAL MODEL OF THE REGIONAL CENTRE FOR CARDIOLOGY AND CARDIAC SURGERY BASED ON PUBLIC-PRIVATE PARTNERSHIP.

OBJECTIVE: The aim: To substantiate the model of the Regional Center for Cardiology and Cardiac Surgery (RCCCS) based on the principles of public-private partnership (PPP). PATIENTS AND METHODS: Materials and methods: A systematic approach and analysis, medical-statistical and sociological method, expert assessment and method of conceptual modelling. RESULTS: Results: A comprehensive medical and social study of the morbidity rate of the population of the Kyiv region (Ukraine) with circulatory system diseases (CSD), as well as an analysis of the activities of the cardiological service of the Kyiv region in 2010-2019, have been made. Deficiencies in the organisation of medical care were identified, and strategic directions for its improvement were substantiated. The results of a sociological survey of CSD patients, cardiologists and experts - health care organisers have been analysed. According to the results of the expert assessment, health care institutions (HCI) providing cardiac care to the population in the Kyiv region are not ready to work under the conditions of the market economy; there is no appropriate regulatory framework, economic and legal independence of HCI, there is no market strategy for the development of HCI. CONCLUSION: Conclusions: The model of RCCCS, based on the principles of PPP being a medical institution of a new organisational and legal form, is capable of providing high-quality and affordable highly specialised medical care of the third level to the population with diseases of the circulatory system at the regional level.

The impact of collaborative organisational models and general practice size on patient safety and quality of care in the English National Health Service: A systematic review.

Collaborative primary care has become an increasingly popular strategy to manage existing pressures on general practice. In England, the recent changes taking place in the primary care sector have included the formation of collaborative organisational models and a steady increase in practice size. The aim of this review was to summarise the available evidence on the impact of collaborative models and general practice size on patient safety and quality of care in England. We searched for quantitative and qualitative studies on the topic published between January 2010 and July 2023. The quality of articles was assessed using the Newcastle-Ottawa Scale and the Critical Appraisal Skills Programme checklist. We screened 6533 abstracts, with full-text screening performed on 76 records. A total of 29 articles were included in the review. 19 met the inclusion criteria following full-text screening, with seven identified through reverse citation searching and three through expert consultation. All studies were found to be of moderate or high quality. A predominantly positive impact on service delivery measures and patient-level outcomes was identified. Meanwhile, the evidence on the effect on pay-for-performance outcomes and hospital admissions is mixed, with continuity of care and access identified as a concern. While this review is limited to evidence from England, the findings provide insights for all health systems undergoing a transition towards collaborative primary care.

Clinical and Organizational Nursing Innovations in Primary Care: Findings From a Stakeholders' Symposium.

Nursing innovations in primary care, based on interprofessional care models, could be better identified, recognized, and deployed. This article presents the results of a symposium discussing the implementation of nursing innovations in primary care in Quebec, Canada, in partnership with researchers and stakeholders. Built on the appreciative inquiry approach, 9 nursing innovations were described. To support the implementation of such nursing innovations responding to current primary care issues and population needs, 4 recommendations emerged: the need to implement strategies to achieve optimal scope of practice for primary care nurses; the importance to develop funding and organizational models that support primary care nursing innovation; the need to enhance a collaborative and democratic governance open to innovation; and the opportunity to create partnerships with the research community and teaching institutions.

The impact of participation in agricultural industry organizational models on crop yields: evidence from Chinese wheat growers.

Increasing income for grain farmers is crucial to mobilise farmers' incentive for grain cultivation. This article, based on the survey data of 2032 wheat growers in Anhui Province, China, employs the Logit model, multinomial Logit model, and entropy balance-OLS regression method to empirically analyze the factors influencing wheat growers' participation in agricultural industrial organization models and the impact of their participation decisions on planting returns. The research found that: (1) Wheat growers with richer resource endowments are more likely to participate in agricultural industrial organization models. Factors such as household head's education level, training experience, quality of arable land, scale of operation, and labor endowment are crucial determinants of wheat growers' decisions to participate in industrial organization models. (2) Participation in agricultural industrial organizations significantly enhances the net income of wheat growers. Comparatively, the income-boosting effect is more pronounced for those participating in the "household + farmer cooperatives/agricultural enterprises" model. (3) The mechanisms through which wheat growers' participation in different agricultural industrial organization models affects their crop yields vary. The income-enhancing effects of wheat growers' participation in the "household + farmer cooperatives/agricultural enterprises" model of industrial organization primarily stem from the improvement in land productivity and market bargaining power. On the other hand, the income-enhancing effects of participation in the "household + village collective + farmer cooperatives/agricultural enterprises" model are mainly attributed to the improvement in market bargaining power. The policy implication is that priority should be given to cultivating and developing industrial organisations based on the model of "household + farmers' co-operatives/agribusinesses" in regions where farmers are richly endowed with resources, and at the same time, the development of industrial organisations based on the model of "household + village collectives + farmers' co-operatives/agribusinesses" should be supplemented in accordance with local conditions. At the same time, the development of "household + village collectives + farmers' cooperatives/agribusinesses" mode is supplemented according to local conditions.

Emergency Department waiting-time in the post pandemic era: new organizational models, a challenge for the future.

BACKGROUND AND AIM: Covid-19 has profoundly changed the Emergency Department system in Lombardy, especially for the type of accesses and the number of diagnoses. Accordingly, the pre-hospital rescue system has undergone heavy changes, in particular regarding the times of rescue. Despite this, studies concerning the post-pandemic phase are lacking to understand whether the conditions of the emergency systems has resumed to the pre-pandemic period. The aim of the study is to evaluate the length of stay (LOS) phenomenon in the emergency departments (EDs) in the post-pandemic era. METHODS: a retrospective observational study was conducted, which analyzed the first six months of the years 2019, 2021 and 2022. The pandemic peak phase, corresponding to the first months of 2020, wasn't included. The investigated area included the provinces of Milan and Monza, a metropolitan area with 4 million inhabitants. RESULTS: The average time spent by patients in the ED increased by +3.8 hours in 2022 and by +1.3 hours in 2021 compared to 2019. The average time from ED access to hospitalization also increased by +4.8 hours in 2022 and +5.0 hours in 2021 compared to 2019. The percentage of time in ED recorded in a National Emergency Department Overcrowding Study (NEDOCS) in black code in 2022 reached 5.4% against 1.7% in 2021 and 0.5 % in 2019. CONCLUSIONS: data show an increase in the time spent in the EDs and an increase in the overcrowding, according to the NEDOCS index. New management models and a reorganization of EDs are needed as the workload has increased significantly.

Organisational models supported by technology for the management of diabetic disease and its complications in a diabetic clinic setting: study protocol for a randomised controlled trial targeting type 2 diabetes individuals with non-ideal glycaemic values (Telemechron study).

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a non-communicable disease representing one of the most serious public health challenges of the twenty-first century. Its incidence continues to rise in both developed and developing countries, causing the death of 1.5 million people every year. The use of technology (e.g. smartphone application-App) in the health field has progressively increased as it has been proved to be effective in helping individuals manage their long-term diseases. Therefore, it has the potential to reduce the use of health service and its related costs. The objective of this study is to evaluate the impact of using a digital platform called "TreC Diabete" embedded into a novel organisational asset targeting poorly controlled T2DM individuals in the Autonomous Province of Trento (PAT), Italy. METHODS: This trial was designed as a multi-centre, open-label, randomised, superiority study with two parallel groups and a 1:1 allocation ratio. Individuals regularly attending outpatient diabetes clinics, providing informed consent, are randomised to be prescribed TreC Diabete platform as part of their personalised care plan. Healthcare staff members will remotely assess the data shared by the participants through the App by using a dedicated online medical dashboard. The primary end-point is the evaluation of the Hb1Ac level at 12-month post-randomisation. Data will be analysed on an intention-to-treat (ITT) basis. DISCUSSION: This trial is the first conducted in the PAT area for the use of an App specifically designed for individuals with poorly controlled T2DM. If the effects of introducing this specific App within a new organisational asset are positive, the digital platform will represent a possible way for people diagnosed with T2DM to better manage their health in the future. Results will be disseminated through conferences and peer-reviewed journals once the study is completed. TRIAL REGISTRATION: ClinicalTrials.gov NCT05629221. Registered on November 29, 2022, prior start of inclusion.

Sound psychometric properties of a short new screening tool for patient safety climate: applying a Rasch model analysis.

BACKGROUND: WHO recommends repeated measurement of patient safety climate in health care and to support monitoring an 11 item questionnaire on sustainable safety engagement (HSE) has been developed by the Swedish Association of Local Authorities and Regions. This study aimed to validate the psychometric properties of the HSE. METHODS: Survey responses (n = 761) from a specialist care provider organization in Sweden was used to evaluate psychometric properties of the HSE 11-item questionnaire. A Rasch model analysis was applied in a stepwise process to evaluate evidence of validity and precision/reliability in relation to rating scale functioning, internal structure, response processes, and precision in estimates. RESULTS: Rating scales met the criteria for monotonical advancement and fit. Local independence was demonstrated for all HSE items. The first latent variable explained 52.2% of the variance. The first ten items demonstrated good fit to the Rasch model and were included in the further analysis and calculation of an index measure based on the raw scores. Less than 5% of the respondents demonstrated low person goodness-of-fit. Person separation index > 2. The flooring effect was negligible and the ceiling effect 5.7%. No differential item functioning was shown regarding gender, time of employment, role within organization or employee net promotor scores. The correlation coefficient between the HSE mean value index and the Rasch-generated unidimensional measures of the HSE 10-item scale was r = .95 (p < .01). CONCLUSIONS: This study shows that an eleven-item questionnaire can be used to measure a common dimension of staff perceptions on patient safety. The responses can be used to calculate an index that enables benchmarking and identification of at least three different levels of patient safety climate. This study explores a single point in time, but further studies may support the use of the instrument to follow development of the patient safety climate over time by repeated measurement.

How to optimize dust pollution control in opencast coal mines: Analysis of a joint social regulation model based on evolutionary game theory.

The carbon peaking and carbon neutrality goals drive innovation in pollution governance systems, unleashing the potential of social supervisory forces to achieve coordinated governance by multiple stakeholders. In order to improve dust pollution control in opencast coal mines, this study combines prospect theory with evolutionary game theory, analyzing the evolutionary game process of coordinated governance activities of coal mining enterprises, local regulators, and social camps in the management of dust pollution against the backdrop of national supervisions. The research indicates that the perceived value of dust pollution has a significant impact on the strategic choices of the three agents involved in the game. Coal mining enterprises tend to be risk averse, and by reducing the cost of dust pollution control and increasing the additional benefits of pollution control, it can promote pollution control behavior by coal mining enterprises. Local regulators are also risk averse, but not sensitive to risk benefits. Strengthening pollution subsidy incentives and environmental fines can help promote dust pollution control behavior by coal mining enterprises. However, increasing the strength of the rewards strategy is not conducive to local regulators' own regulatory responsibilities, and environmental fines have limited binding effects. The strategic choices of social camps' supervision have a restrictive effect on the strategic choices of coal mining enterprises and local regulators, promoting the evolution of equilibrium results in the direction of maximizing social benefits. When coal mining enterprises actively governance pollution, local regulators strictly regulated, and social camps do not monitor, the system reaches its optimal equilibrium state. The research results clarify the mechanism and specific effects of social supervision of opencast coal mine dust pollution control, guide the participation of the public in dust pollution control, and regulate the behavior strategies of coal mining enterprises and local regulators, providing the scientific basis for management.

[Staffing standards in residential facilities: a regional regulatory survey]. / Standard di personale nelle strutture residenziali: un'indagine sulla normativa regionale.

. Staffing standards in residential facilities: a regional regulatory survey. INTRODUCTION: Residential facilities are present in all Regions and several data useful to better understand the activities performed are available through the residential care information flow. To date, some information useful for analysing staffing standards is difficult to capture and very likely in the Italian Regions heterogeneous care modalities and staffing levels are present. AIM: To investigate the staffing standards of residential facilities in Italian Regions. METHODS: A review of regional regulations was carried out, between January and March 2022, on the website Leggi d'Italia, searching for documents on staffing standards in residential facilities. RESULTS: 45 documents were analysed and 16 from 13 regions were included. There are important inhomogeneities between regions. For example, Sicily sets unique staffing standards irrespective of the severity/complexity of the residents; the number minutes of nursing care per patient, for residents in intensive residential care may vary from 90 to 148 minutes/day. Standards have been set for nurses but not always for health care assistants, physiotherapists and social workers. CONCLUSIONS: Only a few regions have defined standards for all the main professions in the community health system. The variability described should be interpreted accounting for the socio-organisational contexts of the region, the organisational models adopted, and the staffing skill-mix.

[The resignations among nurses in the Veneto healthcare institutions. A retrospective study]. / Il fenomeno delle dimissioni tra gli infermieri nelle Aziende Sanitarie del Veneto. Uno studio retrospettivo.

. The resignations among nurses in the Veneto healthcare institutions. A retrospective study. INTRODUCTION: The phenomenon of large-scale resignations is complex, heterogeneous and cannot be attributed solely to the pandemic crisis, during which many people reconsidered the role of work in their lives. The health system was particularly exposed to the shocks caused by the pandemic. AIMS: To describe the turnover and analyse the resignations of nurses in the NHS hospitals and districts of the Veneto Region. METHODS: The hospitals were categorised into 4 types: Hub and Spoke of level 1 and 2. The positions of nurses with permanent contracts between 1 January 2016 and 31 December 2022 were analysed, considering active, nurses on duty for at least one day. The data were extracted from the human resource management database of the Region. Unexpected resignations were considered those occurring before the retirement date (59 years for women and 60 for men). Negative and overall turnover rates were calculated. RESULTS: The risk of unexpected resignations was increased for nurses not resident in Veneto, of male gender and employed at a Hub hospital. CONCLUSIONS: The flight from the NHS is in addition to the physiological flow of retirements, due to increase in the coming years. It is necessary to: act on the retention capacity and attractiveness of the profession; implement organisational models based on task sharing and shifting; implement digital tools; favour flexibility and mobility to improve the balance between work and personal life; efficiently integrate professionals quali-fied abroad.

Child and adolescent mental health services in a devolved healthcare system: a qualitative exploration of sustainable practices.

BACKGROUND: The transference of research evidence into routine healthcare practice remains poorly understood. This includes understanding the prerequisites of longer-term viability. The present study investigated the sustainable practices of GM i-THRIVE, a programme which reconceptualizes mental health services for children and young people (CYP) in Greater Manchester, United Kingdom. We aimed to establish whether a sustainable future was likely, and to identify areas of focus to improve that likelihood. METHODS: The NHS Sustainability Model, typically completed as a questionnaire measure, was converted into interview questions. The responses of nine professionals, from a variety of roles across the CYP mental health workforce, were explored using inductive thematic framework analysis. Selected participants completed the original questionnaire. RESULTS: Five themes (communication; support; barriers to implementation; past, present, and future: the implementation journey; and the nuances of GM i-THRIVE) and 21 subthemes formed the final thematic framework. Relationships with senior leaders and with colleagues across the workforce were seen as important. Leaders' roles in providing meaning and fit were emphasized. Whilst training delivered the programme's aims well, monitoring its dissemination was challenging. Widespread issues with dedicating sufficient time to implementation were raised. The flexibility of the programme, which can be applied in multiple ways, was discussed positively. This flexibility links to the idea of GM i-THRIVE as a mindset change, and the uniqueness of this style of intervention was discussed. To varying degrees, themes were supported by responses to the quantitative measure, although several limitations to the use of the questionnaire were discovered. Consequently, they were used to infer conclusions to a lesser degree than originally intended. CONCLUSIONS: Professionals involved with GM i-THRIVE reported many elements that indicate a positive future for the programme. However, they suggested that more attention should be given to embedding the core concepts of the model at the current stage of implementation. Limitations relating to its use within our study are discussed, but we conclude that the NHS Sustainability Model is a suitable way of guiding qualitative implementation research. It is especially valuable for localized interventions. The constraints of our small sample size on transferability are considered.

Components of Professional Practice Models.

OBJECTIVE: This study describes common components of nursing professional practice models (NPPMs) of Magnet ® -designated nursing service organizations. BACKGROUND: Components of professional practice models have not been consistently analyzed, suggesting a need to identify their concepts. Evidence-based guidelines may be unavailable to assist in the creation and revision of models. METHODS: A checklist was used to analyze 56 Web-based NPPMs of Magnet-designated nursing departments. RESULTS: Checklist items showed a match with parent organizations, an emphasis on patient- or family-centered care, a commitment to quality nursing services, and nursing's professional distinctiveness. Responses indicated engagement in shared governance and support of nursing staff's professional development. The concepts of health, care of sick and well people, and scope of nursing services were inconsistently addressed and call for further research. CONCLUSION: Nurse leaders should examine concepts in NPPMs and the extent they distinguish nursing's professional identity both within and externally to the organization.

Pursuing innovation in academic medical centers: Models, activities, and influential factors.

BACKGROUND: Academic medical centers (AMCs) are well recognized for their innovations that enhance frontline care, but there is little study of their innovation management processes, which is key for advancing theory regarding the effectiveness of innovation efforts to improve care. PURPOSE: We aimed to identify organizational models used for frontline innovation by AMCs in the United States, core activities within models, and factors that influence innovation success. METHODS: We conducted a qualitative study of 12 AMCs using data from semistructured interviews with centers' innovation leaders. Inclusion required satisfying two of three criteria in 2021 (only met by 35 AMCs nationally): listed in the professional association of innovation leaders (Council of 33), Becker's review of most innovative hospitals, and/or top 20 U.S. News and World Report best hospitals honor roll. We analyzed the interview data using the constant comparative method. RESULTS: Innovative AMCs pursue innovation through innovation centers (using a centralized or multicenter model) or within clinical departments (department-level model). All three models emphasize seven activities, although performed differently: sourcing ideas, developing ideas, implementing innovations, fundraising, managing partnerships, measuring success, and managing mindset. Several factors influenced success: role performance, operational challenges, technology, public policy, customer clarity, stakeholder buy-in, diversity of input, and focus. The centralized model struggled less with standardization and coordination issues. CONCLUSION: AMCs have options for structuring their innovation efforts. However, there are consistent activities for successful innovation management and factors that they must manage. PRACTICE IMPLICATIONS: AMCs can select among innovation models to fit their circumstances but likely need to perform seven activities well for success.

Cost-Effectiveness of the Early Arthritis Clinic Organizational Model.

OBJECTIVE: Early diagnosis and tight control improve outcomes of rheumatoid arthritis (RA). However, whether establishing an early arthritis clinic (EAC) is sustainable for national health systems is not known. This analysis aimed to compare effectiveness and costs of an EAC compared to patients followed by the current standard of care. METHODS: A retrospective study on administrative health databases of patients with a new diagnosis of RA was conducted: 430 patients followed in an EAC were enrolled, and 4 non-EAC controls were randomly matched for each. During 2 years of follow-up, the mean health care costs (outpatient, inpatient, pharmaceutical, and global) and 3 effectiveness measures (number and length of hospitalization and quality of care) of the EAC and non-EAC were estimated. The incremental cost-effectiveness ratio was calculated as well as the cost-effectiveness acceptability curve. RESULTS: The cohorts included patients with a mean age of 55.4 years, and 1,506 patients (70%) were female. The mean pharmaceutical (2,602 versus 1,945 euros) and outpatient (2,447 versus 1,778 euros) costs were higher in the EAC cohort. Conversely, a higher rate of non-EAC patients had a low adherence to quality-of-care indicators. The expected number of hospitalizations and the length of stay were statistically significantly higher in the non-EAC versus EAC. CONCLUSION: Despite an expected increase in outpatient costs (visits and diagnostic tests) and pharmaceutical costs, the reduction in terms of number and length of hospitalizations and the higher adherence to international quality-of-care guidelines support the effectiveness of the EAC model.

As startups no contexto da organização capitalista financeira e as subjetividades empreendedoras / Startups in the context of financial capitalist organization and entrepreneurial subjectivities / Startups en el contexto de la organización capitalista financiera y subjetividades emprendedoras

As startups são empresas que apresentam modelos de negócios marcados pela inovação, rapidez, flexibilidade e alta capacidade de adaptação aos mercados. Atuando em diferentes setores socioeconômicos, elas prometem criar e transformar produtos e serviços. A emergência e disseminação dessas empresas ocorrem em um momento histórico de mudanças iniciadas a partir de 1970 e marcadas pelas crises geradas com o esgotamento do paradigma da sociedade urbano industrial. No Brasil, o número desse modelo de negócio apresentou uma expansão expressiva, alcançando a marca de 13.374 nos últimos cinco anos. Atento a esse cenário, o objetivo desta pesquisa consistiu em compreender como sujeitos, grupos e instituições atribuem sentidos à experiência de trabalho nas chamadas startups. Na parte teórica, as condições sociais e econômicas que possibilitaram a emergência e disseminação das startups são analisadas em uma perspectiva crítica. A parte empírica, por sua vez, apresenta depoimentos de empreendedores relatando o contexto geral de atuação nas startups. Ao final deste artigo, conclui-se que há uma instrumentalização capitalística de componentes subjetivos específicos selecionados e colocados em circulação para fortalecer o modo de produção capitalista financeirizado.(AU)

Startups are companies that have business models characterized by innovation, speed, flexibility, and a high capacity to adapt to markets. Operating in different socioeconomic sectors, they promise to create and transform products and services. The emergence and dissemination of these companies occur at a historical moment of changes that began from 1970 and are marked by the crises generated by the exhaustion of the paradigm of industrial urban society. In Brazil, the number of businesses in this model showed a significant expansion, reaching 13,374 companies in the last five years. Attentive to this scenario, the objective of this research was to understand how subjects, groups, and institutions attribute meanings to the work experience in so-called startups. In the theoretical part, the social and economic conditions that enabled the emergence and dissemination of startups are analyzed in a critical perspective. The empirical part presents entrepreneurs reporting the general context of action in startups. At the end of this article, it is concluded that there is a capitalistic instrumentalization of specific subjective components that are selected and put into circulation to strengthen the financed capitalist production.(AU)

Las startups son empresas que tienen modelos de negocio marcados por la innovación, la velocidad, la flexibilidad y una alta capacidad de adaptación a los mercados. Desde diferentes sectores socioeconómicos, las startups prometen crear y transformar productos y servicios. La aparición y difusión de estas empresas se produce en un momento histórico de cambios que comenzó a partir de 1970 y que está marcado por crisis generadas por el agotamiento del paradigma de la sociedad urbana industrial. En Brasil, estas empresas se expandieron significativamente alcanzando la marca de 13.374 empresas en los últimos cinco años. En este escenario, el objetivo de esta investigación fue entender cómo los sujetos, grupos e instituciones atribuyen significados a la experiencia laboral en las startups. En la parte teórica, se analizan las condiciones sociales y económicas que permitieron el surgimiento y la difusión de las startups en una perspectiva crítica. La parte empírica presenta testimonios de emprendedores que informan sobre el trabajo en startups. La investigación concluye que hay una instrumentalización capitalista de componentes subjetivos específicos que se seleccionan y ponen en circulación para fortalecer el modo de producción capitalista financiero.(AU)

Assessment of the impact of organisational model of transvenous lead extraction on the effectiveness and safety of procedure: an observational study.

OBJECTIVES: To estimate the impact of the organisational model of transvenous lead extraction (TLE) on effectiveness and safety of procedures. DESIGN: Post hoc analysis of patient data entered prospectively into a computer database. SETTING: Data of all patients undergoing TLE in three centres in Poland between 2006 and 2021 were analysed. PARTICIPANTS: 3462 patients including: 985 patients undergoing TLE in a hybrid room (HR), with cardiac surgeon (CS) as co-operator, under general anaesthesia (GA), with arterial line (AL) and with transoesophageal echocardiography (TEE) monitoring (group 1), 68 patients-TLE in HR with CS, under GA, without TEE (group 2), 406 patients-TLE in operating theatre (OT) using 'arm-C' X-ray machine with CS under GA and with TEE (group 3), 154 patients-TLE in OT with CS under GA, without TEE (group 4), 113 patients-TLE in OT with anaesthesia team, using the 'arm-C' X-ray machine, without CS (group 5), 122 patients-TLE in electrophysiology lab (EPL), with CS under intravenous analgesia without TEE and AL (group 6), 1614 patients-TLE in EPL, without CS, under intravenous analgesia without TEE and AL (group 7). KEY OUTCOME MEASURE: Effectiveness and safety of TLE depending on organisational model. RESULTS: The rate of major complications (MC) was higher in OT/HR than in EPL (2.66% vs 1.38%), but all MCs were treated successfully and there was no MC-related death. The use of TEE during TLE increased probability of complete procedural succemss achieving about 1.5 times (OR=1.482; p<0.034) and were connected with reduction of minor complications occurrence (OR=0.751; p=0.046). CONCLUSIONS: The most important condition to avoid death due to MC is close co-operation with cardiac surgery team, which permits for urgent rescue cardiac surgery. Continuous TEE monitoring plays predominant role in immediate decision on rescue sternotomy and improves the effectiveness of procedure.