Rethinking the Healthcare Facilities: The Role of the Buffer Space.

OBJECTIVES: A working group conducted a survey on the use of the principle of buffer space (BS), which in case of emergencies, could benefit healthcare settings. The aim of the preliminary investigation is to define new research lines in hospitals' functional design. BACKGROUND: The global experience of the COVID-19 pandemic highlighted challenges faced by hospitals when responding promptly to emergencies, including spatial reorganization and suspension of ordinary medical activities for ensuring adequate management of the emergency surge of patients. METHODS: The group designed questionnaires to be administered to healthcare staff and healthcare designers aimed at understanding varied conceptions and features of BSs. Content across the two surveys overlapped significantly, allowing for direct comparisons of responses, while also including tailored questions in relation to the respective experience and skills of the two groups of respondents. RESULTS: 102 healthcare professionals and 56 designers took part to the survey. Analysis of the responses permitted for initial recommendations regarding BS typology including (a) proximity to the emergency department (ED), intensive care units (ICUs), and inpatient wards (IWs); (b) location within hospitals but separate from other medical areas; (c) need for independent access; (d) organizational and spatial features similar to ED, ICUs, and IWs; (e) existing as a fully flexible operational space; and (f) BS bed capacity to be approximately 12% of ED beds. CONCLUSIONS: Although the analysis is related to the Italian context, the expansion of this preliminary research to alternate healthcare facilities and geographic areas is necessary for reaching a wide consensus by different professionals on this field. It serves as a starting point for future investigations regarding the implementation of BS in hospital settings.

Structural accreditation of healthcare facilities: comparison of the requirements by Italian Presidential Decree 14/01/1997 and regional regulations. A proposal for updating the minimum environmental units at national level.

BACKGROUND AND AIM: The Decree of the President of the Italian Republic 14/01/1997 is the reference norm related to the accreditation of public and private healthcare structures. This guideline establishes the minimum structural, technological and organizational requirements that each structure operating in the Italian territory must comply with. METHODS: In occasion of the project work for the postgraduate training course in healthcare management by ALTEMS School, a team of researchers conducted a survey on the state of updating of the minimum structural requirements indicated in the norm-in particular those relating to hospital facilities- with those adopted by the individual regions through the analysis of the most up-to-date regional regulations. RESULTS: Precisely starting from the comparison of regional references and from the regulations on the subject of structural accreditation which suggest strategic environmental units and which address some key-aspects relating to the contemporary design of healing environments (i.e. semi-intensive care units, hybrid operating theatres, etc.), the outcome of the project work is to define a proposal to update the national reference document, also in the light of the currently changing needs in terms of hospital design. CONCLUSIONS: The research aims to become a starting milestone for future investigations. The team investigated - in this first phase - the functional areas listed in the norm, and the next step aims to extend the analysis also to the innovative functions (i.e. buffer spaces, hybrid operating theatres, sub-intensive care units, etc.) and/or introduced only the last years which have only been regulated in some regions.

Public health leadership in the COVID-19 era: how does it fit? A scoping review.

The COVID-19 pandemic has put a lot of pressure on all the world's health systems and public health leaders who have often found themselves unprepared to handle an emergency of this magnitude. This study aims to bring together published evidence on the qualities required to leaders to deal with a public health issue like the COVID-19 pandemic. This scoping literature review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. A search of relevant articles was performed in the PubMed, Scopus and Web of Science databases. A total of 2499 records were screened, and 45 articles were included, from which 93 characteristics of effective leadership were extrapolated and grouped into 6 clusters. The qualities most frequently reported in the articles were human traits and emotional intelligence (46.7%) and communication skills such as transparency and reliability (48.9%). Responsiveness and preparedness (40%), management skills (33.3%) and team working (35.6%) are considered by a significant percentage of the articles as necessary for the construction of rapid and effective measures in response to the emergency. A considerable proportion of articles also highlighted the need for leaders capable of making evidence-based decisions and driving innovation (31.1%). Although identifying leaders who possess all the skills described in this study appears complex, determining the key characteristics of effective public health leadership in a crisis, such as the COVID-19 pandemic, is useful not only in selecting future leaders but also in implementing training and education programmes for the public health workforce.

Narrative Review of the COVID-19 Pandemic's First Two Years in Italy.

Italy was the first country in the western world to be affected by the COVID-19 pandemic, arguably among the worst-affected ones, counting 12 million cases and 150 thousand deaths two years since the first case. Facing new challenges, Italy has enacted different strategies and policies to limit the spread of the SARS-CoV-2 virus and treat those affected by COVID-19. This narrative review provided an overview of factors, measures, and actions that shaped Italy's first two years of the COVID-19 pandemic by investigating epidemiological data and using a mixed-method approach. This narrative review aimed to summarize the most relevant aspects and measures and analyze available data to provide policymakers and healthcare providers with the instruments to learn from this pandemic and improve their preparedness for future pandemic events. The first two years of the pandemic differ in that, during the first year, significant necessary changes to the way health systems were organized were implemented, increasing healthcare spending and adopting social and physical distancing measures that were stricter than the ones adopted in the second year. However, as the pandemic progressed, increased knowledge of the virus and related variants, as well as the introduction of highly effective vaccines, which were not equally available to the whole population, resulted in a stratification of COVID-19 infections and deaths based on factors such as age, vaccination status, and individual susceptibility to the virus.

Leadership Effectiveness in Healthcare Settings: A Systematic Review and Meta-Analysis of Cross-Sectional and Before-After Studies.

To work efficiently in healthcare organizations and optimize resources, team members should agree with their leader's decisions critically. However, nowadays, little evidence is available in the literature. This systematic review and meta-analysis has assessed the effectiveness of leadership interventions in improving healthcare outcomes such as performance and guidelines adherence. Overall, the search strategies retrieved 3,155 records, and 21 of them were included in the meta-analysis. Two databases were used for manuscript research: PubMed and Scopus. On 16th December 2019 the researchers searched for articles published in the English language from 2015 to 2019. Considering the study designs, the pooled leadership effectiveness was 14.0% (95%CI 10.0-18.0%) in before-after studies, whereas the correlation coefficient between leadership interventions and healthcare outcomes was 0.22 (95%CI 0.15-0.28) in the cross-sectional studies. The multi-regression analysis in the cross-sectional studies showed a higher leadership effectiveness in South America (ß = 0.56; 95%CI 0.13, 0.99), in private hospitals (ß = 0.60; 95%CI 0.14, 1.06), and in medical specialty (ß = 0.28; 95%CI 0.02, 0.54). These results encourage the improvement of leadership culture to increase performance and guideline adherence in healthcare settings. To reach this purpose, it would be useful to introduce a leadership curriculum following undergraduate medical courses.

Health technology assessment applied to emergency preparedness: a new perspective.

Emergency preparedness is a continuous quality improvement process through which roles and responsibilities are defined to effectively anticipate, respond to, and recover from the impact of emergencies. This process results in documented plans that provide a backbone structure for developing the core capacities to address health threats. Nevertheless, several barriers can impair an effective preparedness planning, as it needs a 360° perspective to address each component according to the best evidence and practice. Preparedness planning shares common principles with health technology assessment (HTA) as both encompass a multidisciplinary and multistakeholder approach, follow an iterative cycle, adopt a 360° perspective on the impact of intervention measures, and conclude with decision-making support. Our "Perspective" illustrates how each HTA domain can address different component(s) of a preparedness plan that can indeed be seen as a container of multiple HTAs, which can then be used to populate the entire plan itself. This approach can allow one to overcome preparedness barriers, providing an independent, systematic, and robust tool to address the components and ensuring a comprehensive evaluation of their value in the mitigation of the impact of emergencies.

The fourth edition of the European Network for Health Technology Assessment Forum: highlights and outcomes.

The European Network for Health Technology Assessment (EUnetHTA) organizes an annual Forum with stakeholders to receive feedback on its activities, processes, and outputs produced. The fourth edition of the EUnetHTA Forum brought together representatives of HTA bodies, patient organizations, healthcare professionals (HCPs), academia, payers, regulators, and industry. The aim of this paper is to provide an overview of the highlights presented at the 2019 EUnetHTA Forum, reporting the main items and themes discussed in the plenary panel and breakout sessions. The leading topic was the concept of unmet medical need seen from different stakeholders' perspectives. Breakout sessions covered the joint production of assessment reports and engagement with payers, patients, and HCPs. Synergies, pragmatism, and inclusiveness across Member States and stakeholders were emphasized as leading factors to put in place a collaboration that serves the interest of patients and public health in a truly European spirit.

HEALTH TECHNOLOGY ASSESSMENT EVIDENCE ON E-HEALTH/M-HEALTH TECHNOLOGIES: EVALUATING THE TRANSPARENCY AND THOROUGHNESS.

OBJECTIVES: Evaluation is crucial for integration of e-Health/m-Health into healthcare systems and health technology assessment (HTA) could offer sound methodological basis for these evaluations. Aim of this study was to look for HTA reports on e-Health/m-Health technologies and to analyze their transparency, consistency and thoroughness, with the goal to detect areas that need improvement. METHODS: PubMed, ISI-WOS, and University of York - Centre for Reviews and Dissemination-electronic databases were searched to identify reports on e-Health/m-Health technologies, published up until April 1, 2016. The International Network of Agencies for Health Technology Assessment (INAHTA) checklist was used to evaluate transparency and consistency of included reports. Thoroughness was assessed by checking the presence of domains suggested by the European network for Health Technology Assessment (EUnetHTA) HTA Core Model. RESULTS: Twenty-eight reports published between 1999 and 2015 were included. Most were delivered by non-European countries (71.4 percent) and only 35.7 percent were classified as full reports. All the HTA reports defined the scope of research whereas more than 80 percent provided author details, summary, discussed findings, and conclusion. On the contrary, policy and research questions were clearly defined in around 30 percent and 50 percent of reports. With respect to the EUnetHTA Core Model, around 70 percent of reports dealt with effectiveness and economic evaluation, more than 50 percent described health problem and approximately 40 percent organizational and social aspects. CONCLUSIONS: E-Health/m-Health technologies are increasingly present in the field of HTA. Yet, our review identified several missing elements. Most of the reports failed to respond to relevant assessment components, especially ethical, social and organizational implications.

COPD management as a model for all chronic respiratory conditions: report of the 4th Consensus Conference in Respiratory Medicine.

BACKGROUND: Non-communicable diseases (NCDs) kill 40 million people each year. The management of chronic respiratory NCDs such as chronic obstructive pulmonary disease (COPD) is particularly critical in Italy, where they are widespread and represent a heavy burden on healthcare resources. It is thus important to redefine the role and responsibility of respiratory specialists and their scientific societies, together with that of the whole healthcare system, in order to create a sustainable management of COPD, which could become a model for other chronic respiratory conditions. METHODS: These issues were divided into four main topics (Training, Organization, Responsibilities, and Sustainability) and discussed at a Consensus Conference promoted by the Research Center of the Italian Respiratory Society held in Rome, Italy, 3-4 November 2016. RESULTS AND CONCLUSIONS: Regarding training, important inadequacies emerged regarding specialist training - both the duration of practical training courses and teaching about chronic diseases like COPD. A better integration between university and teaching hospitals would improve the quality of specialization. A better organizational integration between hospital and specialists/general practitioners (GPs) in the local community is essential to improve the diagnostic and therapeutic pathways for chronic respiratory patients. Improving the care pathways is the joint responsibility of respiratory specialists, GPs, patients and their caregivers, and the healthcare system. The sustainability of the entire system depends on a better organization of the diagnostic-therapeutic pathways, in which also other stakeholders such as pharmacists and pharmaceutical companies can play an important role.

Health assessments for health governance-concepts and methodologies.

Background: For better supporting the science-governance interface, the potential of health assessments appears underrated. Aims: To identify what various types of health assessment have in common; how they differ; which assessment(s) to apply for which purpose; and what needs and options there are for future joint development. Methods: This review is based on five types of health assessment: monitoring/surveillance/reporting, assessment of health impact, of health technology, of health systems performance, health-related economic assessment. The approach is exploratory and includes: applying an agreed set of comparative criteria; circulating and supplementing synoptic tables; and interpreting the results. Results: Two of the assessments deal with the question 'Where do we stand?', two others with variants of 'What if' questions. Economic Assessment can take place in combination with any of the others. The assessments involve both overall 'procedures' and a variety of 'methods' which inescapably reflect some subjective assumptions and decisions, e.g. on issue framing. Resources and assistance exist for all these assessments. The paper indicates which type of assessment is appropriate for what purpose. Conclusions: Although scientific soundness of health assessments is not trivial to secure, existing types of health assessment can be interpreted as a useful 'toolkit' for supporting governance. If current traces of 'silo' thinking can be overcome, the attainability of a more unified culture of health assessments increases and such assessments might more widely be recognized as a prime, 'tried and tested' way to voice Public Health knowledge and to support rational governance and policy-making.

Cost-effectiveness analysis of oral fentanyl formulations for breakthrough cancer pain treatment.

Breakthrough cancer Pain (BTcP) has a high prevalence in cancer population. Patients with BTcP reported relevant health care costs and poor quality of life. The study assessed the cost-effectiveness of the available Oral Fentanyl Formulations (OFFs) for BTcP in Italy. A decision-analytical model was developed to estimate costs and benefits associated with treatments, from the Italian NHS perspective. Expected reductions in pain intensity per BTcP episodes were translated into, percentage of BTcP reduction, resource use and Quality-Adjusted-Life-Years (QALYs). Relative efficacy, resources used and unit costs data were derived from the literature and validated by clinical experts. Probabilistic and deterministic sensitivity analyses were performed. At base-case analysis, Sublingual Fentanyl Citrate (FCSL) compared to other oral formulations reported a lower patient's cost (€1,960.8) and a higher efficacy (18.7% of BTcP avoided and 0.0507 QALYs gained). The sensitivity analyses confirmed the main results in all tested scenarios, with the highest impact reported by BTcP duration and health care resources consumption parameters. Between OFFs, FCSL is the cost-effective option due to faster reduction of pain intensity. However, new research is needed to better understand the economic and epidemiologic impact of BTcP, and to collect more robust data on economic and quality of life impact of the different fentanyl formulations. Different fentanyl formulations are available to manage BTcP in cancer population. The study is the first that assesses the different impact in terms of cost and effectiveness of OFFs, providing new information to better allocate the resources available to treat BTcP and highlighting the need of better data.

[An effective clinical leadrship to strenghten the immunization policies in Italy]. / Una leadership medica efficace a tutela della prevenzione vaccinale in Italia.

Effective governance for health is a prerequisite for implementing a transformation in healthcare. Any change, in order to be fully implemented, requires a strong and transparent leadership. The recent drop in vaccine cover has led our National Health Service to implement a number of changes in health prevention and immunization strategies that make vaccination an optimal paradigm of how healthcare leadership should not remain the focus of few scientists and public health specialists, but it should be more and more widespread at all levels. In fact, as in other areas of health, the implementation of a national evidence-based planning through efficient organization and management is not sufficient to ensure good results, but it is necessary that the whole system - institutions, policy makers, healthcare professionals, media and citizens themselves - is actively involved in driving change, promoting ethical, economic and social value of vaccinations.

How to choose health technologies to be assessed by HTA? A review of criteria for priority setting.

INTRODUCTION: Health Technology Assessment (HTA) plays a key role in the policy and decision-making process. Nevertheless, it is time- and resource-consuming, and therefore requires proper resource allocation. Priority setting, as a best way to organize effective and explicit resource allocation systems, may be applied even in this field. OBJECTIVE: The aim of this study was to provide an overview of criteria used for priority setting in HTA at European level. METHODS: A systematic review of the scientific literature was performed through PubMed alongside consultation of the websites of the European HTA Agencies belonging to the INAHTA. The search was limited to papers written in English and provided with the full text. Documents were considered eligible if providing criteria for priority setting in HTA. RESULTS: Seven scientific articles were retrieved from PubMed and 14 European HTA Agencies released prioritization criteria were analysed. The most relevant criteria were: frequency/burden of disease, economic impact and costs, potential benefits, impact on ethical, social, cultural and/or legal aspects. CONCLUSION: This work is meant to contribute to supranational discussion on priority setting at European level and shows that, despite the available evidence, work still needs to be done toward harmonization and sharing of the criteria to adopt.

An EFQM excellence model for integrated healthcare governance.

PURPOSE: The purpose of this paper is to account for a ten-year experience with the European Foundation for Quality Management (EFQM) Excellence Model implemented in the Trento Healthcare Trust. DESIGN/METHODOLOGY/APPROACH: Since 2000, the EFQM Excellence Model provided an overarching framework to streamline business process governance, to support and improve its enablers and results. From 2000 to 2009, staff performed four internal (self) and four external EFQM-based assessments that provided guidance for an integrated management system. Over the years, key controls and assurances improved service quality through business planning, learning and practice cycles. FINDINGS: Rising assessment ratings and improving results characterized the journey. The average self-assessment score (on a 1,000 points scale) was 290 in 2001, which increased to 610 in 2008. Since 2006, the Trust has been Recognized for Excellence (four stars). The organization improved significantly on customer satisfaction, people results and key service delivery and outcomes. PRACTICAL IMPLICATIONS: The EFQM Model can act as an effective tool to meet governance demands and promote system-level results. The approach to integrated governance discussed here may support similar change processes in comparable organizations. ORIGINALITY/VALUE: The paper describes a unique experience when implementing EFQM within a large Italian healthcare system, which had a broader reach and lasted longer than any experience in Italian healthcare.

Educational and organizational interventions to improve the usefulness of clinical pharmacological advice for personalized drug dosing based on therapeutic drug monitoring.

This study was aimed at increasing the clinical usefulness of clinical pharmacological advice (CPA) for personalized drug dosing based on therapeutic drug monitoring (TDM). Educational and organizational interventions focused on improving the knowledge of clinical pharmacology among hospital healthcare workers and reducing the incidence of errors throughout the process were planned. After a pre-interventional period of risk assessment, different list forms of the types of error occurring in the various phases of the process (Phase 1, request for CPA and blood sampling for TDM; Phase 2, sample delivery to and check in at the CPU; Phase 3, TDM execution and CPA production) were created. In the interventional period, the errors were collected daily and educational programmes were carried out. The pre-intervention error rate was 19.5%, and resulted significantly higher for the requests coming from the medical wards compared with those from the surgical wards or the ICUs (26.0% versus 10.5% versus 13.7%, p < 0.001). The educational programme trained 303 nurses and 145 physicians. Afterwards, the error percentage progressively dropped (15.5% in the 2nd trimester; 12.3% in the 3rd one; 10.5% in the 4th one). The adopted strategy resulted in significant improvements which may be useful both to improve quality of patient care and to reduce waste in healthcare costs.

[Knowledge management and healthcare organizations]. / Knowledge management e organizzazioni sanitarie.

The present scenario is characterized by a high "environmental turbulence". Healthcare professionals and organizations must increase their knowledge, skills and attitudes for choosing wisely. Healthcare organizations are complex adaptive systems which should use integrated governance systems: knowledge management should be a strategic goal. These organizations should become learning organizations: they should build and renovate their knowledge in a systematic, explicit and definite way.

Health technology assessment in Italy.

OBJECTIVES: The aim of this study was to review the history of health technology assessment (HTA) in Italy. METHODS: Founded in 1978, the Italian National Health Service (NHS) has been strongly regionalized mainly after a constitutional reform, which started a devolution process. HTA started in the 1980s at the National Institute of Health and in a few University Hospitals, with a focus on big ticket technology: that process was driven by clinical engineers. RESULTS: In recent years, HTA is becoming an important tool for decision-making processes at central, regional, and local levels. In particular, the National Agency for Regional Health Services (AGENAS) and five regions (of twenty-one) are strongly committed to develop HTA initiatives connected with the planning process. CONCLUSIONS: At the local level, the hospital-based HTA activity is probably the most important peculiarity of the country and the real driver of the HTA movement.