Search

Background Tumor Boards (TBs) are Multidisciplinary Team (MDT) meetings in which different specialists work together closely sharing clinical decisions in cancer care. The composition is variable, depending on the type of tumor discussed. As an organizational tool, MDTs are thought to optimize patient outcomes and to improve care performance. The aim of the study was to perform an umbrella review summarizing the available evidence on the impact of TBs on healthcare outcomes and processes. Methods Pubmed and Web of Science databases were investigated along with a search through citations. The only study design included was systematic review. Only reviews published after 1997 concerning TBs and performed in hospital settings were considered. Two researchers synthetized the studies and assessed their quality through the AMSTAR2 tool. Results Five systematic reviews published between 2008 and 2017 were retrieved. One review was focused on gastrointestinal cancers and included 16 studies; another one was centered on lung cancer and included 16 studies; the remaining three studies considered a wide range of tumors and included 27, 37 and 51 studies each. The main characteristics about format and members and the definition of TBs were collected. The decisions taken during TBs led to changes in diagnosis (probability to receive a more accurate assessment and staging), treatment (usually more appropriate) and survival (not unanimous improvement shown). Other outcomes less highlighted were quality of life, satisfaction and waiting times. Conclusions The study showed that the multidisciplinary approach is the best way to deliver the complex care needed by cancer patients; however, it is a challenge that requires organizational and cultural changes and must be led by competent health managers who can improve teamwork within their organizations. Further studies are needed to reinforce existing literature concerning health outcomes. Evidence on the impact of TBs on clinical practices is still lacking for many aspects of cancer care. Further studies should aim to evaluate the impact on survival rates, quality of life and patient satisfaction. Regular studies should be carried out and new process indicators should be defined to assess the impact and the performance of TBs more consistently.

This work aims to identify policies implemented for healthy food environments in Italy within The Healthy Food Environment Policy Index (Food-EPI) project.Food-EPI tool, which includes two components, thirteen domains and fifty good practice indicators, was adapted for the Italian context. Evidence for implementation was gathered and summarized for all fifty indicators from data sources such as governmental websites, non-government organizations publications and websites and via direct contact with Government officials.The highest level of evidence was found within five domains: food composition (2/2 indicators), labelling (3/4), promotion (4/5), provision (4/5) and leadership (5/5). The domains with less identified evidence were food prices (1/4), food in retail (0/4), trade and investment (0/2) and platforms and interaction (1/4).The evidence summarization and the upcoming stakeholders' meeting to rate the level of implementation for each indicator in Italy have the potential to improve Government commitment to shape healthier food environments.

Breast cancer is the most common malignancy in women, with a complex clinical path that involves several professionals and that requires a multidisciplinary approach. However, the effectiveness of breast cancer multidisciplinary care and the processes that contribute to its effectiveness have not yet been firmly determined. This study aims to evaluate the impact of multidisciplinary tumor boards on breast cancer care outcomes. A systematic literature review was carried out through Scopus, Web of Science and Pubmed databases. The search was restricted to articles assessing the impact of MTB implementation on breast cancer care. Fourteen studies were included in the review. The most analyzed outcomes were diagnosis, therapy and survival. Four out of four studies showed that, with implementation of an MTB, there was a change in diagnosis, and all reported changes in the treatment plan after MTB implementation. A pooled analysis of three studies reporting results on the outcome “mortality” showed a statistically significant 14% reduction in mortality relative risk for patients enrolled versus not enrolled in an MTB. This study shows that MTB implementation is a valuable approach to deliver appropriate and effective care to patients affected by breast cancer and to improve their outcomes.

Background Organizational aspects in Health Technology Assessment (HTA) reports play a significant role in managing policies and strategies to implement new health technologies. The organizational domain, however, is often under-represented in HTA reports. This study explored how organizational assessment is carried out in HTA reports and designed a new perspective through an empirical approach after the comparison with EUnetHTA's Core Model 3.0. Methods Full HTA reports were extracted from the websites of members of International Network of Agencies for HTA and the aspects relating to the organizational assessment were analysed. HTA reports were classified into 4 typologies of technologies (device, diagnosis/screening, intervention and organizational procedures) and organizational aspects described were explored through a framework of 5 domains and 15 subdomains from Core Model. Specific Multiple Correspondence Analyses were carried out to identify technology-related domains for organizational assessment in reports. Results The analysis showed that domains and subdomains of Core Model were not covered homogeneously by the organizational assessments in the HTA reports. Through Multiple Correspondence Analyses, four new technology-related dimensions were identified and named according to the Core Model’s subdomains in the four new clusters. Conclusions This study analyzed the significance of organizational assessments in current literature and the challenges of improving this domain in HTA reports. Through an empirical analysis, we proposed a new methodology to cover the most relevant aspects of organizational appraisal according to new domains to promote support to the assessment of organizational issues in reports and fulfil the needs of future HTA research.

Community-based mental healthcare (CBMH) aims at supplying psychiatric patients with rehabilitative care outside the hospital. The aim of this study was to compare the organization of CBMH in a cross-border region of Germany and the Netherlands.Semi-structured interviews gave insight into characteristics of CBMH approaches applied in the German region of Aachen (IHP) and the Dutch Province of Limburg (FACT). We applied a Delphi technique to select a performance indicator (PI) set for CBMH, which served as a conceptual model to allow comparison.Both approaches are flexible, patient-centred and include the evaluation of quality. Both provide financial and administrative support for the access.CBMH approaches appear to be equally valid from several perspectives even if they revealed, at the same time, important differences related to scope, integration with non-CBMH care resources and geographic coverage. Secondarily, the study provides a contribution to the development of a PI set to compare and evaluate CBMH approaches.Zusammenfassung HINTERGRUND: Gemeindebasierende psychiatrische Versorgung (GPV) zielt darauf ab, Patienten außerhalb des Krankenhauses mit Rehabilitationsmaßnahmen zu versorgen. Ziel dieser Studie war es, die Organisation von GPV-Ansätzen im Grenzgebiet Aachen zur Provinz Limburg zu vergleichen.Interviews gaben Einblicke in die Merkmale der beiden GPV Ansätze. Wir verwendeten Delphi-Verfahren, um ein Leistungsindikatorenset auszuwählen, das als Konzeptmodell diente. Wir verglichen 1) Stärkefallmanagement mit seinem individuellen Hilfeplan in der deutschen Region mit 2) funktioneller konsequenter Gemeinschaftsbehandlung mit seinem intensiven Fallmanagement in der niederländischen Region.Beide Ansätze sind flexibel, patientenorientiert und beinhalten die Bewertung von Qualität. Beide Ansätze bieten finanzielle und administrative Unterstützung für den Versorgungszugang.GPV-Ansätze scheinen aus vielerlei Hinsicht gleichermaßen gültig zu sein, auch wenn sie gleichzeitig wichtige Unterschiede in Bezug auf Umfang, Integration mit Nicht-GPV-Betreuungsressourcen und der geografischen Abdeckung aufzeigen. Sekundär liefert die Studie einen Beitrag zur Entwicklung eines Leistungsindikatorensets, um GPV-Ansätze zu bewerten und zu vergleichen.

Background To keep a high quality of assistance it is important for hospitals to invest in health technologies (HTs) that have the potential of improving health outcomes. Even though guidance exists on how HTs should be introduced, used and dismissed, there is a surprising gap in literature concerning the awareness of hospitals in the actual utilization of HTs. Methods We performed a systematic literature review of qualitative and quantitative studies aimed at investigating hospital contextual factors that influence the actual utilization of HTs. PubMed, Scopus, Web of Science, Econlit and Ovid Medline electronic databases were searched to retrieve articles published in English and Italian from January 2000 to January 2019. The quality of the included articles was assessed using the Critical Appraisal Skills Programme checklist for qualitative studies, Newcastle-Ottawa Scale for the cross-sectional studies and the Mixed Methods Appraisal Tool for mixed method studies. Results We included 33 articles, which were of moderate to high methodological quality. The included articles mostly addressed the contextual factors that impact the implementation of information and communication technologies (ICTs). Overall, for all HTs, the hospital contextual factors were part of four categories: hospital infrastructure, human resource management, financial resources and leadership styles. Conclusion Our systematic review reported that the contextual factors influencing the HTs utilization at hospital level are mainly explored for ICTs. Several factors should be considered when planning the implementation of a new HTs at hospital level. A potential publication bias might be present in our work, since we included articles published only in English and Italian Language, from January 2000 to January 2019. There remains a gap in the literature on the facilitators and barriers influencing the implementation and concrete utilization of medical and surgical HTs, suggesting the need for further studies for a better understanding.

Healthcare organisations are social systems in which human resources are the most important factor. Leadership plays a key role, affecting outcomes for professionals, patients and work environment. The aim of this research was to identify and analyse the knowledge present to date concerning the correlation between leadership styles and nurses’ job satisfaction. A systematic review was carried out on PubMed, CINAHL and Embase using the following inclusion criteria: impact of different leadership styles on nurses’ job satisfaction; secondary care; nursing setting; full-text available; English or Italian language. From 11,813 initial titles, 12 studies were selected. Of these, 88% showed a significant correlation between leadership style and nurses’ job satisfaction. Transformational style had the highest number of positive correlations followed by authentic, resonant and servant styles. Passive-avoidant and laissez-faire styles, instead, showed a negative correlation with job satisfaction in all cases. Only the transactional style showed both positive and negative correlation. In this challenging environment, leaders need to promote technical and professional competencies, but also act to improve staff satisfaction and morale. It is necessary to identify and fill the gaps in leadership knowledge as a future objective to positively affect health professionals’ job satisfaction and therefore healthcare quality indicators.

Background Patients’ increasing needs and expectations require an overall assessment of hospital performance. Several international agencies have defined performance indicators sets but there exists no unanimous classification. The Impact HTA Horizon2020 Project wants to address this aspect, developing a toolkit of key indicators to measure hospital performance. The aim of this review is to identify and classify the dimensions of hospital performance indicators in order to develop a common language and identify a shared evidence-based way to frame and address performance assessment. Methods Following the PRISMA statement, PubMed, Cochrane Library and Web of Science databases were queried to perform an umbrella review. Reviews focusing on hospital settings, published January 2000–June 2019 were considered. The quality of the studies selected was assessed using the AMSTAR2 tool. Results Six reviews ranging 2002–2014 were included. The following dimensions were described in at least half of the studies: 6 studies classified efficiency (55 indicators analyzed); 5 studies classified effectiveness (13 indicators), patient centeredness (10 indicators) and safety (8 indicators); 3 studies responsive governance (2 indicators), staff orientation (10 indicators) and timeliness (4 indicators). Three reviews did not specify the indicators related to the dimensions listed, and one article gave a complete definition of the meaning of each dimension and of the related indicators. Conclusions The research shows emphasis of the importance of patient centeredness, effectiveness, efficiency, and safety dimensions. Especially, greater attention is given to the dimensions of effectiveness and efficiency. Assessing the overall quality of clinical pathways is key in guaranteeing a truly effective and efficient system but, to date, there still exists a lack of awareness and proactivity in terms of measuring performance of nodes within networks. The effort of classifying and systematizing performance measurement techniques across hospitals is essential at the organizational, regional/national and possibly international levels to deliver top quality care to patients.

The WHO declared the novel coronavirus disease a pandemic, with severe consequences for health and global economic activity and Italy is one of the hardest hit countries. This study aims to assess the socio-economic burden of COVID-19 pandemic in Italy through the estimation of Disability-Adjusted Life Years (DALYs) and productivity loss. The observational study was based on data from official governmental sources collected since the inception of epidemic until 28 April 2020. DALYs for a disease combines the years of life lost due to premature mortality in the population and the years lost due to disability of the disease. In addition to DALYs, temporary productivity loss due to absenteeism from work and permanent productivity loss due to premature mortality were estimated using the Human Capital Approach. The total DALYs amount to 2.01 per 1000 persons. The total permanent productivity loss was around EUR 300 million while the temporary productivity loss was around EUR 100 million. This evaluation does not consider other economic aspects related to lockdown, quarantine of contacts, healthcare direct costs etc. The burden of disease methodology is functional metric for steering choices of health policy and allowing the government to be accountable for the utilization of resources.

Background The current economic context calls for rationalizing health resources that can be pursued through disinvestment from low value health technologies to invest in the best performing ones, ensuring high healthcare quality. Oncology is a field where, because of high costs of health technologies and rapid innovation, disinvestment is crucial. Methods On this basis, the research team investigated through a survey, based on a questionnaire, opinions and views of representatives of European countries about disinvestment, in terms of fields of application, potential advocates and barriers, specifically focusing on cancer care. Results A total of 17 questionnaires were filled in (response rate: 32.1%). The survey showed disinvestment is applied in several countries as a tool for containing health care expenditures and identifying obsolete technologies/ineffective interventions. Clinicians' resistance to change and industries' opposition are recognized as the most important barriers to the implementation of disinvestment policies. Potential targets of disinvestment in cancer are seen in diagnostic and therapeutic areas. Conclusion Despite the agreement on fields of waste and of disinvestment policies, operational methods to put disinvestment in place are lacking. Since they should rely on an inclusive assessment of the technology, Health Technology Assessment may represent a good approach.

Background In an era of a growing economic pressure for all health systems, the interest for “disinvestment” in healthcare increased. In this context, evidence based approaches such as Health Technology Assessment (HTA) are needed both to invest and to disinvest in health technologies. In order to investigate the extent of application of HTA in this field, methodological projects/frameworks, case studies, dissemination initiatives on disinvestment released by HTA agencies and organizations located in Europe were searched. Methods In July 2015, the websites of HTA agencies and organizations belonging to the European network for HTA (EUnetHTA) and the International Network of Agencies for HTA (INAHTA) were accessed and searched through the use of the term “disinvestment”. Retrieved deliverables were considered eligible if they reported methodological projects/frameworks, case studies and dissemination initiatives focused on disinvestment in healthcare. Results 62 HTA agencies/organizations were accessed and eight methodological projects/frameworks, one case study and one dissemination initiative were found starting from 2007. With respect to methodological projects/frameworks, two were delivered in Austria, one in Italy, two in Spain and three in U.K. As for the case study and the dissemination initiative, both came from U.K. The majority of deliverables were aimed at making an overview of existing disinvestment approaches and at identifying challenges in their introduction. Conclusions Today, in a healthcare context characterized by resource scarcity and increasing service demand, “disinvestment” from low-value services and reinvestment in high-value ones is a key strategy that may be supported by HTA. The lack of evaluation of technologies in use, in particular at the end of their lifecycle, may be due to the scant availability of frameworks and guidelines for identification and assessment of obsolete technologies that was shown by our work. Although several projects were carried out in different countries, most remain constrained to the field of research. Disinvestment is a relatively new concept in HTA that could pose challenges also from a methodological point of view. To tackle these challenges, it is necessary to construct experiences at international level with the aim to develop new methodological approaches to produce and grow evidence on disinvestment policies and practices. Electronic supplementary material The online version of this article (10.1186/s12913-018-2941-0) contains supplementary material, which is available to authorized users.

Background Public reporting (PR) of healthcare (HC) provider's quality was proposed as a public health instrument for providing transparency and accountability in HC. Our aim was to assess the impact of PR on five main domains: quality improvement; patient choice, service utilization and market share; provider's perspective; patient experience; and unintended consequences. Methods PubMed, Scopus, ISI WOS, and EconLit databases were searched to identify studies investigating relationships between PR and five main domains, published up to April 1, 2016. Results Sixty-two papers published between 1988 and 2015 were included. Nineteen studies investigated quality improvement, 19 studies explored the unintended consequences of PR, 10 explored the effects on market share, 10 on patients' choice, 7 evaluated the provider's perspective, 4 economic outcome, 4 service utilization, 2 purchasers' use of PR and 2 studies explored patient experiences. The effect of PR was diverse throughout the studies-mostly positive on: patient experience (100%), quality improvement (63%), patient choice, service utilization and market share (46%); mixed on provider's perspective and economic outcome (27%) and mainly negative on unintended consequences (68%). Conclusions Our research covering different outcomes and settings reported that PR is associated with changes in HC provider's behavior and can influence market share. Unintended consequences are a concern of PR and should be taken into account when allocating HC resources. The experiences collected in this paper could give a snapshot about the impact of PR on a HC user's perception of the providers' quality of care, helping them to make empowered choices.

The aim of this study was to review experiences of use of the Lean methodology in the hospital setting and assess the impact of the interventions in terms of time of processes, productivity, effects on staff and patientd satisfaction.PubMed, Scopus and CINAHL databases were searched to identify studies evaluating the lean methodology. Two reviewers screened the citations identified and extracted data according to the PRISMA methodology.In total, 635 citations were identified, of which 27 were included in the present review. Most studies showed a positive outcome related to the implementation of the Lean methodology and tools.

Purpose A clinical pathway for patients with acute ischemic stroke was implemented in 2014 by one Italian teaching hospital multidisciplinary team. The purpose of this paper is to determine whether this clinical pathway had a positive effect on patient management by comparing performance data. Design/methodology/approach Volume, process and outcome indicators were analyzed in a pre-post retrospective observational study. Patients’ (admitted in 2013 and 2015) medical records with International Classification of Diseases, ICD-9 code 433.x (precerebral artery occlusion and stenosis), 434.x (cerebral artery occlusion) and 435.x (transient cerebral ischemia) and registered correctly according to hospital guidelines were included. Findings An increase context-sensitive in-patient numbers with more severe cerebrovascular events and an increase in patient transfers from the Stroke to Neurology Unit within three days (70 percent, p=0.25) were noted. Clinical pathway implementation led to an increase in patient flow from the Emergency Department to dedicated specialized wards such as the Stroke and Neurology Unit (23.7 percent, pp=0.85) and no statistically significant differences in 30-day mortality. Research limitations/implications The pre-post retrospective observational study design was considered suitable to evaluate likely changes in patient flow after clinical pathway implementation, even though this design comes with limitations, describing only associations between exposure and outcome. Originality/value Clinical pathway implementation showed an overall positive effect on patient management and service efficiency owing to the standardized application in time-dependent protocols and multidisciplinary/integrated care implementation, which improved all phases in acute ischemic stroke care.

The aim of this study was to map a patient's journey along all stages of his daily care path in an Oncology outpatient department, to identify and eliminatequot;bottleneckquot; situations that interfere with the patient's flow of care. The main key performance indicators used in the study were: waiting times for each stage of the care process, time required for each activity, and resources used.The study was conducted from 17-30 January 2018 at the medical oncology clinic of a large university teaching and research hospital in Italy. We analyzed all the healthcare services provided during the monitoring period, dividing them into: first appointments, therapy, visits for adjustments of the therapeutic plan, visits for i.v. therapy, visits for oral therapy, follow-up visits, other visits (e.g. for positioning of peripherally inserted central catheter). Data collection was performed by administering two questionnaires: a Patient Journey (PJ) questionnaire to patients and a Medical Journey (MJ) questionnaire to clinicians. This project employed Lean principles in order to: view the process and specify value through the patient's point of view, identify waste in processes and eliminate any steps lacking any added value, reduce variation of and leveling workload to improve quality and ?ow of care, engage patients and staff to redesign the process.The response rate in 1351 outpatients who were invited to participate was 63%; for doctors it was 81%. The mean waiting time for first visits and follow up visits performed in a single day was 50 minutes. An audit process was thus performed and a series of quality improvement measures were defined and shared with health professionals.The Lean methodology could provide a robust framework for improved understanding and management of complex system constraints in outpatient oncology clinics, and could result in improved access to treatment and reduced waiting times for patients.

A Surgical Suite (SS) is a complex system in which different healthcare professionals work. Inefficient management could lead to waste of money and time and reduce quality of care. The aim of the study was to carry out an organizational assessment of a SS in northern Italy, in order to identify weaknesses and inadequacies related to its performance and promote strategies to increase efficiency. The study was conducted by process mapping of the working context, qualitative and quantitative analysis of patient documents and an evaluation of the critical issues using the root cause analysis (RCA) tool. The Plan Do Check Act (PDCA) method was used to implement the necessary changes. A detailed description of the staff involved, medical devices available, organization and timing of the SS was performed. Inefficiencies in the unit were caused mainly by insufficient medical devices and underusage of the radiological software Picture Archiving and Communication System (PACS). Root causes of inefficiencies were identified and classified into four areas: organization/structure, personnel, technologies and methods. In particular, critical issues were identified in: the planning processes, the heterogeneity of technical and Information technology skills and educational background of nursing staff, the presence of several computerized information systems and lack of a connection interface between the different software, the lack of internal procedures and paths and lack of continuing professional education opportunities. Two multidisciplinary working tables were launched by the hospital management in order to identify improvement strategies. The evaluation allowed us to define the root causes of SS inefficiency in this hospital, leading to a reorganization with a view to continuous improvement. An innovative aspect of the present study was the use of RCA to perform an organizational assessment in healthcare, rather than as a reactive risk management tool.

Background The elderly, defined here as subjects aged ≥ 65 years, are among at-risk subjects for whom annual influenza vaccination is recommended. For the 2018/19 season, three vaccine types are available for the elderly in Italy: trivalent inactivated vaccine (TIV), adjuvanted TIV (aTIV) and quadrivalent inactivated vaccines (QIV). No health technology assessment (HTA) of seasonal influenza vaccination in the elderly has previously been conducted in Italy. Methods An HTA was conducted in 2017 to analyze the burden of influenza illness, the characteristics, efficacy, safety and cost-effectiveness of available vaccines and the related organizational and ethical implications. This was then contextualized to the 2018/19 influenza season. Comprehensive literature reviews/analyses were performed and a static mathematical model developed in order to address the above issues. Results In Italy, influenza is usually less common in the elderly than in other age-classes, but the burden of disease is the highest; >10% of infected elderly subjects develop complications, and about 90% of all influenza-related deaths occur in this age-class. All available vaccines are effective, safe and acceptable from an ethical standpoint. However, aTIV has proved more immunogenic and effective in the elderly. Furthermore, from the third payer’s perspective, aTIV is highly cost-effective and cost-saving in comparison with TIV and QIV, respectively. Nevertheless, vaccination coverage needs to be improved. Conclusions According to this HTA, aTIV appeared the vaccine of choice in the elderly. HTA should be reapplied whenever new relevant data become available.

Clinical Governance (CG) is a validated framework for continuous quality improvement in health care settings. Quality medical records may reflect the quality of care delivered and are a viable tool to implement CG skills.Aim of this study is to investigate the correlation between the level of implementation of CG dimensions and the quality of medical records.A cross-sectional study was carried out in an Italian Teaching Hospital. CG implementation levels were quantified through a systematic methodology (OPTIGOV©). The overall quality of medical records was measured through a revised version of a National-validated scale. A multiple linear regression model was used to test the likely influence of all the variables constituting the OPTIGOV evaluation on the quality of medical records. 47 hospital wards and 1458 medical records were assessed.A significant and positive association between the quality of medical records and the accountability score (β = 0.15; p0.01) and the clinical audit score (b = 0.11; p = 0.02), was found. Conversely, the risk management score shown a negative and significant correlation (b = -0.17; p0.01). This study confirms that CG plays a central role in driving quality improvement and advocates a systematic implementation of such an approach within healthcare organizations.

Objective: To assess the impact of electronic health record (EHR) on healthcare quality, we hence carried out a systematic review and meta-analysis of published studies on this topic. Methods: PubMed, Web of Knowledge, Scopus and Cochrane Library databases were searched to identify studies that investigated the association between the EHR implementation and process or outcome indicators. Two reviewers screened identified citations and extracted data according to the PRISMA guidelines. Meta-analysis was performed using the random effects model for each indicator. Heterogeneity was quantified using the Cochran Q test and I2 statistics, and publication bias was assessed using the Egger’s test. Results: Of the 23 398 citations identified, 47 articles were included in the analysis. Meta-analysis showed an association between EHR use and a reduced documentation time with a difference in mean of −22.4% [95% confidence interval (CI) = −38.8 to −6.0%; P < 0.007]. EHR resulted also associated with a higher guideline adherence with a risk ratio (RR) of 1.33 (95% CI = 1.01 to 1.76; P = 0.049) and a lower number of medication errors with an overall RR of 0.46 (95% CI = 0.38 to 0.55; P < 0.001), and adverse drug effects (ADEs) with an overall RR of 0.66 (95% CI = 0.44 to 0.99; P = 0.045). No association with mortality was evident ( P = 0.936). High heterogeneity among the studies was evident. Publication bias was not evident. Conclusions: EHR system, when properly implemented, can improve the quality of healthcare, increasing time efficiency and guideline adherence and reducing medication errors and ADEs. Strategies for EHR implementation should be therefore recommended and promoted.

Background: Obesity represents an important public health issue. An assessment of its costs would be useful to provide recommendations for policy and decision-making strategies. The aims of our study were to carry out a systematic review to assess the economic burden of adult obesity in terms of direct and indirect costs and to perform a quality appraisal of the analysed studies. Methods: A literature search was carried out on PubMed, Scopus and Cochrane Library to retrieve cost-of-illness (COI) analyses focused on adult (aged 18 years or more) overweight or obese people and published up to 2013. COI analyses that considered direct and indirect costs were included. Each included manuscript was independently appraised by three groups of researchers on the basis of the British Medical Journal Drummond’s checklist. Results: Approximately 2044 articles were initially retrieved, and 17 were included in the current review. The included studies showed a medium–high-quality level. The available studies seemed to be heterogeneous both in terms of methodology and results reporting. However, as many studies have been conducted from the payer perspective, just direct medical costs can be considered exhaustive. As only three studies included considered also indirect costs, there is no strong evidence to give a comprehensive picture of this phenomenon also from the societal perspective. Conclusion: The review confirmed that obesity absorbs a huge amount of health-care resources. Further research is therefore needed to better understand the economic impact and to identify and promote public health strategies to tackle obesity.

Objective. The Health Technology Assessment (HTA) approach was applied to denosumab in the prevention of osteoporotic fractures in postmenopausal women.Method. Epidemiological, clinical, technical, economic, organizational, and ethical aspects were considered. Medical electronic databases were accessed to evaluate osteoporosis epidemiology and therapeutical approaches. A budget impact and a cost-effectiveness analyses were performed to assess economic implications. Clinical benefits and patient needs were considered with respect to organizational and ethical evaluation.Results. In Italy around four millions women are affected by osteoporosis and have a higher risk for fractures with 70,000 women being hospitalized every year. Bisphosphonates and strontium ranelate are recommended as first line treatment for the prevention of osteoporotic fractures. Denosumab is effective in reducing vertebral, nonvertebral, and hip/femoral fractures with an advantage of being administered subcutaneously every six months. The budget impact analysis estimated a reduction in costs for the National Health Service with the introduction of denosumab. Furthermore, the economic analysis demonstrated that denosumab is cost-effective in comparison to oral bisphosphonates and strontium ranelate. Denosumab can be administered in outpatients by involving General Practitioners in the management. Ethical evaluation is positive because of its efficacy and compliance.Conclusion. Denosumab could add value in the prevention of osteoporotic fractures.

The Day Service was established in Italy to promote appropriateness of care and consists in the delivery of packages of complex outpatient services. A Working Group for the continuous improvement of pre-hospitalization activities of the Regina Elena Scientific Institute in Rome, Italy, established that the outpatient management of surgical patients in the hospital would occur in a Day Service, through a package of services identified at the regional level or appropriate diagnostic and therapeutic pathways. This article describes the experience of the hospital's Day Service and compares results from the last four months of 2013 with those of the first four months of 2014. The introduction of a Day Service has led to a reduction in the number of inappropriate pre-admission tests (mainly computerized tomography, magnetic resonance and Positron emission scans and scintigraphy) and this has had a positive impact not only in terms of organization, reduction of hospital stay and overall hospitalization-related activities, but also from an economic standpoint. The implementation of a Day Service has also improved the overall patient experience, from an organizational point of view, and this is an important aspect, considering that patients at the Regina Elena Scientific Institute are oncological patients, they are often elderly and most reside in other Italian regions.

Influenza epidemics are responsible for high mortality and morbidity rates in particular among elderly and high risk groups. This review is aimed at assessing the economic value of vaccination in these groups. A search of full economic evaluations of influenza vaccination in comparison with no interventions was performed on PubMed from January 1990 to May 2011. Only economic evaluations dealing with elderly and high risk groups were considered. The quality of selected articles was assessed through Drummond's checklist. Sixteen cost-effectiveness analyses and four cost-benefit analyses were included: overall, the quality of studies was fairly good. The vaccination was demonstrated to be cost-effective or cost-saving in almost all studies, independently by the perspective and the type of analysis. Influenza vaccination is a worthwhile intervention from the pharmacoeconomic view-point, anyway a standardization of methods should be desirable in order to guarantee the comparability and transferability of results.

Population ageing is a major challenge for European Union (EU) society and economy, particularly for Italy, which is the oldest country in Europe. According to the World Health Organization, two-thirds of European citizens who have reached the retirement age suffer from at least two chronic conditions, with a strong pressure on healthcare systems. Moreover, EU countries already spend, on average, more than a quarter of their gross domestic product on social protection, above all pensions, health and long term care. The current financial crisis is putting a strain on this system. In this context, it becomes increasingly necessary to promote a healthy and independent ageing, by improving outcomes for patients and society while ensuring health systems sustainability. To this purpose a proactive approach to chronic diseases prevention (primary, secondary and tertiary) as well as an integrated healthcare approach and also patients' empowerment are required so as to make daily life more age-friendly. It is also necessary to share health and social best practices, adopt policies really effective against elderly social exclusion and strengthen older people participation in society. A joint effort of all key stakeholders is needed to create a society in which older people can play an active role.

OBJECTIVES A meta-analysis of observational studies on association between cigarette smoking and pancreatic cancer was performed to focus, particularly, on the role of the studies' quality in affecting meta-analysis results. METHODS A bibliographic search was carried out on PubMed and EMBASE databases until February 15, 2008. Key words were "pancreatic neoplasms," "pancreatic cancer," "smoking," "smoke," "cigarette," "case-control studies," and "cohort studies." Studies about cigarette smoking and pancreatic cancer were selected and assessed on quality. STATA 9.0 was used. RESULTS Six cohort studies and 24 case-control studies were selected, with median quality scores of 8 (range, 3) and 10 (range, 8), respectively. Pooled case-control studies' odds ratio (OR) and cohort studies' risk ratio were, respectively, 1.45 (95% confidence interval [CI], 1.33-1.57) and 1.78 (95% CI, 1.64-1.92). After stratifying for quality scoring, high-quality-scored case-control studies yielded an OR of 1.38 (95% CI, 1.27-1.49), whereas the others gave an OR of 1.52 (95% CI, 1.34-1.73). The results of meta-analysis for cohort studies showed a risk ratio of 1.74 (95% CI, 1.61-1.90) and of 2.10 (95% CI, 1.64-2.67), respectively, for high- and low-quality score studies. CONCLUSIONS There is evidence that cigarette smoking is an important risk factor for pancreatic cancer, but the estimate of the association greatly relies on the studies' quality.

Medical malpractice and litigation have a significant impact on the Italian National Health Service. The aim of this study was to analyze the state of the art of medical errors in Italy, in particular, assessing which specialties are most affected.We performed a literature search in PubMed, Google Scholar; institutional websites (Ministry of Health, Higher Institute of Health, National Agency for Regional Health Services, National Institute of Statistics, National Research Council, Court of Auditors), gray literature and specialized magazines.Results show that data regarding the frequency of medical errors and the effectiveness of prevention measures in Italy are scarce. Most papers published on this topic refer to a few specialties, including Surgery, Radiology, Cardiology, and Laboratory medicine. Surgery is the specialty most affected.Despite a growing attention towards patient safety and quality of healthcare, medical errors continue to occur in clinical practice. Most errors are not due to individual incompetence or negligence but they are rooted in system breakdowns. A systematic approach is therefore required, based on: an analysis of critical aspects in the system; the selection and implementation, at different levels of the system, of appropriate and evidence-based risk management interventions involving all stakeholders; a context analysis to identify barriers and facilitators for change; a performance assessment to verify results and identify actions for improvement.

Background The quality of care includes several aspects which may be influenced by social-economic status. This study analyzes hospitalizations for several conditions, such as chronic diseases, cancer and appendectomy, in Italians and immigrant people living in Italy with the aim to evaluate possible inequalities in the quality of health care services due to migrant status, gender and geographical macro-areas (Northern, Central, Southern Italy). Methods The data source of hospital discharges for stroke, myocardial infarction, chronic liver disease, cervical cancer, mastectomy and appendectomy was the Ministry of Health. ICD 9 codes were used for data collection. Crude and standardized hospitalization rates per 100.000 were calculated. Italian resident population and an estimate of immigrants living in Italy were used as denominators while standardization was done with respect to the European population. The data we used covers the 2006–2008 period. Results Immigrants showed significantly higher hospitalization rates for stroke, cervical cancer and appendectomy and significantly lower hospitalization rates for chronic liver diseases and mastectomy. Males showed significantly higher hospitalization rates than females for myocardial infarction, chronic liver diseases and appendectomy. Notwithstanding, differences related to migrant status and gender varied according to geographical macro-area. With respect to that, Southern Italy showed significantly higher hospitalization rates for stroke, myocardial infarction and chronic liver diseases and significantly lower hospitalization rates for mastectomy and appendectomy. Conclusions The results of this study may reflect inequalities in the quality of health care, in particular in primary and secondary prevention, access to specialized care and inappropriateness, due to migrant status and gender. Also, differences between macro-areas suggest heterogeneities in the integration policies and the promotion of immigrants’ health. Research should be endorsed in this field in order to further describe inequalities and their reasons and in the light of supporting policies development. Electronic supplementary material The online version of this article (doi:10.1186/s12914-014-0032-9) contains supplementary material, which is available to authorized users.

Objectives This study aimed at assessing public health residents’ perceived health system governance (HSG) training needs and to define a competency framework for “good governance” to improve Public Health physicians’ curricula. Methods A questionnaire was administered to all Italian medical residents on postgraduate courses in Hygiene and Preventive medicine. Twenty-five (78.1 %) of the 32 Italian Schools of Public Health and 299/535 residents (55.9 %) took part in this survey. The public health governance competency framework was developed from roles and responsibility at different levels of governance in the Italian Health System context. Results The questionnaire revealed that residents felt the need for more training on all the proposed HSG-related topics. Different governance functions, strategic planning, operational planning, and operational programming were considered when defining roles and responsibilities. Conclusions More efforts should be made to provide organic training plans tailored to the needs of local and national health system. The competencies framework for good governance could be useful for planning professional training in both the academic and the health system settings.

New genetic evidence strongly supports a role for the immune system in the pathogenesis of essential hypertension (EH) through chemokines and their receptors (CCR) involvement. The aim of the present study was to evaluate the possible relation between CCR2 and CCR5 alleles and blood pressure (BP) levels in hypertensive subjects. In all, 118 essential hypertensive outpatients (male 90, female 28; stage I and II; age 27-54 years; not previously treated with antihypertensive drugs) were selected for the study. All of the subjects underwent office BP measurement. Subsequently, 24-h ambulatory BP monitoring (ABPM) was performed with a Spacelabs 90207 monitor during a regular working day. CCR264I and CCR5Delta32 polymorphisms were determined by polymerase chain reaction (PCR), following the standard molecular biology protocols. Allelic frequencies were the following: CCR5Delta32= 0.097, CCR264I=0.101. Logistic regression analysis showed an association between the CCR5Delta32 allele and the following: 24-h systolic BP (SBP >140 mmHg; p = 0.027), values over the 50th percentile of 24-h SBP (p = 0.032), and the values over the 50th percentile of nighttime SBP (p = 0.039). Office BP showed an association with the Delta32 allele in a range over the 75th percentile of SBP (p = 0.087) and the 75th percentile of DBP (p = 0.085). No significant association was observed for CCR264I and BP levels or between physiological nocturnal BP decline and genotype. The observed results not only support the role of the immune system in the development and maintenance of hypertension, but they also indicate an influence of CCR5Delta32 polymorphism on the establishment of BP levels.

Over the past 20 years, the interest of the scientific community was increasingly placed in the field of genetic epidemiology and molecular genetics of blood pressure control. This paper explores references related to essential hypertension, gene and genetic epidemiology indexed in the MedLine health science database during the period 1980-2001. A systematic literature search was performed using selected keywords, such as 'genetic', 'genome' or a combination of words. We considered the study heading and evaluated the time profile of published articles. A total number of 3116 publications was collected and analyzed. Allelic distribution for the most studied polymorphisms of the renin-angiotensin system in different world populations was reviewed and reported together with a detection of their frequency in Italy: essential hypertensive patients (n = 90), healthy unrelated subjects (n = 300). Molecular variants at angiotensinogen (M and T), angiotensin II type 1 receptor (A and C) and angiotensin-converting enzyme (D and I) genes were analyzed by amplified fragment length polymorphism. A significant association was detected by chi2 analysis for angiotensinogen and angiotensin II-type I receptor allele distribution in hypertensive patients, in accordance with previous reports. Genetic data and methods are contributing more and more to epidemiological studies of complex diseases, and their application is influenced by information availability and Genome Project results.

Objective.Systemic lupus erythematosus (SLE) is treated with anti-inflammatory and immunosuppressive drugs and off-label biologics. Belimumab is the first biologic approved after 50 years as an add-on therapy for active disease. This paper summarizes a health technology assessment performed in Italy.Methods.SLE epidemiology and burden were assessed using the best published international and national evidences and efficacy and safety of belimumab were synthesized using clinical data. A cost-effectiveness analysis was performed by a lifetime microsimulation model comparing belimumab to standard of care (SoC). Organizational and ethical implications were discussed.Results.Literature review showed that SLE affects 47 per 100,000 people for a total of 28,500 patients in Italy, 50% of whom are affected by active form of the disease despite SoC. These patients, if autoantibodies and anti-dsDNA positive with low complement, are eligible for belimumab. SLE determines work disability and a 2–5-fold increase in mortality. Belimumab with SoC may prevent 4,742 flares in three years being cost-effective with an incremental cost-effectiveness ratio of €32,859 per quality adjusted life year gained. From the organizational perspective, the development of clear and comprehensive clinical pathways is crucial.Conclusions.The assessment supports the use of belimumab into the SLE treatment paradigm in Italy.

Noroviruses are recognized as the leading cause of human acute viral gastroenteritis worldwide. The rate of outbreaks on cruise ships has grown significantly in recent years. Given the potentially harmful consequences of outbreaks for passengers and crewmembers and the subsequently high costs for cruise companies, disease outbreaks on cruise ships represent a serious public health issue. The aim of our study was to systematically review published studies related to Norovirus outbreaks on commercial cruise ships. We searched the PubMed and Scopus scientific databases. We included eligible studies published from January 1990 to July 2013 that were written in English and described infectious episodes involving at least two passengers and/or crewmembers on a commercial cruise ship. As a result, 15 studies and seven reviews met the inclusion criteria, describing a total of 127 outbreaks. The majority of the cases were reported in Europe and the USA, affecting

Public Health (PH) and Primary Health Care (PHC) need to be better integrated, at different levels of the healthcare system, in order to improve health and social outcomes. The aim of this study was to review international models and approaches supporting the integration of PH and PHC and to classify these according to their main focus. A literature search was performed using the main scientific databases, to identify national and international journal publications regarding models to support integration between PH and PHC. The final set of the documents provided a broad coverage of the topic. Four models of integration were identified: general integration, chronic disease prevention, targeted prevention or care delivery and infection control. Models differed in their levels of implementation, stages of development and focus. This review, by classifying the main characteristics and results of the experiences retrieved, indicates a relatively scarce use of integration models in the global health care landscape, with the exception of Canada. In fact, Canada has been a leader in developing models of integrated health systems that combine tailored approaches to influence personal health behaviour and community-oriented approaches to influence the health of the population. The review also revealed a general lack of experience in evaluating the sustainability of integration between PH and PHC, not only in terms of cost-effectiveness, but also in terms of better health and work conditions and self-perceived quality of care in the population. Collaboration between PH and PHC seems to be an important strategy for achieving principles of equity and access in health care and for ensuring a more equal distribution of health care services.

In the last few years, the need of public reporting of health outcomes has acquired a great importance. The public release of performance results could be a tool for improving health care quality and many attempts have been made in order to introduce public reporting programs within the health care context at different levels. It would be necessary to promote the introduction of a standardized set of outcome and performance measures in order to improve quality of health care services and to make health care providers aware of the importance of transparency and accountability.

AIMS: The aims of the study were to describe the epidemiology of home injuries (HI) among Italian students' mothers and to identify the possible predictors of having HI. METHODS: An anonymous questionnaire was used in several Italian schools. In order to identify predictors of having HI, a multivariate analysis was performed. RESULTS: In our sample (3,610 women), the prevalence of HI was 18%; 6.2% of the interviewed had a severe HI. The multivariate analyses showed that increasing age, to spend more than 13 hours a day at home and to be housewife are risk factors for having HI. CONCLUSIONS: This study reports a high prevalence of HI, highlighting an urgent need for undertaking interventions to develop an adequate culture of safety and prevention.

Background: Graphs are often used in medical communication, both in clinical practice and health management. They can help the processing of quantitative information but may also contribute to drawing wrong conclusions. The aim of the survey is to study the graphical perception of the data at the management level and its possible effects, showing how some criteria of appraisal of a phenomenon are influenced by the graphical format. Methods: One hundred and five medical doctors and health direction professionals of hospitals in Naples, Rome, Siena and Turin were interviewed. Four different graphs or table related to the same hypothetical data on average hospital stay in the period January 2000 to September 2003 were shown to participants, and their impressions were recorded. Results: Less than one-fourth of the participants understood that the data set was the same for the different diagrams. The process of understanding is mostly correlated with being a director, having a degree in medicine and working in central–northern cities. The table seems easier for interpretation (98.1%), more suitable (84.8%), more used (92.4%) and more pleasant than other data presentation. On the other hand radar format had worse results in all questions. Conclusions: The choice of a graphical format may influence the understanding of data. Further research is needed in order to sustain the improvement of medical and health professionals’ knowledge in the display data format.

The stewardship model has been adopted as a system of governance in several countries. In Italy, the Ministry of Health has proposed the use of the stewardship model for implementing the activities of the National Prevention Plan 2010-2012. The authors present the conceptual foundations and methodology used in the development of an assessment tool (audit tool) for evaluating the level of implementation of the stewardship model with regards to the activities of the national prevention plan in all Italian regions.

Pay for Performance is a tool that links payment of healthcare professionals to the quality of health outcomes and processes. In this article the authors discuss the results of a literature review on the subject, highlighting the importance of introducing a Pay for Performance system in primary care, and the advantages and critical issues associated with the system. The experience of the British National Health Service and possible uses of the described payment system in Italy are also briefly discussed.

The aim of this study was to evaluate the association between socio-demographic variables and hospital admissions at high risk of inappropriateness. Hospital discharge data for patients admitted to hospitals in the province of Caltanissetta in the Sicily Region (Italy) in the years 2007-2008 was obtained from the healthcare system database of the Region. Only acute care admissions of1 day duration and regarding patients ? 1 year of age were considered. Data regarding gender, nationality, age, marital status was collected for each admission as well as name of the local health authority in which the patient was registered. Univariate and multivariate analyses were performed using Chi-square and multivariate logistical regression analysis (Hosmer e Lemeshow) Fourteen percent (8.220/58.561) of admissions were found to be at high risk of inappropriateness, which was associated with patient age [1-15 years and 46-65 years OR : 1,55 (I.C. 95%: 1,42-1,69) and 1,62 ( I.C. 95%: 1,53-1,72) respectively], marital status [married OR1,46 (I.C. 95%: 1,38-1,53)], place of residence [patients from the Caltanissetta local health authority OR: 1,22 (I.C. 95%: 1,15-1,30)] and nationality [Italian OR: 2,19 (I.C. 95%: 1,40-0,87) ].

Health impact assessment (HIA) is a multidisciplinary tool aimed at assessing the effects of policies, programs and projects on health. It comprises five phases: screening, scoping, appraisal, reporting and monitoring. A review of the literature was performed on the subject which allowed us to describe good practices for each phase and show that the method is applied in a heterogeneous manner. Despite the correct application of the tool, especially of appraisal and reporting, the evaluation phase should be more widely used.

A study was performed to examine the epidemiology of domestic accidents in Sardinia (Italy). A questionnaire was administered to mothers of public school students attending elementary and middle classes during the 2006-2007 school year. Overall 2.075 mothers (59,3% of eligible mothers) participated in the study, 400 (19,3%) of whom declared having had a domestic accident during the previous year. The most frequent lesions were those of the upper (58%) and lower (24%) extremities. Geographical origin and school attended by the student were both found to be statistically associated with domestic accidents.

Background Hepatitis B (HBV) infection is an important cause of morbidity and mortality and it is associated to a higher risk of chronic evolution in infected children. In Italy the anti-HBV vaccination was introduced in 1991 for newborn and twelve years old children. Our study aims to evaluate time trends of HBV incidence rates in order to provide an assessment of compulsory vaccination health impact. Method Data concerning HBV incidence rates coming from Acute Viral Hepatitis Integrated Epidemiological System (SEIEVA) were collected from 1985 to 2006. SEIEVA is the Italian surveillance national system that registers acute hepatitis cases. Time trends were analysed by joinpoint regression using Joinpoint Regression Program 3.3.1 according to Kim's method. A joinpoint represents the time point when a significant trend change is detected. Time changes are expressed in terms of the Expected Annual Percent Change (EAPC) with 95% confidence interval (95% CI). Results The joinpoint analysis showed statistically significant decreasing trends in all age groups. For the age group 0–14 EAPC was -39.0 (95% CI: -59.3; -8.4), in the period up to 1987, and -12.6 (95% CI: -16.0; -9.2) thereafter. EAPCs were -17.9 (95% CI: -18.7; -17.1) and -6.7 (95% CI: -8.0; -5.4) for 15–24 and ≥25 age groups, respectively. Nevertheless no joinpoints were found for age groups 15–24 and ≥25, whereas a joinpoint at year 1987, before compulsory vaccination, was highlighted in 0–14 age group. No joinpoint was observed after 1991. Discussion Our results suggest that the introduction of compulsory vaccination could have contribute partly in decreasing HBV incidence rates. Compulsory vaccination health impact should be better investigated in future studies to evaluate the need for changes in current vaccination strategy.

A cross-sectional study was performed to assess the frequency of burnout in healthcare workers of a university teaching hospital in Rome (Italy), by means of the Maslach Burnout Inventory. In total 142 healthcare workers participated in the study. Average levels of emotional exhaustion and depersonalization were observed in the study population. Working in emergency care services was found to be correlated with lower levels of personal accomplishment with respect to working in other services. Monitoring burnout in social service and healthcare workers is an effective tool for identifying critical situations in the workplace.

Over the past two decades, scientific research has led to the development of a huge number of new health technologies, among which new vaccines. The decision process underlying the introduction of a new vaccine will be of particular concern in the future and a useful tool is needed to orientate decision makers towards better allocation of economic resources. Health Technology Assessment (HTA) is a multidisciplinary tool that aims to examine the clinical, economic, organizational, ethical, juridical, social and cultural implications of the introduction or the implementation of a specific technology; it could so represent an innovative and effective approach in order to support decision-making processes.

Left ventricular hypertrophy in patients with hypertension is a main clinical prognostic entity The aim of this study was to evaluate the association between mutations at genes of the renin-angiotensin system (RAS) and the development of left ventricular hypertrophy. Genetic polymorphism in angiotensinogen (AGT) and angiotensin Il-type 1 receptor (AT1R) genes was examined in a group of well-selected essential hypertensive caucasians with left ventricular involvement (n = 40) and a group of healthy unrelated caucasians (n = 150). Cardiac morphology and function were assessed by M-mode echocardiography. Molecular variants were analysed by amplified fragment length polymorphism. We observed a statistically significant difference both for AGT and AT1R genotype distribution in patients with left ventricular hypertrophy compared with controls (p0.05). A 0.49 and 0.225 frequency was detected among cases for T and C mutant alleles at AGT and AT1R genes. Mutations in RAS genes are involved in the pathophysiology of target-organ damage in essential hypertension. Evaluation of molecular factors conferring a risk of developing heart involvement may lead to better identification of patient subgroups and more effective control of the clinical course.

Objectives To develop a comparative, cost-effectiveness, and budget impact analysis of Therakos online extracorporeal photopheresis (ECP) compared with the main alternatives used for the treatment of steroid-refractory/resistant chronic graft-versus-host disease (cGvHD) in Italy. Methods The current therapeutic pathway was identified by searching medical databases and from the results of a survey of practice in Italian clinical reference centers. A systematic review was performed to evaluate the efficacy and safety of second-line alternatives. Budget impact and cost-effectiveness analyses were performed from the Italian National Health Service perspective over a 7-year time horizon through the adaption of a Markov model. The following health states were considered: complete and partial response, stable disease, and progression. A discount rate of 3% was applied to costs and outcomes. Results The most common alternatives used in Italy for the management of steroid-refractory/resistant cGvHD were ECP, mycophenolate, pentostatin, and imatinib. The literature review highlighted that complete and partial responses are higher with ECP than with the alternatives while serious adverse events are less common. The economic analysis showed that Therakos online ECP represents the dominating alternative, in that it delivers greater benefit at a lower cost. In fact, according to the alternatives considered, cost saving ranged from €3237.09 to €19,903.51 per patient with 0.04 to 0.21 quality-adjusted life-year gained. Conclusions Therakos online ECP should be considered an effective, safe, and cost-effective alternative in steroid-refractory/resistant cGvHD. There is inequality in access, and a dedicated reimbursement tariff, however, should be introduced to overcome these barriers.

Aims and background Trastuzumab, a humanized monoclonal antibody directed against the extracellular domain of ErbB, has determined clinical benefit for women affected by metastatic or early stage HER2-positive breast cancer and never previously treated with trastuzumab. Trastuzumab is generally used as first-line treatment of HER2+ metastatic breast cancer and is currently administered beyond progression even without clear evidence supporting such clinical practice. In fact, HER2-positive metastatic breast cancer has a high risk of progressing after first-line therapy, and second-line treatments vary. The aim of the study was to investigate by a systematic review the efficacy of trastuzumab-based treatments beyond progression in HER2-positive metastatic breast cancer. Materials and methods We performed a systematic review using Medline, Embase and Cochrane Library data bases and publications in principal meetings or congresses of oncology in Europe and America until September 2008. The main selection criterium was the reporting of time to progression, calculated from the start of each trastuzumab-based therapy to the date of progressive disease or death. Results Twelve studies were selected that included a total of 516 patients. The weighted mean time to progression was 23.66 weeks (standard deviation, 4.37) and the median was 26 weeks (range, 13–39). Interestingly, combined trastuzumab plus vinorelbine treatment showed a lower mean and median time to progression (20.59 and 19.57 weeks, respectively), whereas trastuzumab plus capecitabine yielded a mean time to progression of 30.33 weeks. Conclusions The added value of the present study has been to provide a quantitative summary measure of time to progression which can be used for comparisons between current and future available regimens.

Essential hypertension is a complex trait under polygenic control. Evidences suggests immune system involvement during pathogenesis. CC-chemokine receptor (CCR)5 and CCR2 are characterised by gene polymorphism. Variant alleles are derived from a deletion in the CCR5 gene (CCR5delta32) and a substitution mutation at the CCR2 locus (CCR264I). CCR polymorphic forms have been studied extensively as invasion cofactors for HIV-1, but they have also been implicated in immuno-related disorders. Here, we evaluate the allelic distribution of CCR5 and CCR2 genes in essential hypertension in a case-control study. Genotype frequency in a group of essential hypertensive patients (stage I-II; n=120) and a group of unrelated, healthy Caucasian subjects (n=340) is compared. CCR gene polymorphism is analysed by polymerase chain reaction and restriction enzyme digestion. A statistically significant difference was observed for CCR5 and CCR2 mutant alleles in essential hypertensive patients, compared with the controls (P=0.004 and P=0.003, respectively). CCR5delta32 and CCR264I alleles showed a 0.096 and 0.10 frequency among cases. To date, a role for the immune system in hypertension has not been clarified, nor has the predictive value of CCR polymorphisms.

Left ventricular hypertrophy (LVH) is a major determinant of heart damage. Scientific evidence suggests the influence of genetic factors, but these have yet to be completely clarified. This study investigates a possible relationship between LVH and two chemokine receptor (CCR) gene polymorphisms: CCR5∆32 and CCR264I. Essential hypertensive out-patients (n=118, grade I–II, age 27–54) were recruited from the Catholic University Hypertension Centre. For each subject, clinical data on office blood pressure and M-mode/2D echocardiography were collected. Statistical analysis did not show a significant association between the CCR polymorphisms and LVH in the study population.