Detecting persons at risk for diabetes mellitus type 2 using FINDRISC: results from a community pharmacy-based study.

Background: This cross-sectional study has been developed within the framework of the Italian project 'We love your heart' ('Ci sta a cuore il tuo cuore') and reports the results of the initial type 2 diabetes mellitus (T2DM) risk assessment carried out in a big network of community pharmacies in Italy and Spain. Methods: In total 4002 pharmacists from 854pharmacies were specifically trained to collect data and perform the evaluation of the probability of developing T2DM among pharmacy customers. The risk of developing T2DM within 10 years was evaluated using the FINDRISC. Results: Overall, 7234 (22.1%) subjects were at low risk to develop the disease, whereas 43.3% were at slightly elevated risk (scores 7-11), 19.3% were at moderate (scores 12-14), 13.9% were at high (scores 15-20), and 1.4% were at very high risk (scores > 20). Spanish participants showed higher levels of risk than Italian (16.7 vs. 14.7%) taking the cut-off FINDRISC ≥ 15. Conclusion: This study shows that considerable percentage of persons is likely to develop diabetes in the next 10 years. Analyses of the risk factors indicate that men were more susceptible to develop this disease, as well as the Spanish participants respect to Italian.

Therapy experiences and preferences among patients with anemia: Results of a cross-sectional survey among Italian patients with inflammatory bowel disease.

BACKGROUND: Anemia represents one of the most common and often the least treated complications of inflammatory bowel disease (IBD). AIMS: Our study investigates experiences and preferences concerning anemia treatment in patients with IBD. METHODS: IBD patients previously diagnosed with anemia were invited to participate in an anonymous survey between July and September 2015, which assessed demographic and clinical data, and experiences regarding anemia treatment. RESULTS: A total of 118 IBD patients were invited to participate in the study, of which 100 (85%) were included in the analysis. Seventy-five percent of patients reported a high personal burden related to intravenous therapy, while the majority of companions (76%) declared a moderate burden. The increased importance assigned to the possibility of a single session treatment was significantly associated with age (Beta=0.01; p=0.03), working status (Beta=0.02; p=0.04), anemia severity (severe vs. mild, Beta=0.42; p=0.03), and intravenous treatment (Beta=0.44; p=0.001). CONCLUSIONS: Most patients reported a high personal and a moderate companions' burden. Having the possibility of effective single dose intravenous therapy was of great importance. Patients' perspective provides key information for evaluating the indirect costs of anemia treatment in IBD which, according to the health technology assessment approach, could be useful in a patient centered decision making process.

Determinants of work-related accidents in Italian Regions. / Determinanti regionali del fenomeno infortunistico sul lavoro in Italia.

OBJECTIVE: To identify the determinants of the regional differences in work injuries and mortality rates in Italy. METHODS: Several linear regression models were built assessing the association between regional differences in work mortality and injury rates (as dependent variables) and socio-demographic factors (occupation and population) and variables describing alcohol consumption, mean age and availability of health care (as independent variables). Data sources are from ISTAT, INAIL, Health for All database and the national report Osservasalute. The analysis was carried out using data coming from all the Italian Regions. RESULTS: The mean work mortality rate for the period 2006-2014 was 7.73 (DS 1.85) per 100,000 workers, while the injury rate was 4503.1 (DS 1413.5) per 100,000 workers. Socio-demographic variables and that related to health care (TC availability) were inversely associated with mortality rates, while for the work injury rates, significant associations with alcohol were found, while Gross domestic product and TC availability were inversely associated. CONCLUSIONS: The study pointed out the extreme heterogeneity between different geographical areas in the field of work injury, due to different socio-demographic and economic factors. In the future, health surveillance and work injury and mortality rates could be improved in areas at high risk.

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.

Health technology assessment of belimumab: a new monoclonal antibody for the treatment of systemic lupus erythematosus.

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.

The prevention of postmenopausal osteoporotic fractures: results of the Health Technology Assessment of a new antiosteoporotic drug.

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.

Building successful collaborations between Public Health and Primary Health Care.

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.