Development and first application of an audit system for screening programs based on the PRECEDE-PROCEED model: an experience with breast cancer screening in the region of Lombardy (Italy).

BACKGROUND: High participation and performance are necessary conditions for the effectiveness of breast cancer screening programs. Here we describe the process to define and test a planning software application and an audit cycle based on the PRECEDE-PROCEED model applied to improving breast cancer screening. We developed a planning software application following the phases of the PRECEDE-PROCEED model. The application was co-designed by local cancer screening program coordinators. An audit model was also developed. The revised application and the audit model were tested by all the coordinators of 15 breast cancer screening programs in the region of Lombardy in a 3-day workshop. The project plans produced using the application were compared with those produced in the previous year for clarity and completeness. RESULTS: The 9 phases of the PRECEDE-PROCEED model were adapted to screening as follows: 1) identification of program goals (i.e., participation, sensitivity, false positive); 2) epidemiological issues; 3) best practices analysis; 4) evidence-based actions to be implemented in the screening center and the relationships with partners and stakeholders; 5) priority setting and identification of solutions for each issue; 6) definition of indicators; 7) monitoring; 8) evaluation; 9) impact assessment. The application automatically generated reports for each phase. During the audit cycle, the regional health authority negotiated the targets to be reached with local authorities and collected the improvement plans generated by the application. The plans produced after the application was adopted were more standardized and had clearer indicators for monitoring and evaluation compared to those produced in the previous year. CONCLUSIONS: The software application helps standardize criteria for planning interventions to improve screening programs and facilitates the implementation of the audit cycle.

Creating a Culture of Health in Planning and Implementing Innovative Strategies Addressing Non-communicable Chronic Diseases.

Ongoing demographic changes are challenging health systems worldwide especially in relation to increasing longevity and the resultant rise of non-communicable diseases (NCDs). To meet these challenges, a paradigm shift to a more proactive approach to health promotion, and maintenance is needed. This new paradigm focuses on creating and implementing an ecological model of Culture of Health. The conceptualization of the Culture of Health is defined as one where good health and well-being flourish across geographic, demographic, and social sectors; fostering healthy equitable communities where citizens have the opportunity to make choices and be co-producers of healthy lifestyles. Based on Antonovsky's Salutogenesis model which asserts that the experience of health moves along a continuum across the lifespan, we will identify the key drivers for achieving a Culture of Health. These include mindset/expectations, sense of community, and civic engagement. The present article discusses these drivers and identifies areas where policy and research actions are needed to advance positive change on population health and well-being. We highlight empirical evidence of drivers within the EU guided by the activities within the thematic Action Groups of the European Innovation Partnership on Active and Healthy Aging (EIP on AHA), focusing on Lifespan Health Promotion and Prevention of Age-Related Frailty and Disease (A3 Action Group). We will specifically focus on the effect of Culture on Health, highlighting cross-cutting drivers across domains such as innovations at the individual and community level, and in synergies with business, policy, and research entities. We will present examples of drivers for creating a Culture of Health, the barriers, the remaining gaps, and areas of future research to achieve an inclusive and sustainable asset-based community.

[Recommandation for patient engagement promotion in care and cure for chronic conditions.] / Promozione del patient engagement in ambito clinico-assistenziale per le malattie croniche: raccomandazioni dalla prima conferenza di consenso italiana.

The concept of patient engagement is receiving a growing attention in the healthcare field. The last decades have seen a deep revision of care models in the aim of a greater acknowledge of the patient role, seen as an expert actor, in the healthcare process. On the other side, healthcare systems are facing a growing request for participation expressed by citizens and patients. People claim for being more involved in all the crucial turning point of their healthcare journey and of being better aware of their right and duties. They require a deeper knowledge about all the different therapeutic options with the related risks and advantages. However, although all the different stakeholders agree in considering patient engagement a pragmatic further then ethical priority, a shared consensus related to the strategies and instrument to promote has still to come. Patients and healthcare professional perspective about the factors that may hinder or sustain patient engagement still need to be further studied and at shared recommendations - about the programs better effective and efficient in promoting patient engagement - are still missed. Based on these premises, Università Cattolica of Milano and DG Welfare of Regione Lombardia, under the methodological supervision of the Istituto Superiore di Sanità, promoted a consesus conference entitled "Recommendation for promoting patient engagement in healthcare for chronic conditions". This consensus conferences constituted the occasion of sharing and discussion among experts belonging to different clinical and institutional contexts as well as with representative of patients associations in order to identify good practices and effective tools to promote patient engagement in the care and cure process for chronic conditions.

2015-2018 Regional Prevention Plan of Lombardy (Northern Italy) and sedentary prevention: a cross-sectional strategy to develop evidence-based programmes.

Cross-sector, life-course, and setting approaches are identified in the 2015-2018 Regional Prevention Plan (PRP) of Lombardy Region (Northern Italy) as valuable strategies to ensure the efficacy and sustainable prevention of the non-communicable disease (NCDs). The involvement of non-health sectors in health promotion activities represents a suitable strategy to affect on social, economic, and political determinants and to change environmental factors that could cause NCDs. A dialogue among communities, urban planning, and prevention know-how is a prerequisite to develop a system of policies suitable to promote healthy lifestyle in general and, specifically, active lifestyles. The 2015-2018 Lombardy PRP pursues its aims of health promotion and behavioural risk factors for NCDs prevention through programmes that implement their own setting networks (Health Promoting Schools - SPS; Workplace Health Promotion - WHP) and develop new networks. Sedentary lifestyle prevention and active lifestyle promotion are performed through the approach promoted by the Healthy Cities Programme (WHO), encouraging two main processes: 1. creating integrated capacity-building among health and social prevention services, academic research, and local stakeholders on different urban planning and design issues; 2. promoting community empowerment through active citizens participation. Through this process, Lombardy Region aims to orient its services developing evidence-based programmes and enhancing advocacy and mediating capacity skills in order to create a profitable partnership with non-health sectors. This paper reports the main impact data: 26,000 children that reach school by foot thanks to walking buses, 57% of 145 companies joining WHP are involved in promoting physical activity, 18,891 citizens who attend local walking groups.

[Decisional framework for varicella vaccine: challenges in the face of opportunity]. / Modello decisionale per l'adozione del vaccino antivaricella: una sfida di fattibilità.

INTRODUCTION: Decision makers adopt interventions, including vaccines, which are most beneficial to populations. A transparent, unbiased, and comprehensive framework based on evidence-based criteria is a promising tool to guide decision-making on vaccine adoption: we developed a multi-dimensional framework conceived from the DECIDE - Evidence to decision Framework (EtD framework). We validated the framework by conducting a real data and evidence set collection on varicella vaccination and tested it with a multidisciplinary group. METHODS: The EtD framework presented evidence concerning the varicella vaccination organized in six dimensions: Burden of disease, Vaccine characteristics and impact of immunization program, Values and preferences, Resource use, Equity and Feasibility. Two reviewers completed each dimension with information about varicella vaccine. A multidisciplinary group of 42 participants were asked to evaluate the information in the framework, decide whether to introduce varicella vaccine in the national immunization program, assess the usefulness, and propose some impovements of the decision-making tool. RESULTS: From 33 responders (79%) out of 42, 61% supported the adoption of the varicella vaccine as part of the national immunization program. A half (50%) favored the monovalent vaccine while the other half chose the tetravalent vaccine. About 90% of responders found information in the EtD framework comprehensive, easy to understand, and presented in a way that helped make decisions. CONCLUSIONS: Complete and transparent information are welcome. The EtD identified a situation of important divergences between policy makers regarding the introduction and the choice of vaccine. In our case study, for example, a third of the multidisciplinary group did not recommend the adoption of varicella vaccine.

Ten years (2004-2014) of influenza surveillance in Northern Italy.

As the regional influenza reference centre operating within the Italian network InfluNet, here we report data on virological and epidemiological surveillance of influenza, as well as on the vaccination coverage rates achieved in Lombardy (Northern Italy) over 10 consecutive winter seasons (2004-2014).   Over the past 10 years, influenza vaccine coverage declined both in the general population (from 15.7% in 2004-2005 to 11.7% in 2013-2014) and in the vaccine-target population of individuals ≥65-y-of-age (from 65.3% in 2004-2005 to 48.6% in 2013-2014) and is far below the minimum planned threshold level (75%). The highest influenza-like illness (ILI) rates were recorded during the 2004-2005 and 2009-2010 epidemics (peak incidence: 12.04‰ and 13.28‰, respectively). Both seasons were characterised by the introduction of novel viral strains: A/Fujian/411/2002(H3N2) (a drifted hemagglutinin variant) and A/California/7/2009(H1N1) pandemic virus (a swine origin quadruple reassortant), respectively. Because the antigenic match between vaccine and circulating strains was good in both of these seasons, a relevant proportion of cases may have been prevented by vaccination. A different situation was observed during the 2011-2012 season, when ILI morbidity rates in individuals ≥65-y-of-age were 1.5-6-fold higher than those registered during the other epidemics under review. The higher morbidity resulted from the circulation during the 2011-2012 season of an A/Victoria/361/2011(H3N2)-like variant that presented a reduced genetic match with the A(H3N2) strain included in the 2011-2012 vaccine composition. The continuous surveillance of the characteristics of circulating viruses is an essential tool for monitoring their matching with seasonal vaccine strains. Strategies to increase coverage rates are warranted.

Surveillance and vaccination coverage of measles and rubella in Northern Italy.

Measles and rubella are infectious diseases and humans are the only reservoir of these infections. Effective vaccines are available with the potential for measles (MV) and rubella (RuV) virus eradication. According to the World Health Organisation guidelines, a national plan was approved in Italy in 2013 to achieve the MV/RuV elimination by 2015, and active MV/RuV integrated surveillance initiated. Towards this purpose, a regional laboratory centre was set up on 1 September 2013 in Lombardy, Northern Italy. This paper aimed at: (1) evaluating measles-mumps-rubella (MMR) vaccine coverage and MV/RuV notified cases retrospectively; and (2) presenting the results of MV/RuV integrated surveillance (laboratory confirmed and viral genetic profiles).   The 95% target for MMR vaccine coverage was achieved in 2001, and coverage increased until 2007 (96.6%), but then a decreasing trend was observed. Since 2000 to 2014, 3026 rubella cases were notified, with nearly 58% of them in the 2002 epidemic. From 2009, less than 45 RuV cases per year were reported. From 2000 to 2014, 5024 measles cases were notified. Since 2008, three large outbreaks (in 2008, 2011, and 2013) were observed. From data obtained during our surveillance activity, there were no rubella cases, and 57.5% (46/80) collected samples were MV-positive by real-time RT-PCR. A fragment of the MV N gene was sequenced from 37 MV-positive samples; D8, D9, and B3 genotypes were detected. Data obtained retrospectively and from active surveillance underline the necessity to achieve and maintain high vaccination coverage and to improve surveillance and the effectiveness of healthcare actions.

Conceptual frameworks and key dimensions to support coverage decisions for vaccines.

BACKGROUND: Health policy makers often have to face decisions on whether and how to incorporate new vaccines into immunisation plans. This study aims to review and catalogue the relevant current frameworks and taxonomies on vaccines and connect these to the DECIDE Evidence to Decision framework (EtD), a general framework based on evidence-based criteria to guide decision-making on intervention adoption. METHODS: We systematically searched MEDLINE, EMBASE, Cochrane Library and funding agency websites from 1990 to 2013. We included systematic reviews and primary studies presenting decision-making tools for community vaccine adoption. We qualitatively summarised the reports by purpose, targeted country, principal results, and decisional models. We then extracted and compared the dimensions adopted by vaccine frameworks across studies. RESULTS: Fourteen studies (five systematic reviews and nine primary studies) were included. Several factors frequently influenced decision-makers' views on vaccines: the most frequent political-context factors considered were Importance of illness or problem, Vaccine characteristics, Resource use, and Feasibility. Others such as Values and preferences and Acceptability were less consistently reported. We did not find evidence on the reasons why a framework for vaccine adoption differs from that for decisions on the adoption of an intervention in general, such as the EtD. There are limited data on how dimensions are explained in practical factors and directly linked to coverage decisions. CONCLUSIONS: This review summarises conceptual models and taxonomy of a heterogeneous and evolving area in health policy decisions. A shared and comprehensive framework on vaccine coverage remains to be achieved with its single dimensions (epidemiologic, effectiveness, economic, and social) valued differently across studies. A generic tool such as the EtD conceptualises all relevant dimensions, and might reduce inconsistencies.

[Workplace health promotion: evaluation of evidence of efficacy and methodological recommendations]. / La promozione della salute nei luoghi di lavoro: valutazione di evidenze di efficacia e raccomandazioni metodologiche.

BACKGROUND: During the period 2004-2007 five Italian regions in cooperation with the Universities of Pavia and Perugia and the Italian Cochrane Centre carried out a research project on health promotion programmes. OBJECTIVES: Evaluation of efficacy of health education programmes developed by the Local Health Units from 2000 to 2004. RESULTS: Analysis of 69 of health promotion programmes and 23 Cochrane reviews led to establishing recommendations for health operators; at the workplace the efficacious actions were: to encourage consumption of healthy food (also via automatic distributors of fruit and vegetable snacks) and physical activity, guarantee observance of the smoking ban and/or offer assistance to quit smoking. CONCLUSION: Health promotion projects involve the use of public resources so it is necessary that the potential impact and efficacy be evaluated in the planning process. In particular, it is advisable to examine the data in the literature and assign preference to projects that have proved efficacious.

[Evaluation of an intensive treatment education program for type 1 diabetes in a group of adolescents. A two year follow up]. / Evaluación de un programa de educación de tratamiento intensivo en adolescentes con diabetes tipo 1. Seguimiento por dos años.

During the past decade several reports were published showing that intensive treatment of type 1 diabetes can prevent and delay disease-related microvascular complications. However, several problems were reported in children and adolescents such as frequent hypoglycemic episodes and weight gain. The aim of this study was to describe the results of intensified treatment for type 1 diabetes in a group of Argentinean adolescents after a follow-up of two years. Twenty five adolescents with type 1 diabetes older than 10 years with at least one year from diagnosis were selected. All patients received a one-week teaching program during admission to our center. All patients were followed-up monthly during two years. Treatment schedule included 4-5 controls in fasting conditions, two doses of NPH insulin and four doses of regular insulin according to glycemia and the amount of calculated carbohydrate intake. Median age was 13.5 years (range 10 to 19 years). Mean time from diagnosis to inclusion in the study was 3.8 years (range 1.25 to 9 years). Mean total dose of NPH insulin decreased significantly when measured at the inclusion in the study (0.9 IU/kg) and after a year of follow-up 0.8 IU/kg (p 0.04). However, there were no changes in NPH insulin dose after two years follow-up (0.85 IU/kg). On the contrary, the dose of regular insulin administered on fasting conditions with normal glycemia increased from 0 to 0.21/kg after a year (p 0.0001) and to 0.69 after two years (non significant). Median HbA1C showed a significant reduction from 10 +/- 1.62% to 8.53 +/- 1.04% after a year (p 0.03) and to 8.72 +/- 0.81% after two years. BMI Z score increased from significantly from 0.7 +/- 0.9 to 1.06 +/- 1.15 after a year (p 0.03) with a further reduction without a significant difference from the basal value after two years. We found no significant differences in the frequency of hypoglycemia or other metabolic features. Our results show that intensive treatment of type 1 diabetes in children and adolescents can achieve significant and sustained reductions of HbA1C without increasing the risk of hypoglycemia or other adverse effects.

Evaluación de un programa de educación de tratamiento intensivo en adolescentes con diabetes tipo 1. Seguimiento por dos años. / [Evaluation of an intensive treatment education program for type 1 diabetes in a group of adolescents. A two year follow up]

During the past decade several reports were published showing that intensive treatment of type 1 diabetes can prevent and delay disease-related microvascular complications. However, several problems were reported in children and adolescents such as frequent hypoglycemic episodes and weight gain. The aim of this study was to describe the results of intensified treatment for type 1 diabetes in a group of Argentinean adolescents after a follow-up of two years. Twenty five adolescents with type 1 diabetes older than 10 years with at least one year from diagnosis were selected. All patients received a one-week teaching program during admission to our center. All patients were followed-up monthly during two years. Treatment schedule included 4-5 controls in fasting conditions, two doses of NPH insulin and four doses of regular insulin according to glycemia and the amount of calculated carbohydrate intake. Median age was 13.5 years (range 10 to 19 years). Mean time from diagnosis to inclusion in the study was 3.8 years (range 1.25 to 9 years). Mean total dose of NPH insulin decreased significantly when measured at the inclusion in the study (0.9 IU/kg) and after a year of follow-up 0.8 IU/kg (p 0.04). However, there were no changes in NPH insulin dose after two years follow-up (0.85 IU/kg). On the contrary, the dose of regular insulin administered on fasting conditions with normal glycemia increased from 0 to 0.21/kg after a year (p 0.0001) and to 0.69 after two years (non significant). Median HbA1C showed a significant reduction from 10 +/- 1.62

to 8.53 +/- 1.04

after a year (p 0.03) and to 8.72 +/- 0.81

after two years. BMI Z score increased from significantly from 0.7 +/- 0.9 to 1.06 +/- 1.15 after a year (p 0.03) with a further reduction without a significant difference from the basal value after two years. We found no significant differences in the frequency of hypoglycemia or other metabolic features. Our results show that intensive treatment of type 1 diabetes in children and adolescents can achieve significant and sustained reductions of HbA1C without increasing the risk of hypoglycemia or other adverse effects.