Differences in family caregiver experiences and expectations of end-of-life heart failure care across providers and settings: a systematic literature review.

Heart failure impacts patients' quality of life and life expectancy and significantly affects the daily behaviours and feelings of family caregivers. At the end-of-life, the burden for family caregivers depends on their emotional and sentimental involvement, as well as social costs. OBJECTIVES: The aim of this work is to determine whether and how family caregivers' experiences and expectations vary in relation to the places of care and teams involved in heart failure management. METHODS: A systematic literature review was conducted, by screening manuscripts dealing with the experience of Family Care Givers' (FCGs) of patients with Advanced Heart failure. Methods and results were reported following the PRISMA rules. Papers were searched through three databases (PubMed, Scopus and Web of Science). Seven topics were used to synthetize results by reporting qualitative information and quantitative evidence about the experience of FCGs in places of care and with care teams. RESULTS: Thirty-one papers, dealing with the experience of 814 FCGs, were selected for this systematic review. Most manuscripts came from the USA (N = 14) and European countries (N = 13) and were based on qualitative methods. The most common care setting and provider profile combination at the end of life was home care (N = 22) and multiprofessional teams (N = 27). Family caregivers experienced "psychological issues" (48.4%), impact of patients' condition on their life (38,7%) and "worries for the future" (22.6%). Usually, when family caregivers were unprepared for the future, the care setting was the home, and there was a lack of palliative physicians on the team. DISCUSSION: At the end-of-life, the major needs of chronic patients and their relatives are not health related. And, as we observed, non-health needs can be satisfied by improving some key components of the care management process that could be related to care team and setting of care. Our findings can support the design of new policies and strategies.

The contribution of benchmarking to quality improvement in healthcare. A systematic literature review.

BACKGROUND: Benchmarking has been recognised as a valuable method to help identify strengths and weaknesses at all levels of the healthcare system. Despite a growing interest in the practice and study of benchmarking, its contribution to quality of care have not been well elucidated. As such, we conducted a systematic literature review with the aim of synthesizing the evidence regarding the relationship between benchmarking and quality improvement. We also sought to provide evidence on the associated strategies that can be used to further stimulate quality improvement. METHODS: We searched three databases (PubMed, Web of Science and Scopus) for articles studying the impact of benchmarking on quality of care (processes and outcomes). Following assessment of the articles for inclusion, we conducted data analysis, quality assessment and critical synthesis according to the PRISMA guidelines for systematic literature review. RESULTS: A total of 17 articles were identified. All studies reported a positive association between the use of benchmarking and quality improvement in terms of processes (N = 10), outcomes (N = 13) or both (N = 7). In the majority of studies (N = 12), at least one intervention, complementary to benchmarking, was undertaken to stimulate quality improvement. The interventions ranged from meetings between participants to quality improvement plans and financial incentives. A combination of multiple interventions was present in over half of the studies (N = 10). CONCLUSIONS: The results generated from this review suggest that the practice of benchmarking in healthcare is a growing field, and more research is needed to better understand its effects on quality improvement. Furthermore, our findings indicate that benchmarking may stimulate quality improvement, and that interventions, complementary to benchmarking, seem to reinforce this improvement. Although this study points towards the benefit of combining performance measurement with interventions in terms of quality, future research should further analyse the impact of these interventions individually.

Performance of care for end-of-life cancer patients in Tuscany: The interplay between place of care, aggressive treatments, opioids, and place of death. A retrospective cohort study.

Supportive and palliative care at the end of life (EOL) is a core component of health systems. Providing care at the EOL may require the interaction of several care providers working in different settings including nursing homes, home care, hospices, and hospitals. This work aims to (a) provide evidence on the performance of EOL care for cancer patients across healthcare organizations, with a focus on the place of care, aggressive treatments, opioids, and the place of death and (b) analyze factors associated with dying in hospital. A population-based retrospective study was performed using administrative data from Tuscany region (Italy). Thirteen thousand sixty-six cancer patients who died in 2016 were considered. There is a marked variability in EOL care within regional areas, with the multilevel logistic regression highlighting a greater likelihood of dying in hospital for patients who were admitted to intensive care units or previously hospitalized. There is a lower probability of dying in acute care setting for patients assisted in hospices and in both hospital and hospices/home care and for patients treated with opioids. This intraregional variation highlights the need to improve EOL planning and rethink the delivery of supportive/palliative care. Further investigations on the preferences of patients may lead to more understanding.

Reported experience of patients with single or multiple chronic diseases: empirical evidence from Italy.

BACKGROUND: More and more countries have been implementing chronic care programs, such as the Chronic Care Model (CCM) to manage non-acute conditions of diseases in a more effective and less expensive way. Often, these programs aim to provide care for single conditions instead of the sum of diseases. This paper analyzes the satisfaction and better management of single and multiple chronic patients with the core elements of chronic care programs in Siena, Italy. In addition, the paper also considers whether the CCM introduced in Siena has any influence on satisfaction and better self-management. METHODS: Survey data from patients with single chronic (N = 500) and multiple chronic diseases (N = 454), assisted by the Local Health Authority in Siena (Tuscany, Italy), were considered for the analysis. Variables on education, monitoring system, proactivity, relational continuity, model of care (CCM versus no CCM) and patient demographics were used to detect which strategies are associated with a higher patient-reported ability to better self-manage the disease and overall patient satisfaction. Logistic and ordinary logistic models were executed on data related to patients with both single and multiple chronic diseases. RESULTS: The results showed that monitoring was the sole strategy associated with overall satisfaction and better self-management for both single and multiple chronic patients. Relational continuity also showed a significant positive association with better self-management perception for both patient groups, but had a positive association with patient satisfaction only for single chronic patients. Enrolment in the CCM was not associated with both overall satisfaction and better management for the two patient groups. CONCLUSIONS: Strategies that are significantly associated with satisfaction and perception of better disease self-management were the same for both single and multiple chronic patients. The delivery of care based on the Siena CCM does not seem to make a difference in the perception of better self-management and overall satisfaction for all the patients. Other concurrent strategies implemented by the regional government in Tuscany on primary care monitoring and health promotion could partially explain why CCM does not have a significant influence.

Patient satisfaction, patients leaving hospital against medical advice and mortality in Italian university hospitals: a cross-sectional analysis.

BACKGROUND: Healthcare systems are increasingly focusing on outcomes that are the endpoints of care: patient health status and patient satisfaction. The availability of patient satisfaction (PS) data has encouraged research on its relationship with other outcomes, such as mortality. In Italy, an inter-regional performance evaluation system (IRPES) provides 13 regional healthcare systems with a multidimensional assessment of appropriateness, efficiency, financial sustainability, effectiveness, and equity. For university hospitals, IRPES includes the percentage of patients leaving hospital against medical advice (PLHAMA) and mortality rates at the ward level. This paper investigates the relationship between PS and PLHAMA across and within regional healthcare systems in Italy. Secondly, PLHAMA is used as a PS proxy to investigate its relationship with mortality at the ward level in the IRPES university hospitals. METHODS: PLHAMA and mortality rates were gathered from administrative data, and PS scores from patient surveys. We explored the association between PS and PLHAMA through a correlation analysis, using data for the 13 IRPES regions. We tested this relationship also at the clinical directorate level in 28 hospitals in Tuscany (5482 interviewed patients in 100 clinical directorates). Secondly, we explored the association between PLHAMA and mortality at the ward level through correlation and regression analyses, using data of 405 wards of eight clinical specialties within 24 IRPES university hospitals. RESULTS: Lower PLHAMA rates were associated with a higher PS in both regional and clinical directorate levels. A positive association between PLHAMA and mortality was shown at the ward level for IRPES university hospitals, with different results for medical and surgical clinical specialties. CONCLUSIONS: PS is an important performance dimension that provides healthcare managers and professionals with useful insights for improving care quality and effectiveness. Based on the study results, the PLHAMA rate could be regularly measured to highlight patient dissatisfaction. Due to the association between PLHAMA and mortality, this study also provides evidence of the importance of the patient perspective in assessing the quality of healthcare services. This relationship proved to be significant for surgical clinical units, suggesting the need for further analysing outcomes considering their different determinants in medical and surgical care.

Is the co-location of GPs in primary care centres associated with a higher patient satisfaction? Evidence from a population survey in Italy.

BACKGROUND: Several countries have co-located General Practitioners (GPs) in Primary Care Centres (PCCs) with other health and social care professionals in order to improve integrated care. It is not clear whether the co-location of a multidisciplinary team actually facilitates a positive patient experience concerning GP care. The aim of this study was to verify whether the co-location of GPs in PCCs is associated positively with patient satisfaction with their GP when patients have experience of a multidisciplinary team. We also investigated whether patients who frequently use health services, due to their complex needs, benefitted the most from the co-location of a multidisciplinary team. METHODS: The study used data from a population survey carried out in Tuscany (central Italy) at the beginning of 2015 to evaluate the patients' experience and satisfaction with their GPs. Multilevel linear regression models were implemented to verify the relationship between patient satisfaction and co-location. This key explanatory variable was measured by considering both the list of GPs working in PCCs and the answers of surveyed patients who had experienced the co-location of their GP in a multidisciplinary team. We also explored the effect modification on patient satisfaction due to the use of hospitalisation, access to emergency departments and visits with specialists, by performing the multilevel modelling on two strata of patient data: frequent and non-frequent health service users. RESULTS: A sample of 2025 GP patients were included in the study, 757 of which were patients of GPs working in a PCC. Patient satisfaction with their GP was generally positive. Results showed that having a GP working within a PCC and the experience of the co-located multidisciplinary team were associated with a higher satisfaction (p < 0.01). For non-frequent users of health services on the other hand, the co-location of multidisciplinary team in PCCs was not significantly associated with patient satisfaction, whereas for frequent users, the strength of relationships identified in the overall model increased (p < 0.01). CONCLUSION: The co-location of GPs with other professionals and their joint working as experienced in PCCs seems to represent a greater benefit for patients, especially for those with complex needs who use primary care, hospitals, emergency care and specialized care frequently.

How do hospitalization experience and institutional characteristics influence inpatient satisfaction? A multilevel approach.

Over the last several years, interest in benchmarking health services' quality--particularly patient satisfaction (PS)--across organizations has increased. Comparing patient experiences of care across hospitals requires risk adjustment to control for important differences in patient case-mix and provider characteristics. This study investigates the individual-level and organizational-level determinants of PS with public hospitals by applying hierarchical models. The analysis focuses on the effect of hospital characteristics, such as self-discharges, on overall evaluations and on across hospital variation in scores. Sociodemographics, admission mode, place of residence, hospitalization ward and continuity of care were statistically significant predictors of inpatient satisfaction. Interestingly, it was observed that hospitals with a higher percentage of Patients Leaving Against Medical Advice (PLAMA) received lower scores. The latter result suggests that the percentage of PLAMA may provide a useful measure of a hospital's inability to meet patient needs and a proxy indicator of PS with hospital care.

Impact of continuity on quality of primary care: from the perspective of citizens' preferences and multimorbidity - position paper of the European Forum for Primary Care.

BACKGROUND: Continuity of care is one of the cornerstones of primary care. Initially, the concept of continuity largely corresponded to one care provider and continuity between doctor and patient, but today, healthcare processes and organisations have grown and become more complex. A survey of patients with complex care needs found that in all of 11 countries studied care was often poorly coordinated. Multidimensional models of continuity have to be developed. AIM: To study existing evidence concerning significance of continuity in primary care with special consideration given to the preferences of citizens and to patients with complex care needs. METHODS: Contemporary literature was studied from the aspects of primary care, patients' point of view, multimorbidity and organisational models. Examples from country systems were collected. The topic and drafts were presented and discussed at two EFPC conference workshops. RESULTS: Evidence shows that both patients and caregivers identify and value continuity in the form of regular sources of care, and that provider continuity is related to lower total healthcare costs on a macro level. Continuity is a considerable component of quality in primary care. Methods to measure and compare between primary care centres, organisations and countries to stimulate improvements in continuity is lacking. The complexity of operationalising continuity in the context of multidisciplinary team-based primary care today and in the future remains a challenge. CONCLUSIONS: Continuity is, and will be, an important component of quality in primary care, especially from the perspective of citizens and growing multimorbidity. Methods to develop continuity should be promoted.

Measures of quality, costs and equity in primary health care instruments developed to analyse and compare primary care in 35 countries.

BACKGROUND: The Quality and Costs of Primary Care in Europe (QUALICOPC) study aims to analyse and compare how primary health care systems in 35 countries perform in terms of quality, costs and equity. This article answers the question 'How can the organisation and delivery of primary health care and its outcomes be measured through surveys of general practitioners (GPs) and patients?' It will also deal with the process of pooling questions and the subsequent development and application of exclusion criteria to arrive at a set of appropriate questions for a broad international comparative study. METHODS: The development of the questionnaires consisted of four phases: a search for existing validated questionnaires, the classification and selection of relevant questions, shortening of the questionnaires in three consensus rounds and the pilot survey. Consensus was reached on the basis of exclusion criteria (e.g. the applicability for international comparison). Based on the pilot survey, comprehensibility increased and the number of questions was further restricted, as the questionnaires were too long. RESULTS: Four questionnaires were developed: one for GPs, one for patients about their experiences with their GP, another for patients about what they consider important, and a practice questionnaire. The GP questionnaire mainly focused on the structural aspects (e.g. economic conditions) and care processes (e.g. comprehensiveness of services of primary care). The patient experiences questionnaire focused on the care processes and outcomes (e.g. how do patients experience access to care?). The questionnaire about what patients consider important was complementary to the experiences questionnaire, as it enabled weighing the answers from the latter. Finally, the practice questionnaire included questions on practice characteristics. DISCUSSION: The QUALICOPC researchers have developed four questionnaires to characterise the organisation and delivery of primary health care and to compare and analyse the outcomes. Data collected with these instruments will allow us not only to show in detail the variation in process and outcomes of primary health care, but also to explain the differences from features of the (primary) health care system.

Systematic and continuous collection of patient-reported outcomes and experience in women with cancer undergoing mastectomy and immediate breast reconstruction: a study protocol for the Tuscany Region (Italy).

INTRODUCTION: Monitoring how patients feel and what they experience during the care process gives health professionals data to improve the quality of care, and gives health systems information to better design and implement care pathways. To gain new insights about specific gaps and/or strengths in breast cancer care, we measure patient-reported outcomes (PROs) and patient-reported experiences (PREs) for women receiving immediate breast reconstruction (iBR). METHODS AND ANALYSIS: Prospective, multicentre, cohort study with continuous and systematic web-based data collection from women diagnosed with breast cancer, who have an indication for iBR after mastectomy treated at any Breast Unit (BU) in Tuscany Region (Italy). Patients are classified into one of two groups under conditions of routine clinical practice, based on the type of iBR planned (implant and autologous reconstruction). Patient-reported information are obtained prior to and after surgery (at 3-month and 12-month follow-up). We estimate that there are around 700 annual eligible patients.Descriptive analyses are used to assess trends in PROs over time and differences between types of iBR in PROs and PREs. Additionally, econometric models are used to analyse patient and BU characteristics associated with outcomes and experiences. PREs are evaluated to assess aspects of integrated care along the care pathway. ETHICS AND DISSEMINATION: The study has been reviewed and obtained a nihil obstat from the Tuscan Ethics Committees of the three Area Vasta in 2017. Dissemination of results will be via periodic report, journal articles and conference presentations.

Performance assessment in the maternity pathway in Tuscany region.

The paper describes the performance measurement system of the maternity pathway used in Tuscany by health care professionals, general managers and regional policy-makers. This system uses 19 indicators grouped in six dimensions: population's state of health; compliance with regional guidelines; efficiency and financial performance; clinical and health assessment; patient satisfaction; and employees' satisfaction. The results are represented on a spider diagram that summarizes the results on the different dimensions. The Tuscan performance measurement system of the maternity pathway has been used to identify best practice within, and their adoption throughout, the Tuscan public health care system.

Are people's health care needs better met when primary care is strong? A synthesis of the results of the QUALICOPC study in 34 countries.

AIM: This article synthesises the results of a large international study on primary care (PC), the QUALICOPC study. BACKGROUND: Since the Alma Ata Declaration, strengthening PC has been high on the policy agenda. PC is associated with positive health outcomes, but it is unclear how care processes and structures relate to patient experiences. METHODS: Survey data were collected during 2011-2013 from approximately 7000 PC physicians and 70 000 patients in 34, mainly European, countries. The data on the patients are linked to data on the PC physicians within each country and analysed using multilevel modelling. FINDINGS: Patients had more positive experiences when their PC physician provided a broader range of services. However, a broader range of services is also associated with higher rates of hospitalisations for uncontrolled diabetes, but rates of avoidable diabetes-related hospitalisations were lower in countries where patients had a continuous relationship with PC physicians. Additionally, patients with a long-term relationship with their PC physician were less likely to attend the emergency department. Capitation payment was associated with more positive patient experiences. Mono- and multidisciplinary co-location was related to improved processes in PC, but the experiences of patients visiting multidisciplinary practices were less positive. A stronger national PC structure and higher overall health care expenditures are related to more favourable patient experiences for continuity and comprehensiveness. The study also revealed inequities: patients with a migration background reported less positive experiences. People with lower incomes more often postponed PC visits for financial reasons. Comprehensive and accessible care processes are related to less postponement of care. CONCLUSIONS: The study revealed room for improvement related to patient-reported experiences and highlighted the importance of core PC characteristics including a continuous doctor-patient relationship as well as a broad range of services offered by PC physicians.

The diabetes self-management educational programs and their integration in the usual care: A systematic literature review.

The increasing prevalence of type 2 diabetes has highlighted the importance of evidence-based guidelines for effective prevention, management and treatment. Diabetes self-management education (SME) produces positive effects on patient behaviours and health status. We analyzed the literature to identify (i) the level of integration between usual care and SME programs and (ii) any possible differences across them in terms of outcomes. Searches were made on three databases - PubMed, Scopus and Web of Science - to identify relevant publications on diabetes SME to 2015, which also describe the provider of usual care. In total, 49 studies met the inclusion criteria. We identified three levels of integration (high, medium and low) between usual care and SME programs based on the level of involvement of usual care professionals within the SME programs. In most cases, the primary care physician was responsible for the diabetes patients. Patient health behaviors and/or outcomes improve in most of the studies, independently from the level of integration. However, findings suggest that when patients/participants could perceive that usual care provider is highly involved in SME delivery, educational programs produced results that appear to be more positive.

Rethinking Healthcare Performance Evaluation Systems towards the People-Centredness Approach: Their Pathways, their Experience, their Evaluation.

Patient experience should be the starting point to achieve a high quality of care. Coherently, healthcare performance evaluation systems, driving the change in line with the main strategic goals, should be designed considering the patient perspective. Instead, they are traditionally defined according to the healthcare service provider's point of view. Consequently, they reproduce a "silo-vision" characterized by a clear separation of responsibilities limited to a specific setting of care or to a single organization. This commentary discusses the importance of using patient-reported measures together with indicators based on administrative data to evaluate cross-setting healthcare services within a multidimensional healthcare performance evaluation system. The experience of the Tuscany regional healthcare Performance Measurement System (PMS), implemented more than 10 years ago and in continuous evolution, represents an innovative example of how to measure the quality of the whole care pathway including patient experience. This new approach is based on a systematic, systemic and standardized collection of patient-reported experience measures in several healthcare pathways and evaluating them using a coherent graphical representation. Targets, incentives and other managerial tools are fixed, overcoming organizational boundaries and integrating the patient point of view with the goal of moving the healthcare system towards a patient-centredness approach to care.

Patient-perceived responsiveness of primary care systems across Europe and the relationship with the health expenditure and remuneration systems of primary care doctors.

BACKGROUND: Health systems are expected to be responsive, that is to provide services that are user-oriented and respectful of people. Several surveys have tried to measure all or some of the dimensions of the responsiveness (e.g. autonomy, choice, clarity of communication, confidentiality, dignity, prompt attention, quality of basic amenities, and access to family and community support), however there is little evidence regarding the level of responsiveness of primary care (PC) systems. METHODS: This work analyses the capacity of primary care systems to be responsive. Data collected from 32 PC systems were used to investigate whether a relationship exists between the responsiveness of PC systems and the PC doctor remuneration systems and domestic health expenditure. RESULTS: There appears to be a higher responsiveness of PC when doctors are paid via capitation than when they only receive a fee for services or a mixed payment method. In addition, countries that spend more on health services are associated with higher levels of dignity and autonomy. CONCLUSION: Quality, as measured from the patient's perspective, does not necessarily overlap with PC performance based on structure and process indicators. The results could also stimulate a new debate on the role of economic resources and PC workforce payment mechanisms in the achievement of quality goals, in this case related to the capacity of PC systems to be responsive.

Catching and monitoring clinical innovation through performance indicators. The case of the breast-conserving surgery indicator.

BACKGROUND: The evolution in the surgical and diagnostic procedures, the attention to women's preferences, the case mix, and differences in professional practices may lead to a variability in the quality of breast cancer clinical pathway. To catch and manage this variability it is important to use valid measures. The aim of this paper is to examine the concurrent validity of the breast-conserving surgery (BCS) indicator and to provide evidence to guide the quality improvement process. METHODS: The BCS indicator was calculated using hospital discharge records (HDRs) and was validated against surgical registry (SR) data in a random sample of 336 women undergoing breast cancer surgery in 2012 in two Tuscan teaching hospitals. The concurrent validity of BCS was examined by cross-tabulating patients using the ICD-9 CM codes for breast surgery obtained from the two data sources. RESULTS: The analysis, carried out involving breast cancer professionals, highlighted that the large majority of interventions coded as "mastectomies" in HDRs are in fact reconstructing procedures, including nipple-sparing, skin-sparing and skin-reducing mastectomies in SR. These results led us to refine the old algorithm, that calculates the proportion of breast-conserving surgery over the total number of breast interventions, and reclassify breast cancer surgical procedures into three categories: conservative, reconstructive and traditional mastectomy. Based on this new classification algorithm, the percentages of (I) reconstructive interventions were 16% at Florence TH and 38.3% at Pisa TH; (II) breast-conserving interventions were respectively 72.8 and 52.1%; and (III) mastectomies 11.2 and 9.6%. After adjusting for age in a logistic regression model, the percentages of reconstructive interventions at Florence and Pisa were respectively 22 and 34% and those of breast-conserving interventions 63 and 53%. CONCLUSIONS: Our results indicate that breast cancer care indicators should be refined by distinguishing reconstructive procedures (nipple/skin-sparing surgery with implant or breast tissue expander insertion) from traditional mastectomy. The involvement of breast care professionals in the choice of indicators proved to be crucial to capture the up-to-date breast cancer surgical practice and inform the quality improvement process.

Effectiveness of the Baby Friendly Community Initiative in Italy: a non-randomised controlled study.

OBJECTIVE: To assess the effectiveness of the Baby Friendly Community Initiative (BFCI) on exclusive breast feeding at 6 months. DESIGN: Controlled, non-randomised trial. SETTING: 18 Local Health Authorities in 9 regions of Italy. PARTICIPANTS: 5094 mother/infant dyads in 3 cohorts were followed up to 12 months after birth in 3 rounds of data collection: at baseline, after implementation of the intervention in the early intervention group and after implementation in the late intervention group. 689 (14%) dyads did not complete the study. INTERVENTION: Implementation of the 7 steps of the BFCI. MAIN OUTCOME MEASURES: The rate of exclusive breast feeding at 6 months was the primary outcome; breast feeding at discharge, 3 and 12 months was also measured. RESULTS: The crude rates of exclusive breast feeding at discharge, 3 and 6 months, and of any breast feeding at 6 and 12 months increased at each round of data collection after baseline in the early and late intervention groups. At the end of the project, 10% of infants were exclusively breast fed at 6 months and 38% were continuing to breast feed at 12 months. However, the comparison by adjusted rates and logistic regression failed to show statistically significant differences between groups and rounds of data collection in the intention-to-treat analysis, as well as when compliance with the intervention and training coverage was taken into account. CONCLUSIONS: The study failed to demonstrate an effect of the BFCI on the rates of breast feeding. This may be due, among other factors, to the time needed to observe an effect on breast feeding following this complex intervention.

Does feedback influence patient - professional communication? Empirical evidence from Italy.

Healthcare providers often look for feedback from patient surveys. Does health-professional awareness of patient survey results improve communication between patients and providers? To test this hypothesis, we analyzed the data of two surveys on organizational-climate and patient experience in Italy. The two surveys were conducted in 26 hospitals in the Tuscany region and involved 8942 employees and 5341 patients, respectively. Statistical analysis showed that the patient experience index significantly improved by 0.35 points (scale: 0-100) when the professionals' knowledge of the patient survey results increased by 1%. These findings suggest that the control systems should focus more on the dissemination phase of patient survey results among health professionals in order to improve the quality of services.

A controlled study on baby-friendly communities in Italy: methods and baseline data.

AIM: This study reports the research methods and baseline data of a project aimed at assessing the effect of an intervention based on the 7 Steps of the Baby Friendly Community Initiative (BFCI) on the rate of exclusive breastfeeding at 6 months in Italy. SUBJECTS AND METHODS: In this controlled, nonrandomized study, nine Local Health Authorities were assigned to an early and nine to a late intervention group. Data on breastfeeding in infants followed up from birth to 12 months were gathered at baseline and in two subsequent rounds, after the 7 Steps were implemented in the early and late intervention groups, respectively. Step-down logistic regression analysis, corrected for the cluster effect, was used to compare breastfeeding rates between groups. RESULTS: At baseline, there were no significant differences in breastfeeding rates at birth (n=1,781) and at 3 (n=1,854), 6 (n=1,601), and 12 (n=1,510; loss to follow-up, 15.2%) months between groups. At birth, 96% of mothers initiated breastfeeding, 72% exclusively (recall from birth). At 3 months, 77% of infants were breastfed, 54% exclusively with 24-hour and 46% with 7-day recall. At 6 months, the rate of any breastfeeding was 62%, with 10% and 7% exclusive breastfeeding with 24-hour and 7-day recall, respectively. At 12 months, 31% of the children continued to breastfeed. CONCLUSIONS: The project is ongoing and will allow estimation of the effect of the BFCI.