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Contains fulltext : 221871.pdf (preprint version ) (Closed access), When newly born into this world, there is an overwhelming multitude of things to learn, ranging from learning to speak to learning how to solve a mathematical equation. Amidst this abundance, action perception is developing already in the first months of life. Why would learning about others' actions be among the first items to acquire? What is the relevance of action perception for young infants? Part of the answer probably lies in the strong dependence on others. Newborn human infants need caretakers even for fulfilling their basic needs. Weak neck muscles make it hard for them to lift up their head, and most of their movements come across as uncoordinated. Clearly, getting themselves a drink or dressing themselves is not part of their repertoire. Their reliance on their caregivers makes these caregivers and their actions important for the young infant. Seeing that the caregiver responds to their calls can already reduce some of the stress that comes with being so dependent. As such, it is helpful for an infant to learn to distinguish different actions of the caregiver. Not only are the caregivers' actions focused on the infant's physical needs, but also on helping the infant to regulate her emotions. Parents typically comfort a baby by softly rocking them, and by talking and smiling to them. Social interaction between caregiver and infant thus starts immediately after birth, and these interactions help them to bond. In the context of social interaction, it is useful to be able to distinguish a smile from a frown. Interpreting the facial actions of others is vital to successful communication. Moreover, in the period in which infants are still very limited in their own actions, observing others' actions forms a main resource for learning about the world. Making sense of others' actions is therefore of central importance already during early development.

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The aim of this thesis is to provide the methodology used to develop and validate population-based prognostic scores, and to assess the effectiveness and cost-effectiveness of the diagnostic-therapeutic path of diabetes, using the healthcare utilization databases (or administrative databases) of Italian regions. Thus, the thesis is structured into the following three main parts. First, the reasons to justify the need of real-world studies in addition to evidence from randomized controlled trials, the definitions of real-world data and real-world evidence, and an overview of the Italian healthcare utilization databases are given. Second, because patients should be monitored according to their risk to experience adverse outcomes (e.g., all-cause mortality, hospital admissions), prognostic scores could be used. However, the main limitation in the use of pre-existing score is that they are usually developed in countries different from Italy and from hospital-based or pharmacy-based surveys, so hindering their applicability to all beneficiaries of the National Health Service. Therefore, two population-based prognostic scores were developed and validated using data from some Italian regions. The usefulness of one of these scores (i.e., the so-called Multisource Comorbidity Score) in the risk adjustments and as a tool for health policy planning is also shown. Third, tracing the work carried out from the “Monitoring and assessing care pathways” working group of the Italian Ministry of Health, a description of the following activities is provided: I. the development of process indicators to monitor and assess the quality of care of patients suffering from some chronic disease; II. the comparison of care quality between regions; III. the validation of the diabetes care indicators with respect to selected outcomes (i.e., the assessment of their effectiveness); IV. the assessment of the costs from the National Health Service perspective (calculated by the amount that the Region, The aim of this thesis is to provide the methodology used to develop and validate population-based prognostic scores, and to assess the effectiveness and cost-effectiveness of the diagnostic-therapeutic path of diabetes, using the healthcare utilization databases (or administrative databases) of Italian regions. Thus, the thesis is structured into the following three main parts. First, the reasons to justify the need of real-world studies in addition to evidence from randomized controlled trials, the definitions of real-world data and real-world evidence, and an overview of the Italian healthcare utilization databases are given. Second, because patients should be monitored according to their risk to experience adverse outcomes (e.g., all-cause mortality, hospital admissions), prognostic scores could be used. However, the main limitation in the use of pre-existing score is that they are usually developed in countries different from Italy and from hospital-based or pharmacy-based surveys, so hindering their applicability to all beneficiaries of the National Health Service. Therefore, two population-based prognostic scores were developed and validated using data from some Italian regions. The usefulness of one of these scores (i.e., the so-called Multisource Comorbidity Score) in the risk adjustments and as a tool for health policy planning is also shown. Third, tracing the work carried out from the “Monitoring and assessing care pathways” working group of the Italian Ministry of Health, a description of the following activities is provided: I. the development of process indicators to monitor and assess the quality of care of patients suffering from some chronic disease; II. the comparison of care quality between regions; III. the validation of the diabetes care indicators with respect to selected outcomes (i.e., the assessment of their effectiveness); IV. the assessment of the costs from the National Health Service perspective (calculated by the amount that the Region

– OBJECTIVE: Few models of transition have been proposed for inflammatory bowel disease (IBD). The aim of the present study is to evaluate the feasibility of a transition model and the predictive factors for success/failure. PATIENTS AND METHODS: Patients with low activity or remission IBD were enrolled. Proposed model: three meetings every four-six weeks: the first one in the pediatric center (Bambino Gesù Children’s Hospital); the second one, in the adult center (Foundation Polyclinic University A. Gemelli), with pediatric gastroenterologists; the last one, in the adult center, with adult gastroenterologists only. Questionnaires included anxiety and depression clinical scale, self-efficacy, quality of life, visual-analogic scale (VAS). Transition was considered successful if the three steps were completed. RESULTS: Twenty patients were enrolled (range 18-25 years; M/F: 12/8; Ulcerative Colitis/ Crohn’s Disease 10/10); eight accepted the transition program, four delayed the process and eight refused. Patients who completed transition generated higher scores on the resilience scale, better scores on well-being perception, and had lower anxiety scores. Patients who failed transition were mostly women. The perceived utility of the transition program was scored 7.3 on a VAS scale. CONCLUSIONS: The proposed transition program seems to be feasible. Psychological scores may help in selecting patients and predicting outcomes.

Background: In recent years, novel radiation therapy techniques have moved clinical practice toward tailored medicine. An essential role is played by the decision support system, which requires a standardization of data collection. The Aim of the Prediction Models In Stereotactic External radiotherapy (PRE.M.I.S.E.) project is the implementation of systems that analyze heterogeneous datasets. This article presents the project design, focusing on brain stereotactic radiotherapy (SRT). Materials & methods: First, raw ontology was defined by exploiting semiformal languages (block and entity relationship diagrams) and the natural language; then, it was transposed in a Case Report Form, creating a storage system. Results: More than 130 brain SRT's variables were selected. The dedicated software Beyond Ontology Awareness (BOA-Web) was set and data collection is ongoing. Conclusion: The PRE.M.I.S.E. project provides standardized data collection for a specific radiation therapy technique, such as SRT. Future aims are: including other centers and validating an extracranial SRT ontology. Lay abstract Radiotherapy moves clinical practice toward tailored medicine, where a decision support system is essential. The Prediction Models In Stereotactic External radiotherapy (PRE.M.I.S.E) project aims to implement a system that can analyze heterogeneous datasets. This article presents the project design for brain stereotactic radiotherapy (SRT). First, a raw ontology, which is a classification system where uniform and nonambiguous definitions represent each variable and all their relationships, was defined by exploiting semiformal and natural language. It was then it was transposed in a case report form, setting a storage system. More than 130 brain SRT's variables were selected. The dedicated software BOA-Web (Beyond Ontology Awareness) was set. PRE.M.I.S.E. provides standardized data collection for SRT. Future aims are: including other centers and validating an extracranial SRT

Background: A potential association between the use of angiotensin-receptor blockers (ARBs) and angiotensin-converting-enzyme (ACE) inhibitors and the risk of coronavirus disease 2019 (Covid-19) has not been well studied. Methods: We carried out a population-based case-control study in the Lombardy region of Italy. A total of 6272 case patients in whom infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was confirmed between February 21 and March 11, 2020, were matched to 30,759 beneficiaries of the Regional Health Service (controls) according to sex, age, and municipality of residence. Information about the use of selected drugs and patients' clinical profiles was obtained from regional databases of health care use. Odds ratios and 95% confidence intervals for associations between drugs and infection, with adjustment for confounders, were estimated by means of logistic regression. Results: Among both case patients and controls, the mean (±SD) age was 68±13 years, and 37% were women. The use of ACE inhibitors and ARBs was more common among case patients than among controls, as was the use of other antihypertensive and non-antihypertensive drugs, and case patients had a worse clinical profile. Use of ARBs or ACE inhibitors did not show any association with Covid-19 among case patients overall (adjusted odds ratio, 0.95 [95% confidence interval {CI}, 0.86 to 1.05] for ARBs and 0.96 [95% CI, 0.87 to 1.07] for ACE inhibitors) or among patients who had a severe or fatal course of the disease (adjusted odds ratio, 0.83 [95% CI, 0.63 to 1.10] for ARBs and 0.91 [95% CI, 0.69 to 1.21] for ACE inhibitors), and no association between these variables was found according to sex. Conclusions: In this large, population-based study, the use of ACE inhibitors and ARBs was more frequent among patients with Covid-19 than among controls because of their higher prevalence of cardiovascular disease. However, there was no evidence that ACE inhibitors or ARBs affect

Aim. To provide information on the balance between the cardiovascular (CV) benefit and the diabetogenic harm of statin therapy in the current clinical practice. Methods. All the 115,939 residents (older than 50 years) in the Italian Lombardy Region newly treated with statins between 2003 and 2005, were followed from the first statin prescription until 2012 to identify those experiencing a macrovascular complication and those with at least one sign suggestive of new onset diabetes. The proportion of days of follow-up covered by statin prescriptions measured adherence with statins. Hazard ratio, and relative 95% confidence interval (CI), for the two considered outcomes associated with statin adherence, were separately estimated (proportional hazard models). Number needed to treat (NNT) and number needed to harm (NNH), i.e., number of individuals who must be treated with statins in order to prevent a macrovascular complication, or to generate a new onset diabetes, respectively, were calculated to evaluate the balance between CV benefit and diabetogenic harm of statin therapy. Results. Compared to those at very low adherence with statins, patients at high adherence showed a significant reduction of macrovascular risk (28%, 95% CI: 23%-33%) and a greater risk of developing diabetic condition (67%, 50%-86%). In the whole cohort, the NNT was 26, whereas the NNH 65. NNT was lower than NNH also in all considered strata of age, gender, clinical profile. Conclusions. This large cohort investigation provides real-world evidence that the balance between CV benefit and diabetogenic harm of statin therapy is largely favourable to treatment benefits.

Background: Multimorbidity is a growing concern for healthcare systems, with many countries experiencing demographic transition to older population profiles. A simple multisource comorbidity score (MCS) has been recently developed and validated. A very large real-world investigation was conducted with the aim of measuring inequalities in the MCS distribution across Italy. Methods: Beneficiaries of the Italian National Health Service aged 50-85 years who in 2018 were resident in one of the 10 participant regions formed the study population (15.7 million of the 24.9 million overall resident in Italy). MCS was assigned to each beneficiary by categorizing the individual sum of the comorbid values (i.e. the weights corresponding to the comorbid conditions of which the individual suffered) into one of the six categories denoting a progressive worsening comorbidity status. MCS distributions in women and men across geographic partitions were compared. Results: Compared with beneficiaries from northern Italy, those from centre and south showed worse comorbidity profile for both women and men. MCS median age (i.e. the age above which half of the beneficiaries suffered at least one comorbidity) ranged from 60 (centre and south) to 68 years (north) in women and from 63 (centre and south) to 68 years (north) in men. The percentage of comorbid population was lower than 50% for northern population, whereas it was around 60% for central and southern ones. Conclusion: MCS allowed of capturing geographic variability of multimorbidity prevalence, thus showing up its value for addressing health policy in order to guide national health planning.

OBJECTIVES: Although it has been postulated that patients might benefit from the centralization of high-volume specialized centres, conflicting results have been reported on the relationship between the number of lung resections performed and the long-term, all-cause mortality rates among patients who underwent surgery for lung cancer. A population-based observational study was performed to contribute to the ongoing debate. METHODS: The 2613 patients, all residents of the Lombardy region (Italy), who underwent lung resection for lung cancer from 2012 to 2014 were entered into the cohort and were followed until 2018. The hospitals were classified according to the annual number of pulmonary resections performed. Three categories of lung resection cases were identified: low (≤30), intermediate (31-95) and high (>95). The outcome of interest was all-cause death. A frailty model was used to estimate the death risk associated with the categories of numbers of lung resections performed, taking into account the multilevel structure of the data. A set of sensitivity analyses was performed to account for sources of systematic uncertainty. RESULTS: The 1-year and 5-year survival rates of cohort members were 90% and 63%. Patients operated on in high-volume centres were on average younger and more often women. Compared to patients operated on in a low-volume centre, the mortality risk exhibited a significant, progressive reduction as the numbers of lung resections performed increased to intermediate (-13%; 95% confidence interval +10% to-31%) and high (-26%; 0% to-45%). Sensitivity analyses revealed that the association was consistent. CONCLUSIONS: Further evidence that the volume of lung resection cases performed strongly affects the long-term survival of lung cancer patients has been supplied.

Objective: Several factors affect adherence to antihypertensive drug treatment, but whether these factors include a sex difference is unclear. Aim of the study was to compare persistence with antihypertensive drug therapy between men and women in a large cohort of patients.Methods:The 60 526 residents of the Italian Lombardy Region aged 40-80 years newly treated with antihypertensive drugs during 2010 were identified and followed for 1 year after the first prescription. Discontinuation of treatment was defined as lack of prescription renewal for at least 90 days. Log-binomial regression models were fitted to estimate the risk ratio of treatment discontinuation in relation to sex. Other than for the whole population, analyses were stratified according to age, comorbidity status and the initial antihypertensive treatment strategy.Results:Thirty-seven percent of the patients discontinued the drug treatment during follow-up. Compared with women, men had a 10% lower risk of discontinuation of drug treatment (95% confidence interval: 8-12). Persistence on antihypertensive treatment was better in men than in women, this being the case in both younger (40-64 years) and older patients (65-80 years), in patients starting treatment with any major antihypertensive drug and in patients who had a low comorbidity status. There was no evidence that men and women had a different risk of treatment discontinuation when their comorbidity status was worse, or initial antihypertensive treatment was based on drug combinations.Conclusion:Our data show that in a real-life setting, men are more persistent to antihypertensive drug therapy than women.

The current coronavirus disease 2019 (COVID-19) pandemic has made us aware of the weaknesses and often the inadequacies of our current technologies and practices and has presented us with a huge challenge: to reorganize the way we work and sometimes even think, in order to ensure the safety of our patients. The Italian Society of Thoracic Surgery has launched various initiatives in response to the COVID-19 pandemic, aimed at facilitating the exchange of information, strategies and personal experiences between institutions. This article presents the results of a survey amongst all Italian thoracic surgery units accredited to SICT, with the aim of providing a glimpse of the current working conditions in these units, and an understanding of the impact of COVID-19 on their daily activities and patient care.

BACKGROUND: acute myocardial infarction (AMI), ischemic heart diseases (IHDs) and stroke are serious cardiovascular diseases (CVDs) which may lead to hospitalizations, require periodical medical monitoring and life-long drugs use, thus having a high impact on public health and Healthcare Service expenditure. In this contest, Italian Healthcare Administrative Databases (HADs), which routinely collect patient-level information on healthcare services reimbursed by the National Healthcare service, are increasingly used for identification of these CVDs. ObjectiveS: to identify and describe all AMI, IHDs and stroke case-identification algorithms by means of Italian HADs, through the review of papers published in the past 10 years. Methods: this study is part of a project that systematically reviewed case-identification algorithms for 18 acute and chronic conditions by means of HADs in Italy. PubMed was searched for original articles, published between 2007 and 2017, in Italian or English. The search string consisted of a combination of free text and MeSH terms with a common part that focused on HADs and a disease-specific part. All identified papers were screened by two independent reviewers. Pertinent papers were classified according to the objective for which the algorithm had been used, and only articles that used algorithms for primary objectives (I disease occurrence; II population/cohort selection; III outcome identification) were considered for algorithm extraction. The HADs used (hospital discharge records, drug prescriptions, etc.), ICD-9 and ICD-10 codes, ATC classification of drugs, follow-back periods, and age ranges applied by the algorithms have been reported. Further information on specific objective(s), accuracy measures, sensitivity analyses and the contribution of each HAD, have also been recorded. Results: the search strategy has led to the identification of 611 papers for AMI,801 for IHDs and 791 for stroke. Among these,45,12 and 31 papers for AMI, IHD

Background: Little is known about the comparative risk of death with atypical or conventional antipsychotics (APs) among persons with cardiovascular or cerebrovascular disease (CCD). Research design and methods: A cohort study was conducted using five Italian claims databases. New atypical AP users with CCD aged ≥65 (reference) were matched to new conventional AP users. Mortality per 100 person-years (PYs) and hazard ratios (HR), estimated using Cox models, were reported. Incidence and risk of death were estimated for persons having drug–drug interactions. Outcome occurrence was evaluated 180 days after AP initiation. Results: Overall 24,711 and 27,051 elderly new conventional and atypical AP users were identified. The mortality rate was 51.3 and 38.5 deaths per 100 PYs for conventional and atypical AP users. Mortality risk was 1.33 (95%CI: 1.27–1.39) for conventional APs. There was no increased mortality risk with single drug–drug interactions (DDIs) vs. no DDI. AP users with ≥1 DDI had a 29% higher mortality risk compared to no DDI in the first 90 days of treatment (HR: 1.29 (95% CI: 1.00–1.67)). Conclusions: Conventional APs had a higher risk of death than atypical APs among elderly persons with CCD. Having ≥1 DDI was associated with an increased risk of death.

Aims: Women with pre-existing diabetes should plan for optimal care of the disease before, during and after pregnancy. The aim of this study was to assess the quality of diabetes mellitus monitoring and care before, during and after pregnancy in a large cohort of women. Methods: 1913 diabetic women resident in the Lombardy Region (Italy) who experienced at least a birth between 2011 and 2015 and exhibited signs of diabetes ≥2 years before delivery were identified using the healthcare utilization database. Antidiabetic care was defined via outpatient examinations (i.e., assessments of glycated haemoglobin, lipid profile, urine albumin excretion and serum creatinine, and dilated eye exams) and use of antidiabetic drugs. Differences in adherence to recommendations before, during and after pregnancy were assessed by the non-parametric McNemar's test among the whole cohort and among the subgroup with type 1 diabetes. Results: Adherence to recommendations was very poor before pregnancy, ranging from 13% to 42% for dilated eye and serum creatinine exam, respectively. During pregnancy, a significant portion of women increased adherence to all recommendations (e.g., glycated haemoglobin from 20% to 47%, p-value < 0.001), with the exception of lipid profile control. After pregnancy, adherence dropped to pre-pregnancy levels. A similar trend was observed in the use of antidiabetic drugs. Although women with type 1 diabetes showed better adherence across all periods, the same patterns emerged. Conclusions: Besides an improvement in the indicators of clinical adherence during pregnancy, the management of diabetes among pregnant women remains sub-optimal both before and after the birth.

Objective: To determine whether out-of-hospital healthcare and adverse outcomes are better in stroke patients admitted to a neurology ward compared with those admitted to general wards. Methods: Beneficiaries of the National Health Service from the Italian Lombardy Region who were discharged alive after hospital admission during the year 2009 for ischemic stroke (9776 patients) or intracerebral or subarachnoid hemorrhage (1102 patients) entered into the cohort and were followed until 2012. Exposure of interest was the ward type where inpatients were admitted (neuro vs. general wards). Outcomes were out-of-hospital healthcare (i.e., drug prescriptions, diagnostic procedures, and laboratory clinical evaluations) and adverse clinical outcomes (i.e., all-cause death and hospital readmission). Exposure-outcome associations were investigated. High-dimensional propensity score methodology was used for taking into account confounders. Mediation analysis was used to verify whether the association between ward type and clinical outcomes is mediated by out-of-hospital adherence to healthcare. Results: Better adherence to out-of-hospital healthcare received from patients discharged from neuro, rather than general, wards was observed being the proportions of adherent patients 42.4% and 39.5%, respectively. Compared with general wards, discharge from neuro was associated with reduced 3-year emergency admissions (from 50.1 to 47.5% among ischemic stroke patients) and reduced 3-year mortality (from 37.5 to 27.0% among hemorrhagic stroke patients). From 10 to 15% of outcome risk, reductions were mediated by better adherence to out-of-hospital healthcare. Conclusions: For patients with acute ischemic and hemorrhagic stroke, admission to neuro vs. general wards is associated with better out-of-hospital healthcare and long-term adverse outcomes.

Blood pressure (BP) control in patients with hypertension is variable worldwide, and in general, it results largely unsatisfactory. Factors responsible for this phenomenon include insufficient national cardiovascular healthcare policies for prevention, poor patient compliance with prescribed treatment schedules, and the reluctance of physicians to modify treatment strategies when BP is still elevated, that is, the so-called therapeutic inertia. A further important factor favoring poor BP control is the limited use of combination drug treatment, despite evidence of its superior ability to control BP in patients with difficult-to-treat hypertension. In addition, combination treatment allows to achieve BP control more easily (and more quickly) as compared with monotherapy. This article, after briefly examining the main features of BP control, will review the importance in the treatment of hypertension of the drug combination strategy, based on the recommendations of the 2018 European Society of Cardiology/European Society of Hypertension guidelines. Empahsis will be given to the drug combination treatment as first step of the antihypertensive therapeutic intervention. The potential drawbacks and barriers to combination drug treatment as initial therapeutic strategy will also be briefly discussed.

Objective: To validate a set of indicators for quality of diabetes care through their relationship with measurable clinical outcomes. Design: A retrospective cohort study was carried out from 2010 to 2015. Setting: Population-based study. Data were retrieved from healthcare utilization databases of three Italian regions (Lombardy, Emilia Romagna and Lazio) on the whole covering 20 million citizens. Participants: The 77 285 individuals who were newly taken in care for diabetes during 2010 entered into the cohort. Interventions: Exposure to selected clinical recommendations (i.e. periodic controls for glycated hemoglobin, lipid profile, urine albumin excretion, serum creatinine and dilated eye exams) was recorded. Main outcomes measures: A composite outcome was employed taking into account hospitalizations for brief-term diabetes complications, uncontrolled diabetes, long-term vascular outcomes and no traumatic lower limb amputation. A multivariable proportional hazards model was fitted to estimate hazard ratio, and 95% confidence intervals (CI), for the exposure-outcome association. Results: Among the newly taken in care patients with diabetes, those who adhered to almost none (0 or 1), just some (2 or 3) or almost all (4 or 5) recommendations during the first year after diagnosis were 44%, 36% and 20%, respectively. Compared patients who adhered to almost none recommendation, significant risk reductions of 16% (95% CI, 6-24%) and 20% (7-28%) were observed for those who adhered to just some and almost all recommendations, respectively. Conclusions: Tight control of patients with diabetes through regular clinical examinations must to be considered the cornerstone of national guidance, national audits and quality improvement incentives schemes.

Enormous progress has been made globally in the use of evidence derived from patients’ clinical information as they access their routine medical care. The value of real-world data lies in their complementary nature compared with data from randomised controlled trials: less detailed information on drug efficacy but longer observational periods and larger, more heterogeneous study populations reflecting clinical practice because individuals are included who would not usually be recruited in trials. Real-world data can be collected in various types of electronic sources, such as electronic health records, claims databases and drug or disease registries. These data sources vary in nature from country to country, according to national healthcare system structures and national policies. In Italy, a growing number of healthcare databases have been used to evaluate post-marketing drug utilisation and safety in the last two decades. The aim of this narrative review is to describe the available Italian sources of real-world data and their contribution to generating post-marketing evidence on drug use and safety. We also discuss the strengths and limitations of the most commonly used Italian healthcare databases in addressing various research questions concerning drug utilisation, comparative effectiveness and safety studies, as well as health technology assessment and other areas

Background: Incidence and prognostic impact of heart failure (HF) progression has been not well addressed. Methods: From 2009 until 2015, consecutive ambulatory HF patients were recruited. HF progression was defined by the presence of at least two of the following criteria: step up of ≥1 New York Heart Association (NYHA) class; decrease LVEF ≥ 10 points; association of diuretics or increase ≥ 50% of furosemide dosage, or HF hospitalization. Results: 2528 met study criteria (mean age 76; 42% women). Of these, 48% had ischemic heart disease, 18% patients with LVEF ≤ 35%. During a median follow-up of 2.4 years, overall mortality was 31% (95% CI: 29%–33%), whereas rate of HF progression or death was 57% (95% CI: 55%–59%). The 4-year incidence of HF progression was 39% (95% CI: 37%–41%) whereas the competing mortality rate was 18% (95% CI: 16%–19%). Rates of HF progression and death were higher in HF patients with LVEF ≤ 35% vs >35% (HF progression: 42% vs 38%, p = 0.012; death as a competing risk: 22% vs 17%, p = 0.002). HF progression identified HF patients with a worse survival (HR = 3.16, 95% CI: 2.75–3.72). In cause-specific Cox models, age, previous HF hospitalization, chronic obstructive pulmonary disease, chronic kidney disease, anemia, sex, LVEF ≤ 35% emerged as prognostic factors of HF progression. Conclusions: Among outpatients with HF, at 4 years 39% presented a HF progression, while 18% died before any sign of HF progression. This trend was higher in patients with LVEF ≤ 35%. These findings may have implications for healthcare planning and resource allocation.

Background: Little is known about the comparative risk of death with atypical or conventional antipsychotics (APs) among persons with cardiovascular or cerebrovascular disease (CCD). Research design and methods: A cohort study was conducted using five Italian claims databases. New atypical AP users with CCD aged ≥65 (reference) were matched to new conventional AP users. Mortality per 100 person-years (PYs) and hazard ratios (HR), estimated using Cox models, were reported. Incidence and risk of death were estimated for persons having drug–drug interactions. Outcome occurrence was evaluated 180 days after AP initiation. Results: Overall 24,711 and 27,051 elderly new conventional and atypical AP users were identified. The mortality rate was 51.3 and 38.5 deaths per 100 PYs for conventional and atypical AP users. Mortality risk was 1.33 (95%CI: 1.27–1.39) for conventional APs. There was no increased mortality risk with single drug–drug interactions (DDIs) vs. no DDI. AP users with ≥1 DDI had a 29% higher mortality risk compared to no DDI in the first 90 days of treatment (HR: 1.29 (95% CI: 1.00–1.67)). Conclusions: Conventional APs had a higher risk of death than atypical APs among elderly persons with CCD. Having ≥1 DDI was associated with an increased risk of death.