Cost-effectiveness of outpatient adherence to recommendations for monitoring of patients hospitalized for heart failure.

AIMS: A set of indicators to assess the quality of care for patients hospitalized for heart failure was developed by an expert working group of the Italian Health Ministry. Because a better performance profile measured using these indicators does not necessarily translate to better outcomes, a study to validate these indicators through their relationship with measurable clinical outcomes and healthcare costs supported by the Italian National Health System was carried out. METHODS AND RESULTS: Residents of four Italian regions (Lombardy, Marche, Lazio, and Sicily) who were newly hospitalized for heart failure (irrespective of stage and New York Heart Association class) during 2014-2015 entered in the cohort and followed up until 2019. Adherence to evidence-based recommendations [i.e. renin-angiotensin-aldosterone system (RAS) inhibitors, beta-blockers, mineralocorticoid receptor antagonists (MRAs), and echocardiograms (ECCs)] experienced during the first year after index discharge was assessed. Composite clinical outcomes (cardiovascular hospital admissions and all-cause mortality) and healthcare costs (hospitalizations, drugs, and outpatient services) were assessed during the follow-up. The restricted mean survival time at 5 years (denoted as the number of months free from clinical outcomes), the hazard of clinical outcomes (according to the Cox model), and average annual healthcare cost (expressed in euros per person-year) were compared between adherent and non-adherent patients. A non-parametric bootstrap method based on 1000 resamples was used to account for uncertainty in cost-effectiveness estimates. A total of 41 406 patients were included in this study (46.3% males, mean age 76.9 ± 9.4 years). Adherence to RAS inhibitors, beta-blockers, MRAs, and ECCs were 64%, 57%, 62%, and 20% among the cohort members, respectively. Compared with non-adherent patients, those who adhered to ECCs, RAS inhibitors, beta-blockers, and MRAs experienced (i) a delay in the composite outcome of 1.6, 1.9, 1.6, and 0.6 months and reduced risks of 9% (95% confidence interval, 2-14%), 11% (7-14%), 8% (5-11%), and 4% (-1-8%), respectively; and (ii) lower (€262, €92, and €571 per year for RAS inhibitors, beta-blockers, and MRAs, respectively) and higher costs (€511 per year for ECC). Adherence to RAS inhibitors, beta-blockers, and MRAs showed a delay in the composite outcome and a saving of costs in 98%, 84%, and 93% of the 1000 bootstrap replications, respectively. CONCLUSIONS: Strict monitoring of patients with heart failure through regular clinical examinations and drug therapies should be considered the cornerstone of national guidelines and audits.

Cancer and Pregnancy: Estimates in Italy from Record-Linkage Procedures between Cancer Registries and the Hospital Discharge Database.

The aim of this study is to describe the frequency and trend of pregnancy-associated cancer (PAC) in Italy, an increasingly relevant phenomenon due to postponing age at childbirth. To this purpose, a population-based retrospective longitudinal study design based on cohorts of women aged 15-49 diagnosed with cancer and concomitant pregnancy is proposed. The study uses 19 population-based Cancer Registries, covering about 22% of Italy, and linked at an individual level with Hospital Discharge Records. A total of 2,861,437 pregnancies and 3559 PAC are identified from 74,165 women of the cohort with a rate of 1.24 PAC per 1000 pregnancies. The most frequent cancer site is breast (24.3%), followed by thyroid (23.9%) and melanoma (14.3%). The most frequent outcome is delivery (53.1%), followed by voluntary termination of pregnancy and spontaneous abortion (both 12.0%). The trend of PAC increased from 2003 to 2015, especially when the outcome is delivery, thus confirming a new attitude of clinicians to manage cancer throughout pregnancy. This represents the first attempt in Italy to describe PAC from Cancer Registries data; the methodology is applicable to other areas with the same data availability. Evidence from this study is addressed to clinicians for improving clinical management of women with PAC.

Development of a Set of Indicators for Measuring and Improving Quality of Rehabilitation Care after Ischemic Stroke.

Stroke is the leading global cause of permanent disability and the second leading cause of dementia within the first year of the event. Systematic quality improvement interventions such as Audit & Feedback (A&F) can monitor and improve the performance of post-stroke care in conjunction with the use of quality indicators (QIs). The scientific literature shows limited studies on quality improvement and QIs design for poststroke rehabilitation. In Italy, the National Outcomes Evaluation Programme (PNE) annually provides several QIs concerning the acute wards. On the contrary, indicators for quality assessment of post-acute stroke rehabilitation are not available nationwide. In recent years, the Italian Ministry of Health has funded a national network project, the aim of which is to provide and evaluate the effectiveness of A&F strategies in healthcare improvement. Part of this project is the development of a set of IQs for ischemic stroke rehabilitation used to conduct an A&F. In this study, we describe the design and development process of these QIs from administrative databases and report the results of the pilot test conducted on a small sample of Sicilian rehabilitation facilities, comparing them from 2019 to 2021. Feedback from the participating centers was mainly positive, and the quality indicators were found to be comprehensible and appreciated. However, the study highlighted the need for better adherence to indicators measuring processes of rehabilitation care. The set of quality indicators presented in this study, relevant to inpatient settings, could be considered a starting point on which to base quality improvement initiatives both nationally and internationally.

Chronic polytherapy after myocardial infarction: the trade-off between hospital and community-based providers in determining adherence to medication.

BACKGROUND: The benefits of chronic polytherapy in reducing readmissions and death after myocardial infarction (MI) have been clearly shown. However, real-world evidence shows poor medication adherence and large geographic variation, suggesting critical issues in access to optimal care. Our objectives were to measure adherence to polytherapy, to compare the amount of variation attributable to hospitals of discharge and to community-based providers, and to identify determinants of adherence to medications. METHODS: This is a population-based study. Data were obtained from the information systems of the Lazio and Tuscany Regions, Italy (9.5 million inhabitants). Patients hospitalized with incident MI in 2010-2014 were analyzed. The outcome measure was medication adherence, defined as a Medication Possession Ratio (MPR) ≥ 0.75 for at least 3 of the following drugs: antiplatelets, ß-blockers, ACEI/ARBs, statins. A 2-year cohort-study was performed. Cross-classified multilevel models were applied to analyze geographic variation. The variance components attributable to hospitals of discharge and community-based providers were expressed as Median Odds Ratio (MOR). RESULTS: A total of 32,962 patients were enrolled. About 63% of patients in the Lazio cohort and 59% of the Tuscan cohort were adherent to chronic polytherapy. Women and patients aged 85 years and over were most at risk of non-adherence. In both regions, adherence was higher for patients discharged from cardiology wards (Lazio: OR = 1.58, p < 0.001, Tuscany: OR = 1.59, p < 0.001) and for patients with a percutaneous coronary intervention during the index admission. Relevant variation between community-based providers was observed, though when the hospital of discharge was included as a cross-classified level, in both Lazio and Tuscany regions the variation attributable to hospitals of discharge was the only significant component (Lazio: MOR = 1.30, p = 0.001; Tuscany: MOR = 1.31, p = 0.001). CONCLUSION: Adherence to best practice treatments after MI is not consistent with clinical guidelines, and varies between patient groups as well as within and between regions. The variation attributable to providers is affected by the hospital of discharge, up to two years from the acute episode. This variation is likely to be attributable to hospital discharge processes, and could be reduced through appropriate policy levers.

Acute Pancreatitis During and After Pregnancy: Incidence, Risk Factors, and Prognosis.

BACKGROUND: Acute pancreatitis may complicate pregnancy and both are associated with gallstones, but its incidence is not well known. AIMS: To validate hospital discharge records in diagnosing acute pancreatitis and gallstones and to evaluate acute pancreatitis incidence in non pregnant, pregnant and after delivery using hospital discharge records METHODS: We identified all hospital discharge records of hospitalized Sicilian women of childbearing age (2011-2016). We determined agreement between 300 hospital discharge records and hospital records in diagnosing acute pancreatitis and gallstones. Acute pancreatitis incidence, prognosis, and their relationship with age and gallstones were calculated in the three groups using hospital discharge records. RESULTS: There was 92% and 88% agreement in diagnosing acute pancreatitis and gallstones between hospital discharge and hospital records. In non pregnant, 1,564 of 7,236,863 women-years (21.61/100,000 person-years) developed acute pancreatitis. During pregnancy, 34 of 226,492 women-years developed acute pancreatitis (20.02/100,000 person-years). Postpartum acute pancreatitis incidence was higher than non pregnant, only in the first 2 years with the peak in the first semester (95.4/100,000 person-years). The increased incidence of postpartum acute pancreatitis was associated with gallstones in youngest women (gallstones acute pancreatitis in women below 20 years old versus non pregnant: rate ratios 16.61; 95% CI 8.40-32.87). CONCLUSIONS: Agreement in acute pancreatitis and gallstones diagnosis between hospital discharge and hospital records was accurate. Acute pancreatitis incidence was increased only in the first 2 years after delivery in young women with gallstones.

[Effects of high temperature and air pollution on the risk of preterm births. Analysis in six Italian cities, 2001-2010]. / Effetti delle alte temperature e dell'inquinamento atmosferico sul rischio di nascita pretermine. Analisi in sei città italiane, 2001-2010.

OBJECTIVES: to evaluate the association between short term maternal exposure to high temperature and air pollution on preterm births (PBs), which represent the first cause of perinatal mortality and morbidity in developed Countries, and to identify maternal risk factors enhancing individual susceptibility. DESIGN: time series. SETTING E PARTICIPANTS: all singleton live-births occurred in six Italian cities between 1st April and 31st October of each year in the period 2001-2010 were identified through the Certificate of Delivery Care Registry (CedAP). MAIN OUTCOME MEASURES: births occurred between 22nd and 36th week of gestation were defined as preterm births. Daily values were obtained for maximum apparent temperature (MAT), PM10, NO2, and O3. Exposures-preterm births association was estimated using a generalized additive model (GAM) with a Poisson distribution. Exposure and city-specific lag structure were computed using a non-linear distributed lag model (DLNM). RESULTS: 121,797 newborns were enrolled, 6,135 (5.0%) of which were PBs. For MAT, a linear relationship was observed for Turin (Piedmont Region, Northern Italy), Trieste (Friuli Venezia Giulia Region, Northern Italy), Rome (Lazio Region, Central Italy), and Palermo (Sicily Region, Southern Italy), while non-linear relationship was found for Bologna (Emilia-Romagna Region, Northern Italy) and Venice (Veneto Region, Northern Italy). The relative risks (RR) for MAT, computed comparing the 90th vs. the 75th percentile, vary from 1.02 (95%CI 0.95-1.09; lag 0-2) in Palermo to 1.94 (95%CI 1.32-2.85; lag 0-3) in Venice. For pollutants, a significant effect for 10 µg/m3 (IQR) increase of PM10 in Rome (RR: 1.07; 95%CI 1.02-1.12; lag 12-22) and for 16 µg/m3 (IQR) increase of O3 in Palermo (RR: 1.29; 95%CI 1.03-1.62; lag 2-9) was detected. In Rome, a significant effect modification by age and education level of the MAT-PB relationship and by education level and clinical conditions of PM10-PB was found. CONCLUSIONS: results showed a clear positive association between MAT and the risk of NP and a lower and variable effect of pollutants. It is important and necessary to limit the impact of these risk factors on the probability of NP with appropriate prevention programmes.

[The epidemiological surveillance in the programme of public health intervention in the national priority contaminated sites of Sicily Region (Southern Italy): update of mortality, hospitalization, and cancer incidence]. / La sorveglianza epidemiologica nel programma regionale di interventi sanitari nei siti di interesse nazionale della Sicilia: aggiornamento della mortalità, dell'ospedalizzazione e dell'incidenza oncologica.

OBJECTIVES: to update the health profile of populations residing in the national priority contaminated sites (NPCSs) in Sicily Region (Southern Italy) through a description of mortality and hospitalization for causes and through cancer incidence. This new profile is part of the implementation of the epidemiological surveillance system within the new Programme of care intervention for health protection in these populations and in the new Regional Prevention Plan. DESIGN: geographic population survey providing, for each NPCS considered in this study, a comparison between the local population and the populations of the neighbouring areas. SETTING AND PARTICIPANTS: the study population included the residents in the municipalities residing in the NPCSs of Augusta-Priolo, Gela, Milazzo, and Biancavilla. MAIN OUTCOME MEASURES: the standardized mortality ratio (SMR), morbidity (SHR), and tumour incidence (SIR), with the respective 95% confidence intervals, were estimated using the Mortality Registry as source for the mortality index, the database of the hospital discharged as source for the morbidity index, and the data from the Regional Network of Tumour Registers as source for the incidence index. RESULTS: in the local comparison, excess of hospitalization in both sexes was reported in Augusta-Priolo for liver cirrhosis, mental disorders, and digestive tract disease, and an excess of incidence and mortality for leukaemia in women and prostate cancer in men. In the NPCS of Gela, there was an excess of hospitalization in both sexes for blood and hematopoietic diseases, circulatory and nervous system diseases, coupled with the same excess of mortality. Excess of incidence and mortality of stomach tumours in men and incidence of lung cancer in women were observed. The area of ​​Milazzo was characterized by an excess of incidence and mortality for melanoma in men. In the municipality of Biancavilla, there is evidence of excess of hospitalization for respiratory diseases and endocrine glands diseases in both sexes, while a mortality excess for circulatory system diseases was highlighted. The excess of incidence of mesothelioma in both men and women was confirmed. CONCLUSION: data from the new surveillance system help to define the health profile in the NPCSs of Sicily. Even using the local level of comparison, that was added to the traditional approach in geographic studies for the NPCSs available to date, the particular impact of some chronic diseases in these populations has been confirmed also in recent years.

Prevalence and incidence of inflammatory bowel disease in two Italian islands, Sicily and Sardinia: A report based on health information systems.

BACKGROUND: Few epidemiological data about inflammatory bowel disease (IBD) in Italy are available. AIMS: To estimate IBD prevalence and incidence in two Italian regions - Sicily and Sardinia - using regional health information systems. METHODS: Data from hospital discharges and disease-specific payment exemptions register were retrieved and underwent record-linkage procedures. Standardized prevalence and incidence were calculated as rates per 100,000 inhabitants. RESULTS: In Sicily, during the year 2013, the overall IBD incidence rate was 27 per 100,000 inhabitants, while the incidence rate of Crohn's disease (CD) was 16 for males and 13 for females, and the incidence of ulcerative colitis (UC) was 15 and 11 for males and females, respectively. At the date of December 31st, 2013, the standardized prevalence rate of IBD was estimated at 300 cases per 100,000 inhabitants. In Sardinia, during the period 2008-2010, the average IBD incidence rate per 100,000 was 15, with an incidence rate of 5 per 100,000 for CD, and 10 per 100,000 for UC, while the standardized prevalence rate of IBD was estimated at 187 cases per 100,000 inhabitants. CONCLUSIONS: The particularly high incidence of CD in Sicily, and the marked difference of IBD occurrence between the two islands deserve future investigations.

[A composite indicator for maternity hospital classification]. / Un indicatore composito per la classificazione dei punti nascita.

OBJECTIVES: to propose a composite indicator for maternity hospital classification. DESIGN: descriptive analysis of maternity hospitals through a composite indicator and analysis of its association with infant readmissions within 30 days from the childbirth. SETTING AND PARTICIPANTS: 56 maternity units in Sicily, accounting for 44.436 newborns in 2014. MAIN OUTCOME MEASURES: infant readmission rates within 30 days from the childbirth. RESULTS: low-level hospitals show higher infant readmission rates (odds ratio: 1.3) which may be seen as a signal of inappropriateness of maternity care. CONCLUSIONS: the proposed indicator allows for a classification of maternity hospitals taking into account for different dimensions of the quality of care; it allows the identification of critical signals related to the considered dimensions.

Improvement in the management of chronic obstructive pulmonary disease following a clinical educational program: results from a prospective cohort study in the Sicilian general practice setting.

Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disorder of the lungs associated with progressive disability. Although general practitioners (GPs) should play an important role in the COPD management, critical issues have been documented in the primary care setting. The aim of this study was to evaluate the effectiveness of an educational program for the improvement of the COPD management in a Sicilian general practice setting. The effectiveness of the program, was evaluated by comparing 15 quality-of-care indicators developed from data extracted by 33 GPs, at baseline vs. 12 and 24 months, and compared with data from a national primary care database (HSD). Moreover, data on COPD-related and all-cause hospitalizations over time of COPD patients, was measured. Overall, 1,465 patients (3.2%) had a registered diagnosis of COPD at baseline vs. 1,395 (3.0%) and 1,388 (3.0%) over time (vs. 3.0% in HSD). COPD patients with one spirometry registered increased from 59.7% at baseline to 73.0% after 2 years (vs. 64.8% in HSD). Instead, some quality of care indicators where not modified such as proportion of COPD patients treated with ICS in monotherapy that was almost stable during the study period: 9.6% (baseline) vs. 9.9% (after 2 years), vs. 7.7% in HSD. COPD-related and all-cause hospitalizations of patients affected by COPD decreased during the two observation years (from 6.9% vs. 4.0%; from 23.0% vs. 18.9%, respectively). Our study showed that educational program involving specialists, clinical pharmacologists and GPs based on training events and clinical audit may contribute to partly improve both diagnostic and therapeutic management of COPD in primary care setting, despite this effect may vary across GPs and indicators of COPD quality of care.

[Distance from the nearest hospital and mortality for acute miocardial infarction (AMI) in Sicily Region (Southern Italy)]. / Distanza dalle strutture ospedaliere e mortalità per infarto miocardico acuto (IMA) in Sicilia.

OBJECTIVES: to analyse the effect of distance between the Municipality of residence and the nearest hospital on out-of-hospital mortality rate of patients died for acute myocardial infarction (AMI). DESIGN: analysis of out-of-hospital mortality using a record linkage database. SETTING AND PARTICIPANTS: Sicilian Municipalities; 4,999 deaths with acute myocardial infarction as primary cause of death, by excluding patients hospitalised within the 15 days before the death event. MAIN OUTCOME MEASURES: acute myocardial infarction out-of-hospital mortality in Sicilian Municipalities, with the exclusion of patients hospitalised within 15 days before the death event. RESULTS: during the years 2009-2011, 7,473 subjects died for acute myocardial infarction in Sicily. 4,999 (66.92%) patients were not hospitalised in the 15 days before the death event; 2,001 of these (40.01%) lived quite far from the nearest hospital (more than 17 minutes of traveling time). After adjustment for age, gender and socioeconomic status, the distance between the residential Municipality and the nearest hospital was significantly associated with increased mortality (27% higher risk of out-of-hospital mortality for patients living far from the nearest hospital, compared to those living in municipalities with at least one hospital). CONCLUSIONS: the distance between the residential Municipality and the nearest Municipality with at least one hospital is associated with an increase in out-of-hospital mortality rate after acute myocardial infarction. However, besides the limitations of using a distance metric (at a municipality level), the clinical history of the subjects under study is not explicitly taken into account. Further studies are needed in order to explore the reasons for this correlation and to further analyse the relationship between distance and mortality (in- and out-of-hospital). Nevertheless, the results presented provide useful information for healthcare service management policies.