Patient Safety and Surgery: the Experience of the Lombardy Region. A Project on External Evaluation of Best Practices Implementation.

Meta-analysis studies published over the past 20 years document that approximately 10 -14 % of hospitalised patients have an adverse event in Surgery and at least half of these adverse events are considered preventable using the current standards of care. In order to improve the safety of surgical patients and increasing adherence to current standard of care in surgery, including communication within the team and teamwork, in 2007 the WHO launched the campaign "Safe Surgery Saves Lives". The WHO has also built a checklist for safety in the operating room containing 19 item in support of the operating team. The Ministry of Health in 2009 has taken the instruments produced by WHO in the "Guide to Safety in the operating room: Recommendations and Checklist". Studies conducted in industrialized countries report a strong heterogeneity in compliance to the check list for the surgical safety, with a range of between 38% and 96%. The aim of this project was to adopt the methodology of the external "peer review" to improve quality and patient safety applied to the surgical process and assess the degree of implementation of good practice in the operating room, both in public and private structures. Between 2015 and 2018 we have carried out 16 external evaluation visits. These visits included a first plenary session followed by the inspection of the operating theaters identified and a second plenary session. Several factors emerged during the visits; these factors represent both the strengths and criticalities of the organizations. The creation of a team of experts, coordinated by the Lombardy Region with the role of leadership, using the "peer review" methodology, is the leverage to promote among operators the growth of awareness of the usefulness of the tools.

Use of preventive drugs during the last year of life in older adults with cancer or chronic progressive diseases.

PURPOSE: To evaluate the prescription of preventive medications with questionable usefulness in community dwelling elderly adults with cancer or chronic progressive diseases during the last year of life. METHODS: Through the utilization of the healthcare databases of the Lombardy region, Italy, we identified two retrospective cohorts of patients aged 65 years or more, who died in 2018 and had a diagnosis of either a solid cancer (N = 19 367) or a chronic progressive disease (N = 27 819). We estimated prescription of eight major classes of preventive drugs 1 year and 1 month before death; continuation or initiation of preventive drug use during the last month of life was also investigated. RESULTS: Over the last year of life, in both oncologic and non-oncologic patients, we observed a modest decrease in the prescription of blood glucose-lowering drugs, anti-hypertensives, lipid-modifying agents, and bisphosphonates, and a slight increase in the prescription of vitamins, minerals, antianemic drugs, and antithrombotic agents (among oncologic patients only). One month before death, the prescription of preventive drugs was still common, particularly for anti-hypertensives, antithrombotics, and antianemics, with more than 60% of patients continuing to be prescribed most preventive drugs and an over 10% starting a therapy with an antithrombotic, an antianemic, or a vitamin or mineral supplement. CONCLUSION: These findings support the need for an appropriate drug review and improvement in the quality of drug prescription for vulnerable populations at the end-of-life.

Cost-effectiveness of the adherence with recommendations for clinical monitoring of patients with diabetes.

BACKGROUND AND AIMS: To validate a set of indicators for monitoring the quality of care of patients with diabetes in 'real-life' practice through its relationship with measurable clinical outcomes and healthcare costs. METHODS AND RESULTS: A population-based cohort study was carried out by including the 20,635 patients, residents in the Lombardy Region (Italy), who in the year 2012 were newly taken-in-care for diabetes. Adherence with clinical recommendations (i.e., controls for glycated haemoglobin, lipid profile, urine albumin excretion and serum creatinine) was recorded during the first year after the patient was taken-in-care, and categorized according whether he/she complied with none or almost none (0 or 1), just some (2) or all or almost all (3 or 4) the recommendations, respectively denoted as poor, intermediate and high adherence. Short- and long-term complications of diabetes, and healthcare cost incurred by the National Health Service, were assessed during follow-up. Compared with patients with poor adherence, those with intermediate and high adherence respectively showed (i) a delay in outcome occurrence of 13 days (95% CI, -2 to 27) and 23 days (9-38), and (ii) a lower healthcare cost of 54 € and 77 €. In average, a gain of 18 Euros and 15 Euros for each day free from diabetic complication by increasing adherence respectively from poor to intermediate and from poor to high were observed. CONCLUSION: Close control of patients with diabetes through regular clinical examinations must be considered the cornerstone of national guidance, national audits, and quality improvement incentive schemes.

Terrorist attacks and minority perceived discrimination.

A growing strand of the literature finds a causal negative impact of terrorism on undifferentiated discriminatory attitudes toward Muslims, migrants, and other minorities. In this paper, we argue that jihadist terrorism threatens first and foremost Muslims. To evaluate this claim, we estimate the causal effect of jihadist terrorism on the perceived discrimination among Muslims through a 2×2 quasi-experimental design. Exploiting "natural experiments" driven by exogenous variation in terror threat caused by jihadist attacks that unexpectedly occurred during the fieldwork of a large survey, we compare the perceived ethoracial discrimination of the relevant minority (Muslims) against other minorities (non-Muslims) before and after five different terror attacks in five different European countries. We find that jihadist attacks increase perceived ethnoracial discrimination among Muslims while reducing it among non-Muslims, and that individual-level factors including social status and economic insecurity mitigate public opinion responses to a greater extent than group-level factors do. Hence, while in-group attitudes toward out-groups tend to be undifferentiated, the experience of out-groups in the aftermath of jihadist attacks depends on the specific identity of the respondents.

Sex-differences in factors and outcomes associated with adherence to statin therapy in primary care: Need for customisation strategies.

Despite the invaluable efficacy of statins, adherence to therapy is extremely poor in clinical practice. Improvement interventions should be as personalized as possible, but it is necessary to know factors that most influence adherence, and sex seems to be a key determinant. Thus, we aimed at exploring potential areas of sex-differences in statin adherence in a real-world population. For this purpose, we assessed adherence (as proportion of days covered) on a wide cohort of new statin users aged >40 years, and we evaluated its association with several covariates through sex-stratified log-binomial regression models. In addition, to compare also the benefits of optimal statin adherence in primary prevention of cardiovascular disease between men and women, we implemented sex-stratified Cox proportional hazard models. Our study showed that women are more likely to stop or be less adherent to statin treatment than men. Moreover, we observed significant sex-differences on effect size of several factors associated with adherence that should be taken into consideration for the management of patients. Finally, we observed no significant difference between men and women regarding statin efficacy in terms of reduction of incident hospitalization for ischemic heart disease and/or non-haemorrhagic cerebrovascular disease. These results invoke the responsibility of physicians to a prompt and personalized intervention. Physicians should consider routine screening for non-adherence in their clinical practice, target patients at higher risk of non-adherence, and improved motivation and communication.

Measuring multimorbidity inequality across Italy through the multisource comorbidity score: a nationwide study.

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.

Is Switching from Oral Antidiabetic Therapy to Insulin Associated with an Increased Fracture Risk?

BACKGROUND: Observational studies showed that exposure to exogenous insulin increases fracture risk. However, it remains unclear whether the observed association is a function of the severity of underlying type 2 diabetes mellitus, complications, therapies, comorbidities, or all these factors combined. That being so, and because of the relative infrequency of these events, it is important to study this further in a large-database setting. QUESTION/PURPOSES: (1) Is switching from oral antidiabetic agents to insulin associated with an increased fracture risk? (2) How soon after switching does the increased risk appear, and for how long does this increased risk persist? METHODS: Data from healthcare utilization databases of the Italian region of Lombardy were used. These healthcare utilization databases report accurate, complete, and interconnectable information of inpatient and outpatient diagnoses, therapies, and services provided to the almost 10 million residents in the region. The 216,624 patients on treatment with oral antidiabetic therapy from 2005 to 2009 were followed until 2010 to identify those who modified their antidiabetic therapy (step 1 cohort). Among the 63% (136,307 patients) who experienced a therapy modification, 21% (28,420 patients) switched to insulin (active exposure), and the remaining 79% (107,887 patients) changed to another oral medication (referent exposure). A 1:1 high-dimension propensity score matching design was adopted for balancing patients on active and referent exposure. Matching failed for 3% of patients (926 patients), so the cohort of interest was formed by 27,494 insulin-referent couples. The latter were followed until 2012 to identify those who experienced hospital admission for fracture (outcome). A Cox proportional hazard model was fitted to estimate the hazard ratio (HR) for the outcome risk associated with active-exposure (first research question). Between-exposure comparison of daily fracture hazard rates from switching until the 24 successive months was explored through the Kernel-smoothed estimator (second research question). RESULTS: Compared with patients on referent exposure, those who switched to insulin had an increased risk of experiencing any fracture (HR = 1.5 [95% CI 1.3 to 1.6]; p < 0.001). The same risk was observed for hip and vertebral fractures, with HRs of 1.6 (95% CI 1.4 to 1.8; p < 0.001) and 1.8 (95% 1.5 to 2.3; p < 0.001), respectively. Differences in the daily pattern of outcome rates mainly appeared the first 2 months after switching, when the hazard rate of patients on active exposure (9 cases for every 100,000 person-days) was higher than that of patients on referent exposure (4 cases for every 100,000 person-days). These differences persisted during the remaining follow-up, though with reduced intensity. CONCLUSIONS: We found quantitative evidence that switching from oral antidiabetic therapy to insulin is associated with an increased fracture risk, mainly in the period immediately after the start of insulin therapy. The observed association may result from higher hypoglycemia risk among patients on insulin, which leads to a greater number of falls and resulting fractures. However, although our study was based on a large sample size and highly accurate data, its observational design and the lack of clinical data suggest that future research will need to replicate or refute our findings and address the issue of causality, if any. Until then, though, prescribers and patients should be aware of this risk. Careful control of insulin dosage should be maintained and measures taken to reduce fall risk in these patients. LEVEL OF EVIDENCE: Level III, therapeutic study.

Perinatal outcome and healthcare resource utilization in the first year of life after antiepileptic exposure during pregnancy.

Healthcare administrative databases of Italy's Lombardy Region were analyzed with the aim to assess perinatal outcomes and healthcare resource utilization during the first year of life in infants exposed to antiepileptic drugs (AEDs) during pregnancy. Drug prescriptions dispensed in the 12 months before delivery to women, who delivered between 2005 and 2011, were analyzed. Neonates were classified as cases if exposed to AEDs, and each case was randomly matched to seven controls. No significant differences were observed in the risk of congenital malformations between 526 cases and 3682 controls except for valproic acid (odds ratio (OR): 2.29; 95% confidence interval (CI): 1.24-4.22) where cases were more likely to be small for gestational age (χ2 = 7.66; p = 0.006). Cases also had a higher probability than controls of needing at least one specialist visit in a child neuropsychiatry outpatient service (OR: 1.74; 95% CI: 1.22-2.49).

Adherence to recommendations and clinical outcomes of patients hospitalized for stroke: the role of the admission ward-a real-life investigation from Italy.

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.

Effectiveness of adherence to recommended clinical examinations of diabetic patients in preventing diabetes-related hospitalizations.

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.

Early cardiovascular protection by initial two-drug fixed-dose combination treatment vs. monotherapy in hypertension.

Aims: Guidelines support use of drug combinations in most hypertensive patients, and recently treatment initiation with two drugs has been also recommended. However, limited evidence is available on whether this leads to greater cardiovascular (CV) protection compared to initial monotherapy. Methods and results: Using the healthcare utilization database of the Lombardy Region (Italy), the 44 534 residents of the region (age 40-80 years) who in 2010 started treatment with one antihypertensive drug (n = 37 078) or a two-drug fixed-dose combination (FDC, n = 7456) were followed for 1 year after treatment initiation to compare the risk of hospitalization for CV disease associated with the two treatment strategies. To limit the confounding associated with non-randomized between-group comparisons, data were also analysed by: (i) matching the two groups by the high-dimensional propensity score (HDPS) and (ii) comparing, in patients experiencing one or more CV events (n = 2212), the CV event incidence during subperiods in which patients were prescribed mono- or FDC therapy (self-controlled case series design). Compared to initial monotherapy, patients on initial FDC therapy showed a reduced 1 year risk of hospitalization for any CV event (-21%, P < 0.01). This was the case also when groups were compared according to the HDPS analysis (-15%, P < 0.05). Finally, in patients experiencing CV events, the event incidence was much less when, during the 1 year follow-up, they were under FDC therapy than under monotherapy (-56%, P < 0.01). The reduced risk of hospitalization was always significant for ischaemic heart disease and new onset atrial fibrillation, and included hospitalization for cerebrovascular disease and heart failure when monotherapy and FDC therapy were compared within patients. Conclusion: In a real-life setting, a comparison of the incidence of early CV events during antihypertensive monotherapy and FDC shows that the latter strategy leads to a more effective CV protection. This scores in favour of a two-drug FDC strategy as first step in the hypertensive population.

Management, prognosis and predictors of unfavourable outcomes in patients newly hospitalized for transient ischemic attack: a real-world investigation from Italy.

BACKGROUND: Understanding the gap between evidence-based recommendations and real-world management is important to inform priority setting and health service planning. METHODS: The 7,776 residents in the Italian Lombardy Region who were newly hospitalized for transient ischemic attack (TIA) during 2008-2009 entered into the cohort and were followed until 2012. Exposure to medical care including selected drugs, diagnostic procedures and laboratory tests was recorded. A composite outcome was employed taking into account all-cause death and hospitalization for stroke and acute myocardial infarction. A multivariable proportional hazards model was fitted to estimate hazard ratio, and 95% confidence intervals (CI), for the exposure-outcome association. RESULTS: During the first year after discharge, 8.6, 49.7 and 48.5% of patients did not use any drugs, diagnostic procedures and laboratory tests respectively. Patients exposed to medical care had 59% reduced risk (95% CI, 50 to 66%) with respect to those who did not use any of these services. CONCLUSIONS: Although the Italian National Health System supplies universal coverage for healthcare, several TIA patients receive suboptimal care. Systematic improvements are necessary in order to improve patient outcomes.

Antiepileptic drug use in Italian children over a decade.

PURPOSE: The aim of the study was to evaluate prescription profiles of antiepileptic drugs (AEDs) and to assess hospitalizations and specialist visits in pediatric patients with epilepsy. METHODS: The data sources were administrative health databases of Italy's Lombardy Region, which collect prescriptions for drugs, diagnostic tests, specialist visits, and hospital discharge forms. All patients aged 0-16 years with at least seven AED (group N03A of the International Anatomical Therapeutic Chemical Classification) prescriptions over two consecutive years between 2003 and 2010 were identified and classified as prevalent or incident cases (no prescriptions in two previous years). The first prescription to incident cases was analyzed. For each incident case, drug prescriptions, specialist visits, diagnostic tests, and hospitalizations in the 24 months following the first (index) prescription were monitored. RESULTS: A total of 6527 incident cases (5.4/10,000 person-years, 95% CI 5.4-5.5) were identified. Valproic acid and carbamazepine were the most prescribed drugs (65.9 and 15.0%, respectively). The use of newer AEDs increased over time. In the 24-month observation period, 74% of incident cases continued the treatment with the index AED. The percentage of cases who changed therapy was higher in preschoolers (34%) and decreased with age. In all, 21% of incident cases were hospitalized for epilepsy and 86% had a specialist visit in the 24 months after the first AED prescription. CONCLUSIONS: In conclusion, older AEDs, particularly valproic acid, remained the first therapeutic approach to pediatric epilepsy in Italy. For three quarters of cases, the initial AED treatment was likely effective and well tolerated.

Use of antidepressant medication in pregnancy and adverse neonatal outcomes: A population-based investigation.

BACKGROUND: Untreated depression and antidepressant use during pregnancy may have negative consequences for births. There are still conflicting data on the potential harmful effects of prenatal antidepressant treatment on child health. OBJECTIVE: To investigate the relationship between the use of antidepressant medication during pregnancy and selected neonatal outcomes. METHODS: A population-based cohort study including 9825 deliveries exposed to an antidepressant between 9 months before last menstrual date through to delivery, from January 2005 to December 2010 in the Lombardy region of Italy, was conducted. We evaluated the prevalence ratio (PR) of low Apgar score, small for gestational age, intrauterine hypoxia and birth asphyxia, neonatal convulsion, and other respiratory conditions, among infants born to mothers exposed to an antidepressant during pregnancy using log-binomial regression analysis. Fine stratification was applied to the propensity score to account for all potential confounders. Sensitivity and subgroup analyses restricted to specific types of antidepressant, time of exposure, and women with vaginal deliveries and full-term births were also performed. RESULTS: A total of 33.4% of women filled at least one prescription during pregnancy. Compared to infants born to mothers with exposure to antidepressants only before pregnancy, those with exposure to antidepressants during pregnancy had an increased prevalence ratio of a low Apgar score (PR, 1.63, 95% CI, 1.01-2.61), intrauterine hypoxia and birth asphyxia (aPR, 1.37, 1.08-1.73), neonatal convulsion (aPR, 2.81, 1.07-7.36), and other respiratory condition (aPR, 1.24, 1.00-1.52). Results were similar in the sensitivity and subgroup analyses. CONCLUSIONS: Use of antidepressants during pregnancy may have an increased risk for several neonatal outcomes.

Mother's education and the risk of several neonatal outcomes: an evidence from an Italian population-based study.

BACKGROUND: Maternal socioeconomic disparities strongly affect child health, particularly in low and middle income countries. We assessed whether neonatal outcomes varied by maternal education in a setting where healthcare system provides universal coverage of health services to all women, irrespective of their socioeconomic status. METHODS: A population-based study was performed on 383,103 singleton live births occurring from 2005 to 2010 in Lombardy, an Italian region with approximately 10 million inhabitants. The association between maternal education, birthplace and selected neonatal outcomes (preterm birth, low birth weight, small-for-gestational age, low 5-min Apgar score, severe congenital anomalies, cerebral distress and respiratory distress) was estimated by fitting logistic regression models. Model adjustments were applied for sociodemographic, reproductive and medical maternal traits. RESULTS: Compared with low-level educated mothers, those with high education had reduced odds of preterm birth (Odds Ratio; OR = 0.81, 95% CI 0.77-0.85), low birth weight (OR = 0.78, 95% CI 0.70-0.81), small for gestational age (OR = 0.82, 95% CI 0.79-0.85), and respiratory distress (OR = 0.84, 95% CI 0.80-0.88). Mothers born in a foreign country had higher odds of preterm birth (OR = 1.16, 95% CI 1.11-1.20), low Apgar score (OR = 1.18, 95% CI 1.07-1.30) and respiratory distress (OR = 1.19, 95% CI 1.15-1.24) than Italian-born mothers. The influence of maternal education on neonatal outcomes was confirmed among both, Italian-born and foreign-born mothers. CONCLUSIONS: Low levels of education and maternal birthplace are important factors associated with adverse neonatal outcomes in Italy. Future studies are encouraged to investigate factors mediating the effects of socioeconomic inequality for identifying the main target groups for interventions.

Cesarean delivery rates and obstetric culture - an Italian register-based study.

INTRODUCTION: Cesarean delivery rates are rising due to multiple factors, including less use of operative vaginal delivery and vaginal birth after cesarean delivery, which often reflect local obstetric practices. Objectives of the study were to analyze the relations between cesarean delivery, these practices, and perinatal outcomes. MATERIAL AND METHODS: We included all deliveries in the 72 hospitals of Lombardia, a region in northern Italy, during the year 2013. The delivery certificate was used as data source. Pearson's correlation coefficient and logistic regression were used for statistical analysis. RESULTS: We included 87 896 deliveries. The number of deliveries per hospital ranged from 140 to 6123. The rate of cesarean delivery was 28.3% (range 9.9-86.4%), operative vaginal delivery 4.7% (range 0.2-10.0%), and vaginal birth after cesarean 17.3% (range 0-79.2%). We found a significant inverse correlation between rates of overall cesarean delivery and operative vaginal delivery (r = -0.25, p = 0.04). The correlation between rate of overall cesarean delivery and vaginal birth after cesarean was also inverse and significant (r = -0.57, p < 0.001). There was no association between overall cesarean delivery rate and the rates of Apgar score at 5 min <7 in term and late preterm neonates (r = -0.92, p = 0.46) and of perinatal mortality (r = -0.19, p = 0.13), respectively. The associations were independent of hospital volume of activity. CONCLUSIONS: An obstetric practice that encourages vaginal instrumental delivery in delayed second stage of labor or vaginal birth after previous cesarean delivery, could reduce the rising cesarean delivery rate. This will require a change in obstetric culture, continuing education of healthcare providers, and leadership.

Emergency department visits in older people: pattern of use, contributing factors, geographical differences and outcomes.

AIMS: To assess the pattern of use of Emergency Departments (EDs), factors contributing to the visits, geographical distribution and outcomes in people aged 65 years or more living in the Italian Lombardy Region in 2012. METHODS: Based on an administrative database the study population was divided into groups according to the number of ED visits. A multinomial logistic regression model was performed to compare the characteristics of each group. The Getis-Ord's G statistic was used to evaluate the clusters of high and low visit prevalence odd ratios (OR) at district level. To estimate the severity of the disease leading to ED attendance, visits were stratified based on the level of emergency and outcome. RESULTS: About 2 million older people were included in the analyses: 78 % had no ED visit, 15 % only 1, 7 % 2 or more. Male sex, age 85 years or more, high number of drugs, ED visits and hospital admissions in the previous year and the location of an ED within 10 km from the patient's place were all factors associated with a higher risk to have more ED visits. Clusters of high and low prevalence of visits were found for occasional users. Overall, 83 % of ED visit with a low emergency triage code at admission had as visit outcome discharge at home. CONCLUSIONS: In older people several variables were associated with an increased risk to have a high number of ED visits. Most of the visits were done for non-urgent problems and significant geographic differences were observed for occasional users.

Changes in clinical outcomes for community-dwelling older people exposed to incident chronic polypharmacy: a comparison between 2001 and 2009.

PURPOSE: The purpose of this study is to explore the effect of incident chronic polypharmacy on 1-year hospitalization, institutionalization, and mortality among older people and to evaluate whether or not the effect differed according to index year (2001 or 2009), sex, and age. METHODS: Data were obtained from the administrative database of the Lombardy region (Northern Italy). We compared community-dwelling elderly people with an incident exposure to chronic polypharmacy (five or more drugs during 1 month for at least 6 months in 1 year) in either index year (2001 and 2009) with not exposed elderly people in the same years. Multivariable logistic (institutionalization) and Cox (hospitalization and death) were performed including year, sex, age classes, and number of drugs as covariates and their respective interaction terms by chronic polypharmacy. RESULTS: We analyzed 1,800,257 elderly subjects in 2001 and 1,567,575 in 2009, with a prevalence of chronic polypharmacy of 1.46% and 2.86%, respectively. Overall, 1-year hospitalization, institutionalization, and mortality rates were lower in 2009 than in 2001. Chronic polypharmacy was significantly associated with the outcomes in multivariable analyses: hazard or odds ratios 1.16 (95% confidence interval 1.14-1.17) for hospitalization, 1.21 (1.12-1.30) for institutionalization, and 1.11 (1.08-1.14) for death. There was no consistent effect modification by index year or sex, whereas chronic polypharmacy was no longer a risk factor for adverse outcomes among those older than 85 years (p < 0.0001 for interaction). CONCLUSIONS: Incident chronic polypharmacy remained an independent predictor of adverse outcomes among community-dwelling elderly people, despite a reduction over time of 1-year hospitalization, institutionalization, and mortality rates.

Persistence with inhaled corticosteroids reduces the risk of exacerbation among adults with asthma: A real-world investigation.

BACKGROUND AND OBJECTIVE: Real-world evidence suggests that persistence with inhaled corticosteroids (ICS), the mainstay of asthma drug therapy, is generally poor. The effect of persistence with ICS on the risk of asthma exacerbation was addressed in a population-based study. METHODS: The cohort of 2335 beneficiaries of the National Health Service provided by the Italian Region of Lombardy, aged 18-40 years and newly treated with ICS during 2005-2008, was followed from their first ICS dispensation until 2010. Discontinuation of treatment with ICS and starting oral corticosteroid therapy during follow-up were respectively regarded as proxies of poor persistence with asthma medication and asthma exacerbation (outcomes). A proportional hazards model was fitted to identify predictors of ICS discontinuation. Case-crossover and case-case-time-control designs and conditional logistic regressions were used to estimate the association between persistence with ICS and asthma exacerbation. RESULTS: Cumulative incidences of discontinuation were 36%, 57% and 78% at 6 months, 1 year and 5 years, respectively. Predictors of poor persistence were female gender, use of antibiotics during follow-up, absence of use of short-acting beta-agonists prior to and after starting treatment with ICS and starting and maintaining ICS monotherapy during follow-up. The odds ratios of asthma exacerbation (and 95% confidence intervals) associated with ICS exposure during the current period, contrasted with exposure during the reference period, were 0.4 (0.2, 0.9) and 0.3 (0.1, 1.0) from case-crossover and case-case-time-control estimates, respectively. CONCLUSION: Persistence with ICS treatment in adults with asthma reduces the risk of exacerbation in the real-life setting.

Incidence, Predictors, and Clinical Implications of Discontinuing Therapy with Inhaled Long-Acting Bronchodilators among Patients with Chronic Obstructive Pulmonary Disease.

Incidence, predictors and effect of discontinuation of long-acting bronchodilators on the risk of death or hospital admission among adults with Chronic Obstructive Pulmonary Disease (COPD) were assessed in a large population-based prospective study carried out by linking Italian healthcare utilization databases. Specifically, the cohort of 17,490 beneficiaries of the National Health Service in the Italian Region of Lombardy, aged 40 years or older, who started long-acting bronchodilators therapy during 2005-2008 was followed from first dispensation until 2012. During this period, patients who experienced discontinuation of long-acting bronchodilators were identified. Hospitalizations for COPD and deaths for any cause (composite clinical outcome) were also identified during follow-up. A Cox proportional hazards model was fitted to identify predictors of discontinuation. The case-crossover design was used to assess the implications of treatment discontinuation on the clinical outcome risk. Cumulative incidences of discontinuation were, respectively, 67%, 80%, and 92% at 6 months, 1 year, and 5 years since initial treatment. Significant predictors of discontinuation were female gender, younger age, starting treatment with fixed-dose combination of inhaled bronchodilators and corticosteroids, using antibiotics, inhaled long-acting bronchodilators and corticosteroids and not using short-acting bronchodilators, other respiratory drugs and systemic corticosteroids during follow-up. Odds ratios (95% confidence intervals) for the clinical outcome associated with not discontinuing long-acting bronchodilators was 0.64 (0.50 to 0.82). In conclusion, in the real-life setting, discontinuation of inhaled long-acting bronchodilators in adults with COPD is high even after just 6 months, even though persistence to these drugs reduces the risk of severe outcomes.