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.

Multiple Medication Adherence and Related Outcomes in Community-Dwelling Older People on Chronic Polypharmacy: A Retrospective Cohort Study on Administrative Claims Data.

Poor medication adherence compromises treatment efficacy and adversely affects patients' clinical outcomes. This study aims to assess (1) multiple medication adherence to the most common drug classes chronically prescribed to older people, (2) the factors associated, and (3) the clinical outcomes. This retrospective cohort study included 122,655 community-dwelling patients aged 65-94 years old, newly exposed to chronic polypharmacy, and recorded in the Lombardy Region (northern Italy) administrative database from 2016 to 2018. Multiple medication adherence was assessed for drugs for diabetes, antithrombotics, antihypertensives, statins, and bisphosphonates, by calculating the daily polypharmacy possession ratio (DPPR). One-year mortality, nursing home, emergency department (ED), and hospital admission rates were calculated for 2019. The most prescribed drugs were antihypertensives (89.0%). The mean (std.dev) DPPR was 82.9% (15.6). Being female (OR = 0.85, 95%CI: 0.84-0.86), age ≥85 years (OR = 0.77, 95%CI: 0.76-0.79), and multimorbidity (≥4 diseases, OR = 0.88, 95%CI: 0.86-0.90) were associated with lower medication adherence. A higher DPPR was associated with clinical outcomes-in particular, improved survival (HR = 0.93 for 10/100-point increase, 95%CI: 0.92-0.94) and lower incidence in nursing home admissions (SDHR = 0.95, 95%CI: 0.93-0.97). Adherence to the most common chronic drugs co-prescribed to the older population was high. Better multiple medication adherence was associated with better clinical outcomes.

Is EuroSCORE II still a reliable predictor for cardiac surgery mortality in 2022? A retrospective study study.

OBJECTIVES: The European System for Cardiac Operation Risk Evaluation II (EuroSCORE II) is the most common tool used to evaluate the perioperative risk of mortality after cardiac surgery in Europe, and its use is currently recommended by the relevant guidelines. However, recently, its role has been questioned: Several papers have suggested that these algorithms may no longer be adequate for risk prediction due to an overestimation of adult cardiac surgical risk. Our goal was to validate the EuroSCORE II in the prediction of 30-day in-hospital mortality in patients undergoing open cardiac surgery in a high-volume hospital. METHODS: In this retrospective cohort study, we included all patients who underwent cardiac surgery from January 2016 to May 2022 within the departments of cardiac surgery of the Monzino Cardiology Centre in Milan, Italy. We evaluated the discrimination power of the EuroSCORE II by using the receiver operating characteristic curve and the corresponding area under the curve. We performed calibration plots to assess the concordance between the model's prediction and the observed outcomes. RESULTS: A total of 4,034 patients were included (mean age = 65.1 years; 68% males), of which 674 (16.7%) underwent isolated coronary artery bypass grafting. The EuroSCORE II showed a good discrimination power in predicting 30-day in-hospital mortality (area under the curve = 0.834). However, for interventions performed in an elective setting, very low values of the EuroSCORE II overestimated the observed mortality, whereas for interventions performed in an emergency setting, EuroSCORE II values above 10 extensively underestimated the observed mortality. CONCLUSIONS: Our study suggests that the EuroSCORE II seems not to be a reliable score in estimating the true risk of death, especially in high-risk patients.

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.

The bimodal "rise and fall" ACS curve overlapping COVID-19 pandemic peaks.

BACKGROUND: The COVID-19 outbreak harmed acute coronary syndromes. During the national lockdown in Italy, the fear of post-admission contagion translated into significant delays in seeking medical help among STEMI (ST-elevation myocardial infarction) patients. OBJECTIVE AND METHODS: Our analysis aimed to assess the ACS (Acute Coronary Syndromes) admissions during the pandemic, together with time to presentation and clinical outcomes compared to 2019 in a cardiovascular hub in Milan. Data of ACS patients admitted during the pandemic year 2020 were extracted by the hospital's database and compared to a historical cohort of patients admitted for the same clinical indications in 2019. RESULTS: A total of 599 ACS cases were recorded in 2020 vs. 386 cases in 2019, with a net 55% increase, associated with late clinical presentations, a threefold increase in cardiogenic shock, and a more than two-fold higher mortality rate. CONCLUSIONS: The ultimate goal of this analysis is to preserve the life-saving focus on universal and prompt STEMI diagnosis and treatment, even in a time of dynamic global crisis.

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.

Medication adherence in community-dwelling older people exposed to chronic polypharmacy.

BACKGROUND: To evaluate medication adherence and associated factors of seven of the most common drug classes prescribed to community-dwelling older people. METHODS: This is a retrospective cohort study on medication adherence in community-dwelling older people (65-94 years old) on chronic polypharmacy and recorded from 2013 to 2015 in the administrative database of the Lombardy region (Northern Italy). Adherence was assessed for diabetic drugs, antithrombotic agents, drugs acting on the renin-angiotensin system, statins, bisphosphonates, antidepressants and drugs for obstructive airway diseases by calculating the medication possession ratio (MPR). Patients were then divided in fully (MPR ≥80%), partially (40%≤MPR<80%) and poorly adherent (10%

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.

Impact of liver disease on oral anticoagulant prescription and major adverse events in patients with atrial fibrillation: analysis from a population-based cohort study.

AIMS: Data on the impact of liver disease (LD) in patients with atrial fibrillation (AF) and the role of oral anticoagulant (OAC) drugs for stroke prevention are limited. METHODS AND RESULTS: A retrospective observational population-based cohort study on the administrative health databases of Lombardy region Italy. All AF patients ≥40 years admitted to hospital from 2000 to 2018 were considered. Atrial fibrillation and LD diagnosis were established using ICD9-CM codes. Use of OAC was determined with Anatomical Therapeutic Chemical codes. Primary study outcomes were stroke, major bleeding, and all-cause death. Among 393 507 AF patients, 16 168 (4.1%) had concomitant LD. Liver disease AF patients were significantly less treated with OAC. Concomitant LD was associated with an increased risk in all the study outcomes [hazard ratio (HR): 1.18, 95% confidence interval (CI): 1.11-1.25 for stroke; HR: 1.57, 95% CI: 1.47-1.66 for major bleeding; HR: 1.41, 95% CI: 1.39-1.44 for all-cause death]. Use of OAC in patients with AF and LD resulted in a reduction in stroke (HR: 0.80, 95% CI: 0.70-0.92), major bleeding (HR: 0.86, 95% CI: 0.74-0.99), and all-cause death (HR: 0.77, 95% CI: 0.73-0.80), with similar results according to subgroups. A net clinical benefit (NCB) analysis suggested a positive benefit/risk ratio in using OAC in AF patients with LD (NCB: 0.408, 95% CI: 0.375-0.472). CONCLUSION: In AF patients, concomitant LD carries a significantly higher risk for all clinical outcomes. Use of OAC in AF patients with LD was associated with a significant favourable benefit/risk ratio, even in high-risk patient subgroups.

Influence of adherence with guideline-driven recommendations on survival in women operated for breast cancer: Real-life evidence from Italy.

BACKGROUND: A set of indicators to assess the quality of care for women operated for breast cancer was developed by an expert working group of the Italian Health Ministry in order to compare the Italian regions. A study to validate these indicators through their relationship with survival was carried out. METHODS: The 16,753 women who were residents in three Italian regions (Lombardy, Emilia-Romagna and Lazio) and hospitalized for breast cancer surgery during 2011 entered the cohort and were followed until 2016. Adherence to selected recommendations (i.e., surgery timeliness, medical therapy timeliness, appropriateness of complementary radiotherapy and mammographic follow-up) was assessed. Multivariable proportional hazards models were fitted to estimate hazard ratios for the association between adherence with recommendations and the risk of all-cause mortality. RESULTS: Adherence to recommendations was 53% for medical therapy timeliness, 73% for appropriateness of mammographic follow-up, 74% for surgery timeliness and 82% for appropriateness of complementary radiotherapy. Risk reductions of 26%, 62% and 56% were observed for adherence to recommendations on medical therapy timeliness, appropriateness of complementary radiotherapy and mammographic follow-up, respectively. There was no evidence that mortality was affected by surgery timeliness. CONCLUSIONS: Clinical benefits are expected from improvements in adherence to the considered recommendations. Close control of women operated for breast cancer through medical care timeliness and appropriateness of radiotherapy and mammographic monitoring must be considered the cornerstone of national guidance, national audits, and quality improvement incentive schemes.

Rehospitalization for pneumonia after first pneumonia admission: Incidence and predictors in a population-based cohort study.

BACKGROUND AND OBJECTIVES: Hospital readmissions are a frequent complication of pneumonia. Most data regarding readmissions are obtained from the United States, whereas few data are available from the European healthcare utilization (HCU) systems. In a large cohort of Italian patients with a previous hospitalization for pneumonia, our aim was to evaluate the incidence and predictors of early readmissions due to pneumonia. METHODS: This is a observational retrospective, population based, cohort study. Data were retrieved from the HCU databases of the Italian Lombardy region. 203,768 patients were hospitalized for pneumonia between 2003 and 2012. The outcome was the first rehospitalization for pneumonia. The patients were followed up after the index hospital admission to estimate the hazard ratio, and relative 95% confidence interval, of the outcome associated with the risk factors that we had identified. RESULTS: 7,275 patients (3.6%) had an early pneumonia readmission. Male gender, age ≥70 years, length of stay of the first admission and a higher burden of comorbidities were significantly associated with the outcome. Chronic use of antidepressants, antiarrhythmics, glucocorticoids and drugs for obstructive airway diseases were also more frequently prescribed in patients requiring rehospitalization. Previous use of inhaled broncodilators, including both beta2-agonists and anticholinergics, but not inhaled steroids, were associated with an increased risk of hospital readmission. CONCLUSIONS: Frail elderly patients with multiple comorbidities and complex drug regimens were at higher risk of early rehospitalization and, thus, may require closer follow-up and prevention strategies.

Better adherence with out-of-hospital healthcare improved long-term prognosis of acute coronary syndromes: Evidence from an Italian real-world investigation.

BACKGROUND: Patients who experience a hospital admission for acute coronary syndromes (ACS) exhibit poor prognosis over the years. The purposes of this study were to evaluate the real-world patterns of out-of-hospital practice in the management of ACS patients and to assess their impact on the risk of selected outcomes. METHODS: The cohort of 87,530 residents in the Lombardy Region (Italy) who were newly hospitalised for ACS during 2011-2015 was followed until 2018. Exposure to medical treatment including use of selected drugs, diagnostic procedures and laboratory tests was recorded. The main outcome of interest was re-hospitalisation for cardiovascular (CV) outcomes. Proportional hazards models were fitted to estimate hazard ratio, and 95% confidence intervals (CI), for the exposure-outcome association. Analyses were stratified according to the ACS type. RESULTS: The cumulative incidence of re-hospitalisation for CV disease was 33%, 42% and 38% at 5 years after index discharge among STEMI, NSTEMI and unstable angina patients. Within one year from index discharge, between 70% and 80% of patients had at least a prescription of statins, beta-blockers and renin-angiotensin-system blocking agents, underwent ECG and lipid profile examination, and had a cardiologic examination. One patient in five underwent cardiac rehabilitation. Compared with patients who did not adhere to healthcare recommendations, the risk of CV hospital readmission was reduced from 10% (95% CI: 4%-10%) to 23% (12%-32%) among patients who underwent lipid profile examinations and who experienced cardiac rehabilitation. CONCLUSION: Close out-of-hospital healthcare must be considered the cornerstone for improving the long-term prognosis of ACS patients.

Antihypertensive Treatment in Elderly Frail Patients: Evidence From a Large Italian Database.

Aim of our study was to assess the relationship between adherence with antihypertensive drugs and the risk of death in frail versus nonfrail old individuals. Using the database of the Lombardy Region (Italy), we identified 1 283 602 residents aged ≥65 years (mean age 76) who had ≥3 prescriptions of antihypertensive drugs between 2011 and 2012. A nested case-control design was applied, with cases being the cohort members who died during the observation period (7 years). Logistic regression was used to model the association of interest, with adjustment for potential confounders. Adherence was measured by the proportion of the follow-up covered by prescriptions, and the analysis was separately performed in patients with a good, medium, poor, and very poor clinical status, as assessed by a score that has been shown to be a sensitive predictor of death in the Italian population. The 7-year death probability increased from 16% (good) to 64% (very poor) clinical status. Compared with patients with very low adherence with antihypertensive treatment (<25% of follow-up time covered by prescriptions), those with high adherence (>75% of time covered by prescriptions) exhibited a lower risk of all-cause mortality in each group, the difference decreasing progressively (-44%, -43%, -40%, and -33%) from the good to the very poor clinical status. Adherence with antihypertensive drug treatment was also associated with a lower risk of cardiovascular mortality. Adherence with antihypertensive appears to be protective in frail old patients, but the benefit is less marked than in patients with a good clinical status.

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.

An In-hospital Pathway for Acute Coronary Syndrome Patients During the COVID-19 Outbreak: Initial Experience Under Real-World Suboptimal Conditions.

Owing to the COVID-19 outbreak in Lombardy, Italy) there is an urgent need to manage cardiovascular emergencies, including acute coronary syndrome (ACS), with appropriate standards of care and dedicated preventive measures and pathways against the risk of SARS-CoV-2 infection. For this reason, the Government of Lombardy decided to centralize the treatment of ACS patients in a limited number of centers, including our university cardiology institute, which in the past 4 weeks became a cardiovascular emergency referral center in a regional hub-and-spoke system. Therefore, we rapidly developed a customized pathway to allocate patients to the appropriate hospital ward, and treat them according to ACS severity and risk of suspected SARS-CoV-2 infection. We present here the protocol dedicated to ACS patients adopted in our center since March 13, 2020, and our initial experience in the management of ACS patients during the first 4 weeks of its use. Certainly, the protocol has room for further improvement as everyone's experience grows, but we hope that it could be a starting point, adaptable to different realities and local resources.

Balancing cardiovascular benefit and diabetogenic harm of therapy with statins: Real-world evidence from Italy.

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.

Cardiac patient care during a pandemic: how to reorganise a heart failure unit at the time of COVID-19.

To date, the pandemic spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has involved over 100 countries in a matter of weeks, and Italy suffers from almost 1/3 of the dead cases worldwide. In this report, we show the strategies adopted to face the emergency at Centro Cardiologico Monzino, a mono-specialist cardiology hospital sited in the region of Italy most affected by the pandemic, and specifically we describe how we have progressively modified in a few weeks the organization of our Heart Failure Unit in order to cope with the new COVID-19 outbreak. In fact, on the background of the pandemic, cardiovascular diseases still occur frequently in the general population, but we observed consistent reduction in hospital admissions for acute cardiovascular events and a dramatic increase of late presentation acute myocardial infarction. Despite a reduction of healthcare workers number, our ward has been rearranged in order to take care of both COVID-19 and cardiovascular patients. In particular according to a triple step procedure we divided admitted patients in confirmed, suspected and excluded cases (respectively allocated in "red", "pink" and "green" separated areas). Due to the absence of definite guidelines, our aim was to describe our strategy in facing the current emergency, in order to reorganize our hospital in a dynamic and proactive manner. To quote the famous Italian writer Alessandro Manzoni 'It is less bad to be agitated in doubt than to rest in error.'