Compassionate mind training for people with Parkinson's disease: A pilot study and predictors of response.

INTRODUCTION: People with Parkinson's disease (PD) often present with disabling neuropsychiatric symptoms. Compassionate mind training (CMT) is a psychological approach effective in reducing stress and promoting psychological well-being. Heart rate variability (HRV), a measure reflecting sympathovagal balance, has been associated with psychological well-being and a compassionate attitude. AIM: To assess the feasibility and effectiveness of CMT in enhancing the quality of life and psychological well-being in PD patients. Additionally, we evaluated HRV as a physiomarker for assessing the CMT outcomes. METHODS: Twenty-four PD patients participated in the study. A 6-week online CMT intervention was delivered on a weekly basis. At baseline and post-intervention patients completed questionnaires assessing depression, anxiety and quality of life. In a subsample of 11 patients, HRV was measured at baseline and post-intervention in three conditions: at rest, during stress and after 3 min of deep breathing. RESULTS: The attendance rate was 94.3%. Quality of life and perceived stigma improved post-intervention as compared with baseline (p = 0.02 and p = 0.03 for PD Questionnaire-39 total score and Stigma subscore, respectively). After CMT, patients presented better physiological regulation to stress, as measured by higher HRV as compared with baseline (p = 0.005). Notably, patients who were more resilient to stress at baseline (less decrease in HRV during stress) experienced a more substantial reduction in anxiety and depression following CMT. CONCLUSIONS: CMT is feasible and can improve quality of life and stigma in PD patients. HRV emerges as a promising physiomarker for predicting and measuring the outcomes of psychological interventions in PD.

Mortality and healthcare assessment among patients with chronic disease over 2 years of COVID-19: a population-based study in a large hard-hit Italian region.

OBJECTIVES: We aimed to provide a region-wide comprehensive account of the indirect effects of COVID-19 on patients with chronic disease, in terms of non-COVID-19 mortality, and access to both inpatient and outpatient health services over a 2-year pandemic period. DESIGN: Population-based retrospective study. SETTING: Adult patients, affected by at least 1 of 32 prevalent chronic conditions, residing in the Emilia-Romagna Region in Italy, during the years 2020 (N=1 791 189, 47.7% of the overall adult regional population) and 2021 (N=1 801 071, 47.8%). RESULTS: Overall, non-COVID-19 mortality among patients with chronic disease during the pandemic (2.7%) did not differ substantially from the expected mortality (2.5%), based on a 3 years prepandemic period (2017-2019) and adjusting for the demographic and clinical characteristics of the population under study. Indeed, while the first pandemic wave was characterised by a significant non-COVID-19 excess mortality (March: +35%), the subsequent phases did not show such disruptive variations in non-COVID-19 deaths, which remained around or even below the excess mortality threshold. End-of-life care of patients with chronic disease, especially for non-COVID-19 cases, significantly shifted from hospitalisations (-19%), to homecare (ADI: +7%; w/o ADI: +9%). Overall, healthcare of patients without COVID-19 chronic disease decreased, with similar negative trends in hospitalisations (-15.5%), major procedures (-19.6%) and ER accesses (-23.7%). Homecare was the least affected by the pandemic, with an overall reduction of -9.8%. COVID-19 outbreak also impacted on different types of outpatient care. Rehabilitation therapies, specialist visits, diagnostic and lab tests were considerably reduced during the first pandemic wave and consequent lockdown, with access rates of patients without COVID-19 chronic disease below -60%. CONCLUSIONS: This work thoroughly describes how a large and well-defined population of patients without COVID-19 chronic disease has been affected by the changes and reorganisation in the healthcare system during 2 years of the pandemic, highlighting health priorities and challenges in chronic disease management under conditions of limited resources.

The incidence and risk factors of selected drug prescriptions and outpatient care after SARS-CoV-2 infection in low-risk subjects: a multicenter population-based cohort study.

Background: Knowledge about the dynamics of transmission of SARS-CoV-2 and the clinical aspects of COVID-19 has steadily increased over time, although evidence of the determinants of disease severity and duration is still limited and mainly focused on older adult and fragile populations. Methods: The present study was conceived and carried out in the Emilia-Romagna (E-R) and Veneto Regions, Italy, within the context of the EU's Horizon 2020 research project called ORCHESTRA (Connecting European Cohorts to increase common and effective response to SARS-CoV-2 pandemic) (www.orchestra-cohort.eu). The study has a multicenter retrospective population-based cohort design and aimed to investigate the incidence and risk factors of access to specific healthcare services (outpatient visits and diagnostics, drug prescriptions) during the post-acute phase from day-31 to day-365 after SARS-CoV-2 infection, in a healthy population at low risk of severe acute COVID-19. The study made use of previously recorded large-scale healthcare data available in the administrative databases of the two Italian Regions. The statistical analysis made use of methods for competing risks. Risk factors were assessed separately in the two Regions and results were pooled using random effects meta-analysis. Results: There were 35,128 subjects in E-R and 88,881 in Veneto who were included in the data analysis. The outcome (access to selected health services) occurred in a high percentage of subjects in the post-acute phase (25% in E-R and 21% in Veneto). Outpatient care was observed more frequently than drug prescriptions (18% vs. 12% in E-R and 15% vs. 10% in Veneto). Risk factors associated with the outcome were female sex, age greater than 40 years, baseline risk of hospitalization and death, moderate to severe acute COVID-19, and acute extrapulmonary complications. Conclusion: The outcome of interest may be considered as a proxy for long-term effects of COVID-19 needing clinical attention. Our data suggest that this outcome occurs in a substantial percentage of cases, even among a previously healthy population with low or mild severity of acute COVID-19. The study results provide useful insights into planning COVID-19-related services.

Direct impact of 2 years of COVID-19 on chronic disease patients: a population-based study in a large hard-hit Italian region.

OBJECTIVES: We aimed to provide a region-wide comprehensive account of the direct effects of COVID-19 on chronic disease patients, in terms of disease incidence, severity and mortality, over a 2-year pandemic period (2020-2021). DESIGN: Population-based retrospective study. SETTING/PARTICIPANTS: Adult patients, affected by at least 1 of 32 prevalent chronic conditions, residing in the Emilia-Romagna Region in Italy, during the years 2020 (N=1 791 189, 47.7% of the overall adult regional population) and 2021 (N=1 801 071, 47.8%). RESULTS: COVID-19 incidence among chronic disease patients was 4.1% (74 067 cases) in 2020 and 7.3% (126 556 cases) in 2021, varying across pathologies, with obesity and dementia showing the highest incidence. Hospitalisation rate for pneumonia or acute respiratory distress syndrome among SARS-CoV-2-positive patients was 15.4%. COVID-19-related excess mortality, that is, deaths from COVID-19 as either main or contributing (1.5% of the total) cause of death, was observed during the three pandemic waves, with observed/expected death ratios ranging from +38% (March 2020) to +11% (December 2021). Increased risks of both COVID-19-related hospitalisation and death were associated with male gender, elderly age and many pre-existing pathologies, including cardiovascular, cerebrovascular and respiratory diseases, neurological and psychiatric disorders, and metabolic dysfunctions. The higher the number of concomitant pathologies, the greater the risk of COVID-19-related adverse outcomes: the likelihood of hospitalisation and death more than doubled for people with more than two comorbidities, compared with those with one underlying condition. CONCLUSIONS: This study presents a thorough and up-to-date quantification of the direct impact of COVID-19 on chronic disease patients. The results obtained are particularly relevant considering that people with pre-existing chronic conditions accounted for almost all cases of COVID-19-related hospitalisation (82.6%) and death (91.5%) in a vast region of Italy, among the hardest hit by the pandemic.

Analysis of the relation between adverse events and overall survival in patients treated with pembrolizumab as a first-line treatment for metastatic NSCLC.

BACKGROUND: Many trials supported pembrolizumab as a first-line monotherapy to significantly improve overall survival (OS) in selected patients with previously untreated metastatic Non-Small Cell Lung Cancer (mNSCLC) and a PD-L1 TPS of ≥50% without EGFR/ALK mutations. The aim of this study was to reveal the correlation between OS and adverse events in real-world settings after 42 months. METHODS: This retrospective observational study involved 98 patients with mNSCLC, TPS ≥ 50%, and no EGFR/ALK aberrations. Patients were treated with pembrolizumab (200 mg q3w) as a first-line treatment. Clinical data, including PD-L1 expression, Performance Status (ECOG-PS), treatment duration, toxicity, and outcomes were retrieved from local electronic medical records and from the Italian Regulatory Agency Registry. RESULTS: The cohort's main characteristics were as follows: median age 73 [44-89] years, 64.3% were male and 35.7% were female, an ECOG-PS score of 0 (n = 73) and 1 or 2 (n = 25), and a PD-L1 > 90% in 29.6% of patients. The entire cohort had stage IV NSCLC at diagnosis. The median number of cycles was 8.5 at a median follow-up of 13 months. The median OS of 13.6 months (95% CI: 11.7-NA) was not influenced by sex and PD-L1, but was significantly associated with ECOG-PS (p = 0.02). Immune-Related Adverse Events (irAEs) occurred in 77.5% of patients (30.1% cutaneous, 27.5% gastrointestinal, and 20.4% endocrinological), but no grade 4 or 5 irAEs were identified. Patients experiencing any type of toxicity had a significantly longer median OS (20.39 months, 95% CI: 13.08-NA) than those with no toxicities (6.46 months, 95% CI: 1.41-NA, p = 0.006). CONCLUSION: The percentage of irAEs detected was comparable to that reported in KEYNOTE-024 and KEYNOTE-042. These real-world findings demonstrated the significant correlation between OS and cutaneous toxicities.

Effectiveness of community hospital post-acute care on mortality, re-admission, institutionalization, and activation of a home care programme in Emilia-Romagna region, Italy.

BACKGROUND: In Italy, there is scant evidence on the impact of Community Hospitals (CHs) on clinical outcomes. AIMS: To assess the effectiveness of CHs versus long-term care hospital or inpatient rehabilitation facilities on mortality, re-admission, institutionalization, and activation of a home care programme in the Emilia-Romagna Region (ERR-Italy) after acute hospitalisation. METHODS: We implemented a cohort study drawing upon the ERR Administrative Healthcare Database System and including hospital episodes of ERR residents subject ≥ 65 years, discharged from a public or private hospital with a medical diagnosis to a CH or to usual care between 2017 and 2019. To control for confounding, we applied a propensity score matching. RESULTS: Patients transferred to CHs had a significantly lower risk of dying but an increased risk of being readmitted to community or acute hospital within 30/90 days from discharge. The hazard of institutionalisation within 30/90 days was significantly lower in the whole population of the CH exposed group but not among patients with cardiac or respiratory chronic diseases or diabetes. The activation of a home care program within 90 days was slightly higher for those who were transferred to a CH. DISCUSSION: The findings of our study show mixed effects on outcomes of patients transferred to CHs compared to those who followed the post-acute usual care and should be taken with cautious as could be affected by the so-called 'confounding by indication'. CONCLUSIONS: The study contributes to the intermediate care available evidence from a region with a well-established care provision through CHs.

General and COVID-19-Related Mortality by Pre-Existing Chronic Conditions and Care Setting during 2020 in Emilia-Romagna Region, Italy.

In 2020, the number of deaths increased in Italy, mainly because of the COVID-19 pandemic; mortality was among the highest in Europe, with a clear heterogeneity among regions and socio-demographic strata. The present work aims to describe trends in mortality and to quantify excess mortality variability over time and in relation to demographics, pre-existent chronic conditions and care setting of the Emilia-Romagna region (Northern Italy). This is a registry-based cross-sectional study comparing the 2020 observed mortality with figures of the previous five years by age, sex, month, place of death, and chronicity. It includes 300,094 deaths in those 18 years of age and above resident in the Emilia-Romagna region. Excess deaths were higher during the first pandemic wave, particularly among men and in March. Age-adjusted risk was similar among both men and women (Mortality Rate Ratio 1.15; IC95% 1.14-1.16). It was higher among females aged 75+ years and varied between sub-periods. Excluding COVID-19 related deaths, differences in the risk of dying estimates tended to disappear. Metabolic and neuropsychiatric diseases were more prevalent among those that deceased in 2020 compared to the deaths that occurred in 2015-2019 and therefore can be confirmed as elements of increased frailty, such as being in long-term care facilities or private homes as the place of death. Understanding the impact of the pandemic on mortality considering frailties is relevant in a changing scenario.

In- and out-of-hospital mortality for myocardial infarction during the first wave of the COVID-19 pandemic in Emilia-Romagna, Italy: A population-based observational study.

BACKGROUND: The COVID-19 pandemic has put several healthcare systems under severe pressure. The present analysis investigates how the first wave of the COVID-19 pandemic affected the myocardial infarction (MI) network of Emilia-Romagna (Italy). METHODS: Based on Emilia-Romagna mortality registry and administrative data from all the hospitals from January 2017 to June 2020, we analysed: i) temporal trend in MI hospital admissions; ii) characteristics, management, and 30-day mortality of MI patients; iii) out-of-hospital mortality for cardiac cause. FINDINGS: Admissions for MI declined on February 22, 2020 (IRR -19.5%, 95%CI from -8.4% to -29.3%, p = 0.001), and further on March 5, 2020 (IRR -21.6%, 95%CI from -9.0% to -32.5%, p = 0.001). The return to pre-COVID-19 MI-related admission levels was observed from May 13, 2020 (IRR 34.3%, 95%CI 20.0%-50.2%, p<0.001). As compared to those before the pandemic, MI patients admitted during and after the first wave were younger and with fewer risk factors. The 30-day mortality remained in line with that expected based on previous years (ratio observed/expected was 0.96, 95%CI 0.84-1.08). MI patients positive for SARS-CoV-2 were few (1.5%) but showed poor prognosis (around 5-fold increase in 30-day mortality). In 2020, the number of out-of-hospital cardiac deaths was significantly higher (ratio observed/expected 1.17, 95%CI 1.08-1.27). The peak was reached in April. INTERPRETATION: In Emilia-Romagna, MI hospitalizations significantly decreased during the first wave of the COVID-19 pandemic. Management and outcomes of hospitalized MI patients remained unchanged, except for those with SARS-CoV-2 infection. A concomitant increase in the out-of-hospital cardiac mortality was observed. FUNDING: None.

Multimorbidity epidemiology and health care utilization through combined healthcare administrative databases.

BACKGROUND: multimorbidity analysis provides essential information to support health policy in the field of prevention, clinical management, and resources allocation in order to guarantee personalized and adequate strategies for patients with multiple chronic pathologies. OBJECTIVES: to present the application of a methodology based upon data retrieved in healthcare administrative databases to investigate the extent of multimorbidity (coexistence of two or more chronic condition), evaluating its epidemiology, its impact on healthcare resources, and identifying patterns of associative multimorbidity, based on non-random association among chronic diseases. DESIGN: observational study based on regional healthcare data record linkage. SETTING AND PARTICIPANTS: all people aged 18 years or older permanently or temporarily resident in Emilia-Romagna Region (Northern Italy) during 2017 (amounting to 3,901,252 persons) were included. MAIN OUTCOME MEASURES: period prevalence and incidence of 32 chronic diseases; identification of patients affected by two or more concurrent chronic diseases (multimorbid patients), and evaluation of their period prevalence, incidence, healthcare resources use, and costs. Factorial analysis was applied to assess association among chronic diseases and to estimate groups of chronic conditions non-randomly coexisting (patterns of multimorbidity) among the elderly (people aged 65+ years). RESULTS: the multimorbidity incidence rate in 2017 was 2.7% (4.9% in the elderly) and the multimorbidity period prevalence, evaluated on the 3,901,252 adult residents, was 25.2%, ranging from 2.8% in people aged <40 years to 72.5% in octogenarians, with no major difference by gender. Sixty one percent of the elderly suffered from two or more concurrent chronic diseases and, among these, four groups of chronic condition non-randomly coexisting were recognized (cardiovascular, neuropsychiatric, metabolic, and pain pattern). These four multimorbidity patterns affected 39.6% of over 65. The impact on healthcare resources use was considerable: about 70% of all provided healthcare services and 72% of the costs incurred by Regional Health Service was allocated to multimorbid patients (81% and 86.7%, respectively, among the elderly). CONCLUSIONS: healthcare administrative databases are a valuable tool to assess the frequency of multimorbidity and its impact on healthcare resources. Patients belonging to the four common patterns of multimorbidity identified in this study explained a high proportion of multimorbidity prevalence and healthcare resources use.

[Indirect effects of the COVID-19 pandemic on cardiovascular mortality]. / Effetti indiretti della pandemia COVID-19 sulla mortalità cardiovascolare.

The dramatic impact of the COVID-19 pandemic extends beyond the risk of deaths related to virus infection. Excess deaths from other causes, particularly cardiovascular deaths, have been reported worldwide. Our study based on administrative databases of the Emilia-Romagna region demonstrates a 17% excess of out-of-hospital cardiac deaths in the first 2020 semester with a peak of +62% on April. The excess of cardiac deaths may be explained by the indirect consequences of the response to the COVID-19 pandemic. These include a dramatic reduction of hospital admissions during the pandemic, particularly for acute coronary syndromes; an increase of out-of-hospital cardiac arrests; a reduction of outpatient clinic activities and cardiac procedures; long-term cardiovascular effects of COVID-19; and unfavorable cardiac effects of the lockdown imposed by the spread of COVID-19 infection. The knowledge of the indirect consequences of COVID-19 pandemic is important for planning cardiologic strategies.

Cost Determinants of Continuum-Care Episodes for Hip Fracture.

Many factors affect the healthcare costs and outcomes in patients with hip fracture (HF). Through the construction of a Continuum-Care Episode (CCE), we investigated the costs of CCEs for HF and their determinants. We used data extracted from administrative databases of 5094 consecutive elderly patients hospitalized in 2017 in Emilia Romagna, Italy, to evaluate the overall costs of the CCE. We calculated the acute and post-acute costs from the date of the hospital admission to the end of the CCE. The determinants of costs by type of surgical intervention (total hip replacement, partial hip replacement, open reduction, and internal fixation) were investigated using generalized linear regression models. Regardless of the type of surgical intervention, hospital bed-based rehabilitation in public or private healthcare facilities either followed by rehabilitation in a community hospital/temporary nursing home beds or not were the strongest determinants of costs, while rehabilitation in intermediate care facilities alone was associated with lower costs. CCE's cost and its variability is mainly related to the rehabilitation setting. Cost-wise, intermediate care resulted to be an appropriate setting for providing post-acute rehabilitation for HF, representing the one associated with lower overall costs. Intermediate care organizational setting should be privileged when planning integrated care HF pathways.

Medical Costs of Patients with Type 2 Diabetes in a Single Payer System: A Classification and Regression Tree Analysis.

BACKGROUND AND OBJECTIVES: Many studies and systematic reviews have estimated the healthcare costs of diabetes using a cost-of-illness approach. However, in the studies based on this approach patients' heterogeneity is rarely taken into account. The aim of this study was to stratify patients with type 2 diabetes into homogeneous cost groups based on demographic and clinical characteristics. METHODS: We conducted a retrospective cost-of-illness study by linking individual data on health services utilization retrieved from the administrative databases of Emilia-Romagna Region (Italy). Direct medical costs (either all-cause or diabetes-related) were calculated from the perspective of the regional health service, using tariffs for hospitalizations and outpatient services and the unit costs of prescriptions for drugs. The determinants of costs identified in a generalized linear regression model were used to characterize subgroups of patients with homogeneous costs in a classification and regression tree analysis. RESULTS: The study population consisted of a cohort of 101,334 patients with type 2 diabetes, followed up for 1 year, with a mean age of 70.9 years. Age, gender, complications, comorbidities and living area accounted significantly for cost variability. The classification tree identified ten patient subgroups with different costs, ranging from a median of €483 to €39,578. The two subgroups with highest costs comprised dialysis patients, and the largest subgroup (57.9%) comprised patients aged ≥ 65 years without renal, cardiovascular and cerebrovascular complications. CONCLUSIONS: Classification of patients into homogeneous cost subgroups can be used to improve the management of, and budget allocation for, patients with type 2 diabetes.

Disease management in diabetes care: When involving GPs improves patient compliance and health outcomes.

Although the study of the association between interventions in primary care and health outcomes continues to produce mixed findings, programs designed to promote the greater compliance of General Practitioners and their diabetic patients with guidelines have been increasingly introduced worldwide, in an attempt to achieve better quality diabetes care through the enhanced standardisation of patient supervision. In this study, we use clinical data from the Diabetes Register of one large Local Health Authority (LHAs) in Italy's Emilia-Romagna Region for the period 2012-2015. Firstly, we investigate whether GPs' participation in the local Diabetes Management Program (DMP) leads to improved patient compliance with regional guidelines. Secondly, we test whether the monitoring activities prescribed for diabetics by the Regional diabetes guidelines have a positive impact on patients' health outcomes and increase appropriateness in health care utilization. Our results show that such a Program, which aims to increase GPs' involvement and cooperation in following the Regional guidelines, achieves its goal of improved patient compliance with the prescribed actions. In turn, through the implementation of the DMP and the greater involvement of physicians, Regional policies have succeeded in promoting better health outcomes and improved appropriateness of health care utilization.

Cardiac device therapy in patients with left ventricular dysfunction and heart failure: 'real-world' data on long-term outcomes (mortality, hospitalizations, days alive and out of hospital).

BACKGROUND: The impact on long-term outcomes of implantable cardioverter defibrillators (ICDs) and biventricular defibrillators for cardiac resynchronization (CRT-D) devices in 'real world' patients with heart failure (HF) needs to be assessed in terms of clinical effectiveness. METHODS AND RESULTS: A registry including consecutive HF patients who underwent a first implant of an ICD (891 patients) or a CRT-D device (709 patients) in 2006-2010 was followed (median 1487 days and 1516 days, respectively), collecting administrative data on survival, all-cause hospitalizations, cardiovascular or HF hospitalizations, and days alive and out of hospital (DAOH). Survival free from death/cardiac transplant was 61.9% and 63.8% at 5 years for ICD and CRT-D patients, respectively. Associated comorbidities (Charlson Comorbidity Index) had a significant impact on death/cardiac transplant, as well as on hospitalizations. The median values of DAOH% were 97.4% for ICD and 97.7% for CRT-D patients, but data were highly skewed, with the lower quartile of DAOH% values including values ranging between 0% and 52.8% for ICD and between 0% and 56.1% for CRT-D patients. Charlson Comorbidity Index was a very strong predictor of DAOH%. CONCLUSIONS: Patients who were implanted in 'real world' clinical practice with an ICD or a CRT-D device have, on average, a relatively favourable outcome, with a survival of around 62-64% at 5 years, but with an important burden of hospitalizations. Comorbidities, as evaluated by means of the Charlson Comorbidity Index, have a significant impact on outcomes in terms of mortality/heart transplant, hospitalizations and days spent alive and out of hospital.

[Transcatheter aortic valve implantation: a systematic review of the literature on efficacy and safety data]. / Protesi valvolari aortiche transcatetere: revisione sistematica della letteratura su efficacia e sicurezza.

BACKGROUND: Aortic stenosis is the most common valve disease and transcatheter aortic valve replacement is considered as an alternative to surgical valve replacement or to medical treatment in inoperable or high-risk patients, but it is not suitable for all patients with severe aortic stenosis, taking into account also the high cost associated. OBJECTIVE: To evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) for aortic stenosis via percutaneous, (transfemoral, or endovascular approach) or surgically (transapical, or transventricular) approach. RESULTS: The present review includes 10 randomized controlled trials (RCTs) and 29 observational studies. We combined the outcomes from the individual trials through meta-analysis where possible. We assessed the overall quality of the evidence for the primary outcome using the GRADE system. Regarding TAVI vs. standard surgery, there were no significant differences between TAVI and conventional surgery for mortality at 1 year or more, the frequency of stroke, and heart attack; for mortality at 30 days, no difference was observed in RCTs and the result was in favor of TAVI in observational studies. Another outcome in favor of TAVI was the frequency of major bleeding that was significantly lower in patients treated with TAVI. The quality of the evidence ranged from moderate to very low. Regarding TAVI vs. medical therapy, for the outcome death at 1 year or more, if we consider the RCTs, the results are favorable to TAVI, while in observational studies no significant differences were observed between the two interventions. In contrast, for the outcome mortality at 30 days, in RCTs no significant differences between the two interventions were observed, while the results were favorable to TAVI in observational studies. For the frequency of stroke in the single RCT that reported this outcome, it was significantly lower in patients treated with medical therapy, with no significant differences in the results of observational studies. The results related to the frequency of heart attack from observational studies are in favor of TAVI. The quality of the evidence ranged from low to very low. CONCLUSIONS: Candidates for TAVI are those patients for which conventional open-heart surgery is not recommended because of the risk due to advanced age or important comorbidities.

[Transcatheter aortic valve implantation versus aortic valve replacement: cost analysis from the regional health service and hospital perspectives]. / I costi di ricovero e follow-up delle procedure di sostituzione valvolare aortica per via percutanea e cardiochirurgica a confronto: analisi secondo le prospettive del Sistema Sanitario Regionale e dell'Ospedale.

BACKGROUND: The aim of this study was to estimate the cost of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (AVR) procedures, together with the cost of the first-year hospitalizations following the index ones, in 4 Italian regions where diffusion level of TAVI and coverage decisions are different. METHODS: The cost analysis was performed evaluating 372 patients enrolled consecutively from December 1, 2012 to September 30, 2015. The index hospitalization cost was calculated both from the hospital perspective through a full-costing approach and from the regional healthcare service perspective by applying the regional reimbursement tariffs. The follow-up costs were calculated for one year after the index hospitalization, from the regional healthcare sservice perspective, through the identification of hospital admissions for cardiovascular pathologies after the index hospitalization and computation of the relative regional tariffs. RESULTS: The mean hospitalization cost was € 32 120 for transfemoral TAVI (232 procedures), € 35 958 for transapical TAVI (31 procedures) and € 17 441 for AVR (109 procedures). From the regional healthcare service perspective, the mean transfemoral TAVI cost was € 29 989, with relevant regional variability (range from € 19 987 to € 36 979); the mean transapical TAVI cost was € 39 148; the mean AVR cost was € 32 020. The mean follow-up costs were € 2294 for transfemoral TAVI, € 2335 for transapical TAVI, and € 2601 for AVR. CONCLUSIONS: In our study, transapical TAVI resulted more expensive than transfemoral TAVI, while surgical AVR was cheaper than both (less than 40%). Costs of the transfemoral approach showed great variability between participating regions, probably due to different hospital costs, logistics, patients' selection and reimbursement policy. A central level of control would be appropriate to avoid unjustified differences in access to innovative procedures between different Italian regions.

Same-day transfer for the invasive strategy of patients with non-ST-segment elevation acute coronary syndrome admitted to spoke hospitals: Data from the Emilia-Romagna Regional Network.

BACKGROUND: The service strategy (same-day transfer between spoke hospital and hub centre with catheterisation laboratory (cath-lab) facility to perform invasive procedures) has been suggested to improve the management of patients with non-ST-segment elevation acute coronary syndrome (NSTEACS) admitted to spoke hospitals. We used data from a large prospective Italian registry to describe application, performance and outcome of the service strategy in the daily clinical practice. METHODS: This study was based on an observational, post-hoc analysis of all consecutive NSTEACS patients admitted to spoke non-invasive hospitals of the Emilia-Romagna regional network and receiving coronary artery angiography (CAA)±percutaneous coronary intervention (PCI). We evaluated: application of service strategy, time to cath-lab access, hospital stay length, 30-days occurrence of adverse events. RESULTS: From January 2011-December 2012, 2952 NSTEACS consecutive patients were admitted to spoke non-invasive hospitals and received CAA. Overall, 1765 (60%) patients were managed with a service strategy. After multivariable analysis, service strategy emerged as independent predictor of faster access to cath-lab (within 72 h: hazard ratio (HR) 2.3, 95% confidence interval (CI) 1.9-2.7, p<0.0001; within 24 h: HR 2.8, 95% CI 2.2-3.3, p<0.0001, respectively). Service strategy significantly reduced hospital stay length (-5.5 days, p<0.0001). We estimated a mean of €1590 saved for each patient managed with service strategy. Thirty-day occurrence of adverse events did not differ between patients managed with or without a service strategy. CONCLUSIONS: In our daily clinical practice, a service strategy seems to be an effective approach to optimise the invasive management of NSTEACS patients admitted to spoke hospitals.

[Quality indicators for the assessment of ST-segment elevation acute myocardial infarction (STEMI) networks. How hospital discharge records could be integrated with Emergency medical services data: the Emilia-Romagna STEMI network experience]. / Indicatori per la valutazione dei percorsi di rete dell'infarto miocardico acuto con sopraslivellamento del tratto ST: integrazione dei dati amministrativi provenienti dalle schede di dimissione ospedaliera e dal flusso emergenza-urgenza. Esperienza della Regione Emilia-Romagna.

BACKGROUND: The assessment of the regional network for ST-segment elevation acute myocardial infarction (STEMI) is fundamental for quality assurance. Since 2011 all Italian Health Authorities, in addition to hospital discharge records (HDR), must provide a standardized information flow (ERD) about emergency department (ED) and emergency medical system (EMS) activities. The aim of this study was to evaluate whether data integration of ERD with HDR may allow the development of appropriate quality indicators. METHODS: Patients admitted to coronary care units (CCU) for STEMI between January 1 to December 31, 2013, were identified from the regional HDR database. All data were linked to those of the regional ERD database. Four quality indicators were defined: 1) rates of EMS activation, 2) rates of EMS direct transfer to the catheterization laboratory (Cath-lab), 3) transfer rates from a Spoke to a Hub hospital with angioplasty facilities, and 4) median time spent in ED. RESULTS: In 2013, 2793 patients with STEMI were admitted to the CCU. Of these, 1684 patients (60%) activated EMS and were transported to Spoke or Hub hospitals; 955 (57%) entered directly in CCU/Cath-lab; 677 were transferred directly to a Hub hospital ED without being admitted to a Spoke hospital. The median ED time in Hub hospital was 47 min (IQR 24-136) and in Spoke hospital 53 min (IQR 30-131). CONCLUSIONS: The integration among administrative data banks (i.e., HDR with ERD) allowed the assessment of the regional STEMI network and the identification of potentially useful quality indicators. Their easy availability should enable comparisons with local, national and international standards, and may favor quality improvement.

[Considerations on what we can (and what we should not) ask to registries]. / Riflessioni e confronti su cosa possiamo (e cosa non dobbiamo) chiedere ai registri.

This article presents a summary of the discussion which took place during the works of PRIER II in the session dedicated to the methodology of registries. Following a thorough analysis of the possible methods and the limits which deal with the collection of clinical data through the registries, the different points of view were compared, perhaps the most relevant, related to this activity. All this has been done by taking advantage by the possibility to observe aspects from different points of view. In particular, the exercise considered those who have to deal with the methodological aspects of the registries as an operator of public health or as a private operator who creates services for companies. The final goal, again, was to line up a few essential points accompanied by reasoning and comments useful to anyone who wants to address the issue of registries from the methodological point of view.