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.

Use of Azithromycin Attributable to Acute SARS-CoV-2 Infection.

PURPOSE: In the early stages of the COVID-19 pandemic, preliminary results that later proved to be incorrect suggested the possible efficacy of anti-infective drugs such as azithromycin for the treatment of SARS-CoV-2 infection. These preliminary data may have influenced the prescription of azithromycin. However, no individual-level data linking the use of this antibiotic to acute SARS-CoV-2 infection are available. The present analysis aims to fill this gap. METHODS: A retrospective population-based cohort design was used including patients diagnosed with SARS-CoV-2 infection in the period ranging from February 2020 to February 2022. The data source for antibiotic consumption was the drug database of outpatient prescriptions of Emilia-Romagna Region (Italy). Antibiotics were classified according to the Anatomical Therapeutic Chemical (ATC) classification system. Consumption rates and percentages of azithromycin DDDs (defined daily doses) during the acute phase of the infection were compared with a previous control period and with the post-acute phase. Analyses were stratified by four groups according to the prevalent virus variant at time of diagnosis. RESULTS: Comparing the previous control period with the acute phase of infections, the rates of azithromycin consumption (DDD per 1000 individuals per day) increased from 1.17 to 23.11, from 0.80 to 33.03, from 0.81 to 21.01, and from 1.02 to 9.76, in the pre-Alpha, Alpha, Delta, and Omicron periods, respectively. Similarly, the percentages of individuals receiving azithromycin, and the azithromycin DDDs percentages over total systemic antibiotics DDDs increased in acute phases of infection compared with control periods. The consumption rates and percentages returned to preinfection levels in the post-acute phase. In the study period, 12.9% of the use of azithromycin in the entire adult population of Emilia-Romagna was attributable to acute SARS-CoV-2 infection. CONCLUSIONS: Considering the low likelihood of bacterial coinfections, the increased azithromycin consumption in the acute phase of SARS-CoV-2 infection suggests inappropriate prescribing of this antibiotic.

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.

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.

Recent temporal trends for first-time hospitalization for acute myocardial infarction. Treatment patterns and clinical outcome in a large cohort study.

BACKGROUND: The objective was to report recent trends in the incidence, adoption of evidence-based treatment, and clinical outcomes for first-time hospitalization for acute myocardial infarction. METHODS: This is a large retrospective population-based cohort study using medical administrative data (International Classification of Diseases, Ninth Revision, Clinical Modification, codes) performed in the Emilia-Romagna Region of Italy (approximately 4.5 million inhabitants). We identified 60,673 patients with a first hospitalization for acute myocardial infarction from 2002 through 2009. RESULTS: The standardized incidence rate per 100,000 person-years of acute myocardial infarction increased from 173 cases in 2002 to a peak of 197 cases in 2004 and then decreased each year thereafter to 167 cases in 2009. The proportion of patients who underwent coronary angiography and angioplasty in the acute phase increased over time, respectively, from 45.4% and 27.1% to 72.3% and 57.2% (P < .001). Medication use within 12 months of discharge increased for aspirin, ß-blockers, and statins. A reduction in crude and adjusted in-hospital all-cause (16.1% in 2002 vs 12.8% in 2009, P < .001) and cardiovascular mortality (13.6% in 2002 vs 9.5% in 2009, P < .001) was observed over time. At 1 year after hospital discharge, no significant variations occurred in adjusted risk for all-cause mortality or cardiovascular mortality. Notably, crude and adjusted risk for in-hospital and postdischarge bleeding showed a significant increment. CONCLUSIONS: The utilization of evidence-based treatments in patients with myocardial infarction increased between 2002 and 2009. These changes in practice over time favored a reduction in early case fatality at the cost of a significant increase in bleeding.

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.

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.

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.

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.

Impact of computed tomography coronary angiography on other diagnostic tests.

OBJECTIVES: Information on the impact of computed tomography coronary angiography (CTCA) on patterns of care is scarce. In particular, it is not clear if, and to what extent, its adoption actually leads to a reduction in the use of other diagnostics tools. The aim of this study was to evaluate whether the adoption of CTCA in Emilia-Romagna (an Italian region with a population of 4.4 million) had any effect on utilization rates of myocardial perfusion scintigraphy (MPS) and coronary angiography (CA). METHODS: Interrupted time series (ITS) were applied to monthly volumes of MPS and CA tests performed from 2003 to 2010, to assess trends in usage rates for those procedures before and after CTCA was adopted by all the healthcare organizations operating in the region. RESULTS: After an increase in the first year of CTCA introduction, its use remained stable over the study period. After September 2006, a significant decrease in MPS volumes (31 percent; p < .0001) and a much less tangible decrease in CA volumes (5 percent; p < .0001), were detected by ITS analyses. CONCLUSIONS: This study demonstrates that the use of CTCA had a greater impact on MPS usage rates than on CA.

Assessment of coronary artery disease and calcified coronary plaque burden by computed tomography in patients with and without diabetes mellitus.

PURPOSE: To compare the coronary atherosclerotic burden in patients with and without type-2 diabetes using CT Coronary Angiography (CTCA). METHODS AND MATERIALS: 147 diabetic (mean age: 65 ± 10 years; male: 89) and 979 nondiabetic patients (mean age: 61 ± 13 years; male: 567) without a history of coronary artery disease (CAD) underwent CTCA. The per-patient number of diseased coronary segments was determined and each diseased segment was classified as showing obstructive lesion (luminal narrowing >50%) or not. Coronary calcium scoring (CCS) was assessed too. RESULTS: Diabetics showed a higher number of diseased segments (4.1 ± 4.2 vs. 2.1 ± 3.0; p < 0.0001); a higher rate of CCS > 400 (p < 0.001), obstructive CAD (37% vs. 18% of patients; p < 0.0001), and fewer normal coronary arteries (20% vs. 42%; p < 0.0001), as compared to nondiabetics. The percentage of patients with obstructive CAD paralleled increasing CCS in both groups. Diabetics with CCS ≤ 10 had a higher prevalence of coronary plaque (39.6% vs. 24.5%, p = 0.003) and obstructive CAD (12.5% vs. 3.8%, p = 0.01). Among patients with CCS ≤ 10 all diabetics with obstructive CAD had a zero CCS and one patient was asymptomatic. CONCLUSIONS: Diabetes was associated with higher coronary plaque burden. The present study demonstrates that the absence of coronary calcification does not exclude obstructive CAD especially in diabetics.

[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.

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.

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.

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.

Implantable electrical devices for prevention of sudden cardiac death: data on implant rates from a 'real world' regional registry.

AIMS: International and national consensus guidelines define appropriate indications for implantable cardioverter-defibrillators (ICDs), but the variability in implant rates in 'real world' clinical practice is still unknown. METHODS AND RESULTS: In Emilia-Romagna, an Italian region with around 4.3 million inhabitants, a web-based registry was instituted to collect data for all ICDs implanted. Between January 2006 and December 2008, data from all consecutive patients resident in this region who underwent first implant of an ICD or a biventricular ICD were collected and standardized, considering each regional area (i.e. each of the nine provinces). The overall number of implanted ICDs had an increase in years 2007 and 2008, with a relative increase in comparison to 2006, by 14 and 48% respectively, reaching an average value of 16.2 per 10,000 inhabitants in 2008. Most of the increase was due to a rise in ICDs for primary prevention. The ratio between the implant rates of the provinces with the highest and the lowest implant rates, respectively, was around 2 in 2008. CONCLUSION: Implant rates for ICDs, considering both primary and secondary prevention of sudden death, show up to two-fold variations even in a geographical region where the general level of health care is advanced and well appreciated by the population. The lack of a common strategy for sudden death prevention, approved by both physicians and institutional regional authorities, together with some degree of variability in translating guidelines into clinical practice, were identified as the main factors explaining the heterogeneity in ICD implant rates.

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.

Coronary calcium score as gatekeeper for 64-slice computed tomography coronary angiography in patients with chest pain: per-segment and per-patient analysis.

We sought to investigate the performance of 64-slice CT in symptomatic patients with different coronary calcium scores. Two hundred patients undergoing 64-slice CT coronary angiography for suspected coronary artery disease were enrolled into five groups based on Agatston calcium score using the Mayo Clinic risk stratification: group 1: score 0, group 2: score 1-10, group 3: score 11-100, group 4: score 101-400, and group 5: score > 401. Diagnostic accuracy for the detection of significant (>/=50% lumen reduction) coronary artery stenosis was assessed on a per-segment and per-patient base using quantitative coronary angiography as the gold standard. For groups 1 through 5, sensitivity was 97, 96, 91, 90, 92%, and specificity was 99, 98, 96, 88, 90%, respectively, on a per-segment basis. On a per-patient basis, the best diagnostic performance was obtained in group 1 (sensitivity 100% and specificity 100%) and group 5 (sensitivity 95% and specificity 100%). Progressively higher coronary calcium levels affect diagnostic accuracy of CT coronary angiography, decreasing sensitivity and specificity on a per-segment base. On a per-patient base, the best results in terms of diagnostic accuracy were obtained in the populations with very low and very high cardiovascular risk.

Web-based toolkit to facilitate European collaboration on evidence generation on promising health technologies.

BACKGROUND: Several countries have developed policy frameworks allowing timely access to promising health technologies on the condition that additional evidence is generated. However, an important barrier to evidence generation is the lack of structured collaboration among health technology assessment (HTA) agencies. OBJECTIVES: One of the aims of Work Package 7 (WP7) of the European network for Health Technology Assessment (EUnetHTA) Project was to determine the types of structured collaboration that could facilitate evidence generation and to develop a Web-based toolkit to support such collaboration. METHODS: Collaboration modalities were defined by all WP7 Partners. Initial emphasis was on information sharing. Standardized forms for information sharing were developed and tested. An information technology development phase followed with the creation of the Web-based toolkit (Web site). RESULTS: Three levels of collaboration were agreed on: (i) sharing information, (ii) coordinated action, and (iii) joint action. The Web site allows access to structured and standardized forms for requesting information, posting information in response to a request, and posting information spontaneously. An online database contains all of the information requested or posted. Pilot tests on twenty-one promising technologies were satisfactory. CONCLUSIONS: This new Web site for sharing information on evidence generation should help countries reach robust decisions on the timely adoption of promising health technologies. It will only become fully operational if EUnetHTA Partners supply relevant, accurate, and updated information, and regularly use the Web site.

Internal evaluation of the European network for health technology assessment project.

OBJECTIVES: The internal evaluation studied the development of the European network for Health Technology Assessment (EUnetHTA) Project in achieving the general objective of establishing an effective and a sustainable network of health technology assessment (HTA) in Europe. METHODS: The Work Package 3 group was dedicated to this task and performed the work. Information on activities during the project was collected from three sources. First, three yearly cross-sectional studies surveyed the participants' opinions. Responses were by individuals or by institutions. The last round included surveys to the Steering Committee, the Stakeholder Forum, and the Secretariat. Second, the Work Package Lead Partners were interviewed bi-annually, five times in total, to update the information on the Project's progress. Third, additional information was sought in available documents. RESULTS: The organizational structure remained stable. The Project succeeded in developing tools aimed at providing common methodology with intent to establish a standard of conducting and reporting HTA and to facilitate greater collaboration among agencies. The participants/agencies expressed their belief in a network and in maintaining local/national autonomy. The Work Package Leaders expressed a strong belief in the solid base of the Project for a future network on which to build, but were aware of the need for funding and governmental support. CONCLUSIONS: Participants and Work Package Leaders have expressed support for a future network that will improve national and international collaboration in HTA based on the experience from the EUnetHTA project.