Vaginal birth after caesarean birth in Italy: variations among areas of residence and hospitals.

BACKGROUND: The rates of caesarean section (CS) are increasing globally. CS rates are one of the most frequently used indicators of health care quality. Vaginal Birth After Caesarean (VBAC) could be considered a reasonable and safe option for most women with a previous CS. Despite this fact, in some European countries, many women who had a previous CS will have a routine CS subsequently and VBAC rates are extremely variable across countries. VBAC use is inversely related to caesarean use. The objective of the present study was to analyze VBAC rates with respect to caesarean rates and the variations among areas of residence, hospitals and hospital ownership types in Italy. METHODS: This study was based on information from the Hospital Information System (HIS). We collected data from all deliveries in Italy from January 1, 2010 to December 31, 2014 and we considered only deliveries with a previous caesarean section. Applying multivariate logistic regression analysis, the adjusted proportions of VBAC for each Local Health Units (LHU), each hospital and by hospital ownership types were calculated. Cross-classified logistic multilevel models were performed to analyze within geographic, hospitals and hospital ownership types variations. RESULTS: We studied a total of 77,850 deliveries with a previous caesarean section in Italy between January 1, 2010 and December 31, 2014. The proportion of VBAC in Italy slightly increased in the last few years, from 5.8% in 2010 to 7.5% in 2014. Proportions of VBAC ranged from 0.29 to 50.05% in Italian LHUs. The LHUs with lower proportions of VBAC deliveries were characterized by higher values for primary caesarean deliveries. Private hospitals showed the lowest mean of crude VBAC proportions but the highest variation among hospitals, ranging from 0 to 47.1%. CONCLUSIONS: Hospital rates of caesarean section for women with at least one previous caesarean section vary widely, and only some of the variation can be explained by case-mix and hospital-level factors, suggesting that additional factors influence practices. Identifying disparities in VBAC may have important implications for health services planning and targeted efforts to reduce overall rates of caesarean deliveries.

Regional Outcome Evaluation Program (P.Re.Val.E.): Reduction of inequality in access to effective health care in the Lazio region of Italy (2012-2015).

BACKGROUND: Inequalities in health among groups of various socio-economic status (as measured by education, occupation, and income) constitute one of the main challenges for public health. Since 2006, the Lazio Regional Outcome Evaluation Program (P.Re.Val.E.), presents a set of indicators of hospital performance based on quality standards driven by strong clinical recommendations, and measures the variation in the access to effective health care for different population groups and providers in the Lazio Region. One of the aims of the program was to compare population subgroups in order to promote equity in service provision. Since June 2013, a new management strategy has been put in place that assigned specific goals based on performance assessment to the chief executive officers of the hospitals. AIM: To evaluate whether, in recent years, there has been a reduction in the differential access to effective health care, among individuals with different educational levels. METHODS: We enrolled all patients discharged from both public and private hospitals of the Lazio region between 2012 and 2015, living in Lazio region. We analysed the proportion of patients with ST-elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention within 90 minutes (primary PCI), the proportion of patients with hip fracture (HF) who underwent surgery within 2 days, and the proportion of women with primary C-section. We applied multivariate logistic regression models to assess the effect of educational level on health outcomes, adjusting for demographic characteristics and comorbidities that could affect the outcomes. For each year of the study period, we compared adjusted proportions of outcomes for the highest and the lowest level of education by using percentage differences. RESULTS: In the Lazio region, 44.6% of STEMI patients (N = 3,299) were treated with primary PCI, 54.4% of patients with hip fractures (N = 6,602) underwent surgery within 2 days, and 27.7% of women without a previous C-section (N = 34,718) delivered via C-section, in 2015. The corresponding proportions in 2012 were 27.8%, 31.3% and 31.5%, respectively. By comparing the adjusted proportions in patients with the highest education level (a university degree or higher) to those with the lowest level education level (None/Primary school), a decrease in the percentage difference was observed during the study period. In STEMI and delivery cohorts, the improvement of outcomes involved the least and the most educated patients, respectively, and the difference between the two educational levels was close to zero in 2015, whereas for hip patients, the improvement was more evident among the less educated patients. CONCLUSIONS: In the Lazio region, we observed a reduction in the differential access to effective heath care by educational level, in different clinical areas. Different factors might explain these results. On top of the public disclosure of outcome data, the management strategy applied in mid-2013 might have driven the overall improvement of the health system for the considered conditions, helping to achieve a fairer access to health.

Volume and health outcomes: evidence from systematic reviews and from evaluation of Italian hospital data. / Volumi di attività ed esiti delle cure: prove scientifiche in letteratura ed evidenze empiriche in Italia.

BACKGROUND Improving quality and effectiveness of healthcare is one of the priorities of health policies. Hospital or physician volume represents a measurable variable with an impact on effectiveness of healthcare. An Italian law calls for the definition of «qualitative, structural, technological, and quantitative standards of hospital care¼. There is a need for an evaluation of the available scientific evidence in order to identify qualitative, structural, technological, and quantitative standards of hospital care, including the volume of care above or below which the public and private hospitals may be accredited (or not) to provide specific healthcare interventions. OBJECTIVES To identify conditions/interventions for which an association between volume and outcome has been investigated. To identify conditions/interventions for which an association between volume and outcome has been proved. To analyze the distribution of Italian health providers by volume of activity. To measure the association between volume of care and outcomes of the health providers of the Italian National Health Service (NHS). METHODS Systematic review An overview of systematic reviews was performed searching PubMed, EMBASE, and The Cochrane Library up to November 2016. Studies were evaluated by 2 researchers independently; quality assessment was performed using the AMSTAR checklist. For each health condition and outcome, if available, total number of studies, participants, high volume cut-off values, and metanalysis have been reported. According to the considered outcomes, health topics were classified into 3 groups: positive association: a positive association was demonstrated in the majority of studies/participants and/or a pooled measure (metanalysis) with positive results was reported; lack of association: both studies and/or metanalysis showed no association; no sufficient evidence of association: both results of single studies and metanalysis do not allow to draw firm conclusions on the association between volume and outcome. Analysis of the distribution of Italian hospitals by volume of activity and the association between volume of activity and outcomes: the Italian National Outcome evaluation Programme 2016 The analyses were performed using the Hospital Information System and the National Tax Register (year 2015). For each condition, the number of hospitals by volume of activity was calculated. Hospitals with a volume lower than 3-5 cases/year were excluded. For conditions with more than 1,500 cases/year and frequency of outcome ≥1%, the association between volume of care and outcome was analyzed estimating risk-adjusted outcomes. RESULTS Bibliographic searches identified 80 reviews, evaluating 48 different clinical areas. The main outcome considered was intrahospital/30-day mortality. The other outcomes vary depending on the type of condition or intervention in study. The relationship between hospital volume and outcomes was considered in 47 out of 48 conditions: 34 conditions showed evidence of a positive association; • 14 conditions consider cancer surgery for bladder, breast, colon, rectum, colon rectum, oesophagus, kidney, liver, lung, ovaries, pancreas, prostate, stomach, head and neck; • 11 conditions consider cardiocerebrovascular area: nonruptured and ruptured abdominal aortic aneurysm, acute myocardial infarction, brain aneurysm, carotid endarterectomy, coronary angioplasty, coronary artery bypass, paediatric heart surgery, revascularization of lower limbs, stroke, subarachnoid haemorrhage; • 2 conditions consider orthopaedic area: knee arthroplasty, hip fracture; • 7 conditions consider other areas: AIDS, bariatric surgery, cholecystectomy, intensive care unit, neonatal intensive care unit, sepsis, and traumas; for 3 conditions, no association was demonstrated: hip arthroplasty, dialysis, and thyroidectomy. for the remaining 10 conditions, the available evidence does not allow to draw firm conclusions about the association between hospital volume and considered outcomes: surgery for testicular cancer and intracranial tumours, paediatric oncology, aortofemoral bypass, cardiac catheterization, appendectomy, colectomy, inguinal hernia, respiratory failure, and hysterectomy. The relationship between volume of clinician/surgeon and outcomes was assessed only through the literature re view; to date, it is not possible to analyze this association for Italian health provider hospitals, since information on the clinician/surgeon on the hospital discharge chart is missing. The literature found a positive association for 21 conditions: 9 consider surgery for cancer: bladder, breast, colon, colon rectum, pancreas, prostate, rectum, stomach, and head and neck; 5 consider the cardiocerebrovascular area: ruptured and nonruptured abdominal aortic aneurysm, carotid endarterectomy, paediatric heart surgery, and revascularization of the lower limbs; 2 consider the orthopaedic area: knee and hip arthroplasty; 5 consider other areas: AIDS, bariatric surgery, hysterectomy, intensive care unit, and thyroidectomy. The analysis of the distribution of Italian hospitals concerned the 34 conditions for which the systematic review has shown a positive volume-outcome association. For the following, it was possible to conduct the analysis of the association using national data: unruptured abdominal aortic aneurysm, coronary angioplasty, hip arthroplasty, knee arthroplasty, coronary artery bypass, cancer surgery (colon, liver, breast, pancreas, lung, prostate, kidney, and stomach), laparoscopic cholecystectomy, hip fracture, stroke, acute myocardial infarction. For these conditions, the association between volume and outcome of care was observed. For laparoscopic cholecystectomy and surgery of the breast and stomach cancer, the association between the volume of the discharge (o dismissal) operating unit and the outcome was analyzed. The outcomes differ depending on the condition studied. The shape of the relationship is variable among different conditions, with heterogeneous slope of the curves. DISCUSSION For many conditions, the overview of systematic reviews has shown a strong evidence of association between higher volumes and better outcomes. The quality of the available reviews can be considered good for the consistency of the results between the studies and for the strength of the association; however, this does not mean that the included studies are of good quality. Analyzing national data, potential confounders, including age and comorbidities, have been considered. The systematic review of the literature does not permit to identify predefined volume thresholds. The analysis of national data shows a strong improvement in outcomes in the first part of the curve (from very low to higher volumes) for most conditions. In some cases, the improvement in outcomes remains gradual or constant with the increasing volume of care; in other, the analysis could allow the identification of threshold values beyond which the outcome does not further improve. However, a good knowledge of the relationship between effectiveness of treatments and costs, the geographical distribution and the accessibility to healthcare services are necessary to choose the minimum volumes of care, under which specific health procedures could not been provided in the NHS. Some potential biases due to the use of information systems data should also be considered. The different way of coding among hospitals could lead to a different selection of cases for some conditions. Regarding the definition of the exposure (volume of care), a possible bias could result from misclassification of health providers with high volume of activity. Performing the intervention in different departments/ units of the same hospital would result in an overestimation of the volume of care measured for hospital rather than for department/unit. For the conditions with a further fragmentation within the same structure, the association between volumes of discharge department and outcomes has also been evaluated. In this case, the two curves were different. The limit is to attribute the outcome to the discharge unit, which in case of surgery may not be the intervention unit. A similar bias could occur if the main determinant of the outcome of treatment was the caseload of each surgeon. The results of the analysis may be biased when different operators in the same hospital/unit carried out the same procedure. In any case, the observed association between volumes and outcome is very strong, and it is unlikely to be attributable to biases of the study design. Another aspect on which there is still little evidence is the interaction between volume of the hospital and of the surgeon. A MEDICARE study suggests that in some conditions, especially for specialized surgery, the effect of the surgeon's volume of activity is different depending on the structure volume, whereas it would not differ for some less specialized surgery conditions. The data here presented still show extremely fragmented volumes of both clinical and surgical areas, with a predominance of very low volume structures. Health systems operate, by definition, in a context of limited resources, especially when the amount of resources to allocate to the health system is reduced. In such conditions, the rationalization of the organization of health services based on the volume of care may make resources available to improve the effectiveness of interventions. The identification and certification of services and providers with high volume of activity can help to reduce differences in the access to non-effective procedures. To produce additional evidence to guide the reorganization of the national healthcare system, it will be necessary to design further primary studies to evaluate the effectiveness and safety of policies aimed at concentrating interventions in structures with high volumes of activity.

Long-Term Outcome of Acute Coronary Syndromes in Young Patients.

INTRODUCTION: Acute coronary syndromes (ACS) in young patients are uncommon and their influence on morbidity and mortality in this population is still debated. AIM: We investigated clinical and angiographic characteristics, risk factors and outcome in young patients diagnosed with ACS, compared with those of older patients, evaluating survival free from death and/or nonfatal myocardial infarction (MI) and/or coronary revascularization (primary endpoint), and then with respect to each component of the primary endpoint. METHODS: We retrospectively analyzed 1696 patients diagnosed with ACS between 2007 and 2013. 116 were aged ≤45 years (young adults), 1116 were >45 and <75 years (older adults) and 464 were ≥75 years. RESULTS: Young adults were mostly male, with a prevalent diagnosis of STEMI, had less frequently typical cardiovascular risk factors and lower prevalence of extensive coronary artery disease. Over a median 3 years follow up, survival free from composite endpoint was better in young than in older adult patients (11.2 vs. 24.2%; p = 0.001), mainly due to a lower rate of death while the occurrence of non fatal MI and of coronary revascularization was similar (7.8 vs. 8.7%, p = 0.86; 8.7 vs. 12.9%, p = 0.23 respectively). Diabetes was the strongest independent risk factor of worse prognosis in the young cohort (OR 3.47; 95% CI 1.01-11.9; p = 0.04). CONCLUSIONS: Young adults showed peculiar clinical features and lower mortality compared with older adults. Morbidity was not different between the two populations, with diabetes independently associated with a worse prognosis.

Outcome After General Anesthesia Versus Monitored Anesthesia Care in Transfemoral Transcatheter Aortic Valve Replacement.

OBJECTIVE: To evaluate outcomes of monitored anesthesia care (MAC) compared with general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). DESIGN: Secondary analysis from the observational and prospective OBSERVANT (OBservational Study of Effectiveness of avR-taVi procedures for severe Aortic steNosis Treatment) study. SETTING: Multicenter study, including Italian hospitals performing TAVR interventions. PARTICIPANTS: One thousand four hundred ninety-four patients with severe and symptomatic aortic stenosis. INTERVENTIONS: Transfemoral TAVR under general or local anesthesia. MEASUREMENTS AND MAIN RESULTS: A propensity score procedure was applied, and 310 pairs were matched with similar baseline characteristics (EuroSCORE II: local anesthesia 6.6±5.9% v general anesthesia 7.0±7.7%, p = 0.430). MAC was associated with similar 30-day mortality compared with GA (3.9% v 4.8%, p = 0.564). TAVR was performed under MAC without any increased risk of other adverse events. The risk of paravalvular regurgitation≥mild was similar between the study groups (MAC 49.5% v general anesthesia 57.0%, p = 0.858). Two patients receiving on MAC had severe paravalvular regurgitation, whereas this complication was not observed after GA. Permanent pacemaker implantation was 19.1% in the MAC group v 14.8% in the GA group (p = 0.168). Mean intensive care unit stay was 3.5 days for the GA group v 2.9 days for the MAC group (p = 0.086). A similar 3-year survival rate was observed (MAC 69.4% v GA 69.9%, p = 0.966). CONCLUSIONS: Transfemoral TAVR can be performed under MAC with similar immediate and late outcomes as compared with GA. A possible risk of severe paravalvular regurgitation and pacemaker implantation with TAVR under MAC requires further investigation.

Stereotyped subset #1 chronic lymphocytic leukemia: a direct link between B-cell receptor structure, function, and patients' prognosis.

Chronic lymphocytic leukemia (CLL) with stereotyped B-cell receptor (BCR) belonging to subset #1 (IGHV1-5-7/ IGKV1-39) display a poor outcome. To characterize their genetic and genomic features and BCR function, we selected 20 subset #1 CLL from a series of 579 cases. Subset #1 CLL, all showing unmutated IGHV, were associated with the presence of del(11q) (50%) in comparison with unmutated CLL, unmutated stereotyped CLL other than subset #1 and with cases using the same IGHV genes but a heterogeneous VH CDR3 (non-subset #1 CLL). There were no distinctive features regarding CD38, ZAP-70, and TP53 disruption. NOTCH1, SF3B1, and BIRC3 were mutated in 15%, 0%, and 5% of cases, respectively, while BIRC3 was deleted in 22% of cases. Microarray unsupervised analysis on 80 unmutated/mutated/stereotyped/non-stereotyped CLL showed a tight clustering of subset #1 cases. Their genomic signature exhibited several differentially expressed transcripts involved in BCR signal transduction, apoptosis regulation, cell proliferation, and oxidative processes, regardless of del(11q). Accordingly, BCR ligation with anti-IgM revealed a significant higher proliferation of subset #1 versus unmutated non-subset #1 CLL, both at baseline and after 24­48 hr stimulation. Subset #1 CLL represent a paradigmatic example of the direct link between BCR structure, function, and patients prognosis.

The role of socio-economic factors on prevalence and health outcomes of persons with diabetes in Rome, Italy.

BACKGROUND: We investigated the role of socio-economic status on diabetes prevalence, on mortality and hospitalization in a large population-based cohort enrolled in Rome, Italy. METHODS: Diabetic residents aged ≥ 35 years in 2007 were identified using multiple data sources. The effect of the deprivation of the area of residence on diabetes prevalence and on mortality and hospitalization (years 2008-10) was investigated by multilevel regression models, both among diabetic and non-diabetic populations. RESULTS: Prevalence of diabetes (8.3%) was directly related to the deprivation of the area of residence, especially for women. Diabetes increased the risk of mortality and hospitalization, mainly for cardiovascular complications, compared with non-diabetic subjects, with increasing relative risks in more deprived areas. The social gradients observed among diabetic patients are modest compared with non-diabetic subjects, both for some acute complications (myocardial infarction, stroke) and chronic complications (ischaemic heart disease, nephropathy, retinopathy and amputation). CONCLUSIONS: Prevalence of diabetes is directly related to deprivation, especially for women. Diabetes increases the risk of mortality and hospitalization for cardiovascular complications. However, similar to another study conducted in Northern Italy, we found that social differences in health outcomes do not differ between people with and without diabetes, suggesting that the care for diabetic patients living in Rome is provided without social disparities, and in some cases, it protects against the adverse effects of social inequalities. The Italian care system for diabetes deserves to be further investigated, as it could represent a model for the care of other chronic conditions and for contrasting social inequities in health.