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

BACKGROUND: Multimorbidity is a growing concern for healthcare systems, with many countries experiencing demographic transition to older population profiles. A simple multisource comorbidity score (MCS) has been recently developed and validated. A very large real-world investigation was conducted with the aim of measuring inequalities in the MCS distribution across Italy. METHODS: Beneficiaries of the Italian National Health Service aged 50-85 years who in 2018 were resident in one of the 10 participant regions formed the study population (15.7 million of the 24.9 million overall resident in Italy). MCS was assigned to each beneficiary by categorizing the individual sum of the comorbid values (i.e. the weights corresponding to the comorbid conditions of which the individual suffered) into one of the six categories denoting a progressive worsening comorbidity status. MCS distributions in women and men across geographic partitions were compared. RESULTS: Compared with beneficiaries from northern Italy, those from centre and south showed worse comorbidity profile for both women and men. MCS median age (i.e. the age above which half of the beneficiaries suffered at least one comorbidity) ranged from 60 (centre and south) to 68 years (north) in women and from 63 (centre and south) to 68 years (north) in men. The percentage of comorbid population was lower than 50% for northern population, whereas it was around 60% for central and southern ones. CONCLUSION: MCS allowed of capturing geographic variability of multimorbidity prevalence, thus showing up its value for addressing health policy in order to guide national health planning.

Developing and validating a novel multisource comorbidity score from administrative data: a large population-based cohort study from Italy.

OBJECTIVE: To develop and validate a novel comorbidity score (multisource comorbidity score (MCS)) predictive of mortality, hospital admissions and healthcare costs using multiple source information from the administrative Italian National Health System (NHS) databases. METHODS: An index of 34 variables (measured from inpatient diagnoses and outpatient drug prescriptions within 2 years before baseline) independently predicting 1-year mortality in a sample of 500 000 individuals aged 50 years or older randomly selected from the NHS beneficiaries of the Italian region of Lombardy (training set) was developed. The corresponding weights were assigned from the regression coefficients of a Weibull survival model. MCS performance was evaluated by using an internal (ie, another sample of 500 000 NHS beneficiaries from Lombardy) and three external (each consisting of 500 000 NHS beneficiaries from Emilia-Romagna, Lazio and Sicily) validation sets. Discriminant power and net reclassification improvement were used to compare MCS performance with that of other comorbidity scores. MCS ability to predict secondary health outcomes (ie, hospital admissions and costs) was also investigated. RESULTS: Primary and secondary outcomes progressively increased with increasing MCS value. MCS improved the net 1-year mortality reclassification from 27% (with respect to the Chronic Disease Score) to 69% (with respect to the Elixhauser Index). MCS discrimination performance was similar in the four regions of Italy we tested, the area under the receiver operating characteristic curves (95% CI) being 0.78 (0.77 to 0.79) in Lombardy, 0.78 (0.77 to 0.79) in Emilia-Romagna, 0.77 (0.76 to 0.78) in Lazio and 0.78 (0.77 to 0.79) in Sicily. CONCLUSION: MCS seems better than conventional scores for predicting health outcomes, at least in the general population from Italy. This may offer an improved tool for risk adjustment, policy planning and identifying patients in need of a focused treatment approach in the everyday medical practice.

[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 limits and profits of registries]. / Riflessioni e confronti sui limiti e i vantaggi dei registri.

The article collects the summary of the discussion occurred in the setting of PRIER II, in the session dedicated to the taxonomy of registries. Shown below, some specific contributions by health professionals working at the regional departments, which deal with registries, as well as the contribution on the same subject by specialists working at some pharmaceutical companies. In particular, after the presentation summarized in the article by prof. Giuseppe Costa1, the contributions, respectively by a representative of the Emilia-Romagna Region, of a health and hospital service and by the PRIER II workgroup, are following. Finally, a collective work with all participants to the working group took place to focus on all the issues considered to be crucial in defining clinical registries. At the same discussion table, institutional representatives of the regulatory national and regional branch were also invited to take into consideration the points of view of all public and private registry users, in particular in their benefits, limits and purposes. Going through the discussion on a specific check list and deepening a number of statements identified by the working group, a list of key points, essential to characterize each clinical registry, was produced.

Does breast cancer screening level health inequalities out? A population-based study in an Italian region.

BACKGROUND: Although population-based screening has the potential to reduce inequalities in breast cancer survival, evidence on this topic is controversial. The objective of this study was to evaluate whether the full implementation of a mammography screening programme in Emilia-Romagna in Italy had an impact on variations in breast cancer survival by educational level. METHODS: A cohort study was performed, including all women <70 years and residing in Emilia-Romagna who had infiltrating breast cancer registered in 1997-2000 (transitional screening period) or 2001-03 (consolidation screening period). Cancer cases were retrieved from the regional Breast Cancer Registry and followed up for 5 years. Educational level was determined from census data and allocated to cancer cases by individual record linkage. Age at diagnosis was classified into two groups (30-49, 50-69: screening target population). RESULTS: A total of 9639 cases were analyzed. In the 1997-2000 period, low-educated women had significantly lower survival compared with high-educated women, both in the younger and in the older age-groups. After the full implementation of the screening programme, these differences decreased in both age-groups, until disappearing completely among women in the age-group invited to screening. CONCLUSIONS: Our findings suggest that a fee-free population-based organized mammography screening programme with active invitation of the whole target population could be effective in reducing differences in survival in the population targeted by the screening.

Evaluation of the survival benefit of Trauma-Centre care in the Italian setting.

BACKGROUND: Trauma Centres (TC) are expected to have a lower mortality - after controlling for injury-severity - than non-designated hospitals in order to justify their funding. This benefit has been demonstrated in the USA not long ago, while the evidence from other settings is still limited. We evaluated the mortality benefit of TC care in an Italian setting, where the first Trauma System with designated TCs was instituted six years ago. MATERIALS AND METHODS: We compared 30-day mortality among 4059 severely injured patients treated in the three TCs and in 12 other hospitals of the region Emilia-Romagna, Italy between 2007 and 2011. We used propensity-score weighting to adjust for differences in potential confounders. RESULTS: In the overall population there was no difference in the adjusted mortality - OR (95% CI) 1.02 (0.81-1.29). However, an interaction existed between TC care and injury severity. Subgroup analyses showed that the benefit of TC care was significant for the patients with a TMPM-ICD9 severity score>0.12 - OR (95% CI) 0.70 (0.52-0.97). These patients comprised about one-third of the study population. Further subgroup investigations showed that this effect was concentrated in the patients with less than 45 years. CONCLUSIONS: The risk of death for patients with particularly severe injuries is significantly lower when they are treated in TCs as compared to Non-Trauma Centres, especially if they are younger than 45 years. TC care should be provided to a larger number of patients than currently done.

Relevance of gender in patients with acute myocardial infarction undergoing coronary interventions.

AIMS: To evaluate whether gender differences in terms of up to 4-year outcome still persist within patients with acute myocardial infarction (AMI) who uniformly underwent coronary revascularization, we performed a gender comparison in a large contemporary multicentre percutaneous intervention (PCI) registry. MATERIALS AND METHODS: We retrospectively analyzed data from 18,351 patients with AMI, who underwent percutaneous coronary interventions (5093 women and 13,258 men) in the Emilia Romagna region of Italy between July 2002 and December 2007. Median follow-up was 1174 days. RESULTS: After propensity score adjustment, differences in gender-related mortality were not temporarily homogeneous: 30-day adjusted mortality was higher in women than in men [hazard ratio (HR): 1.40, P < 0.0001], whereas thereafter female gender showed a significantly lower mortality risk (HR: 0.84, P = 0.01). Notably, younger women (<50 years old) both in the acute and postacute period had more than 3.6 higher risk of mortality when compared with men, whereas older women, particularly after the first 30-day post AMI, had similar (50-80 years old) or even better (≥ 80 years old) survival compared with men. Finally 1-month adjusted risk of heart failure and post PCI vascular complications requiring surgical treatment was higher in women while there was no detectable difference in terms of early and late AMI/unstable angina, stroke and angiographic stent thrombosis. CONCLUSION: In a contemporary large real-world AMI population treated with PCI, we found gender-related temporal and age-dependent adjusted differences in mortality. Our data suggest the hypothesis that biological gender-related differences could, in part, explain these findings.

[The cost of innovation in treating aortic stenosis: transcatheter aortic valve implantation]. / Il costo dell'innovazione nel trattamento della stenosi aortica: l'impianto transcatetere di protesi valvolare aortica.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) represents a promising therapeutic option for patients affected by severe aortic stenosis, but it is currently associated with high costs. Therefore, the assessment of its economic impact becomes urgent to support decision-makers' choices about its use, patient access to treatment and reimbursement mechanisms. METHODS: A retrospective, observational, single-center (the teaching hospital located in Bologna, Italy) study was conducted. All patients with severe symptomatic aortic stenosis undergoing TAVI during the enrolment period (February 2008-August 2010) were included. The procedures were performed with both bioprostheses approved for clinical use and through different vascular access: CoreValve transfemoral (CV-TF), CoreValve transsubclavian (CV-TS), Edwards Sapien transapical (ES-TA), Edwards Sapien transfemoral (ES-TF). Costs of the whole index hospitalization have been calculated from the hospital perspective. Healthcare resource consumption was measured at patient level and assessed using unit costs (micro-costing approach). RESULTS: Overall, 87 consecutive patients (48 CV-TF, 12 CV-TS, 20 ES-TA, 7 ES-TF) were included in the study. They presented a high-risk profile (age 83.3 ± 5.4 years; logistic EuroSCORE 23.3 ± 12.3%) and important comorbidity. In-hospital mortality was 3.4%. Total cost of hospitalization was, on average, €35.841 (range €27.267-69.744) of which 68% was attributable to the procedure. A huge variation in costs was observed among different treatment groups. Patients treated with transfemoral implant (CV-TF: €33.977; ES-TF: €31.442) were on average less expensive than others (CV-TS: €37.035; ES-TA: €41.139). CONCLUSIONS: Our findings show that treating patients with TAVI places a heavy burden on hospital budget. Hence, due to the shortage of financial resources, affordability of TAVI requires further attention.

Pre-hospital ECG in patients undergoing primary percutaneous interventions within an integrated system of care: reperfusion times and long-term survival benefits.

AIMS: Treatment delay is a powerful predictor of survival in STEMI patients undergoing primary PCI. We investigated the effectiveness of pre-hospital triage with direct referral to PCI, alongside more conventional referral strategies. METHODS AND RESULTS: From January 2003 to December 2007, 1,619 STEMI patients were referred for primary PCI at our cathlab through two main triage groups: i.e., 1) following pre-hospital triage (n=524), 2) via more conventional triages (n=1,095) represented by the S. Orsola-Malpighi hospital emergency department triage (hub hospital) and local hospital triage. Pre-hospital diagnosis was associated with a 76 minute reduction in pain-to-balloon time (143 [107-216] vs. 219 [149-343], p=0.001) allowing mechanical revascularisation within 90 minutes from the first medical contact in the vast majority of the patients (>80%). Clinically, pre-hospital triage showed no significant reductions in terms of adjusted long-term mortality (HR 0.81, 95% CI 0.61-1.08; p=0.16) in the overall population. However, significant adjusted survival benefits were observed in high-risk groups (i.e., cardiogenic shock, TIMI risk score >30, diabetes mellitus). CONCLUSIONS: This study shows that pre-hospital diagnosis allows for significant reductions in primary PCI treatment delays and suggests the hypothesis that this referral strategy might provide long-term survival benefits especially in high-risk patients.

Long-term clinical outcomes and cost-effectiveness analysis in multivessel percutaneous coronary interventions: comparison of drug-eluting stents, bare-metal stents and a mixed approach in patients at high and low risk of repeat revascularisation.

AIMS: To evaluate the long-term effectiveness and cost-efficacy of drug-eluting stents (DES) in a real world setting of multivessel percutaneous coronary intervention (PCI). METHODS AND RESULTS: We evaluated the 2-year outcome of all multivessel PCI in de novo lesions enrolled in a prospective web-based multicentre registry from July 2003 to December 2006. Among the 2,898 eligible patients, 1,315 were treated with bare-metal stent (BMS) alone, 657 with DES alone, and 926 with both. At 2-years, use of DES was associated with a lower propensity score adjusted incidence of major adverse cardiac events (MACE), death and myocardial infarction, and target vessel revascularisation (TVR) compared with BMS but only in patients at high risk of TVR. No difference was apparent between "pure" DES and the mixed approach. The matched cost-effectiveness analysis revealed DES to be more costly and more effective with a reasonable incremental cost-efficacy ratio for any MACE avoided only in patients with a high risk of TVR and only in comparison with "pure" BMS patients. CONCLUSIONS: In this real-world multivessel PCI registry, the use of DES and a mixed approach were associated with a 2-year reduction of adverse clinical outcomes in comparison with BMS especially in patients with a high risk of TVR. DES were cost-effective only in patients at high risk of TVR.