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Introduction COVID-19 case fatality rate in hospitalized patients varies across countries and studies. Reliable estimates, specific for age, sex, and comorbidities, are needed to monitor the epidemic, to compare the outcome in different settings, and to correctly design trials for COVID-19 interventions. The aim of this study was to provide population-based survival curves of hospitalized COVID-19 patients. Materials and methods A cohort study was conducted in three areas of Northern Italy, heavily affected by SARS-CoV-2 infection (Lombardy and Veneto Regions, and Reggio Emilia province), using a loco-regional COVID-19 surveillance system, linked to hospital discharge databases. We included all patients testing positive for SARS-CoV-2 RNA by RT-PCR on nasopharyngeal/throat swab samples who were hospitalized from 21 February to 21 April 2020. Kaplan-Meier survival estimates were calculated at 14 and 30 days for death in any setting, stratifying by age, sex, and the Charlson Index. Results Overall, 42,926 hospitalized COVID-19 patients were identified. Patients' median age was 69 years (IQR: 57-79), 62.6% were males, and 6.0% had a Charlson Index ≥3. Survival curves showed that 22.0% (95% CI 21.6-22.4) of patients died within 14 days and 27.6% (95% CI 27.2-28.1) within 30 days from hospitalization. Survival was higher in younger patients and in females. The negative impact of comorbidities on survival was more pronounced in younger age groups. Conclusion The high fatality rate observed in the study (28% at 30 days) suggests that studies should focus on death as primary endpoint during a follow-up of at least one month.

Objectives To review the evidence of the effects of centralization of cancer surgery on postoperative mortality. Methods We searched Medline, Embase, Cinahl, Cochrane and Scopus (up to November 2019) for studies that (i) assessed the effects of centralization of cancer surgery policies on in-hospital or 30-day mortality, or (ii) described changes in both postoperative mortality for a surgical intervention and degree of centralization using reduction in the number of hospitals or increases in the proportion of patients undergoing cancer surgery at high volume hospitals as proxy. PRISMA guidelines were followed. We estimated pooled odds ratios (OR) and conducted meta-regression to assess the relationship between degree of centralization and mortality. Results A total of 41 studies met our inclusion criteria of which 15 evaluated the effect of centralization policies on postoperative mortality after cancer surgery and 26 described concurrent changes in the degree of centralization and postoperative mortality. Policy evaluation studies mainly used before-after designs (n = 13) or interrupted time series analysis (n = 2), mainly focusing on pancreatic, oesophageal and gastric cancer. All but one showed some degree of reduction in postoperative mortality, with statistically significant effects demonstrated by six studies. The pooled odds ratio for centralization policy effect was 0.68 (95% Confidence interval: 0.54–0.85; I2 = 80%). Meta-regression analysis of the 26 descriptive studies found that an increase of the proportion of patients treated at high volume hospitals was associated with greater reduction in postoperative mortality. Conclusions Centralization of cancer surgery is associated with reduced postoperative mortality. However, existing evidence tends to be of low quality and estimates of the effect size are likely inflated. There is a need for prospective studies using more robust approaches, and for centralization efforts to be accompanied by well-designed evaluations of their effectiveness.

BackgroundCOVID-19 case fatality rate in hospitalized patients varies across countries and studies, but reliable estimates specific for age, sex, and comorbidities are needed to design trials for COVID-19 interventions. Aim of this study is to provide population-based survival curves of hospitalized COVID-19 patients.MethodsA cohort study was conducted in Lombardy, Veneto, and Reggio Emilia using COVID-19 registries linked to hospital discharge databases containing patient clinical histories. All patients with positive SARS-CoV-2 RT-PCR test on oral/nasopharyngeal swabs hospitalized from 21st February to 21st April 2020 were identified. Kaplan Meier survival estimates were calculated at 14 and 30 days for death in any setting, stratifying by age, sex and Charlson Index.FindingsOverall, 42,926 hospitalized COVID-19 patients were identified. Patients’ median age was 69 years (IQR: 57-79), 62·6% were males, 69·4% had a Charlson Index of 0. In total, 11,205 (26·1%) patients died over a median follow-up of 24 days (IQR: 10-35). Survival curves showed that 22·0% of patients died within 14 days and 27·6% within 30 days of hospitalization. Survival was higher in younger patients and in females. Younger patients with comorbidities had a lower survival than older ones with comorbidities.InterpretationOver 27% of hospitalized COVID-19 patients died within one month in three areas of Northern Italy that were heavily affected by SARS-CoV-2 infection. Such a high fatality rate suggests that trials should focus on survival and have follow-up of at least one month.FundingThe study did not receive any external funding.Research in contextEvidence before this studyTwo recent systematic reviews with meta-analyses report case fatality rates of three to four percent in COVID-19 patients. Most studies on hospitalized cohorts report only slightly higher figures. These figures do not correspond to those derived from routinely collected clinical data in most European countries, reporting a 10% case fatality rate which has been increasing over time since the epidemic started.Robust and precise survival estimates of hospitalized COVID-19 patients which take into account prognostic factors such as age, sex and burden of comorbidities are needed to design appropriate phase II and phase III clinical studies of drugs targeting COVID-19.Added value of this studyIn this study we present the first survival estimates by age, sex and Charlson index for a large population-based cohort of Italian hospitalized COVID-19 patients.Implications of all the available evidenceOver 27% of COVID-19 patients died within one month from hospital admission. Such a high fatality rate suggests that studies should prioritize mortality as primary outcome. Furthermore, we found that the fatality rate reaches a plateau 30 days after hospitalization, suggesting that studies should have at least one month of follow up to observe deaths; shorter follow-up could lead to overestimation of treatment benefits.

ObjectivesTo describe the age- and sex-specific prevalence of SARS-CoV-2 disease (COVID-19) and its prognostic factors.DesignPopulation-based prospective cohort study on archive data.SettingPreventive services and hospital care in the province of Reggio Emilia, Northern Italy.ParticipantsAll 2653 symptomatic patients who tested positive for SARS-CoV-2 from February 27 to April 2, 2020 in the province of Reggio Emilia.Main outcome measuresHospitalization and death up to April 2, 2020.ResultsFemales had higher prevalence of infection than males below age 50 (2.61 vs. 1.84 ‰), but lower in older ages (16.49 vs. 20.86 ‰ over age 80). Case fatality rate reached 20.7% (22/106) in cases with more than 4 weeks follow up. After adjusting for age and comorbidities, men had a higher risk of hospitalization (hazard ratio (HR) 1.4 95% confidence interval (95% CI) 1.2 to 1.6) and of death (HR 1.6, 95% CI 1.2 to 2.1). Patients over age 80 compared to < age 50 had HR 7.1 (95% CI 5.4 to 9.3) and HR 27.8 (95% CI 12.5 to 61.7) for hospitalization and death, respectively. Immigrants had a higher risk of hospitalization (HR 1.3, 95% CI 0.99 to 1.81) than Italians and a similar risk of death. Risk of hospitalization and of death were higher in patients with heart failure (HR 1.6, 95% CI 1.2 to 2.1and HR 2.3, 95% CI 1.6 to 3.2, respectively), arrhythmia (HR 1.5, 95% CI 1.2 to 1.9 and HR 1.8, 95% CI 1.3 to 2.5, respectively), dementia (HR 1.2, 95% CI 0.9 to 1.8 and HR 1.8, 95% CI 1.1 to 2.8, respectively), ischemic heart disease (HR 1.3, 95% CI 1.0 to 1.7 and HR 1.7, 95% CI 1.2 to 2.5, respectively), diabetes (HR 1.5, 95% CI 1.3 to 1.9 and HR 1.6, 95% CI 1.1 to 2.2, respectively), and hypertensions(HR 1.4, 95% CI 1.2 to 2.6 and HR 1.6, 95% CI 1.2 to 2.1, respectively), while COPD increased the risk of hospitalization (HR 1.9, 95% CI 1.4 to 2.5) but not of death (HR 1.1, 95% CI 0.7 to 1.7). Previous use of ACE inhibitors has no effect on risk of death (HR 0.97, 95% CI 0.69 to 1.34)ConclusionsThe mechanisms underlying these associations are mostly unknown. A deeper understanding of the causal chain from infection, disease onset, and immune response to outcomes may explain how these prognostic factors act.

Beta-blockers (BB), ACE inhibitors/angiotensin receptor blockers(ACEi/ARBs) and aldosterone antagonists (AA) do represent diseasemodifying drugs and have become the cornerstone of heart failure(HF) pharmacological therapy [1]. However, it is never safe to assumethat treatments of proven efficacy in younger, healthier patients willprovide equivalent benefit in older patients [2] but current guidelinesrarely distinguish the use of these therapies on the basis of age [3].To help clarify these issues a retrospective cohort study was under-taken byidentifyingall patients hospitalized for HF and never hospital-ized for HFin theprevious 10 years, discharged from 1 January 2009 to31December 2010in theEmilia–Romagna, 4.3 million resident inhabi-tants in the Italian region. Inclusion criteria were one of the followingICD9-CM codes as principal discharge diagnosis: 428.0, 428.1, 428.2x,428.3x, 428.4x, 428.9x, 402.01, 402.11, 402.91, 404.01, 404.03, 404.11,404.13, 404.91, 404.93, and 398.91. Exclusion criteria were: age≤75 years,residenceoutsideEmilia–Romagnaregionanddeathwithin90 days of discharge. Accordingly, the eventual HF disease-modifyingdrug was prescribed away from the known clinically “vulnerable”phase regardless of standard medical therapy [4].Theeligiblecohortwascategorizedin6groupsofpatientsbasedonadrugprescriptionwithin90daysfromhospitaldischarge:1)noBB/ACEi/ARBs/AA (“No drug”); 2) single ACEi/ARBs (“only ACEi/ARBs”); 3) singleBB (“only BB”); 4) ACEi/ARBs plus BB (“double therapy”); 5) BB plusACEi/ARBs plus AA (“triple therapy”); and 6) other different combina-tions between BB and/or ACEi/ARBs and/or AA ( “other combinations”).Data were collected from the Emilia–Romagna Region administra-tive healthcare databases, which capture information about health ser-vice utilization from the entire region. Patients' information wasretrievedfromtheregionaldatabaseofhospitaldischarges,theregionaloutpatient and inpatient drug prescription database and the regionalmortality registry. The following ATC classes were used: C07 class(BB); C09A' 'C09B' 'C09C' 'C09D class (ACEi/ARBs); and C03DA class(AA). Individuals were linked across data files with anonymous patientidentifiers and were followed for 1 year.Foreachpatient,informationonage,gender,comorbiditiesandproce-dures was retrieved from the previous 10 years of hospitalization fromindex admission. The study outcomes were 1-year all-cause mortality,HFrehospitalizationandall-causerehospitalizationfromindexdischarge.All the outcomes were calculated crude and adjusted. Continuous vari-ables were expressed as mean ± SD a nd median and compared using aK-sample equality of median test. Categorical variables were expressedas percentages and the Chi-squar e test was used for comparison.IncidenceofeventswasestimatedbytheKaplan–Meiermethodandcompared using the Log-rank test. Observations were censored at thetime of the event or at the end of follow-up. One-year adjusted risk ofevents was evaluated by using Cox's proportional hazards modelsadjusting for all variables reported in Table 1. We used a multivariatestepwise Cox regression analysis for variable selection with entry andstay probability of 0.1 (10%). Results are reported as Hazard Ratios(HR) with 95% confidence intervals.Allstatisticaltestsweretwo-sided(p-valueb0.05wasconsideredtobe significant). All analyses were performed with the SAS 9.1.3 version(Service Pack 4, SAS Institute Inc., Cary, NC, USA) (SAS Institute, Cary,NC,USA)andtheSTATA12.1(STATACorpLP,CollegeStation,TX,USA).Clinical baseline and demographic characteristics of patients areshownin Table1.After1-yearfollow-upperiodfromindexHFhospital-ization,1690(18.1%)deathand5273(56.4%)hospitalreadmissionshadoccurred. The 1-year HF-related hospital readmissions were 1686 (31%of the total hospital readmissions).

We explored whether influenza vaccination (IV) affects susceptibility to SARS-CoV-2 infection and clinical outcomes in COVID-19 patients in 17,608 residents of the Italian province of Reggio Emilia undergoing a SARS-CoV-2 test. Exposure to IV was ascertained and the strength of the association with SARS-CoV-2 positivity expressed with odds ratios (OR). Rates of hospitalisations and death in those found positive were assessed and hazard ratios (HR) were estimated. The prevalence of IV was 34.3% in the 4885 SARS-CoV-2 positive and 29.5% in the 12,723 negative subjects, but the adjusted OR indicated that vaccinated individuals had a lower probability of testing positive (OR = 0.89, 95% CI 0.80&ndash, 0.99). Among the 4885 positive individuals, 1676 had received IV. After adjusting for confounding factors, there was no association between IV and hospitalisation (1.00, 95% CI 0.84&ndash, 1.29) or death (HR = 1.14, 95% CI 0.95&ndash, 1.37). However, for patients age &ge, 65 vaccinated close to the SARS-CoV-2 outbreak, HRs were 0.66 (95% CI: 0.44&ndash, 0.98) and 0.70 (95% CI 0.50&ndash, 1.00), for hospitalisation and death, respectively. In this study, IV was associated with a lower probability of COVID-19 diagnosis. In COVID-19 patients, overall, IV did not affect outcomes, although a protective effect was observed for the elderly receiving IV almost in parallel with the SARS-CoV-2 outbreak. These findings provide reassurance in planning IV campaigns and underscore the need for exploring further their impact on COVID-19.

The adoption of a surgical checklist is strongly recommended worldwide as an effective practice to improve patient safety; however, several studies have reported mixed results and a number of issues are still unresolved. The main objective of this study was to explore the impact of the first 5-year period of a surgical checklist-based intervention in a large regional health care system in Italy (4 500 000 inhabitants). We conducted a retrospective longitudinal study on 1 166 424 patients who underwent surgery in 48 public hospitals between 2006 and 2014. The adherence to the checklist was measured between 2011 and 2013 through a computerized database. The effects of the intervention were explored through multivariable logistic regression and difference-in-differences (DID) approaches, based on current administrative data sources. In-hospital and 30-days mortality, 30-days readmissions and length-of-stay (LOS) ⩾8 days were the observed outcomes. Adherence to the checklist showed marked variations across hospitals (0%-93.3%). A pre/post analysis detected statistically significant differences between surgical interventions performed in hospitals with higher adherence to the checklist (⩾75% of the surgeries) and those performed in other hospitals, as for the 30-days readmissions rate (odds ratio [OR]: 0.96; 95% confidence interval [CI]: 0.94-0.98) and LOS ⩾ 8 days rate (OR: 0.88; 95% CI: 0.87-0.89). These findings were confirmed after risk adjustment and DID analysis. No association was observed with mortality outcomes. On the whole, our study attained mixed results. Although a protective effect of the surgical checklist use could not be proved over the first 5 years of this regional implementation experience, our research offers some methodological insights for practical use in the evaluation process of large-scale implementation projects.

Aim of the study was to compare four different strategies of dual antiplatelet therapy (DAPT) in patients with acute coronary syndromes (ACS) treated with PCI. DAPT with Clopidogrel, Ticagrelor and Prasugrel has proved to be effective in patients with ACS treated with percutaneous coronary intervention (PCI) by reducing major adverse cardiovascular outcomes (MACE). However, the effect of the different strategies in a real-world population deserves further verification. A retrospective analysis of 2404 discharged ACS patients treated with PCI was performed, with a median follow-up of 1 year. The study population was stratified in four drug treatment cohorts: ASA + Clopidogrel (A-C), ASA + Plavix (A-PLx), ASA + Ticagrelor (A-T), ASA + Prasugrel (A-P). We assessed the incidence of net adverse cardiovascular events (NACE): all-cause death, myocardial infarction (MI), target vessel revascularization (TVR), stroke and bleeding during follow-up. At 1-year, the use of A-C and A-PLx was associated with the highest cumulative incidence of NACE in comparison with A-T and A-P therapies (respectively 14.8 and 29.6% vs. 9.2 and 6%). This difference was mainly driven by the mortality and TVR outcomes. Considering selection bias and differences in the patients baseline characteristics, the association of A-T and A-P seems to be superior in comparison with a DAPT strategy of A-C and A-PLx in low risk ACS-PCI patients from real world. In our Region the prescription is consistent with guidelines recommendations and Clopidogrel and Plavix are still predominantly used in older patients with more comorbidities, and this could partially explain the inferiority of this association.

ObjectiveTo evaluate cross-sectional patient distribution and standardised 30-day mortality in the intensive care units (ICU) of an inclusive hub and spoke trauma system.SettingICUs of the Integrated System for Trauma Patient Care (SIAT) of Emilia-Romagna, an Italian region with a population of approximately 4.5 million.Participants5300 patients with an Injury Severity Score (ISS) >15 were admitted to the regional ICUs and recorded in the Regional Severe Trauma Registry between 2007 and 2012. Patients were classified by the Abbreviated Injury Score as follows: (1) traumatic brain injury (2) multiple injuriesand (3) extracranial lesions. The SIATs were divided into those with at least one neurosurgical level II trauma centre (TC) and those with a neurosurgical unit in the level I TC only.ResultsA higher proportion of patients (out of all SIAT patients) were admitted to the level I TC at the head of the SIAT with no additional neurosurgical facilities (1083/1472, 73.6%) compared with the level I TCs heading SIATs with neurosurgical level II TCs (1905/3815; 49.9%). A similar percentage of patients were admitted to level I TCs (1905/3815; 49.9%) and neurosurgical level II TCs (1702/3815, 44.6%) in the SIATs with neurosurgical level II TCs. Observed versus expected mortality (OE) was not statistically different among the three types of centre with a neurosurgical unit; however, the best mean OE values were observed in the level I TC in the SIAT with no neurosurgical unit.ConclusionThe Hub and Spoke concept was fully applied in the SIAT in which neurosurgical facilities were available in the level I TC only. The performance of this system suggests that competition among level I and level II TCs in the same Trauma System reduces performance in both. The density of neurosurgical centres must be considered by public health system governors before implementing trauma systems.

The current cardiovascular literature advocates an overall beneficial balance between the advantages of oral anticoagulants and antiplatelet drugs in preventing and treating thromboembolic events and their disadvantages in promoting hemorrhage. However, traumatic injuries have usually received little attention despite several studies from the surgical literature showing worse outcomes in anticoagulated trauma registry patients. To quantify at population level too this seemingly deleterious impact, we investigated the effects of anticoagulants and antiplatelet use on the risk for hospital admission for acute traumatic causes.A population-based, case-control study in an Italian region with 4.5 million inhabitants was conducted. Cases were all the 59,348 adult residents admitted to the hospital for traumatic injuries in the years 2010 and 2011. Controls were age- and sex-matched residents selected by incidence density sampling. By conditional logistic regression adjusted for comorbidities, we estimated the risk for traumatic hospital admission while on anticoagulant, antiplatelet, and combined medications.The odds ratios (ORs) for anticoagulation and combined medications were 1.21 (95% confidence interval [CI], 1.15-1.28) and 1.39 (95% CI, 1.21-1.62). These effects were generally consistent across subgroups of demographic and clinical characteristics and particularly important in the head injured (e.g., OR for anticoagulation, 2.00; 95% CI, 1.77-12.27). Antiplatelets alone had no overall effect (OR, 1.02; 95% CI, 0.99-1.05). The number-needed-to-harm of anticoagulation was 595.Oral anticoagulation increased the population risk for traumatic hospital admission, with a further increase in case of concurrent antiplatelet use. Because this effect is most likely to derive from the prohemorrhagic properties of these drugs, injured patients should be included in the future evaluations of the cost-benefit profiles of these medications.Epidemiologic/prognostic study, level III.

SUMMARY What is known and objective: Since 2005, a mounting base of evidence has identified that conventional antipsychotic medications are associated with an increased risk of mortality among elderly patients when compared to atypical antipsychotics. This study sought to explore the feasibility of using the EmiliaRomagna Region (RER) database for comparative safety analyses by replicating and refining risk estimates of this well-known drug safety example through meta-analysis. Methods: We identified a cohort of 23 681 Italian RER patients (aged ≥65) who initiated treatment with a conventional or atypical antipsychotic between 1 July 2009 and 30 June 2011. We compared 180-day mortality using Cox proportional hazards models adjusted for risk factors for death, use of other medications and measures of health services utilization intensity, all measured before antipsychotic initiation. We conducted a metaanalysis of studies with similar methods against which to compare our results. Results: Among 14 462 and 9219 patients prescribed conventional and atypical antipsychotics, respectively, we observed 2402 (166%) and 821 (89%) deaths during follow-up. Conventional antipsychotic initiators were older and generally had higher prevalence of outcome risk factors and higher baseline health service use intensity. The crude hazard ratio (HR) was 195 [95% confidence interval (CI), 180–211], which decreased to 147 (95% CI, 135–160) after full adjustment. We identified seven published studies that examined this association using similar methods. The pooled HR from these studies was 134 (95% CI, 128–139). Including our study, the meta-analysis yielded a summary estimate of 135 (95% CI, 131– 140) and did not introduce any heterogeneity (I 2 = 0%; P = 0455). What is new and conclusions: Our results support the use of the RER database for pharmacoepidemiological studies and provide an up-to-date and pooled estimate of the magnitude of the association between mortality and conventional vs. atypical antipsychotics.

Background Some studies have indicated that marginal bone loss at implants and at teeth are similar, while results from other studies showed that implants lost more bone than teeth in the same dentition. Aim To determine the amount of progressive marginal bone loss that had occurred at implants and teeth in the same segment of the dentition following implant placement in partially dentate subjects. Material and Methods A total of 217 patients with a total of 573 implants and 318 teeth present in the same segments of the dentition were included. Radiographs were available from 1 year (baseline) and ≥3 years after loading. Results The mean bone loss that occurred between the two examinations was at implants 0.42 ± 0.68 mm and at teeth 0.44 ± 0.52 mm. Thirty-eight subjects (18%) had ≥1 implant exhibiting >1 mm bone loss. Bone loss at the 148 implants in this category of patients was 1.30 ± 1.04 mm with a corresponding loss at the 69 teeth of 0.53 ± 0.62 mm. Eighteen subjects (8%) had ≥1 tooth that exhibited >1 mm bone loss. The mean amount of bone loss in this sample was 1.37 ± 0.87 mm (38 teeth) and 0.29 ± 0.31 mm (56 implants). Conclusions This study showed that marginal bone loss at implants and teeth in many partially dentate subjects might be independent phenomena.

TMPM-ICD9 is the latest injury-severity measure based on empirical estimation from ICD-9-CM codes. It is candidate to replace expert-based AIS measures worldwide because of easier accessibility and better predictive performances. In Italy and other countries administrative ICD coding is generally less complete than dedicated AIS coding. We attempted to ascertain how this affects TMPM performances.Discrimination (c statistics) and calibration (calibration curves, Akaike's criterion) of hierarchical logistic regression models for hospital mortality comprising TMPM or ISS were compared using trauma-registry data on 3570 patients of years 2007-2009. The completeness of AIS vs. ICD-9-CM coding was also investigated through the ratio of the respective numbers of codes per patient. Model discrimination was further analyzed after stratification according to the above ratio (1 and ≤ 1).The models with TMPM showed worse performances. The differences, concerned calibration (graphical evidence) in univariate models and discrimination (-1.2% of area under the ROC curve, p0.05) in models completed with age, gender, mechanism of injury, motor GCS and systolic pressure. In parallel, ICD coding was less complete than AIS, as expected: 68% of patients had a ratio1. The discrimination of TMPM vs. ISS models improved when the ratio changed from1 to ≤ 1.The predictive performances of TMPM-ICD9 vs. ISS were lower than in the previous studies; the sub-optimal quality of ICD coding was a main cause. Imperfect administrative coding may hence hamper the TMPM-ICD9 revolution, although in our setting the negligible differences and the ready availability of administrative data may still give reason for adopting TMPM-ICD9.

We sought to: (1) estimate the proportion of patients who initiated beta-blocker therapy after acute myocardial infarction (AMI) in Regione Emilia-Romagna (RER); (2) examine predictors of post-AMI beta-blocker initiation; and (3) assess adherence to such therapy.Using healthcare claims data covering all of RER, we identified a cohort of 24,367 patients with a hospitalization for AMI between 2004 and 2007, who were discharged from the hospital alive and without contraindications to beta-blocker therapy. We estimated the proportion of eligible patients with at least one prescription for a beta-blocker following discharge and performed a multivariable logistic regression analysis to identify independent predictors of post-AMI beta-blocker initiation. We computed the proportion of days covered (PCD) as a measure of medication adherence at 6 and 12 months post-discharge. Following discharge, 16,383 (67%) cohort members initiated beta-blocker therapy. Independent predictors of beta-blocker initiation included age and receipt of invasive procedures during hospitalization, such as coronary artery bypass graft surgery (odds ratio [OR], 2.37; 95% confidence interval [CI], 2.00-2.81), percutaneous transluminal coronary angioplasty (OR, 1.42; 95% CI, 1.31-1.54), and cardiac catheterization (OR, 1.21; 95% CI, 1.11-1.32). Among initiators, adherence to beta-blocker treatment at 6 and 12 months was low and decreased in each study year.Overall, use of and adherence to post-AMI beta-blocker therapy was suboptimal in RER between 2004 and 2007. Older patients and those with indicators of frailty were less likely to initiate therapy. The proportion of patients adherent at 6 and 12 months decreased over time.

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 100 000 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.

e18842Background: After specific treatments, patients may be transferred to other non-acute wards, discharged to home or entrust to local care facilities. This process is frequently hampered by soc...

High residual platelet reactivity (RPR) on clopidogrel treatment has been associated with increased risk for ischemic events during follow-up in patients with acute coronary syndromes. The aim of this study was to assess the incidence, predictors, and clinical consequences of high RPR in a large population of patients with non-ST-segment elevation acute coronary syndromes who underwent percutaneous coronary intervention and stenting. Overall, 833 patients received point-of-care testing of platelet inhibition 30 days after percutaneous coronary intervention. High RPR was diagnosed on the basis of P2Y₁₂ reaction units >230. The incidence and predictors of death, myocardial infarction, stroke, and serious bleeding events were assessed up to 1 year from the day of testing. P2Y₁₂ reaction units were normally distributed, and 264 patients were classified as poor responders (31.7%). Independent predictors of response to clopidogrel were male gender (odds ratio [OR] 1.51), age (OR 0.96), diabetes mellitus (OR 0.51), and use of proton pump inhibitors (OR 0.59). At 1 year, poor responders showed higher rates of death (4.6% vs 1.9%, p = 0.032) and serious bleeding events (4.9% vs 1.8%, p = 0.009) compared with good responders. After adjustment for confounders, high RPR did not emerge as an independent predictor of mortality (OR 0.57, 95% confidence interval [CI] 0.23 to 1.42, p = 0.23) or serious bleeding events (OR 0.61, 95% CI 0.25 to 1.52, p = 0.29). The results did not change using the a cut-off value for P2Y₁₂ reaction units of 208. In conclusion, 1/3 of patients with acute coronary syndromes who underwent percutaneous coronary intervention and stenting showed high on-treatment RPR on bedside monitoring. They had a worse prognosis, but the level of platelet inhibition was not independently associated with the incidence of ischemic or bleeding events.

Aims In accordance with current guidelines, patients discharged after acute myocardial infarction (AMI) are usually prescribed agents acting on the renin–angiotensin system (ACE-I/ARB). However, adherence to prescribing medications is a recognized problem and most studies demonstrating the value of adherence were limited by their non-randomized design and by ‘healthy-adherer’ bias. Herein we sought to evaluate the relationship between adherence to ACE-I/ARB and risk of subsequent AMIs, by using the self-controlled case-series design which virtually eliminates interpersonal confounding, being based on intrapersonal comparisons. Methods and results We linked data from three longitudinal registries containing information about hospitalizations, drug prescriptions, and vital status of all residents in an Italian region. From 30 089 patients hospitalized for AMI in the years 2009–11, we enrolled the 978 with non-fatal re-AMIs at Days 31–365 after discharge, receiving at least one ACE-I/ARB prescription collected at any of the regional pharmacies. Using information on prescriptions, each individual's observation time was then divided into periods exposed or unexposed to ACE-I/ARB. The relative re-AMI incidence rate ratios (IRRs) of ACE-I/ARB exposure were estimated by conditional Poisson regression. During drug-covered periods, the risk of AMI recurrence was ∼20% lower, i.e. the IRR (rate of recurrent AMI in exposed versus unexposed periods) was 0.79 (95% CI 0.66–0.96, P = 0.001). The benefit of ACE-I/ARB was confirmed also by sensitivity analyses considering only first recurrences, excluding cases with AMI within previous 3 years, or with long, not AMI, hospital re-admission. Conclusions Poor adherence to ACE-I/ARB prescription medication was associated with a 20% increased risk of recurrent AMI. This was consistent with previous research, but the SCSS study design, even if not randomized, eased previous concerns about healthy-adherer bias.

Colorectal cancer (CRC) occurs rarely in young individuals (45 yr) and represents one of the criteria for suspecting hereditary cancer families. In this study we evaluated clinical features and molecular pathways (chromosomal instability [CIN] and microsatellite instability [MSI]) in early-onset CRC of 71 patients.Detailed family and personal history were obtained for each patient. Expression of APC, beta-catenin, p53, MLH1, MSH2, and MSH6 genes was evaluated by immunohistochemistry. MSI analysis was performed and constitutional main mutations of the mismatch repair (MMR) genes were searched by gene sequencing.Fourteen (19.7%) out of the 71 cases showed both MSI and altered expression of MMR proteins. In the 57 MSI-negative (MSI-) lesions altered expression of APC, beta-catenin, and p53 genes were found more frequently than in MSI-positive(MSI+) tumors. Seven (50%) out of the 14 patients with MSI+ tumors presented clinical features of Lynch syndrome (hereditary non-polyposis colorectal cancer [HNPCC]) and in all but one, constitutional mutations in MLH1 or MSH2 genes could be detected. The same mutations were also found in other family members.Our study demonstrates the involvement of CIN in a majority of early-onset colorectal tumors. Furthermore, we identified Lynch syndromes in seven cases (50%) of early-onset colorectal carcinomas with impairment of the MMR system. These results suggest that patients with early-onset CRC should be screened for hereditary cancer syndrome through clinical and molecular characterizations.

Background Beta‐blockers ( BB ) are recommended in secondary prevention of acute myocardial infarction ( AMI ), but adherence to prescription medication is a recognized problem. Most literature on the consequences of poor adherence to prescribed BB is limited by the possibility of “healthy adherer bias” and better‐designed studies have been advocated. Methods and Results We investigated the association between adherence to BB prescription and risk of subsequent AMI s using the self‐controlled case series design, which allows improved control of interpersonal confounding, being based on intrapersonal comparisons. From all the 30 089 patients hospitalized for AMI in the years 2009–2011 in an Italian region we selected those that suffered subsequent AMI s at days 31 to 365 from discharge (1328), and then the 1207 that had at least one BB prescription collected at any of the regional pharmacies. Using information on prescriptions, each individual's observation time was then divided into periods exposed or unexposed to BB and the relative AMI incidence rate ratios ( IRR ) of BB exposure were estimated by conditional P oisson regression. The IRR (rate of recurrent AMI in exposed versus unexposed periods) was 0.79 (95% CI 0.69 to 0.90, P =0.001). Various sensitivity analyses confirmed the robustness to possible failure of assumptions, ie, considering only first recurrences ( IRR 0.76, 95% CI 0.66 to 0.88, P IRR 0.76, 95% CI 0.65 to 0.89, P IRR 0.60, 95% CI 0.43 to 0.83, P =0.002). Conclusions Adherence to recommended BB therapy was associated with a 20% reduction of recurrent AMI s, consistently with previous research, but with decreased concerns about healthy‐adherer bias.

We sought to evaluate the rates, time course, and causes of death in the long-term follow-up of unselected patients with acute coronary syndromes (ACS). We enrolled 2046 consecutive patients hospitalized from January 2004 to December 2005 with an audited final diagnosis of ACS. The primary study end point was 5-year all-cause mortality. In our series, 896 patients had ST-segment elevation (STE) and 1,150 non-ST-segment elevation (NSTE). Mean age of the study population was 71.6 years. Primary percutaneous coronary intervention was performed in 86% of STE-ACS, and 70% of NSTE-ACS was managed invasively. The 5-year all-cause mortality was 36.4% for STE-ACS and 42.0% for NSTE-ACS, with patients with STE-ACS showing a trend boarding statistical significance toward a lower risk of mortality (hazard ratio [HR] = 0.88, 95% confidence interval [CI] 0.76 to 1.02, p = 0.08). Landmark analysis demonstrated that patients with STE-ACS had a higher risk of 30-day mortality (STE-ACS vs NSTE-ACS HR = 1.53, 95% CI 1.16 to 2.06, p = 0.003) whereas the risk of NSTE-ACS increased markedly after 1 year (STE-ACS vs NSTE-ACS HR = 0.67, 95% CI 0.53 to 0.84, p = 0.001). The contribution of noncardiovascular (CV) causes to overall mortality increased from 3% at 30 days to 34% at 5 years, with cancer and infections being the most common causes of non-CV death both in STE-ACS and NSTE-ACS. In conclusion, long-term mortality after ACS is still too high both for STE-ACS and NSTE-ACS. Although patients with STE-ACS have a higher mortality during the first year, the mortality of patients with NSTE-ACS increases later, when non-CV co-morbidities gain greater importance.

Background The so-called off hour effect—that is, increased mortality for patients admitted outside normal working hours—has never been demonstrated in trauma care. However, most of the studies excluded transferred cases. Because these patients are a special challenge for trauma systems, we hypothesised that their processes of care could be more sensitive to the off hour effect. Methods The study design was retrospective, cohort and population based. We compared the mortality of all patients by daytime and night-time admittance to hospitals in an Italian region, with 4.5 million inhabitants, following a major injury in 2011. Logistic regression was used, adjusted for demographics and severity of injury (TMPM-ICD9), and stratified by transfer status. Results 1940 major trauma cases were included; 105 were acutely transferred. Night-time admission had a significant pejorative effect on mortality in the adjusted analysis (OR=1.49; 95% CI 1.05 to 2.11). This effect was most evident in transferred cases (OR=3.71; 95% CI 1.11 to 12.43). Conclusions The night-time effect in trauma care was demonstrated for the first time and was maximal in transferred cases. This may explain why it was not found in previous studies where these patients were mostly excluded. Also, the use of population based data—whereby patients not accessing trauma centre care and presumably receiving poorer care were included—may have contributed to the findings.

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, β-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.

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.

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 (

OBJECTIVES We sought to compare the 1-year risk of re-hospitalization for acute coronary syndrome (ACS) between patients taking clopidogrel with proton pump inhibitors (PPIs) vs. clopidogrel without PPIs. MATERIALS AND METHODS We conducted a retrospective cohort study among 3896 patients with ACS, at low risk for gastrointestinal bleeding, discharged from all hospitals of the Emilia-Romagna region of Italy during the period January-August 2008. Patients' consumption of clopidogrel and PPIs at hospital discharge and follow-up was based on pharmacy refill data. Of these 3896 patients, 90% (n = 3519) were prescribed PPIs at hospital discharge and/or at some time during follow-up. RESULTS At 1-year follow-up, hospitalization for ACS occurred in 15% of patients taking clopidogrel with PPIs vs. 3.4% of those taking clopidogrel without PPIs (P

Aims Despite the American Society of Echocardiography (ASE)/European Association of Echocardiography (EAE) recommended the use of left ventricular (LV) mass to diagnose left ventricular hypertrophy (LVH), several laboratories continue to use only the septal thickness by M-mode because it appears easier to measure. Aim of the study was to investigate the discrepancy between the categorization of LVH severity based on measurement of septal thickness and indexed LV mass and the relative prognostic utility of these two methods. Methods and results Observational cohort study. Unselected adults (>18 years) referred to the echocardiography laboratory for any indication had septal thickness and LV mass measured by the ASE/EAE formula using LV linear dimensions indexed to body surface area. LVH was categorized as absent, mild, moderate, and severe according to the ASE/EAE guideline sex-specific categorization cut-offs for septal thickness and LV mass. Follow-up for death was obtained from the national death index. A total of 2545 subjects (mean age 61.9 ± 15.8, 53% women, mean diastolic septal thickness 10.3 ± 2.2 mm, and mean indexed LV mass 107.5 ± 37.3 g/m2) were enrolled. Agreement between the two methods in classifying LVH degree across the four categories was 52.6% (Kappa = 0.29, 95% confidence interval (CI): 0.26–0.32, P < 0.001). Of the 2513 subjects without severely thickened septum, 472 (18.9%) had severely abnormal indexed LV mass. Vice versa, of the 2045 individuals without severely abnormal indexed LV mass, only 4 (0.1%) were classified as severe LVH by septal thickness. After a mean follow-up of 2.5 ± 1.2 years 121 (4.7%) deaths occurred. Using indexed LV mass partition values there was a graded association between LVH degree and survival. Compared with patients with normal indexed LV mass, the adjusted hazard ratio (HR) for death from all causes was 2.17 for mild (95% CI: 1.23–3.81, P = 0.007), 3.04 for moderate (95% CI: 1.76–5.24, P < 0.001), and 3.81 for severe (95% CI: 2.43–5.97, P < 0.001) LVH by indexed LV mass. The area under the receiver-operator characteristic (ROC) curve for the four degrees of LVH by indexed LV mass was superior [area under the curve (AUC) = 0.66] to that of the septal thickness partition values (AUC = 0.58, P = 0.0004). Conclusion In a large cohort study of unselected adult outpatients referred to the echocardiography laboratory, the measurements of indexed LV mass applying the ASE/EAE recommended cut-offs yielded remarkable discrepancy in the diagnosis of LVH severity and offered prognostic information beyond that provided by septal thickness only criteria.

The American Society of Echocardiography (ASE) and European Association of Echocardiography (EAE) recommend the use of quantitative estimation of left ventricular (LV) mass and defined partition values for mild, moderate, and severe hypertrophy. However, the prognostic implications associated with this categorization are unknown.In this observational cohort study of unselected adults undergoing echocardiography for any indication, LV hypertrophy was assessed using the ASE/EAE-recommended formula and measurement convention from LV linear dimensions indexed to body surface area. Mortality and incident hospitalizations for cardiovascular disease were the outcomes of this study.Of 2,545 subjects (mean age, 61.9 ± 15.8 years; 56.3% women), 52.9% had normal LV mass, and 15.4% had mild, 12.1% moderate, and 19.6% severe LV hypertrophy. During a mean follow-up period of 2.5 ± 1.2 years, 121 deaths and 292 incident hospitalizations for cardiovascular disease occurred. In multivariate models including age, gender, LV ejection fraction, wall motion score index, significant valvular disease, and atrial fibrillation, the adjusted hazard ratios for death were 1.81 (95% confidence interval [CI], 1.03-3.20; P = .041) for mild, 2.31 (95% CI, 1.33-4.01; P = .003) for moderate, and 2.30 (95% CI, 1.39-3.79, P = .001) for severe LV hypertrophy. The adjusted hazard ratios for incident cardiovascular hospitalizations were 1.24 (95% CI, 0.84-1.82; P = .277) for mild, 2.02 (95% CI, 1.42-2.88; P = .0001) for moderate, and 2.38 (95% CI, 1.75-3.22, P.0001) for severe LV hypertrophy. After adjustment for known risk predictors, there was a 1.3-fold risk for death and cardiovascular disease events per category of LV mass (P = .001).In a cohort study of unselected adult outpatients, the categorization of LV mass according to the ASE/EAE recommendations offered prognostic information independently of age, gender, and other known predictors.

Screening and early diagnosis of cancer represent relatively recent tools in the long-lasting battle against tumors. If the American public opinion manifests its enthusiasm towards screening, the attitude of European is less well known. The purpose of the present study was to assess the level of knowledge and awareness of cancer screening (with particular emphasis on colorectal neoplasms) among middle-aged individuals. The study group consisted of 945 healthy individuals (489 men, 456 women, average age 57 +/- 12.4 years) who were asked to answer a series of questions about cancer screening and surveillance through a questionnaire presented by trained residents. Each interview lasted 20-30 min. Middle-aged Italians of both sexes seem to be aware of the fact that cancer is a frequent disease; moreover, many of the interviewed subjects believe almost all neoplasms are incurable. Diet, style of life, other environmental factors and familial factors are fully appreciated as relevant risk factors. The exact meaning of prevention was clear to less than half of the subjects. When various cancer sites were analyzed, the existence of preventive measures was well known for breast, cervical and prostate tumors, but their role was less clear for colorectal cancer. Only a fraction of the interviewed individuals were willing to undergo screening; the main reasons for refusal were lack of usefulness and fear of results. Among various tests, ultrasound and endoscopy were usually carried out in the presence of symptoms. Finally, multivariate analysis showed that the two factors significantly associated with the decision to undergo screening procedures were increasing age and level of education. The results of the study suggest that middle-aged Italian individuals, predominantly from Northern regions, have a correct perception of some aspects (frequency, risk factors) of cancer biology, whereas the knowledge of other aspects (outcome, prevention) remains poor or approximate. It follows that one of the main objectives of the Political Class should be to obtain a better education of overage individuals about cancer and the many problems related to this common disease.

Purpose: Many studies have evaluated the role of high levels of microsatellite instability (MSI) as a prognostic marker and predictor of the response to chemotherapy in colorectal cancer (CRC); however, the results are not conclusive. The aim of this study was to analyze the prognostic significance of high levels of MSI (MSI-H) in CRC patients in relation to fluorouracil-based chemotherapy. Experimental Design: In three different institutions, 1,263 patients with CRC were tested for the presence of MSI, and CRC-specific survival was then analyzed in relation to MSI status, chemotherapy, and other clinical and pathologic variables. Results: Two hundred and fifty-six tumors were MSI-H (20.3%): these were more frequently at a less advanced stage, right-sided, poorly differentiated, with mucinous phenotype, and expansive growth pattern than microsatellite stable carcinomas. Univariate and multivariate analyses of 5-year–specific survival revealed stage, tumor location, grade of differentiation, MSI, gender, and age as significant prognostic factors. The prognostic advantage of MSI tumors was particularly evident in stages II and III in which chemotherapy did not significantly affect the survival of MSI-H patients. Finally, we analyzed survival in MSI-H patients in relation to the presence of mismatch repair gene mutations. MSI-H patients with hereditary non–polyposis colorectal cancer showed a better prognosis as compared with sporadic MSI-H; however, in multivariate analysis, this difference disappeared. Conclusions: The type of genomic instability could influence the prognosis of CRC, in particular in stages II and III. Fluorouracil-based chemotherapy does not seem to improve survival among MSI-H patients. The survival benefit for patients with hereditary non–polyposis colorectal cancer is mainly determined by younger age and less advanced stage as compared with sporadic MSI-H counterpart.

BACKGROUND The Muir–Torre syndrome (MTS) is an autosomal-dominant genodermatosis characterized by the presence of sebaceous gland tumors, with or without keratoacanthomas, associated with visceral malignancies. A subset of patients with MTS is considered a variant of the hereditary nonpolyposis colorectal carcinoma, which is caused by mutations in mismatch-repair genes. The objective of the current study was to evaluate whether a combined clinical, immunohistochemical, and biomolecular approach could be useful for the identification of Muir–Torre syndrome among patients with a diagnosis of sebaceous tumors and keratoacanthomas. METHODS The authors collected sebaceous skin lesions and keratoacanthomas recorded in the files of the Pathology Department of the University of Modena during the period 1986–2000. Through interviews and examination of clinical charts, family trees were drawn for 120 patients who were affected by these skin lesions. RESULTS Seven patients also were affected by gastrointestinal tumors, thus meeting the clinical criteria for the diagnosis of MTS. In the MTS families, a wide phenotypic variability was evident, both in the spectrum of visceral tumors and in the type of skin lesions. Microsatellite instability was found in five MTS patients: These patients showed concordance with immunohistochemical analysis; moreover, a constitutional mutation in the MSH2 gene was found in 1 patient. Lack of expression of MSH2/MSH6 or MLH1 proteins was evident in the skin lesions and in the associated internal malignancies of 3 patients and 2 patients with MTS, respectively. CONCLUSIONS The clinical, biomolecular, and immunohistochemical characterization of sebaceous skin lesions and keratoacanthomas may be used as screening for the identification of families at risk of MTS, a disease that is difficult to recognize and diagnose. Cancer 2005. © 2005 American Cancer Society.

Patients with stage I (Dukes' A) colorectal carcinoma tend to show a good prognosis; however, recurrences can be observed in some patients. Through a specialized colorectal cancer Registry, we attempted to investigate the epidemiological and clinical features of individuals with Dukes' A neoplasms.From 1984 to 1998, 295 individuals were diagnosed with Stage I /Dukes' A tumors; 150 of these had lesions infiltrating the muscular wall (T2), while 145 had neoplasms limited to the submucosa (T1).Dukes' A tumors represented 13.8% of all registered neoplasms; the percentage doubled over the study period (8.1% in the first year vs. 16.8% in the final year). In each year of observation, the preferential locations were the rectum and sigmoid colon (75% of all lesions). Most patients required surgery, but only 21.3% could be managed by endoscopic polypectomy. Overall 5-year survival was 81.0% (82.1% in T1, 80.0% in T2). Recurrences were seen in 6.8% (2.8% in T1, 10.7% in T2), while 36 patients (12.2%) died of causes unrelated to colorectal cancer. In 17 out of 20 patients who died of cancer, the lesions were localized in the rectosigmoid region. Survival analysis showed a significantly better prognosis (P0.007) for patients with T1 tumors.The proportion of stage I colorectal tumors tended to increase over time. Although the overall prognosis is good in four-fifths of the cases, approximately one-fifth of these patients die of recurrent disease or of other causes. As expected, the prognosis was significantly more favorable for patients with T1 lesions. For patients with T2 tumors, radical surgery is the most appropriate approach.

Background Two-thirds of colorectal malignancies are localised in the left colon and rectum. Recent studies suggest a trend towards an increase of right-sided tumours which might have important implications for screening and surveillance. A colorectal cancer registry was set up in Modena, northern Italy, with the purpose of examining incidence, subsite distribution and staging of colorectal malignancies over a 15-year period. Patients and methods From 1984 to 1998, 2517 tumours in 2462 patients were detected and staged with the tumour node metastasis (TNM) system. The ‘right colon’ was considered from caecum to splenic flexure; the ‘left colon’ included descending and sigmoid colon; and the ‘rectum’ included rectosigmoid junction, ampulla and anus. Results Cancer incidence showed an overall increase. Considering the various subsites, an increase of 33.7% in all colonic segments was shown whereas rectal tumours tended to decline. TNM staging showed a gradual increase of localised lesions (41.2% in 1984 versus 53.3% in 1998), with a proportional reduction of advanced tumours. Conclusions Our study indicates an increase of tumour incidence in all colonic segments more than a shift to the right colon. TNM staging tended to improve with an appreciable increase of localised lesions. These findings could be consequent to a more extensive use of colonoscopy.

3548 Background: Microsatellite instability (MSI) characterizes almost all Hereditary Non-Polyposis Colorectal Cancer (HNPCC) cases and 10–15% of sporadic colorectal cancer (CRC). The clinical outc...

Background Injury scoring is important to formulate prognoses for trauma patients. Although scores based on empirical estimation allow for better prediction, those based on expert consensus, e.g. the New Injury Severity Score (NISS) are widely used. We describe how the addition of a variable quantifying the number of injuries improves the ability of NISS to predict mortality. Methods We analyzed 2488 injury cases included into the trauma registry of the Italian region Emilia-Romagna in 2006-2008 and assessed the ability of NISS alone, NISS plus number of injuries, and the maximum Abbreviated Injury Scale (AIS) to predict in-hospital mortality. Hierarchical logistic regression was used. We measured discrimination through the C statistics, and calibration through Hosmer-Lemeshow statistics, Akaike's information criterion (AIC) and calibration curves. Results The best discrimination and calibration resulted from the model with NISS plus number of injuries, followed by NISS alone and then by the maximum AIS (C statistics 0.775, 0.755, and 0.729, respectively; AIC 1602, 1635, and 1712, respectively). The predictive ability of all the models improved after inclusion of age, gender, mechanism of injury, and the motor component of Glasgow Coma Scale (C statistics 0.889, 0.898, and 0.901; AIC 1234, 1174, and 1167). The model with NISS plus number of injuries still showed the best performances, this time with borderline statistical significance. Conclusions In NISS, the same weight is assigned to the three worst injuries, although the contribution of the second and third to the probability of death is smaller than that of the worst one. An improvement of the predictive ability of NISS can be obtained adjusting for the number of injuries.