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Background: Cluster headache (CH) is the most frequent trigemino-autonomic cephalgia. CH can manifest as episodic (ECH) or chronic cluster headache (CCH) causing significant burden of disease and requiring attack therapy and prophylactic treatment. The few data available on the economic burden of CH come from retrospective studies based on questionnaires, population surveys and medical insurance claims database. Although all these studies showed an important economic burden, they provided different estimates depending on variability of CH awareness and management, healthcare systems, available therapies and use of treatments according to different guidelines., Methods: This prospective study aimed to quantify the total direct and indirect cost of ECH and CCH over a cluster period, both for the patient and for the National Health System (NHS), using data from subjects who consecutively attended an Italian tertiary headache centre between January 1, 2018 and December 31, 2018., Results: A total 108 patients (89 ECH, 19 CCH) were included. Mean attack frequency was 2.3 ± 1.4 per day. Mean total cost of a CH bout was €4398 per patient and total cost of CCH was 5.4 times higher than ECH (€13,350 vs. €2487, p <  0.001). Direct costs represented the 72.1% of total cost and were covered for the 94.8% by the NHS. The costs for any item of expense were higher for CCH than for ECH (p <  0.001). Mean indirect costs for a CH bout were €1226 per patient and were higher for CCH compared to ECH (€3.538 vs. €732), but the difference was not significant. Days with reduced productive capacity impacted for the 64.6% of the total indirect costs. The analysis of the impact CH on work showed that 27%% of patients felt that CH had limited their career, 40% had changed their work pattern, 20% had changed their place of employment and 10% had lost a job due to the disease., Conclusion: Our results provide a valuable estimate of the direct and indirect costs of ECH and CCH in the specific setting of a tertiary headache centre and confirm the high economic impact of CH on both the NHS and patients.

Background and Objective: Breast cancer is the second leading cause of cancer death worldwide. The economic burden of breast cancer is crucial for the sustainability of healthcare systems. The objective of this study was to estimate the burden of HR+/HER2- metastatic breast cancer (MBC) in Italy, in terms of incidence, prescription patterns, healthcare resource utilisation and costs for the National Health System (NHS)., Methods: A cohort study based on healthcare administrative data (ReS database), covering > 10 million Italians, was performed. Incident cases of HR+/HER2- MBC were identified among adult women in 2013. The cohort was followed-up for 2 years to describe healthcare utilisation and integrated costs (pharmaceuticals, hospitalisations and outpatient services) for NHS. Prescription patterns were described as first-line choice and therapeutic changes. Specific therapeutic changes were used as proxies of disease progression. A survival analysis was performed to estimate the time from diagnosis to first disease progression., Results: Of 5174,723 women, 355 cases of de novo HR+/HER2- MBC were selected (incidence: 6.9 per 100,000). During the 1st follow-up year, they generated an average cost of €7543, whereas €4834 in the 2nd year. The 85.9% received a monotherapy, while the 14.1% received a combination therapy. The most used monotherapy was nonsteroidal-aromatase-inhibitors (45.9%), while the most prescribed combination was tamoxifen + luteinizing hormone releasing hormone (LHRH) analogues (6.2%). Therapeutic changes occurred in 45.4% of patients, especially from chemotherapy to nonsteroidal-aromatase-inhibitors, after an average of 276.8 days from the first treatment. Disease progression was identified in 22.5% of patients occurring after a mean 13 ± 6 months from diagnosis., Conclusions: This detailed picture of HR+/HER2- MBC, based on real-world data, could be helpful in health technology assessment and expenditure forecasts of future therapeutic strategies for this condition in Italy.

Enormous progress has been made globally in the use of evidence derived from patients' clinical information as they access their routine medical care. The value of real-world data lies in their complementary nature compared with data from randomised controlled trials: less detailed information on drug efficacy but longer observational periods and larger, more heterogeneous study populations reflecting clinical practice because individuals are included who would not usually be recruited in trials. Real-world data can be collected in various types of electronic sources, such as electronic health records, claims databases and drug or disease registries. These data sources vary in nature from country to country, according to national healthcare system structures and national policies. In Italy, a growing number of healthcare databases have been used to evaluate post-marketing drug utilisation and safety in the last two decades. The aim of this narrative review is to describe the available Italian sources of real-world data and their contribution to generating post-marketing evidence on drug use and safety. We also discuss the strengths and limitations of the most commonly used Italian healthcare databases in addressing various research questions concerning drug utilisation, comparative effectiveness and safety studies, as well as health technology assessment and other areas.

Healthcare administrative databases of Italy's Lombardy Region were analyzed with the aim to assess perinatal outcomes and healthcare resource utilization during the first year of life in infants exposed to antiepileptic drugs (AEDs) during pregnancy. Drug prescriptions dispensed in the 12 months before delivery to women, who delivered between 2005 and 2011, were analyzed. Neonates were classified as cases if exposed to AEDs, and each case was randomly matched to seven controls. No significant differences were observed in the risk of congenital malformations between 526 cases and 3682 controls except for valproic acid (odds ratio (OR): 2.29; 95% confidence interval (CI): 1.24-4.22) where cases were more likely to be small for gestational age (χ 2  = 7.66; p = 0.006). Cases also had a higher probability than controls of needing at least one specialist visit in a child neuropsychiatry outpatient service (OR: 1.74; 95% CI: 1.22-2.49)., (Copyright © 2018 Elsevier Inc. All rights reserved.)

The assessment of chronic excessive alcohol consumption by ethyl glucuronide (EtG) determination in hair is generally based on a cut-off value of 30 pg/mg recognized by regulatory authorities and scientific societies that guide the decision process. The ongoing debate about the risks connected with the straightforward application of this cut-off refers to the factors that may influence the detected EtG concentration. The present contribution to this debate evaluates the seasonal variation of the averaged EtG values along a seven-year period. Over 65 000 data points have been statistically analyzed to provide a mathematical model that interprets the data, gives insight into several influencing factors, and forecasts progressive data-points of the time series. This model shows that there is an annual pattern in the data exhibiting lower EtG concentrations during warm seasons and higher values in cold seasons. The estimated EtG cycles are characterized by the seasonal variation of ±2.78 pg/mg above and below the overall mean (with 5.56 pg/mg absolute difference overall). This seasonal factor associated with EtG quantification might result in a potential source of bias, at least in the regional/climatic conditions observed in the samples' collection area. Moreover, the EtG time series reveals that the change in the sample pre-treatment procedure has an effect on the modeled pattern as an abrupt increment (+38%) in the mean value of the EtG concentration. This change corresponds to the time when the former protocol of cutting hair into small segments before extraction was substituted by pulverization with a ball mill., (© 2018 John Wiley & Sons, Ltd.)

The past decade has seen extraordinary increase in worldwide availability of and access to several large multiple sclerosis (MS) databases and registries. MS registries represent powerful tools to provide meaningful information on the burden, natural history, and long-term safety and effectiveness of treatments. Moreover, patients, physicians, industry, and policy makers have an active interest in real-world observational studies based on register data, as they have the potential to answer the questions that are most relevant to daily treatment decision-making. In 2014, the Italian MS Foundation, in collaboration with the Italian MS clinical centers, promoted and funded the creation of the Italian MS Register, a project in continuity with the existing Italian MS Database Network set up from 2001. Main objective of the Italian MS Register is to create an organized multicenter structure to collect data of all MS patients for better defining the disease epidemiology, improving quality of care, and promoting research projects in high-priority areas. The aim of this article is to present the current framework and network of the Italian MS register, including the methodology used to improve the quality of data collection and to facilitate the exchange of data and the collaboration among national and international groups.

Background: In heart failure (HF) sleep problems and sleep-related breathing disorders are frequently reported and are associated with poor prognosis. However, only few large clinical studies have investigated this issue in heart failure through breathing pattern analysis by polysomnography., Methods and Results: 370 HF patients, with either moderate-severe reduced ejection fraction or with clinical decompensation, consecutively referred to 10 participating cardiology centers, have been enrolled in the PROMISES Study, an Italian project aimed at generating a large, multidisciplinary database of anthropometric, clinical, echocardiographic and sleep data, the last derived from overnight unattended cardio-respiratory polysomnography in HF patients. Obstructive sleep apnea was the most frequent form of sleep related breathing disorders observed in our cohort (35.4% with an AHI cutoff of 15). The possible determinants of sleep related breathing disorders were analyzed through stepwise logistic regression analysis and two multivariate models showing that a markedly reduced left ventricular ejection fraction was the most important factor associated with central sleep apneas (OR = 7.7 for AHI cutoff = 15 and LVEF ≤ 35%) together with male gender and increasing age. Conventional risk factors for obstructive sleep apnea did not identify HF patients affected by this condition. Conversely, a greater neck circumference was associated with an increased risk for central apneas., Conclusions: Our paper offers a deeper insight into the features of SRBD and its determinants in HF patients, leading in turn to a better clinical management of these comorbid patients., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Introduction: In this drug utilization study, we aimed at assessing the pattern of triptan use in Italy by means of the drug prescription databases of two local health authorities, accounting for approximately 1 million citizens., Methods: The study population included all residents aged 18 to 84 years in the Vercelli province (about 175,000 inhabitants) and in the Umbria region (about 885,000 inhabitants), who had at least one dispensation for triptans in 2012. A frequent user, who might be at risk of medication-overuse headache (MOH), was defined as a patient being dispensed at least 10 defined daily doses (DDD) of triptans every month for at least three consecutive months., Results: Triptans were used by 0.7%-1% of the population. While most patients were dispensed fewer than 60 DDDs per year, about 10% of all triptan users were classified as frequent users. In both areas, patients below the age of 29 were less likely to be frequent users while the 40- to 49-year-old population was the most affected, with no sex difference. About two-thirds of frequent users persisted in this behavior for an additional three-month period in the following six months., Conclusions: Our data indicate that approximately 10% of all triptan users in the Italian population are potentially at risk for MOH. An approach based on drug prescription databases could be useful to identify patients at risk for MOH., (© International Headache Society 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.)

Objective: We provide a nationwide population study of patients with congenital muscular dystrophy in Italy., Methods: Cases were ascertained from the databases in all the tertiary referral centers for pediatric neuromuscular disorders and from all the genetic diagnostic centers in which diagnostic tests for these forms are performed., Results: The study includes 336 patients with a point prevalence of 0.563 per 100,000. Mutations were identified in 220 of the 336 (65.5%). The cohort was subdivided into diagnostic categories based on the most recent classifications on congenital muscular dystrophies. The most common forms were those with α-dystroglycan glycosylation deficiency (40.18%) followed by those with laminin α2 deficiency (24.11%) and collagen VI deficiency (20.24%). The forms of congenital muscular dystrophy related to mutations in SEPN1 and LMNA were less frequent (6.25% and 5.95%, respectively)., Conclusions: Our study provides for the first time comprehensive epidemiologic information and point prevalence figures for each of the major diagnostic categories on a large cohort of congenital muscular dystrophies. The study also reflects the diagnostic progress in this field with an accurate classification of the cases according to the most recent gene discoveries., (© 2015 American Academy of Neurology.)

Background: Studies investigating drug-induced anaemia are relatively scarce and mostly related to specific drugs or patients with specific pathologies., Objective: To analyse all reports of suspected drug-induced anaemias recorded in the National Pharmacovigilance Database of the Italian Medicines Agency., Method: The cases of suspected drug-induced anaemias analysed were those retrieved from the Italian National Pharmacovigilance Database from January 2001 to December 2013., Results: The active substances involved were 375 in 3,305 reports of drug-induced anaemia; of these, 72 % were reported as serious. In 35 % of the reports patients were in polytherapy. In 24.3 % of the cases relevant DDIs were identified. We found a PRR value of 57.29 for peginterferon alfa-2a, of 12.57 for ribavirin, of 13 for flu vaccine for the occurrence of autoimmune haemolytic anaemia. The drugs mostly involved in the cases where the Naranjo causality was probable or possible were acetylsalicylic acid, warfarin, ribavirin, peginterferon alfa-2a, carboplatin and acenocoumarol., Conclusions: A possible signal was detected for peginterferon alfa-2a, ribavirin and flu vaccine in the occurrence of autoimmune haemolytic anaemia. A great involvement of clopidogrel, enoxaparin, warfarin, ticlopidine and acetylsalicylic acid in preventable DDI-induced anaemia was detected, highlighting a poor awareness among healthcare providers on this issue.

Indication for the use of trastuzumab was given in Italy in 2000 for the treatment of HER-2 metastatic breast cancer and in 2006 for early stage breast cancer. Information on trastuzumab use and on its possible variation with age in Italy is however limited. Using health care administrative databases, we evaluated the prevalence of the use of trastuzumab, and the probability for administration since the first hospitalization for breast cancer in various age groups, in two series of Italian women diagnosed with breast cancer in the Lombardy region (2004-2009) and in the Palermo district. The ratio between trastuzumab users and patients with a hospitalization for breast cancer increased from 2.9% in 2004 up to 17.2% in 2009 in Lombardy. Patients aged <65 years were more frequent users (9.6%) compared to those aged ≥ 75 years (1.3%). Similarly, in the Palermo district the ratio increased from 10.6% in 2006 to 28.5% in 2008, with subjects aged <65 years more frequently using trastuzumab (19.1%), than subjects aged ≥ 75 years (6.2%). The age ratio between younger and older patients decreased over time in both settings (from 15 in 2004 to 10.2 in 2006, and 5.2 in 2009 in Lombardy, and from 4.0 in 2006 to 2.3 in 2009 in the Palermo district). The proportion of breast cancer patients using trastuzumab increased over time both in Lombardy and in Palermo district, though geographical differences persisted. Younger breast cancers patients were more likely to receive a trastuzumab treatment than elderly ones, but the difference declined over calendar period.

Background: Chronic renal dysfunction (RD) frequently coexists with heart failure (HF) and influences outcome. Patients with acute HF (AHF) and severe RD are frequently excluded in the trials. We characterized these subjects and assessed incidence and predictors of in-hospital and one-year mortalities., Methods: We selected the 455 patients included in the "IN-HF Outcome" Italian registry belonging to the lowest quartile of estimated glomerular filtration rate (eGFR<40 ml/min/1.73 m(2))., Results: Mean eGFR at entry in severe RD patients was 28±9 ml/min/1.73 m(2). Compared to 1368 patients with more preserved eGFR, they were older, with more co-morbidities and more frequently ischemic etiology of HF. In-hospital and one-year all-cause mortality rates were 14% and 44% respectively, twice higher than the entire population. Predictors of in-hospital mortality were an abnormal status of consciousness, older age, hyponatremia, lower systolic blood pressure and eGFR. The same conditions (except eGFR) predicted one-year mortality together with the absence of diabetes and no treatment with beta-blockers or diuretics., Conclusions: In patients with AHF and severe RD, in-hospital and one-year all-cause mortality rates are very high. Independent predictors such as older age, and signs of hypoperfusion and hyponatremia may be identified but preventing and reversing RD remain the key targets for the clinical management of these patients., (© 2013.)

Purpose: Networks exist in many different aspects of the world, at social, economical, biological, and molecular levels. Network science studies their parameters, or quantitative indicators; its instruments make it possible to draw and analyze networks from a mathematical perspective. The present study is an attempt to apply network science techniques to the drug prescription process, a typical subject of Epidemiology for Public Health studies., Methods: A drug prescription network was created using the set of drug prescriptions written during a 6-month period by a group of 99 general practitioners (GPs) operating in Italy. In this network, named co-prescription network, each drug represented a node, and different drugs prescribed to the same patient at the same moment were considered linked together. Drug prescription data for a total of 42 965 patients and 631 232 drug packages were studied. A number of co-prescription networks were obtained and analyzed on the basis of different subsets of patients by age and gender. The network parameters were measured and compared for the various subsets., Results: All the drug prescription networks studied showed scale invariance behavior. The age- and gender-related co-prescription networks showed different patterns, with different levels of complexity., Conclusions: The present study shows that the drug prescription process has specific network aspects and dynamics and, more generally, that it is possible to apply instruments of network science to study public health phenomena from a new, different perspective. Further studies should be encouraged and performed., (Copyright © 2012 John Wiley & Sons, Ltd.)

Purpose: The aim of this study was to describe the pattern of adverse drug reaction (ADR) reports sent by Italian nurses after the enactment of the law involving them in the pharmacovigilance system. We also compared the quantity and quality of reports by nurses with those of reports by hospital physicians sent in the same period., Methods: We analysed the reports sent to the Italian pharmacovigilance database by nurses from January 2004 to December 2010. Only reports with ADRs causality assessment defined as definite, probable or possible were included in the analysis. The nurses' reports were compared with those sent by hospital physicians in the same period. We excluded from this analysis reports associated with vaccines., Results: A total number of 1403 reports by nurses have been evaluated. The percentage of nurses' reports of ADRs, which were serious, were 22.9% lower than the 44.9% of reports by physicians, whereas the proportion of probable ADR reports were higher among nurses than hospital physicians (76% vs 67%). Nurses put more emphasis than physicians on application site disorders (log OR = 0.91, 95%CI = 0.55-1.27), skin reactions (log OR = 0.81, 95%CI = 0.70-0.92) and nervous system reactions (log OR = 0.28, 95%CI = 0.11-0.44), whereas physicians more frequently report blood, platelet and liver disorders. Six drugs are present in both the top 10 drugs reported by nurses and hospital doctors., Conclusion: This study gives evidence for the potential capacity of nurses to improve the detection of ADRs., (Copyright © 2012 John Wiley & Sons, Ltd.)

Background: Few studies have examined the role of cardiovascular drugs on acute ischaemic stroke prognosis., Aims: To evaluate the relationship between a favourable outcome in patients with acute ischaemic stroke and specific demographic, clinical and laboratory variables and cardiovascular drug pretreatment., Methods: The 1096 patients enrolled in the GIFA study (who had a main discharge diagnosis of ischaemic stroke) represent the final patient sample used in this analysis. Drugs considered in the analysis included angiotensin converting enzyme (ACE)-inhibitors, angiotensin II receptor blockers, statins, calcium channel blockers, anti-platelet drugs, vitamin K antagonists and heparins. The outcomes analyzed included in-hospital mortality, cognitive function evaluated by the Hodkinson Abbreviated Mental Test (HAMT), and functional status evaluated by activities of daily living (ADL). The definition of a good outcome was no in-hospital mortality, a HAMT score of ≥ 6 and no ADL impairment., Results: Patients with no in-hospital mortality, a HAMT score of >6 and no ADL impairment were more likely to be younger at baseline and have a lower blood glucose level and a systolic blood pressure (SBP) between 120 and 180 mmHg, a higher plasma total cholesterol level, a lower white blood cell count, and a lower Charlson Index (CI) score, a higher rate of pretreatment with ACE-inhibitors, calcium channel blockers and a lower rate of pretreatment with heparin., Conclusions: Predictors of good outcome, in terms of in-hospital mortality and cognitive and functional performance at discharge, included higher SBP at admission between 120 and 180 mmHg, a SBP plasma total cholesterol levels, a lower CI score, and pretreatment with ACE-inhibitors, calcium channel blockers and anti-platelets., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)

Background: Hip fractures represent one of the most important causes of morbidity and mortality in elderly people. We evaluated the risk and the potential determinants of early, mid and long term mortality, in a population-based cohort of subjects aged ≥ 65 years old., Methods: Using hospital discharge database we identified all hospitalized hip fracture cases of 2006, among residents in Lazio Region aged ≥ 65 years old. The mortality follow-up was performed through a deterministic record-linkage between the cohort and the death registry for the years 2006 and 2007. Kaplan-Meier method was used to calculate cumulative survival probability after admission. Shared frailties Cox regression model was used to estimate adjusted hazard ratios (HRs) for early (within 1 month), mid (1-6 months) and long term (6-24 months) mortality. As possible cofactors we considered age, gender, marital status, education degree, comorbidities, surgical intervention, and hospital volume of surgical treatment for hip fracture., Results: We identified 6,896 patients; 78% were females, median age was 83 and 9% had two or more comorbidities. Five percent died during hospital stay; the cumulative probability of dying at 30, 180 days, and at 2 years was 7%, 18% and 30%. In the first month following admission, we found a significantly increased HR with older age, male sex, not married status, history of hearth disease, chronic pulmonary and renal disease; for those who had surgery there was a significantly increased HR within two days after surgical intervention and a significantly decreased HR thereafter compared to those who received a conservative management. Between 1 and 6 months significantly increased HRs were for older age, male sex and higher hospital volume of surgical treatment. After six months, significantly increased HRs were for older age, male sex, presence of dementia and other low prevalence diseases., Conclusion: In Lazio region the risk of dying after hip fracture is similar to that found in high-income countries. Both clinical and organizational factors of acute care are associated with the risk of early mortality. As time passes, some of these factors tend to become less important while older age, male gender, the presence of cognitive problems and the presence of other comorbidities remain significant., (© 2011 Castronuovo et al; licensee BioMed Central Ltd.)

We introduce CIGNOweb.it, a database of oncology resources for patients, the general public and healthcare professionals. It builds on the previous Italian cancer resource Azaleaweb and offers quality-evaluated content. It meets international bibliographic and technical standards such as the Open Archives Initiative (OAI) for web content interoperability and the Functional Requirements for Bibliographic Records (FRBR) for bibliographic description with respect to the different media, applications, and user needs. Database content is supplied in collaboration with non-profit associations, libraries and the network of Cancer Information Points that is currently being established all over Italy. Expert and customer evaluation and feedback are provided for in the system. The graphic layout has been painstakingly designed to be user-friendly for a non-expert public. CIGNOweb.it is multicentric and will in time offer health information outside the field of oncology. It is designed to become a multilingual tool to organize, optimize and access patient information produced in the languages of the "newer" European countries. It is hoped that CIGNOweb.it will support other European nations in enhancing the structure and organization of their own-language patient health information and will contribute towards making a common health information portal of the European Union a reality.

The epidemiology of acute kidney injury (AKI) has been difficult to explore in the past, due to different definitions across various studies. Nevertheless, this is a very important topic today in light of the high morbidity and mortality of critically ill patients presenting renal dysfunction during their stay in the intensive care unit (ICU). The case mix has changed over the years, and AKI is a common problem in critically ill patients often requiring renal replacement therapy (RRT). The RIFLE and AKIN initiatives have provided a unifying definition for AKI, making possible large retrospective studies in different countries. The present study aims at validating a unified web-based data collection and data management tool based on the most recent AKI definition/classification system. The interactive database is designed to elucidate the epidemiology of AKI in a critically ill population. As a test, we performed a prospective observational multicenter study designed to prospectively evaluate all incident admissions in ten ICUs in Italy and the relevant epidemiology of AKI. Thus, a simple user-friendly web-based data collection tool was created with the scope to serve for this study and to facilitate future multicenter collaborative efforts. We enrolled 601 consecutive incident patients into the study; 25 patients with end-stage renal disease were excluded, leaving 576 patients for analysis. The median age was 66 (IQR 53-76) years, 59.4% were male, while median Simplified Acute Physiology Score II and Acute Physiology and Chronic Health Evaluation II scores were 43 (IQR 35-54) and 18 (IQR 13-24), respectively. The most common diagnostic categories for ICU admission were: respiratory (27.4%), followed by neurologic (17%), trauma (14.4%), and cardiovascular (12.1%). Crude ICU and hospital mortality were 21.7% and median ICU length of stay was 5 (IQR 3-14) days. Of 576 patients, 246 patients (42.7%) had AKI within 24 h of ICU admission, while 133 developed new AKI later during their ICU stay. RIFLE-initial class was Risk in 205 patients (54.1%), Injury in 99 (26.1%) and Failure in 75 (19.8%). Progression of AKI to a worse RIFLE class was seen in 114 patients (30.8% of AKI patients). AKI patients were older, with higher frequency of common risk factors. 116 AKI patients (30.6%) fulfilled criteria for sepsis during their ICU stay, compared to 33 (16.7%) of non-AKI patients (p < 0.001). 48 patients (8.3%) were treated with RRT in the ICU. Patients were started on RRT a median of 2 (IQR 0-6) days after ICU admission. AKI patients were started on RRT a median of 1 (IQR 0-4) day after fulfilling criteria for AKI. Median duration of RRT was 5 (IQR 2-10) days. AKI patients had a higher crude ICU mortality (28.8 vs. 8.1%, non-AKI; p < 0.001) and longer ICU length of stay (median 7 vs. 3 days, non-AKI; p < 0.001). Crude ICU mortality and ICU length of stay increased with greater severity of AKI. 225 (59.4% of AKI patients) had complete recovery of renal function, with a serum creatinine at time of ICU discharge which was ≤120% of baseline; an additional 51 AKI patients (13.5%) had partial renal recovery, while 103 (27.2%) had not recovered renal function at the time of death or ICU discharge. The study supports the use of RIFLE as an optimal classification system to stage AKI severity. AKI is indeed a deadly complication for ICU patients, where the level of severity is correlated with mortality and length of stay. The tool developed for data collection was user-friendly and easy to implement. Some of its features, including a RIFLE class alert system, may help the treating physician to systematically collect AKI data in the ICU and possibly may guide specific decisions on the institution of RRT., (Copyright © 2011 S. Karger AG, Basel.)

Background: Drug-drug interactions (DDIs) are an important cause of adverse drug reactions (ADRs). Many studies have recently considered this issue, but most of them focus only on potential interactions and are often related to the hospital setting. A spontaneous reporting database could be a valuable resource for detection of ADRs associated with DDIs; however, data in the literature are limited., Objective: To detect those patients treated with potentially interacting drugs and the cases where reported adverse reactions are a possible consequence of DDIs, using an Italian spontaneous reporting database., Methods: The data were obtained from a database containing all reports of suspected ADRs from five Italian regions (January 1990 to December 2007) that are the main contributors to the Italian spontaneous reporting system. All reports containing at least two drugs, reported as being suspected of causing the ADR or as concomitant medication, were selected and a list of drug pairs was drawn up. We performed a search to verify which drug pairs are considered a potential DDI, using the Internet version of the DRUGDEX(R) system. For each report containing a potential DDI, we verified whether the description of the adverse reaction corresponded to the interaction effect., Results: The database contained 45 315 reports, of which 17 700 (39.1%) had at least two reported drugs. We identified 5345 (30.2%) reports with potential DDIs, and in 1159 (21.7%) of these reports a related ADR was reported. The percentage of reports with potential DDIs increased in relation to the number of concomitantly administered drugs, ranging from 9.8% for two drugs to 88.3% for eight or more drugs. The percentages of serious or fatal reports of ADRs associated with a DDI were significantly higher than other reports analysed. The mean age, percentage of male patients and the mean number of drugs were also significantly higher in reports with DDIs than in other reports. In 235 of 1159 reports (20.3%), both interacting drugs were recognized as suspect by the reporter. This percentage varies in relation to the drugs involved, ranging from 2% to about 65%. The most frequently reported interaction was digoxin and diuretics, but no fatal ADRs were reported with this combination. The combination of anticoagulant and antiplatelet agents was responsible for the greatest number of serious reactions and deaths., Conclusions: This study validates that spontaneous reporting, despite its limitations, can be an important resource for detecting ADRs associated with the concomitant use of interacting drugs. Moreover, our data confirm that DDIs could be a real problem in clinical practice, showing that more than one in five patients exposed to a potential DDI experienced a related ADR.

A total of 7,389 dementia-free elderly (60-102 years old) enrolled in the "Faenza Project" (Northern Italy) were clinically evaluated by nurses and physicians with the aim of detecting the independent and combined association of medical and social factors with cognitive status. Cognitive Impairment No Dementia (CIND) was defined for MMSE scores ≤ 2 standard deviations than the age- and education-corrected mean score obtained by the nondemented persons of the Faenza cohort. Logistic Regression analysis was used to estimate Odds Ratios and 95% Confidence Intervals (OR, 95%CI) for CIND. The diagnostic procedure identified 402 (5.4%) CIND cases. Diabetes (OR, 95%CI = 1.6, 1.2-2.2), stroke (OR, 95%CI = 1.9, 1.4-2.6), and depressive symptoms (OR, 95%CI = 1.9, 1.4-2.7) emerged as the most relevant medical comorbidities of CIND. Low education (OR, 95%CI = 1.8, 1.1-2.9), low Socio Economic Status (SES) (OR, 95%CI = 1.5, 1.1-2.1), and unmarried status (OR, 95%CI = 1.7, 1.2-2.5) were associated with CIND. Medical and social factors were independently related to CIND occurrence. In comparison to subjects without any of the above mentioned conditions, subjects with one medical and one social factor had an OR, 95%CI for CIND equal to 6.0, 2.9-12.4. The strength of the association increased when more of those conditions occurred in combination, suggesting a synergistic effect. Despite some methodological limitations, data from this cross-sectional population-based Italian study show that low education, low SES, unmarried status together with diabetes, stroke, and depressive symptoms are related to cognitive impairment in the general population. The interaction of medical and social factors further increases the probability of CIND.

The purpose of our study was to determine the incidence of stroke, case-fatality rate and disability at 1 year in the Valley of Aosta (Italy) in the years 2004 and 2005. All suspected strokes occurring between January 1, 2004, and December 31, 2005, in the resident population of the Valley of Aosta were identified according to the WHO criteria for stroke and included in a stroke registry (Cerebrovascular Aosta Registry, CARe) after revision by a clinical panel. Multiple overlapping sources were used to ascertain the cases. In the study period, 553 incident strokes were registered. A CT scan was performed in 94.2% of cases. The crude annual incidence rate was 223 (95% CI 197-249) per 100,000 inhabitants. After age and sex adjustment to the 'European' population, the stroke incidence rate was 126 (95% CI 106-146). In the 1-year follow-up, only a small number of patients with a first-ever stroke in their life time suffered a new event. Compared with the previous study performed in our region (Valley of Aosta) in 1989, a marked decline in the incidence rate was seen after adjustment to the 'European' population, and the 28-day case-fatality rate declined dramatically between 1989 and 2004-2005., (2009 S. Karger AG, Basel.)

AIDA Cefalee is a database for the management of headache patients developed on behalf of the Italian Neurological Association for Headache Research (ANIRCEF). The system integrates a diagnostic expert system able to suggest the correct ICHD-II diagnosis once all clinical characteristics of a patient's headache have been collected. The software has undergone a multicentre validation study to assess: its diagnostic accuracy; the impact of using the software on visit duration; the userfriendliness degree of the software interface; and patients' acceptability of computer-assisted interview. Five Italian headache centres participated in the study. The results of this study validate AIDA Cefalee as a reliable diagnostic tool for primary headaches that can improve diagnostic accuracy with respect to the standard clinical method without increasing the time length of visits even when used by operators with basic computer experience.

The distribution of surnames in the population of the town of Ferrara, as it existed in the memory banks of the Municipality Computer in June 1990, was studied by sex, age and place of birth of residents. Random isonymy was studied separately in persons born before 1901, and in persons born in the nine decades thereafter, ending with the period 1981-90. Isonymy was higher in the older age groups studied. Also other indicators of the abundance of surnames in the distribution, the common ecological indexes derived from entropy, were calculated and compared between age groups. It was found that redundancy, as isonymy, is larger in older age classes than in younger classes. Surname effective number was defined as the inverse of isonymy corrected for sample size, and it was observed that it is practically identical with Fisher's alpha. It was then possible to separate random isonymy into two components, so that for sample size N its formulation becomes Ir = 1/alpha + 1/N It was found that in Ferrara alpha increased significantly in time, indicating enrichment of surnames in the population in the century 1890-1990.