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Healthcare utilisation databases, and other secondary data sources, have been used with growing frequency to assess health outcomes and healthcare interventions worldwide. Their increased popularity as a research tool is due to their timely availability, the large patient populations covered, low cost, and applicability for studying real-world clinical practice. Despite the need to measure Italian National Health Service performance both at regional and national levels, the wealth of good quality electronic data and the high standards of scientific research in this field, healthcare research and public health policies seem to progress along orthogonal dimensions in Italy. The main barriers to the development of evidence-based public health include the lack of understanding of evidence-based methodologies by policy makers, and of involvement of researchers in the policy process. The CRACK programme was launched by some academics from the Lombardy Region. By extensively using electronically stored data, epidemiologists, biostatisticians, pharmacologists and clinicians applied methods and evidence to several issues of healthcare research. The CRACK programme was based on their intention to remove barriers that thwart the process of bridging methods and findings from scientific journals to public health practice. This paper briefly describes aim, articulation and management of the CRACK programme, and discusses why it might find articulated application in Italy.

Background and Aims To assess the risk of hospitalization and mortality within 1 year of severe hypoglycaemia and theirs clinical predictors. Methods and Results We retrospectively examined 399 admissions for severe hypoglycemia in adults with DM at the Emergency Department (ED) of the University Hospital of Novara (Italy) betweeen 2012-2017, and we compared the clinical differences between older (aged ≥ 65 years) and younger individuals (aged 18-64 years). A logistic regression model was used to explore predictors of hospitalization following ED access and 1-year later, according to cardiovascular (CV) or not (no-CV) reasons; 1-year all-cause mortality was also detected. The study cohort comprised 302 patients (median [IQR] age 75 [17] years, 50.3% females, 93.4% white, HbA1c level 7.6% [1.0%]). Hospitalization following ED access occurred in 16.2% of patients and kidney failure (OR .50 [95% CI 1.29-5.03]) was the only predictor of no-CV specific hospitalization; 1-year hospitalization occurred in 24.5% of patients and obesity (OR 3.17 [95% CI 1.20-8.12]) and pre-existing heart disease (OR 3.20 [95% 1.20-9.39]) were associated with CV specific hospitalization; 1-year all-cause mortality occurred in 14.9% of patients and was associated with older age (OR 1.12 [95% CI 1.07-1.18]) and pre-existing heart disease (OR 2.63 [95% CI 1.19-6.14]) Conclusions Severe hypoglycemia is associated with risk of hospitalization and mortality mainly in elderly patients and it may be predictive of future cardiovascular events in diabetic patients with pre-existing heart disease and obesity.

Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): University of Buenos Aires Background Cortisol is a stress marker in patients with acute coronary syndrome (ACS) and it has a permissive effect on the actions of hormones that increase glucose production. Its association with blood glucose levels in diabetic and non-diabetic patients could help to understand the relationship between stress, hyperglycaemia and mortality. Methods Prospective and observational single-centre study. All patients admitted with a diagnosis of ACS to the coronary care unit of a University Hospital were included. The age, sex and clinical characteristics were recorded, along with the clinical outcomes. On admission, blood samples were obtained to measure serum glucose (SG) and cortisol (SC). Results Over a total of 149 patients, 35.37% had a diagnosis of ST-segment elevation ACS. Median age was 69 (60.1 – 79) years, 61.1% were male, 59.5% were hypertense, 18.2% dyslipidemic, 23% smokers, and 28.4% diabetics. Total mortality during hospitalization was 6.8%, and cardiovascular mortality was 6.1%. We observed a significantly higher SC and SG on admission in patients who died (table 1), with a mild and positive correlation between them (Spearman’s rho = 0.24, p = 0.005). Diabetic patients had a higher SG on admission [191.1 mg/dl (157.5 – 250,8) vs. 116.0 mg/dl (99.0 – 141.0), < 0.001]. Diabetes was not associated with mortality, although correlation between glucose and cortisol remained constant in diabetics and non-diabetics (figure 1). Conclusion Hypercortisolemia and hyperglycaemia were associated with an increased in-hospital mortality. Although hyperglycemia confers a worse prognosis, we found that its correlation with cortisol was constant in diabetics and non-diabetics. This suggests that hyperglycaemia could be a surrogate stress marker, not related to diabetes as a risk factor in an acute setting. Serum glucose and cortisol on admission LaboratorySurvivorsNon-survivorsp-valueGlucose (mg/dL)128 (101 - 163)156 (134.5 - 197.2)0.04Cortisol (ug/dL)13.7 (7,98 - 23.65)43.7 (34.6 - 50.0)0.0004Abstract Figure. Serum cortisol and glucose on admission.

Background Little is known on the current global prevalence of atopic dermatitis (AD) in the pediatric population. Objective To estimate the real-world global prevalence of AD in the pediatric population and by disease severity. Methods This international, cross-sectional, web-based survey of children and adolescents (6 months to Results Among 65,661 responders, the 12-month diagnosed AD prevalence (ISAAC plus self-reported diagnosis) ranged from 2.7% to 20.1% across countries; reported AD (ISAAC only) was 13.5% to 41.9%. Severe AD evaluated with both PtGA and POEM was generally less than 15%; more subjects rated AD as mild on PtGA than suggested by POEM. No trends in prevalence were observed based on age or sex; prevalence was generally lower in rural residential settings than urban or suburban. Conclusion This global survey in 18 countries revealed that AD affects a substantial proportion of the pediatric population. Although prevalence and severity varied across age groups and countries, less than 15% had severe AD.

Background Healthcare utilization data are increasingly used for chronic disease surveillance. Nevertheless, no standard criteria for estimating prevalence of high-impact diseases, such as chronic obstructive pulmonary disease (COPD) and asthma, are available. In this study an algorithm for recognizing COPD/asthma cases from HCU data is developed and implemented in the HCU databases of the Italian Lombardy Region (about 10 million residents). The impact of diagnostic misclassification for reliably estimating prevalence was also assessed. Methods Disease-specificdrug codes, hospital discharges together with co-payment exemptions when available, and a combination of them according with patient’s age, were used to create the proposed algorithm. Identified cases were considered for prevalence estimation. An external validation study was also performed in order to evaluate systematic uncertainty of prevalence estimates. Results Raw prevalence of COPD and asthma in 2010 was 3.6 and 3.3% respectively. According to external validation, sensitivity values were 53% for COPD and 39% for asthma. Adjusted prevalence estimates were respectively 6.8 and 8.5% for COPD (among person aged 40 years or older) and asthma (among person aged 40 years or younger). Conclusions COPD and asthma prevalence may be estimated from HCU data, albeit with high systematic uncertainty. Validation is recommended in this setting. Electronic supplementary material The online version of this article (doi:10.1186/s12890-016-0362-6) contains supplementary material, which is available to authorized users.

BackgroundMood disorders are managed predominantly in primary care. However, general practitioners’ (GPs) ability to detect and diagnose patients with mood disorders is still considered unsatisfactory. The aim of the present study was to identify predictors for the early recognition of depressive disorder (DD) and bipolar disorder (BD) in general practice.MethodsA cohort of 1,144,622 patients (605,285 women, 539,337 men) was investigated, using the Health Search IMS Health Longitudinal Patient Database. Predictors of DD or BD were identified at baseline encompassing somatization-related features, lifestyle variables, medical and psychiatric comorbidities. Patients were followed up as long as the following events occurred: diagnoses of DD or BD, death, end of the registration with the GP, end of the study period.ResultsWe found an incidence rate of DD or BD of 53.61 and 1.5 per 10,000 person-years, respectively. For both the conditions, the incidence rate grew with age. Most of the lifestyle variables and medical comorbidities increased the risk of mood disorders. The strongest effect was found for migraine/headache (HR [95% CI] = 1.32 [1.26–1.38]), fatigue (1.32 [1.25–1.39]) irritable bowel syndrome (1.15 [1.08-1.23]), and pelvic inflammation disease (1.28 [1.18–1.38]).ConclusionsSeveral predictors, in particular somatic symptoms, could be interpreted as an early sign of a mood disorder, and represent a valid indication for the GPs diagnostic process of mental disorders.

Background The aim of EDIFICE surveys is to improve insight into the behavior of the French population with regard to cancer prevention and participation in screening programs. Via the colorectal cancer screening program, all average-risk individuals in the 50-74-year age group are invited every 2 years to do a guaiac-based or, since April 2015, an immunochemical fecal occult blood test. Methods The fifth edition of the nationwide observational survey was conducted by phone interviews using the quota method. A representative sample of 1299 individuals with no history of cancer (age, 50-74 years) was interviewed between 22 November and 7 December 2016. The present analysis focuses on minimum lifetime uptake of screening tests, compliance to recommended repeat-screening intervals, and reasons for non-participation. Results In 2016, 64% survey participants had been screened at least once and 38% had been screened in the previous 2 years, suggesting a trend towards increasing participation rates, particularly in the younger age categories and among men. The 2016 data also suggest that the newly implemented FIT-based screening program has been well perceived by the population. Up to one in four individuals cited ``no risk factors'' as the reason for not undergoing screening. This reveals ignorance of the fact that the colorectal cancer screening program actually targets all average-risk individuals in a given age group, without individual risk factors. Conclusion We suggest the next step should be dedicated to educational approaches to explain exactly what screening involves and to persuasive messages targeting those who to date have remained unreceptive to information campaigns.

Background Primary prevention of cancer relies on awareness of and consequent identification of risk factors. We investigated knowledge of breast cancer risk factors not only among laywomen but also among female physicians. Methods The EDIFICE 4 nationwide observational survey was conducted by phone interviews of a representative female population (737 laywomen and 105 female physicians) aged 40-75 years, using the quotamethod. This analysis focuses on spontaneous replies to the question ``In your opinion, what are the five main risk factors that increase the risk of breast cancer?''. Results Heredity/Family history of breast cancer was the most widely recognized risk factor in both study populations (98.1% physicians vs. 54.2% laywomen; P

Zhihua Julia Qiu has over 20 years post PhD experience in academic institutes, pharmaceutical industry and biotechnology startup settings; focused on novel therapeutics discovery and development and diagnostic tools. She is currently a Scientist in the Bioanalytical Sciences department at Genentech; responsible for developing, evaluating and implementing Bioanalytical strategy to support protein therapeutics development. That includes assay development and validation to evaluate PK, antitherapeutic antibodies as well as biomarkers in both nonclinical and clinical studies for Immunology and Oncology indications. In addition, she has led the evaluation of multiple novel technology platforms and transitioning assay platform to enable continuous support for the development of protein therapeutics and antibody–drug conjugates.

International audience; Background:As conservation of whole blood samples undergoing white blood cell (WBC) differential performed by flow cytometry (Hematoflow) is needed, we evaluated the effects of two commercially available fixatives, namely TransfixTM and Streck Cell PreservativeTM.Methods:We focused on 15 normal samples and on 13 various pathological samples. We compared the two fixatives and cold- or room- temperature effects on various parameters provided by the Hematoflow system.Results:We observed that, even after 2 hours of sample treatment, the conservative methods led to significant modifications of the cell percentages due to substantial variations of the epitope expression.Conclusion:None of the different conservation methods is really reliable for WBC differential performed by flow cytometry and thus samples should be analyzed promptly or stored at 4°C.

Blood pressure ( BP) control remains unsatisfactory worldwide. Better knowledge of BP management in clinical practice is needed to develop more effective improving strategies. Using a large Italian primary care database, we selected the subjects diagnosed with hypertension, and extracted the diagnosis of myocardial infarction, angina pectoris/coronary disease, stroke/transitory ischemic attack (TIA), heart failure, atrial fibrillation, peripheral arterial disease, diabetes mellitus, the serum total cholesterol, HDL cholesterol, triglycerides, creatinine, BP, electrocardiogram, weight, height and the prescription of cardiovascular ( CV) drugs. Hypertension was recorded in 119.065 individuals (prevalence 19.3%), 19.134 (16%) had no ambulatory visit and 33.183 (27.8%) had no BP value recorded. Overall, 14.594 (21.9%) had at least one recorded diagnosis showing high CV risk. BP was controlled (mean of BP values

OBJECTIVE The aim of this study was to assess the accuracy of a risk calculator that includes renal function as compared with that of the traditional Framingham Risk Score (FRS) in predicting the risk of mortality of hypertensive individuals managed in primary care. METHODS From the databases of British and Italian General Practitioners, we retrieved demographic and clinical data for 35 101 UK and 27 818 Italian individuals aged 35-74 years with a diagnosis of hypertension. Then, the 5-year incidence of cardiovascular events as well as all-cause and cardiovascular mortality were recorded for both samples. A comparison analysis of the performance of the Individual Data Analysis of Antihypertensive Intervention Trials (INDANA) calculator with that of FRS in predicting 5-year all-cause and cardiovascular mortality risk was made. RESULTS The INDANA calculator was more accurate than the FRS in predicting all-cause [Δc 0.038, 95% confidence interval (CI) 0.026-0.051 for United Kingdom, and 0.018, 95% CI 0.010-0.027 for Italy, both P

BACKGROUND: Stroke represents worldwide the second and seventh cause of death and invalidity, respectively. Patients with ischaemic stroke or transitory ischaemic attack (TIA) are at high risk of recurrence, therefore requiring intensive treatment. Hypercholesterolaemia is a modifiable risk factor for stroke. The general practitioners attitude towards detection and treatment of dyslipidaemia among patients with stroke or TIA in Italy is unknown; we therefore aimed to address this issue taking advantage of the database of The Italian College of General Practitioners. METHODS: Prevalence of the monitored factors (lipid levels, statin prescription, and lipid level control with hypolipidaemic agents prescription) were analysed on a patient population of 465 061. RESULTS: A total of 2555 (49% women and 51% men) patients with a diagnosis of stroke and 2755 patients (52% women and 48% men) with a diagnosis of TIA were included in the study. Total plasma cholesterol (TC) was reported in more than 60% of the patients and low-density lipoprotein cholesterol (LDLc) and high-density lipoprotein cholesterol (HDLc) in less than half. Total plasma cholesterol and LDLc were controlled in 70.3 and 72.8% of the patients, respectively. The percentage of controlled patients decreased to 64% when both LDLc and TC were considered. Statins and fibrates were prescribed in a small proportion of patients (16.9 and 3.5%, respectively). An acceptable control of blood lipids was achieved in a majority of those patients (60.2%). However a relatively large number of patients (646) with high plasma lipids remained untreated. CONCLUSIONS: Monitoring and intervention strategies on plasma lipid levels in patients with a diagnosis of stroke or TIA need to be improved.

Background and aims In Italy, the reimbursed use of incretin mimetics and incretin enhancers was subject to enrollment of patients into a web-based system recording the general demographic and clinical data of patients. We report the utilization data of glucagon-like peptide 1 (GLP1) receptor agonists and dipeptidylpeptidase-4 (DPP4) inhibitors in clinical practice as recorded by the Italian Medicines Agency (AIFA) Monitoring Registry. Methods and results From February 2008 to August 2010, 75,283 patients with type 2 diabetes were entered into the registry and treated with exenatide, sitagliptin, or vildagliptin. The treatment was administered to patients in a wide range of ages (≥75 years, n = 6125 cases), body mass index (BMI) (≥35 kg/m 2 , n = 22,015), and metabolic control (HbA 1c ≥ 11% ((96 mmol/mol), n = 3151). Overall, 1116 suspected adverse drug reactions were registered, including 12 cases of acute pancreatitis (six on exenatide). Hypoglycemic episodes mainly occurred in combination with sulfonylureas. Treatment discontinuation for the three drugs (logistic regression analysis) was negatively associated with the male gender and positively with baseline HbA 1c , diabetes duration, and, limitedly to DPP-4 inhibitors, with BMI. Treatment discontinuation (including loss to follow-up, accounting for 21–26%) was frequent. Discontinuation for treatment failure occurred in 7.7% of cases (exenatide), 3.8% (sitagliptin), and 4.1% (vildagliptin), respectively, corresponding to 27–40% of all discontinuations, after excluding lost to follow-up. HbA 1c decreased on average by 0.9–1.0% (9 mmol/mol). Body weight decreased by 3.5% with exenatide and by 1.0–1.5% with DPP-4 inhibitors. Conclusions In the real world of Italian diabetes centers, prescriptions of incretins have been made in many cases outside the regulatory limits. Nevertheless, when appropriately utilized, incretins may grant results at least in line with pivotal trials.

Objectives Iron deficiency anaemia (IDA) is a global public health concern, being responsible for about 800 000 deaths per year worldwide. To date, few studies have investigated the epidemiology of IDA in Europe. This study therefore aimed to assess the incidence rate and determinants of IDA in four European countries. Methods Demographic and clinical information was obtained from four national primary care databases, respectively, for Italy, Belgium, Germany and Spain. IDA-related determinants were estimated using multivariable Cox regression. Results The annual incidence rates of IDA ranged between 7.2 and 13.96 per 1000 person-years. The estimates were higher in Spain and Germany. Females, younger and older patients were at greater risk of IDA, as well as those suffering from gastrointestinal diseases, pregnant women and those with history of menometrorrhagia, and aspirin and/or antacids users. A Charlson Index >0 was a significant determinant of IDA in all countries. Conclusions The use of primary care databases allowed us to assess the incidence rate and determinants of IDA in four European countries. Given the crucial role of general practitioners in the diagnosis and management of this condition, our findings may contribute to increase the awareness of IDA among physicians as well as to reduce its occurrence among at-risk patients.

Silymarin has long been used as a hepatoprotective remedy. Chronic toxicity studies in rodents have confirmed that silymarin has a very low toxicity. These data support its history as a safe medication in hepatic diseases. In the last years, several studies expanded our understanding of the pharmacology of silymarin and its molecular mechanisms of action. These new insights may affect the handling of silymarin in clinical studies and daily practice. Additionally, scientific knowledge in hepatology is constantly evolving with, particularly, an increase in the field of non-alcoholic fatty liver disease which is considered today as the most frequent liver disease worldwide. In this review, we will describe scientific evidence for the effectiveness of silymarin in hepatic disorders. We will focus on silymarin’s pharmacological effects in non-alcoholic fatty liver disease and on its well described effects in alcoholic liver disease and acute intoxications, e.g. with Amanita species. We will discuss the relevance of pharmacological data as a function of doses or concentrations required for a given effect and of concentrations achieved in the target tissues. Many pharmacological effects of silymarin can be attributed to effects downstream or upstream of its antioxidative and membrane-stabilizing properties. However, despite promising new experimental and clinical data further clinical studies are required including long-term observations and the application of hard clinical endpoints such as survival rates, to further support silymarin’s use for the treatment of hepatic diseases.

Background— Nonadherence to antihypertensive treatment is a common problem in cardiovascular prevention and may influence prognosis. We explored predictors of adherence to antihypertensive treatment and the association of adherence with acute cardiovascular events. Methods and Results— Using data obtained from 400 Italian primary care physicians providing information to the Health Search/Thales Database, we selected 18 806 newly diagnosed hypertensive patients ≥35 years of age during the years 2000 to 2001. Subjects included were newly treated for hypertension and initially free of cardiovascular diseases. Patient adherence was subdivided a priori into 3 categories—high (proportion of days covered, ≥80%), intermediate (proportion of days covered, 40% to 79%), and low (proportion of days covered, ≤40%)—and compared with the long-term occurrence of acute cardiovascular events through the use of multivariable models adjusted for demographic factors, comorbidities, and concomitant drug use. At baseline (ie, 6 months after index diagnosis), 8.1%, 40.5%, and 51.4% of patients were classified as having high, intermediate, and low adherence levels, respectively. Multiple drug treatment (odds ratio, 1.62; 95% CI, 1.43 to 1.83), dyslipidemia (odds ratio, 1.52; 95% CI, 1.24 to 1.87), diabetes mellitus (odds ratio, 1.40; 95% CI, 1.15 to 1.71), obesity (odds ratio, 1.50; 95% CI, 1.26 to 1.78), and antihypertensive combination therapy (odds ratio, 1.29; 95% CI, 1.15 to 1.45) were significantly ( P P =0.032). Conclusions— The long-term reduction of acute cardiovascular events associated with high adherence to antihypertensive treatment underscores its importance in assessments of the beneficial effects of evidence-based therapies in the population. An effort focused on early antihypertensive treatment initiation and adherence is likely to provide major benefits.

Background The Self-Evaluation of Communication Experiences after Laryngeal Cancer (SECEL) questionnaire assesses the impact of total laryngectomy on communication-related quality of life (QOL). This study evaluates the Italian version of the SECEL (I-SECEL), including reliability, concurrent validity, and differences in scores between patients who undergo either total laryngectomy or partial laryngectomy. Methods Eighty patients who underwent either total laryngectomy or partial laryngectomy completed the I-SECEL twice and the Voice Handicap Index (VHI) and Short Form Health Survey (SF-36) questionnaires once. Voice recordings were used for objective and perceptual assessment. Results The I-SECEL demonstrated good test–retest reliability and internal consistency for 2 of 3 subscales. Correlations were moderate to strong between most of the I-SECEL scales and the VHI/SF-36 scales. The I-SECEL scales demonstrated moderate associations with most perceptual and objective measures. Conclusion Preliminary evidence supports the convergent validity, test-retest reliability, and internal consistency of the I-SECEL, notwithstanding low internal consistency and test–retest reliability for 1 subscale. © 2012 Wiley Periodicals, Inc. Head Neck, 35: 1606–1615, 2013

Iron(III)-hydroxide polymaltose complex (IPC) is an iron preparation with non-ionic iron and polymaltose in a stable complex. The usefulness of IPC in the treatment of iron deficiency anemia (IDA) has recently been a topic of much debate. By reviewing the published literature an overview is provided of the existing comparative evidence vs. ferrous sulfate as reference. For this purpose the standard methods and criteria as described by the Cochrane group are employed. The aim was to establish whether there are differences concerning efficacy (primary end-point: hemoglobin after approx. 2 months of treatment) and concerning safety (number of patients with adverse drug reactions [ADRs]). From an initial group of 14 comparative trials identified, 6 comparative studies (1 double blind) conducted in adults could be retained for analysis. Four pediatric studies initially selected had to be rejected because of heterogeneity of data at baseline. In adults (319 IPC, 238 ferrous sulfate) at the end of the study period (8-13 weeks) the mean hemoglobin values were 12.13 +/- 1.19 g/dl with IPC vs. 11.94 +/- 1.84 g/dl with ferrous sulfate (weighted mean difference WMD = 0.01 [95% CI -0.23, 0.21] g/dl). Not all studies reported on ferremia (higher with IPC), transferrin saturation (no difference) or ferritin (lower with IPC). Adverse drug reactions were reported less frequently with IPC (14.9%) than with ferrous sulfate (34.1%; p < 0.001), particularly upper digestive troubles, stained teeth and diarrhea. The meta-analysis of studies conducted in adult patients with iron deficiency anemia, comparing IPC with ferrous sulfate in equivalent doses, showed that the two compounds attained similar hemoglobin levels, thus suggesting similar efficacy. The tolerance of IPC in adults was clearly better than that of ferrous sulfate; the differences were also significant for the individual adverse reactions. This probably reflects a better risk/benefit ratio of IPC in adults. Properly conducted randomized controlled trials, particularly in pediatrics, are needed.

BACKGROUND Elevated blood pressure (BP) is one of the most important modifiable risk factors for cardiovascular diseases. In this study we assessed the excess of cardiovascular risk attributable to high BP and antihypertensive treatment in a sample of Italian patients enrolled by the 'Cholesterol and Health: Education, Control and Knowledge' (CHECK) study. METHODS CHECK is a large, cross-sectional epidemiological study, which randomly enrolled patients aged 40-79 years from 425 Italian General Practices from March 2002 to April 2004. Among 5731 patients enrolled in the study [49.6% men, mean age (standard deviation) 57.7 (10.3) years], 723 (12.6%) had 'optimal' BP, 1496 (26.1%) had 'high normal' BP, and 1942 (33.9%) were hypertensive. RESULTS According to the European Guidelines stratification of the cardiovascular risk-excess attributable to high BP, 34.7% of the sample had a low added risk and 53.2% had a moderate-to-very high added risk. The pharmacological therapy was prescribed in 22.3, 43.9, 61.4, and 76.9% of the patients with low, moderate, high, and very high added risk, respectively. CONCLUSION Overall dietary and drug therapies are under prescribed, as most of the treated patients would require two additional antihypertensive drugs to meet the recommended BP target. This effort could provide significant individual benefit to moderate/high-risk patients.

The recommendations for the management of osteoarthritis (OA) of the hip were proposed by EULAR in 2005. Among the most important objectives of the expert charged to provide these recommendations were their wide dissemination and implementation. Thus, the information generated can be used by each individual country to produce their own set of management guidelines and algorithms for treatment in primary care. According with that previously executed for the EU-LAR recommendation 2003 for the knee, the Italian Society of Rheumatology (SIR) has organised a Consensus on the EULAR recommendations 2005 for the management of hip OA. To obtain an acceptability as large as possible, the group of experts was composed by many physicians interested in the management of hip OA, including Orthopaedics, Rheumatologists, Physiatrists, and General Practitioners. Main aim of the Consensus was to analyse the acceptability and applicability of the recommendations according to own experience and local situations in the Italy. The results of this Consensus have demonstrated that a large majority of the EULAR recommendations are endorsed by the Italian experts. Furthermore, the final document of the Italian Consensus clearly indicated the need that the specialists involved in the management of hip OA strongly encourage the dissemination of the EULAR 2005 recommendations also in Italy.

Objective To describe patterns of persistence and related primary care costs associated with first antihypertensive treatment. Design and setting Retrospective cohort study during 2000–2001, using information from 320 Italian general practitioners. Participants We studied 13 303 patients with newly diagnosed hypertension, who received a first single antihypertensive prescription within 3 months after diagnosis. Main outcome measures Persistence with first-line single treatment, categorized as follows: continuers: patients continuing the first-line medication for at least 1 year; combiners: patients receiving an additional antihypertensive drug and continuing the initial medication; switchers: patients changing from the first-line to another class of antihypertensive drug and discontinuing the initial treatment; discontinuers: patients stopping the first-line treatment without having another prescription until the end of the follow-up. Primary care costs were expressed as the cost of hypertension management per person-year of follow-up. Results In the study cohort, 19.8% were continuers, 22.1% were combiners, 15.4% were switchers, and 42.6% were discontinuers. Continuation was greatest with angiotensin II type 1 receptor blocking agents (25.2%), calcium channel blockers (23.9%) and angiotensin-converting enzyme inhibitors (23.3%). Severe hypertension [hazards ratio 1.30; 95% confidence interval (CI) 1.18 to 1.43] and severe health status (hazards ratio 1.22; 95% CI 1.15 to 1.30) increased the risk of discontinuation. The likelihood of needing an additional antihypertensive drug was associated with mildto- severe baseline blood pressure, diabetes (hazards ratio 1.20; 95% CI 1.06 to 1.36), and familial history of cardiovascular disease (hazards ratio 1.24; 95% CI 1.10 to 1.39). Discontinuers accounted for 22.4% of the total primary care cost. Initial treatment with angiotensin II type 1 receptor blocking agents and b-blockers resulted in incremental primary care costs of s145.2 and s144.2, respectively, compared with diuretics. Combiners and switchers increased the primary care cost by s140.1 and s11.7, compared with continuers. Conclusion Persistence with first-line single antihypertensive drugs is extremely low during the first year of treatment. Potential cost saving should be possible by reducing the high frequency of discontinuation. Diuretics represent the least expensive therapeutic option, although further investigations in the long-term are needed to analyse the effects of persistence on therapeutic effectiveness and related costs. J Hypertens 23:2093–2100

To test the efficacy of a training course on the diagnosis and treatment of schizophrenia, tailored for the general practitioner.A course, in a 3-session format, was given to 215 primary care doctors from the city of Brescia and its province, in Italy. All 706 doctors working in primary care were asked to participate. Of these doctors, 30.5% took part in the study. The first session (215 doctors) assessed baseline knowledge of schizophrenia (June 2002), the second (173 doctors) gave formal teaching and assessed post-lesson knowledge (October 2002), and the third (130 doctors) evaluated the retention of knowledge after 8 months (July 2003). The main outcome measures were total number of schizophrenia symptoms identified, total number of antipsychotics identified, and knowledge about antipsychotic-related adverse events.Post-lesson, general practitioners could identify 6.5 more symptoms (p.001) and 4.9 more antipsychotics (p.001). Compared to baseline, 71.5% vs. 15.4% of doctors had a good knowledge of antipsychotic-related adverse events. Although a loss of knowledge was found after the 8-month follow-up, knowledge at the endpoint was significantly higher than at baseline for the 3 main outcome variables (p.001).The teaching course on schizophrenia for general practitioners was effective, and the knowledge gained after teaching was stable across time.

The potential benefit of silymarin (special extract from the fruits of Silybum marianum) in the treatment of liver diseases remains a controversial issue.For this systematic review electronic databases identified 65 papers for the search terms silymarin, silibinin, silicristin or milk thistle and clinical trial. Only 19 complied with the criteria'double-' or 'single-blind'. These publications were analysed from a clinical point of view and meta-analytic calculations were performed.The clinical evidence ofa therapeutic effect of silymarin in toxic liver diseases is scarce. There is no evidence of a favourable influence on the evolution of viral hepatitis, particularly hepatitis C. In alcoholic liver disease, comparing with placebo, aspartate aminotransferase was reduced in the silymarin-treated groups (p = 0.01) while alkaline phosphatase was not. In liver cirrhosis, mostly alcoholic, total mortality was 16.1% with silymarin vs. 20.5% with placebo (n.s.); liver-related mortality was 10.0% with silymarin vs. 17.3% with placebo(p = 0.01).Based on the available clinical evidence it can be concluded - concerning possible risks /probable benefits - that it is reasonable to employ silymarin as a supportive element in the therapy of Amanita phalloides poisoning but also (alcoholic and grade Child 'A') liver cirrhosis. A consistent research programme, consolidating existing evidence and exploring new potential uses,would be very welcome.

To evaluate prevalence of use and prescribing patterns of antiepileptic drugs (AEDs) in Italian general practice. Primary care data were obtained from the Health Search Database, a longitudinal observational database implemented by the Italian College of General Practitioners (GPs). We selected 465 061 subjects registered by the end of 2005 in the lists of 320 GPs, homogeneously distributed throughout Italy. Prevalence of AED use was assessed in the entire sample and by drug type, age group, year and main geographic area (north, centre and south/islands). Overall, 24 383 subjects (5.2%) received at least one AED prescription in the study period. Prevalence of AED use (with 95% confidence interval) increased progressively from 7.1 (6.9–7.3) in 2000 to 11.8 (11.5–12.1) in 2005 for old AEDs and from 1.1 (1.0–1.2) to 12.2 (11.9–12.5) for new AEDs. Carbamazepine, phenobarbital and valproic acid were the most common AEDs until 2003, when gabapentin became first. There were no differences in prescribing patterns in the three main geographic areas. Newer AEDs were mostly used in patients aged 65 years and older. The more widespread use of newer AEDs was for mood disorders or pain. Older AED currently remain first line drugs for epileptic disorders. An increasing use of AEDs has been recently observed over a 6-year period in Italian general practice, mostly explained by newer compounds used for conditions other than epilepsy.

In order to collect information on food intake, lifestyle and health status of the Italian population, a random cohort of about 2000 adults was selected in collaboration with the Italian society of general practitioners’ network (SIMG). Cohort subjects underwent a full clinical evaluation, by their family doctor, who also collected anthropometric data and information on the prevalence of cardiovascular disease risk factors; they were also administered diary forms developed to assess dietary use of simple sugars, of sugar-containing food and of selected food items. Data obtained indicate that the consumption of simple sugars (either added or as natural part of food) by the Italian adult population is, on average, not high (65 and 67 g/day, among women and men, respectively) and mostly derived from food items such as fruit, milk and yogurt. In addition, no correlations were found, in this low-sugar-consuming cohort, between sugar intake and weight, body mass index and waist circumference. Intakes of simple sugars in the LIZ cohort are not associated with weight, BMI and waist circumference. Prospective data, from cohorts like the LIZ one, might shed further light on the contribution of simple sugar intake to health in countries like Italy.

Background: Haiti is a country with a heavy burden of HIV infection in childbearing women. Previous studies have shown that early infant deaths are common in children of HIV-infected women. This study was designed to define the rates of and risk factors for systemic bacterial and mycobacterial infection in such children and to identify the causative agents. Methods: A cohort of 120 children born to HIV-infected mothers between May 2001 and December 2003 were prospectively observed to 15 months of age. They received comprehensive pediatric care at the GHESKIO Centers. Children were assigned to being HIV-infected by serology, RNA detection, and/or defining clinical illnesses. Blood cultures were obtained before giving antibiotics in children who were febrile or chronically ill. Blood cultures also were obtained at selected visits on well children. Results: The mortality rate in the first 15 months was high, 22 of 106 (207/1000 live births) in these children. Sixteen (70%) deaths were within 6 months of birth. Fourty-eight blood cultures had clinically significant organisms of which 38 were Staphylococcus aureus. Blood cultures were more likely to be positive in symptomatic and in HIV-infected children. Conclusions: Despite perinatal HIV treatment, mortality in children born to HIV-infected mothers remained high. Bacteremia, particularly with Staphylococcus aureus, is a partial explanation for excess illness.

Hintergrund: Das komplexe pflanzliche Arzneimittel Padma 28 basiert auf einer Formel der Tibetischen Medizin und wird seit uber 30 Jahren in der Schweiz zur Behandlung von Durchblutungsstorungen und Symptomen der Claudicatio intermittens (reduzierte Gehstrecke) eingesetzt. Fragestellung: Welche Evidenz liegt zur klinischen Wirksamkeit und Sicherheit dieses Arzneimittels bei Patienten mit peripherer arterieller Verschlusskrankheit (PAVK) vor? Material und Methode: Systematischer Review mit Literaturrecherche in elektronischen Datenbanken (jeweils von deren Beginn bis Herbst 2005) und den Literaturverzeichnissen der gefundenen Arbeiten. Ergebnisse: Es fanden sich 14 Artikel (6 publizierte, 1 unpublizierte und 6 doppelt publizierte Studien sowie 1 Metaanalyse). Sechs Studien untersuchten die maximale Gehstrecke, funf davon zeigten eine signifikante Zunahme derselben. Die gepoolten Daten der Metaanalyse bestatigten eine signifikante und klinisch relevante Verlangerung der Gehstrecke um mehr als 100 m bei knapp einem Funftel der Patienten. Die schwerwiegenden unerwunschten Ereignisse standen nicht im Zusammenhang mit dem Verum, die nicht schwerwiegenden waren gleich haufig wie unter Plazebo. Schlussfolgerungen: Die verfugbare Evidenz zeigt, dass die Multi-Target-Therapie mit Padma 28 eine statistisch signifikante und klinisch relevante Besserung von Symptomen der PAVK, d.h. eine erhohte Gehstrecke, bewirkt.

Summary Background : Despite a long-standing use of herbal drugs with dyspeptic symptoms, little attention has been paid to their clinical evaluation. Aim : To assess efficacy and safety of the herbal drug preparation STW 5 (containing, e.g. Iberis, peppermint, chamomile) in the treatment of functional dyspepsia. Methods : Research in electronic databases, consultation of experts and of the producer identified STW 5 (Iberogast) as descriptor in six randomized-controlled trials. The raw data of three placebo-controlled studies which met the selection criteria, were reanalysed and pooled for meta-analysis; one reference-controlled study supported the safety analysis (STW 5: n = 199, control: n = 198). Results : Pooled data showed verum (n = 138) to be more effective than placebo (n = 135) with regard to the severity of the most bothersome gastrointestinal symptom (P-value: 0.001, odds ratio: 0.22, 95% CI: 0.11–0.47). A fourth randomized-controlled trial showed no significant difference between STW 5 and cisapride. As to safety, adverse events were similar with verum and placebo; no serious adverse events occurred. Discussions : From the point of view of efficacy and safety, the herbal medicinal product STW 5 appears to be a valid therapeutic option for patients seeking phytotherapy for their symptoms of functional dyspepsia.

After a introduction concerning complementary medicine, naturopathy and phytotherapy a general view of soy isoflavones as phytoestrogens will be given. In german speaking countries the term and topic naturopathy has a tradition of 150 years regarding theoretical development and practical use among lay people and health professionals in European culture. In contrary the term complementary medicine has been used for approximately 15 years in englisch speaking countries as a kind of collective name for European and Non-European medical cultures and traditions. Complementay medicine summarizes a huge variety of cultural, medical and qualitywise different medical methods and treatments which can be a contribution to conventional medicine. One of the oldest and intensly researched fields in European and Non-European complementary medicine is the use of herbal drugs (phytotherapy). Soy isoflavones serve as an example to show the differences between phytotherapy based on multicompounds and dietary supplements (neutraceuticals) based on monosubstances. The differing preparations of soy isoflavones are not phytotherapeutic medicine. A review of the experimental and clinical data concerning soy isoflavones as phytoestrogens for the prevention of cancer, menopausal complaints, osteoporosis or cardiovascular diseases indicates that the consumption of food containing phytoestrogens seems to be health protective. Yet, the relevance of supplementation of single phytoestrogens for an additional health effect is not sufficiently proven.

The purpose of the study was to investigate the risk of stroke with typical and atypical anti-psychotics in elderly subjects, weighting for a number of known risk factors, including dementia. Data were retrospectively drawn from the primary care setting from the Health Search Database, which stores information on about 1.5% of the total Italian population served by general practitioners. All elderly patients (65+ years) prescribed an anti-psychotic in monotherapy from January 2000 to June 2003 were selected for the study. A cohort of patients not exposed to anti-psychotics was taken from the same database. Subjects who had previously had a stroke were excluded. The main outcome measure was the incidence of first-ever stroke during exposure to an anti-psychotic.The sample included non-users (69,939), users of atypicals (599), butyrophenones (749), phenotiazines (907) and substituted benzamides (1,968). The crude incidence of stroke in subjects not exposed to anti-psychotics was 12.0/1000 person-years. Risk was significantly higher for those on butyrophenones (47.1/1000), phenotiazines (72.7/1000) and in the atypical anti-psychotic group (47.4/1000). Substituted benzamides had an almost significant higher risk (25.0/1000). Cox regression modelling, weighting for demographic and clinical variables with non-users as the reference group, showed that the risk for stroke was 5.79 times for phenotiazines, 3.55 times for butyrophenones, and 2.46 times for atypicals. Clinicians should be cautious in prescribing phenotiazines and butyrophenones in elderly patients, since the risk for stroke would seem comparable or even greater than with atypicals.

To estimate the cost of the migraine patient in Italy, we undertook an observational, multicenter study. The study was carried out by 902 Italian general practitioners (GPs). GPs asked patients over 14 years of age who came to their surgeries whether they suffered from headaches. If so, the doctor questioned the patient to determine whether he or she was a migraineur according to the IHS criteria. Migraineurs entered a 2-month follow-up programme. GPs interviewed 72 038 patients, of which 4794 were migraineurs. Migraineurs received a diary card to record attacks and the treatment they took. During the two scheduled monthly meetings with the doctor, patients and GPs recorded on diary cards the use of healthcare resources and working days lost due to migraine. Overall, the annual cost of migraine per patient was Lit 1 159 840 (605.03 USD). Our study shows that the overall cost of migraine to the community is very high. Direct costs are higher than in other countries.

Home measurement of blood pressure (BP) can improve compliance. The aim of this study was to evaluate if the efficacy of losartan in hypertension could be enhanced by providing patients with a device for home BP measurement. In this open, randomised, prospective, multi-centre study in 244 Swiss practices, patients with mild-to-moderate hypertension were randomised to a group receiving a home BP measuring device (OMRON) (group 2), or to a group where this device was not provided (group 1). After 8 weeks of treatment with losartan, the responder rates between subjects performing home measurement of BP were compared with those without self-measurement, whereby exclusively sphygmomanometric office BP values were considered. A total of 622 subjects completed the study. Treatment with losartan significantly reduced diastolic (DBP) and systolic BP (SBP) (P or =10 mm Hg DBP from baseline). However, home measurement did not significantly improve BP control in these new patients (81.4% vs 77.7%). Overall, home measurement can lead to a slight improvement of BP control. This improvement was most evident in females, reaching significance.

Severe oral mucositis is a major cause of morbidity following allogeneic hematopoietic stem cell transplantation (AHSCT). Cryotherapy, that is, the application of ice chips on the mucosa of the oral cavity during the administration of antineoplastic agents, may reduce the incidence and severity of chemotherapy-related oral mucositis. In this multicenter randomized study, we addressed whether cryotherapy during MTX administration is effective in the prevention of severe oral mucositis in patients undergoing myeloablative AHSCT. One hundred and thirty patients undergoing myeloablative AHSCT and MTX-containing GVHD prophylaxis were enrolled and randomized to receive or not receive cryotherapy during MTX administration. The incidence of severe (grade 3-4) oral mucositis, the primary end point of the study, was comparable in patients receiving or not cryotherapy. Moreover, no difference was observed in the incidence of oral mucositis grade 2-4 and the duration of oral mucositis grade 3-4 or 2-4, or in the kinetics of mucositis over time. In univariate and multivariate analysis, severe oral mucositis correlated with TBI in the conditioning regimen and lack of folinic acid rescue following MTX administration. Thus, cryotherapy during MTX administration does not reduce severe oral mucositis in patients undergoing myeloablative allogeneic HSCT. Future studies will assess cryotherapy before allogeneic HSCT.

Objective To collect information on the major risk factors and secondary prevention among patients with myocardial infarction in Italy. Methods Data were obtained from the database of the Italian College of General Practitioners; 3588 patients (mean age 68.7 +/- 11.3 years; 2698 men, 888 women; two unrecorded gender), with an average time from event of 6 +/- 5.7 years, were identified. Results Among the major risk factors, data entry ranged from 50.3% for physical activity to 74.9% for blood pressure. Inadequate blood pressure control was present in 49.2% and elevated plasma cholesterol levels (>5.2 mmol/l) in 57.3%; among the latter group, 65% were on lipid-lowering therapy. Only 47.2% of the treated patients achieved a total cholesterol level of

OBJECTIVES: To assess the antipsychotic use and the prevalence/incidence of antipsychotic drug users in Italy during the years 1999-2002. To estimate the persistence with antipsychotic medications, and to measure their off-label use. METHODS: We selected 465,061 individuals registered by June 2002 in the lists of 320 general practitioners, homogeneously distributed throughout Italy, from the Health Search Database. We measured the antipsychotic drug consumption, calculated as defined daily dose (DDD) per 1000 inhabitants per day. We also calculated the number of individuals receiving at least one antipsychotic prescription, to estimate the annual prevalence and incidence of antipsychotic users. Among incident users, we evaluated the percentage of patients adherent to drug label indications and the average duration of treatment, estimated as medical possession ratio (MPR). RESULTS: Atypical antipsychotic use has continuously increased from 1999 to 2002. Women, older people and patients affected by psychotic disorders other than schizophrenia were seen to be more likely to receive antipsychotic prescriptions. Persistence with atypical drug treatment (MPR=0.213 in 2002) appeared longer than that of typical drugs (0.169). The percentage of patients adherent to drug label indications was significantly higher among typical antipsychotic users (P

OBJECTIVE: To assess patient- and doctor-related variables leading physicians to prescribe antibiotics or parenteral antibiotics for acute respiratory infections (ARIs) and to describe the variability as well as the appropriateness of antibiotic use and its predictive factors in general practice. METHODS: We conducted a cross-sectional study among patients aged 15-85 years with a diagnosis of ARIs, using information from 469 GPs from the Health Search Database. Diagnoses were linked with antibiotic prescriptions and other patients and doctor-related variables. Available scientific evidence was used to establish the appropriateness of first-choice antibiotic treatment. Frequency analyses and logistic regressions were used to identify variables associated with antibiotic use and appropriateness. RESULTS: On 67,761 cases of ARIs, antibiotics were prescribed in 63.2%, varying from 80.9% for acute bronchitis to 43.9% for croup, influenza and common cold. Significant associations with antibiotic use were found for geographic location and number of patients under care. The use of diagnostic tests significantly lowered the risk. Geographic location and living in an urban area were associated with parenteral antibiotic use. Amoxicillin (16.7%) and amoxicillin-clavulanate (17.9%) were the most common antibiotics prescribed. Appropriateness was reported in 39.0% of cases, with geographic location, physician's gender and diagnostic tests being the factors more predictive of appropriate antibiotic use. CONCLUSIONS: There is still excessive antibiotic use for ARIs. Its overuse is influenced by the physicians' characteristics and by the environment in which they practice, whilst diagnostic tests might reduce inappropriateness. Therefore, effective strategies for changing diagnostic and therapeutic behaviour are needed.

Background: The etiology of functional dyspepsia (FD) is multi-factorial. Its prevalence is high and it considerably impairs the patients' quality of life. The treatment options are limited. Padma Digestin, a multi-herbal formula from Tibetan Medicine, is traditionally used in malabsorption and dyspeptic symptoms as they do occur in FD, but as yet no clinical data exist on the formula. The aim of this study was to evaluate the safety, tolerability, and efficacy of Padma Digestin in patients with FD in a prospective, open, clinical phase III trial. Patients and Methods: Patients were recruited by general practitioners, internists, and gastroenterologists and treated with 2 × 3 capsules of Padma Digestin daily for 6 weeks. Dyspeptic symptoms were analyzed using the Domestic/International Gastroenterology Surveillance Study (DIGEST) questionnaire extended by the 2 symptoms stomach cramps and lack of appetite. The quality of life was assessed using the Psychological General Well-Being Index (PGWBI-S) questionnaire (short version). Results: 37 patients were admitted and efficacy could be assessed in 31. In the overall efficacy assessment, the Padma Digestin treatment led to a statistically highly significant reduction of the respective most bothersome symptom scores regarding frequency, severity, and impairment of daily activities (p < 0.01). The treatment also led to significant improvements of the individual symptoms of postprandial fullness, nausea, localized and diffuse epigastric pain, stomach cramps, and lack of appetite. The onset of improvement was after a median of 7 days; time until disappearance of the symptoms was after a median of 22 days. The global efficacy and tolerability were rated as good or very good by the doctors and the patients in 84% and 78%, respectively. The PGWBI-S increased from 55 ± 19.5% to 70.5 ± 15.5%, which is nearly the normal value (73.5 ± 15.4%). As for safety, 11 patients reported a total of 17 adverse events (AE), 1 of which was serious but unrelated to the study medication. The AE were mild or moderate. The safety laboratory data showed no statistically significant or otherwise relevant changes. Conclusions: The results show that the formula Padma Digestin has a high tolerability and efficacy in FD symptoms and positively influences psychological well-being and thus quality of life. It therefore represents a much needed extension of the therapeutic repertoire in FD.

The factors that influence colonic transit time in healthy humans are not yet clearly defined. The aim of this study was therefore to determine (a) if there are differences in colonic transit time between men and women and (b) if age, female hormonal status or smoking habits are associated with alterations in these parameters. Colonic transit time was measured in 164 asymptomatic subjects (80 males, 84 females) by a radio-opaque marker technique with one single plain abdominal X-ray. Colonic transit time was significantly shorter in men than in women (30 +/- 2 vs. 42 +/- 3 h, P < 0.05). Colonic transit time in non-smoking males was significantly shorter compared with smoking males (26 +/- 2 vs. 40 +/- 5 h, P < 0.05). In females only height and menstrual cycle influenced colonic transit times. We conclude that gender and smoking habits should be considered when studying colonic transit time in health and disease.