Reduced effectiveness among ß-lactam antibiotics: a population-based cohort study in primary care in Italy.

BACKGROUND: There are few data comparing the relative effectiveness of the individual ß-lactams. OBJECTIVES: To quantify the reduced effectiveness, defined as switching to a different antibiotic being prescribed for the same indication, among new users of ß-lactam antibiotics in primary care. METHODS: A retrospective cohort study was conducted using the Health Search Database, an Italian primary care data source. Patients newly prescribed with ß-lactams for a specific indication between 1 January 2013 and 31 December 2017 were identified. A switch to a different antibiotic for the same indication occurring during a 30day follow-up was the study outcome. Cox regression was adopted to assess the risk of switching between the different ß-lactams. RESULTS: Among 178 256 patients newly treated with ß-lactam antibiotics, 1172 (0.65%) switched to a different antibiotic. Amoxicillin/clavulanate (co-amoxiclav: n = 104 891) and amoxicillin (n = 21 699) were the most frequently prescribed ß-lactams. The other antibiotics showed significantly higher risk of switching when compared with co-amoxiclav for lower respiratory tract [e.g. ceftriaxone, hazard ratio (HR): 1.6, 95% CI: 1.2-2.0], dental [e.g. amoxicillin, HR: 4.2, 95% CI: 2.9-5.9], and middle ear infections [e.g. amoxicillin, HR: 1.8, 95% CI: 1.1-2.7]. The same results were gathered when parenteral formulations were excluded. CONCLUSIONS: The prevalence of reduced effectiveness of newly prescribed ß-lactam antibiotics was lower than 1%. Specifically, the rate of switch to another antibiotic, when it was prescribed to treat low respiratory tract, dental, and middle ear infections, was lower among users of co-amoxiclav than those prescribed with other ß-lactams.

Epidemiology and determinants of chronic migraine: A real-world cohort study, with nested case-control analysis, in primary care in Italy.

BACKGROUND: The proper identification of chronic migraine is one of the mainstays for general practitioners. This study therefore aims to assess the epidemiology and determinants of chronic migraine in primary care in Italy by testing five operational case definition algorithms. METHODS: Five case definition algorithms defining chronic migraine were developed to estimate the prevalence and incidence rate of chronic migraine in the Health Search database. For each algorithm, we conducted a nested case-control analysis to quantify the level of association between certain determinants and incident cases of chronic migraine. RESULTS: Considering a cohort of 1,091,032 patients (52% were females), the prevalence rate of chronic migraine increased from the first to the fifth case definition algorithm ranging from 0.03 to 0.28%. No 95% confidence interval overlapped the others, and every confidence interval reliably maintained 2% precision. Incidence rates showed a growing trend (0.008-0.056 per 100,000 person-years) as well. All case definition algorithms were able to capture sex (i.e. female) and nonsteroidal anti-inflammatory drug (NSAID) overuse as statistically significant determinants of incident cases of chronic migraine. Depression was associated with a statistically significant increase of incidence rate of chronic migraine only for two case definition algorithms. CONCLUSION: Our findings show that prevalence and incidence rate of chronic migraine are underestimated when compared with current literature. On the other hand, we found acceptable correctness of chronic migraine definition in the light of the association with well-known determinants.

Use of azithromycin and risk of ventricular arrhythmia.

BACKGROUND: There are conflicting findings from observational studies of the arrhythrogenic potential of azithromycin. Our aim was to quantify the association between azithromycin use and the risk of ventricular arrhythmia. METHODS: We conducted a nested case-control study within a cohort of new antibiotic users identified from a network of 7 population-based health care databases in Denmark, Germany, Italy, the Netherlands and the United Kingdom for the period 1997-2010. Up to 100 controls per case were selected and matched by age, sex and database. Recency of antibiotic use and type of drug (azithromycin was the exposure of interest) at the index date (occurrence of ventricular arrhythmia) were identified. We estimated the odds of ventricular arrhythmia associated with current azithromycin use relative to current amoxicillin use or nonuse of antibiotics (≥ 365 d without antibiotic exposure) using conditional logistic regression, adjusting for confounders. RESULTS: We identified 14 040 688 new antibiotic users who met the inclusion criteria. Ventricular arrhythmia developed in 12 874, of whom 30 were current azithromycin users. The mean age of the cases and controls was 63 years, and two-thirds were male. In the pooled data analyses across databases, azithromycin use was associated with an increased risk of ventricular arrhythmia relative to nonuse of antibiotics (adjusted odds ratio [OR] 1.97, 95% confidence interval [CI] 1.35-2.86). This increased risk disappeared when current amoxicillin use was the comparator (adjusted OR 0.90, 95% CI 0.48-1.71). Database-specific estimates and meta-analysis confirmed results from the pooled data analysis. INTERPRETATION: Current azithromycin use was associated with an increased risk of ventricular arrhythmia when compared with nonuse of antibiotics, but not when compared with current amoxicillin use. The decreased risk with an active comparator suggests significant confounding by indication.

Epidemiology of Parkinson's Disease: A Population-Based Study in Primary Care in Italy.

BACKGROUND: There are no studies on prevalence, incidence and comorbidities of Parkinson's disease (PD) in the Italian population. METHODS: The database of 700 Italian general practitioners (population, 923,356) was investigated. All patients with International Classification of Diseases Ninth Revision - Clinical Modification (ICD-9-CM) diagnosis of PD during the period 2002-2012 were included. Parkinsonisms were excluded. Clinical conditions preceding PD were identified through ICD-9-CM codes. The Charlson Comorbidity Index was used. PD crude and standardized prevalence and annual incidence were calculated. Crude and adjusted hazard ratios were calculated for comorbidities. RESULTS: A total of 2,204 patients (1,140 men, 1,064 women, age 22-95 years) were included. The crude prevalence of PD was 239/100,000. Prevalence increased exponentially with age. Standardized prevalence was 233 (95% CI 232-235). One hundred ninety-four patients were newly diagnosed, giving a crude incidence of 22/100,000 and a standardized incidence of 23.1/100,000 (95% CI 22.9-23.2). Incidence increased steadily until age 75-84 years and then decreased. Older age, cardiovascular and gastrointestinal disorders, diabetes, and restless-legs syndrome were associated with increased PD risk and smoking and hypersomnia with decreased PD risk. The Charlson Comorbidity Index was associated with PD risk with a documented gradient. CONCLUSIONS: Prevalence and incidence of PD in Italy are in line with studies with the highest case ascertainment. PD risk varies with the number and type of comorbidities.

Prescribing pattern of antipsychotic drugs during the years 1996-2010: a population-based database study in Europe with a focus on torsadogenic drugs.

INTRODUCTION: Antipsychotic drugs (APDs) are used to treat several mental illnesses. Some APDs have long been known to be associated with QT prolongation, potentially leading to torsades de pointes (TdP) and sudden cardiac death (SCD). In 2005, thioridazine was withdrawn because of the risk of SCD, bringing further attention to the arrhythmogenic potential of APDs. AIM: The aim of the current study was to evaluate the use of APDs in five European countries during the years 1996-2010. METHODS: A cohort study was conducted using prescription/dispensing data from seven healthcare databases [the AARHUS University Hospital Database (Denmark), the German Pharmacoepidemiological Research Database (GePaRD) (Germany), Health Search Database/Thales (HSD) and Emilia Romagna Regional Database (ERD) (Italy), PHARMO Database Network and Integrated Primary Care Information (IPCI) (the Netherlands) and The Health Improvement Network (THIN) (the UK), covering a population of 27 million individuals. The annual prescription rate of APDs was measured overall and for individual medications. APDs were classified as torsadogenic according to the Arizona-CERT list. All analyses were stratified by age, gender and calendar year. RESULTS: A total of 559 276 person-years (PYs) of exposure to APDs was captured. The crude annual prescription rate of APD use ranged from 3.0/1000 PYs in ERD to 7.7/1000 PYs in AARHUS. Among APDs with established torsadogenic potential, thioridazine was the most frequently used medication in the UK. Haloperidol was commonly prescribed in Italy and the Netherlands. The use of APDs with torsadogenic potential was much higher in elderly patients. CONCLUSIONS: Substantial use of APDs with torsadogenic potential has been reported in Europe in recent years, in spite of increasing concerns about their arrhythmogenic potential. This use was even greater in elderly patients, who are at higher risk of SCD.

Antibiotic use varies substantially among adults: a cross-national study from five European Countries in the ARITMO project.

PURPOSE: To examine patterns of outpatient and community antibiotic use among adults in five European countries. METHODS: We used healthcare data of 28.8 million adults from six population-based ARITMO project databases to ascertain information on systemic antibiotic use in Denmark (2000-2008), the Netherlands (1999-2010), Italy (2000-2010), the UK (1996-2009), and Germany (2004-2008). We estimated overall, and age-group and sex specific antibiotic use as defined daily doses (DDD) per 1000 inhabitants per day. We computed annual age- and sex-standardized population prevalence of antibiotic use per 1000 persons-years (p-y) and the mean duration (in days) of antibiotic use. RESULTS: The overall antibiotic use varied from 8.7 DDD per 1000 inhabitants per day in the UK to 18.1 DDD in Denmark, representing a 2.1-fold geographical variation. In all countries, prescribing was relatively high among individuals aged 15-19 years; lower in those aged 20-50 years; and then increased steadily reaching 41.8 DDD per 1000 inhabitants per day in individuals ≥ 85 years in Denmark. After age- and sex-standardization, prevalence of antibiotic use varied threefold from 160.2/1000 p-y in the UK to 421.1/1000 p-y in Italy. The ratio of broad- to narrow-spectrum penicillin, cephalosporin, and macrolide use varied from 0.6 in Denmark to 120.2 in Italy. Women used more antibiotics than men did in all countries. Across countries, the mean duration of antibiotic use varied 1.3 to 21.1-fold for different antibiotics. CONCLUSIONS: Antibiotic use is high in women and the elderly. Prescribing patterns vary substantially across European countries, both according to overall consumption, user prevalence, duration, and narrow- versus broad-spectrum antibiotics.

Prevalence and incidence of epilepsy in Italy based on a nationwide database.

OBJECTIVES: To estimate the prevalence and incidence of epilepsy in Italy using a national database of general practitioners (GPs). METHODS: The Health Search CSD Longitudinal Patient Database (HSD) has been established in 1998 by the Italian College of GPs. Participants were 700 GPs, representing a population of 912,458. For each patient, information on age and sex, EEG, CT scan, and MRI was included. Prevalent cases with a diagnosis of 'epilepsy' (ICD9CM: 345*) were selected in the 2011 population. Incident cases of epilepsy were identified in 2011 by excluding patients diagnosed for epilepsy and convulsions and those with EEG, CT scan, MRI prescribed for epilepsy and/or convulsions in the previous years. Crude and standardized (Italian population) prevalence and incidence were calculated. RESULTS: Crude prevalence of epilepsy was 7.9 per 1,000 (men 8.1; women 7.7). The highest prevalence was in patients <25 years and ≥75 years. The incidence of epilepsy was 33.5 per 100,000 (women 35.3; men 31.5). The highest incidence was in women <25 years and in men 75 years or older. CONCLUSIONS: Prevalence and incidence of epilepsy in this study were similar to those of other industrialized countries. HSD appears as a reliable data source for the surveillance of epilepsy in Italy.

Changes in the prescribing pattern of antidepressant drugs in elderly patients: an Italian, nationwide, population-based study.

BACKGROUND: Despite the high use of antidepressants (ADs) among the elderly, there is limited information about the prescribing pattern of these drugs in the Italian elderly population. The aim of this study was to analyze the trend in the use of ADs in the Italian elderly patients in the years 2003-2009, and specifically, to evaluate rates and predictors of AD treatment discontinuation in depressed older patients. METHODS: The nationwide general practice Health Search Database (HSD) was used to identify AD users aged 65 years old and over from 2003 to 2009. ADs were categorized as (1) selective serotonin reuptake inhibitors (SSRIs); (2) serotonin-norepinephrine reuptake inhibitors (SNRIs); (3) tricyclic antidepressants (TCAs); (4) noradrenergic and specific serotonergic antidepressants (NaSSAs); and (5) other ADs. Incidence and prevalence of AD use per 1,000 inhabitants was calculated by drug class and single compound. We also measured rates and predictors of AD discontinuation (i.e., treatment gap ≥ 60 days) during the first year of therapy. RESULTS: Overall, 39,557 AD users ≥65 years (17 % of the total HSD elderly population) were included in the study. SSRIs were increasingly and most frequently prescribed ADs (102.7-195.3 per 1,000 over seven years). The most common indications for AD use were depression and anxiety. Overall, 14 % of AD users continued their AD medication without treatment gaps, 27 % were intermittent AD users and 58 % discontinued their ADs during the first year of follow-up. Specific AD classes such as TCAs and 'other ADs were found to be predictors of discontinuation. In depressed patients, the use of NaSSas, TCAs and 'other ADs as well the concomitant use of >5 drugs (other than ADs) and living in Southern Italy were more likely to predict discontinuation. CONCLUSION: ADs, especially SSRIs, are widely and increasingly prescribed in elderly Italian patients in recent years. The observed high AD discontinuation rates are likely to impact the achievement of a therapeutic endpoint in depressed patients. Patients who are at high risk of AD discontinuation such as those receiving multi-drug therapy or living in Southern Italy should be monitored more closely to improve benefits of AD treatments.

Epidemiology of gout and hyperuricaemia in Italy during the years 2005-2009: a nationwide population-based study.

OBJECTIVE: To assess the epidemiology of gout and hyperuricaemia in the Italian general population during the years 2005-2009. METHODS: Using the Italian primary care database (Health Search/CSD Longitudinal Patient Database), the prevalence, incidence and recurrence rates of gout and/or hyperuricaemia (serum urate level >360 mmol/l (6 mg/dl)) in outpatients aged ≥18 years during the years 2005-2009 were estimated. Rates together with 95% CI were measured overall and stratified by age, gender and calendar year. The characteristics of patients with newly diagnosed gout and hyperuricaemia were investigated and compared with the general population. RESULTS: The prevalence of gout increased from 6.7 per 1000 inhabitants in 2005 to 9.1 per 1000 inhabitants in 2009. It increased with advancing age and was fourfold higher in men. A similar trend was observed for asymptomatic hyperuricaemia (85.4 per 1000 inhabitants in 2005 vs 119.3 per 1000 inhabitants in 2009). The incidence of gout remained stable during the observation years (0.93 per 1000 person years in 2005 vs 0.95 in 2009). Recurrent episode rate was 19.1% during the first year following the first gout attack and 31.6% during the following 5 years. Advanced age, increased levels of uric acid, nephrolithiasis and concomitant use of ciclosporin were the main predictors of recurrence of gout attacks. CONCLUSION: The prevalence of gout and hyperuricaemia increased in Italy from 2005 to 2009. A high recurrence rate for gout attack was observed during the first year following the first episode. Early management of hyperuricaemia in patients at higher risk of recurrent gout attack should be considered in primary care.

Overview on the management of diverticular disease by Italian General Practitioners.

BACKGROUND: Although very common in Western countries, poor epidemiological data on diverticular disease (DD) is available from the family practice. AIMS: To evaluate the behavior of Italian General Practitioners (GPs) on approaching DD. METHODS: Health Search Database was analyzed retrospectively. RESULTS: On a population of 975,523 individuals, 33,597 patients had a registered diagnosis of DD ("lifetime" prevalence = 3.4%, M = 3.2%, F = 3.7%; higher values are found in females over-65 years old; low rates of complications: diverticulitis = 0.3%, bleeding = 0.002%). As risk factors, NSAIDs and ASA were taken by 14.8% and 26.5% respectively, opioids by 7.5%, corticosteroids by 5.2%; as protective factors, 30.4% were under statins and 17.7% under calcium-antagonists. Approximately 13% of patients were referred to specialists. Colonoscopy and abdominal CT were prescribed to 48.5% and to 13% of already diagnosed patients. Among DD sufferers, 27% experienced hospitalization, but only 3.4% of cases were for a DD-linked problem. Treatment included rifaximin (61%), mesalazine (14.7%), probiotics (12.4%), ciprofloxacin (7.6%). CONCLUSION: DD has a large impact in general practice with a higher prevalence in the elderly. GPs are required to pay particular attention to risk factors both for disease development and for its complications in order to reduce the costs deriving from diagnostic procedures, referral and hospitalization.

Prescribing Trends of Codeine-containing Medications and Other Opioids in Primary Care After A Regulatory Decision: An Interrupted Time Series Analysis.

BACKGROUND AND OBJECTIVES: In 2014, the Italian Medicines Agency (AIFA) amended the summary of product characteristics of codeine-containing medications limiting their use for maximum three days. This study attempted to clarify the impact of AIFA intervention on prescribing trends and appropriateness of use of codeine-containing medications and other opioids. METHODS: Using the Health Search Database, a quasi-experimental interrupted time series analysis was conducted to evaluate changes in prescribing trends and appropriateness of use of codeine-containing medications and opioids between 2013 and 2015. RESULTS: Prescribing trends of codeine-containing medications significantly decreased (on average, - 352 days of treatment per month of observation), while long-acting opioids (LAOs) had an overall increase. Trends of inappropriate prescriptions significantly increased for two LAOs (i.e. tapentadol, naloxone-oxycodone), both before and after AIFA intervention. CONCLUSION: The use of paracetamol-codeine combination was effectively decreased in Italy because of AIFA intervention. Instead, prescriptions of tapentadol and oxycodone-naloxone stably increased over the study period irrespective of regulatory intervention. Given that the choice of the most appropriate opioid therapy is not straightforward, especially in elderly and/or comorbid patients, general practitioners should consider carefully alternative therapies on the bases of regulatory interventions.

Improvement in the management of chronic obstructive pulmonary disease following a clinical educational program: results from a prospective cohort study in the Sicilian general practice setting.

Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disorder of the lungs associated with progressive disability. Although general practitioners (GPs) should play an important role in the COPD management, critical issues have been documented in the primary care setting. The aim of this study was to evaluate the effectiveness of an educational program for the improvement of the COPD management in a Sicilian general practice setting. The effectiveness of the program, was evaluated by comparing 15 quality-of-care indicators developed from data extracted by 33 GPs, at baseline vs. 12 and 24 months, and compared with data from a national primary care database (HSD). Moreover, data on COPD-related and all-cause hospitalizations over time of COPD patients, was measured. Overall, 1,465 patients (3.2%) had a registered diagnosis of COPD at baseline vs. 1,395 (3.0%) and 1,388 (3.0%) over time (vs. 3.0% in HSD). COPD patients with one spirometry registered increased from 59.7% at baseline to 73.0% after 2 years (vs. 64.8% in HSD). Instead, some quality of care indicators where not modified such as proportion of COPD patients treated with ICS in monotherapy that was almost stable during the study period: 9.6% (baseline) vs. 9.9% (after 2 years), vs. 7.7% in HSD. COPD-related and all-cause hospitalizations of patients affected by COPD decreased during the two observation years (from 6.9% vs. 4.0%; from 23.0% vs. 18.9%, respectively). Our study showed that educational program involving specialists, clinical pharmacologists and GPs based on training events and clinical audit may contribute to partly improve both diagnostic and therapeutic management of COPD in primary care setting, despite this effect may vary across GPs and indicators of COPD quality of care.

Effectiveness of adherence to lipid lowering therapy on LDL-cholesterol in patients with very high cardiovascular risk: A real-world evidence study in primary care.

BACKGROUND AND AIMS: Despite management guidelines advocating statin/ezetimibe use in very high cardiovascular risk (CV) conditions, adherence to this therapy is still suboptimal and LDL-C target attainment unsatisfactory. We aimed to investigate the level of adherence to statin/ezetimibe and LDL-C target achievement rates in an unselected very high CV risk population in primary care setting in Italy. METHODS: We performed a retrospective population-based study using the Health Search IMS Health Longitudinal Patient Database (HSD), including adult patients at very high CV risk, newly treated with statin, ezetimibe or their combination, with 3 and 6 months of follow-up. RESULTS: Although the large majority of patients had previous major CV events (99.9%), only 61% and 55.14% resulted adherent (Proportion of Days Covered, PDC≥80%) after 3 and 6 months, respectively. High adherence entailed almost a three times higher probability to reach the therapeutic LDL-C target (3 months: OR = 2.26 [95% [CI]: 1.88 to 2.72]; 6-months: OR = 2.74 [95% CI: 2.27 to 3.31]). The odds to treat to LDL-C target was greater for simvastatin-ezetimibe fixed combination, simvastatin, atorvastatin and rosuvastatin, in decreasing order. Finally, poor adherence was slightly more prevalent among patients treated with less effective statins, and at both low and maximal dosage regimens. CONCLUSIONS: This population-based study showed that adherence to statin therapy is poor even among patients who have already experienced a CV event. Failure to achieve recommended LDL-C levels appears imputable to the use of moderate doses and low to standard efficacy statins.

Global cardiovascular risk evaluation: pattern of algorithm use and risk modification in 'real life'.

AIMS: Although calculation of the global cardiovascular risk is strongly recommended, limited data are available regarding the use and the utility of this tool in clinical practice. We aimed at answering the following questions in the setting of Italian general practice: how many patients are evaluated via the cardiovascular risk algorithm; what are their characteristics; and what happens after their evaluation. METHODS: We used the Health Search/CSD Longitudinal Patient Database. The software used by about 800 participating GPs allows the calculation of the global cardiovascular risk in automatic. The following data were yearly extracted from the database within 2004-2008: age, sex, and recorded diagnosis of the main cardiovascular and other information encompassing smoking habits, blood pressure, total cholesterol, high density lipoprotein cholesterol (i.e., variables used to calculate cardiovascular risk), BMI, physical activity, triglycerides, glucose and creatinine; wherever available, current cardiovascular therapy and the automatically computed global cardiovascular risk were also extracted. RESULTS: In 2008, the observed population, aged 35-69 years, numbered 438 922 individuals; 78 617 (17.9%) had at least one calculation of cardiovascular risk; 20 181 patients were re-evaluated at least once: 61.1% among high-risk patients, 43.8% among moderate-risk patients, and 27.2% among low-risk patients. The level of cardiovascular risk measured at baseline increased in 6863 (34%), decreased in 11 791 (58.4%), and did not change in 1527 (7.6%) individuals. Overall, mean cardiovascular risk decreased over 4 years in 2.25% (SD 6.41%; P < 0.01) of patients. CONCLUSION: The calculation of global cardiovascular risk is underused by GPs, who generally assign a higher priority to high-risk individuals. In addition, the use of this algorithm seems to favor a reduction of risk in moderate-risk and high-risk patients.

What is the actual epidemiology of familial hypercholesterolemia in Italy? Evidence from a National Primary Care Database.

BACKGROUND: There are some inconsistencies on prevalence estimates of familial hypercholesterolemia (FH) in general population across Europe due to variable application of its diagnostic criteria. We aimed to investigate the FH epidemiology in Italy applying the Dutch Lipid Clinical Network (DLCN) score, and two alternative diagnostic algorithms to a primary care database. METHODS: We performed a retrospective population-based study using the Health Search IMS Health Longitudinal Patient Database (HSD) and including active (alive and currently registered with their general practitioners (GPs)) patients on December 31, 2014. Cases of FH were identified by applying DLCN score. Two further algorithms, based on either ICD9CM coding for FH or some clinical items adopted by the DLCN, were tested towards DLCN itself as gold standard. RESULTS: We estimated a prevalence of 0.01% for "definite" and 0.18% for "definite" plus "probable" cases as per the DLCN. Algorithms 1 and 2 reported a FH prevalence of 0.9 and 0.13%, respectively. Both algorithms resulted in consistent specificity (1: 99.10%; 2: 99.9%) towards DLCN, but Algorithm 2 considerably better identified true positive (sensitivity=85.90%) than Algorithm 1 (sensitivity=10.10%). CONCLUSION: The application of DLCN or valid diagnostic alternatives in the Italian primary care setting provides estimates of FH prevalence consistent with those reported in other screening studies in Caucasian population. These diagnostic criteria should be therefore fostered among GPs. In the perspective of FH new therapeutic options, the epidemiological picture of FH is even more relevant to foresee the costs and to plan affordable reimbursement programs in Italy.

Homecare for patients with heart failure in Italy.

UNLABELLED: BACKGROUND; Heart failure (HF) represents an important health issue in western countries, especially for the elderly, frail population. A number of HF patients must usually be assisted at home. No information is available about the usual care of HF patients in Italy. The aim of this study was to describe the characteristics of HF patients receiving homecare in the Italian general practice. METHODS: A questionnaire was sent to 320 general practitioners (GPs) involved in the Health Search project. Among these, 148 (46.2%) answered and 376 home-ridden HF patients (60.3% women, median age 85 years) were identified. RESULTS: 257 (57%) patients were in NYHA class III or IV. Multiple relevant concomitant diseases occurred in 326 (86.7%) subjects. Only 140 (37.2%) patients were able to take their pills without any help; caregivers, mainly family members, were required 24 hours a day in 78.7% of cases. The length of homecare was > 1 year in 84.5% of cases. CONCLUSIONS: According to our data, thousands of HF patients are usually assisted at home for long periods in Italy. This is a very old group of subjects with heavy co-morbidity and a high need for continuous, prolonged assistance. Studies specifically aimed at the care of HF patients are needed.

Risk of ESRD and death in patients with CKD not referred to a nephrologist: a 7-year prospective study.

BACKGROUND AND OBJECTIVES: Rising prevalence of CKD requires active involvement of general practitioners to limit ESRD and mortality risk. However, the outcomes of patients with CKD exclusively managed by general practitioners are ill defined. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We prospectively evaluated 30,326 adult patients with nondialysis CKD stages 1-5 who had never received consultation in tertiary nephrology care recruited from 700 general practitioner offices in Italy during 2002 and 2003. CKD stages were classified as stages 1 and 2 (GFR ≥ 60 ml/min per 1.73 m(2) and either albuminuria or an International Classification of Diseases, Ninth Revision, Clinical Modification code for kidney disease), stage 3a (GFR=59-45), stage 3b (GFR=44-30), stage 4 (GFR=29-15), and stage 5 (GFR<15). Primary outcome was the risk of ESRD (dialysis or transplantation) or all-cause death. RESULTS: Overall 64% of patients were in stage 3a, and 4.5% of patients were in stages 3b-5. Patients with stages 1 and 2 were younger, were predominantly men, more frequently had diabetes, and had lower prevalence of previous cardiovascular disease than patients with stages 3a-5. Hypertension was frequent in all CKD stages (80%-94%), whereas there was a lower prevalence of dyslipidemia, albuminuria, and obesity associated with more advanced CKD. During the follow-up (median=7.2 years; interquartile range=4.7-7.7), 6592 patients died and 295 started ESRD. Compared with stages 1 and 2 (reference), mortality risk (hazard ratio, 95% confidence interval) was higher in stages 3b-5 (1.66, 1.49-1.86, 2.75, 2.41-3.13 and 2.54, 2.01-3.22, respectively) but not stage 3a (1.11, 0.99-1.23). Similarly, ESRD risk (hazard ratio, 95% confidence interval) was not higher at stage 3a (1.44, 0.79-2.64) but was greater in stages 3b-5 (11.0, 6.3-19.5, 91.2, 53.2-156.2 and, 122.8, 67.9-222.0, respectively). Among modifiable risk factors, anemia and albuminuria significantly predicted either outcome, whereas hypertension only predicted mortality. CONCLUSIONS: In patients with CKD not referred to nephrology, risks of ESRD and mortality were higher in those with CKD stages 3b-5.

Opportunistic prostate-specific antigen screening in Italy: 6 years of monitoring from the Italian general practice database.

The practice of prostate-specific antigen (PSA) screening has been increasing in Italy despite uncertain scientific evidence and contrary recommendations from most scientific societies. In 2002, a survey of PSA screening diffusion among general practices was performed, looking for screening frequency and age pattern of screened individuals. The objective of this study was to assess whether the features of PSA screening did change after 6 years in the same considered setting. Using the data obtained from 500 Italian general practitioners providing information to the Health Search/CSD Patient database, we selected, for the study purpose 351,091 male individuals. We assumed PSA prescriptions performed during 2005-2008 in individuals without prostate cancer, or benign prostate disease, or urological symptoms history to have a screening purpose. Screening frequency was analyzed in the overall series, by year and by patient's age. Exposure to PSA screening (at least on PSA test in the considered period) of males aged over 50 years raised from 31.4% (confidence interval 95% 31.08-31.70%) during 2002 to 46.4% (confidence interval 95% 46.19-46.68%) during 2008. The highest yearly exposure to PSA screening (55%) and the highest frequency of repeat testing was observed in the 70-79 age range. PSA screening practice has continued to increase in Italy and is often performed in elderly people without any scientific rationale.

Venous thromboembolism in medical patients treated in the setting of primary care: a nationwide case-control study in Italy.

OBJECTIVES: The risk of venous thrombotic events (VTE) among medical outpatients is still not clear and it remains to be clarified whether medical diseases involve the same risk if managed at home or in hospital. The aim of this study was to evaluate in the setting of outpatient family medicine the relationship between VTE and medical conditions known to be at risk during a hospital stay. DESIGN AND SETTING: The study involved a nationwide retrospective observation according to a nested case-control method; 400 general practitioners throughout Italy constituted the network for data collection. Between 2001 and 2004, all cases recorded as having VTE were entered; ten control patients without VTE, matched by sex, physician, and age, were selected from the database for each case. RESULTS: The eligible population comprised 372,000 patients and 1,624 incident VTE were recorded. Univariate analysis indicated hospitalization (OR 5.02; 95% CI 4.01-6.29), cancer (OR 3.06; 95% CI 2.47-3.79), acute infectious disease (OR 2.93; 95% CI 1.94-4.43), neurological disease (OR 2.60; 95% CI 1.56-4.33), congestive heart failure (CHF) (OR 2.48; 95% CI 1.68-3.69), paralysis (OR 1.87; 95% CI 1.51-2.32), COPD (OR 1.58; 95% CI 1.29-1.95), stroke (OR 1.62; 95% CI 1.24-2.12), superficial venous thrombosis (OR 1.51; 95% CI 1.11-2.04, and rheumatic diseases (OR 1.49; 95% CI 1.28-1.74) as significantly associated with an increased risk for VTE. After adjustment, only transient or definitive paralysis, cancer, acute infectious disease, congestive heart failure, neurological diseases, and previous hospitalization remained associated. CONCLUSIONS: This large study indicates that VTE outpatients seen by general practitioners in Italy have a high prevalence of the same medical diseases associated with VTE among patients treated in hospital.