Italian Local Health Units Research Articles

Adherence to treatment and anticoagulation control in vitamin K antagonists-treated patients: an administrative databases analysis in a large Italian population

Oral anticoagulant therapy is essential for the treatment and prevention of many thromboembolic disorders. The aim of the present study is to evaluate the level of anticoagulation intensity in patients treated with vitamin K antagonists (VKAs) in a clinical practice setting and to explore the relationship between anticoagulation intensity and adherence to VKA treatment. We conducted a retrospective cohort study using the administrative databases of three Italian Local Health Units. Patients were enrolled if they had filled at least one prescription for VKAs (ATC code B01AA) between January 1st, 2007 and June 30th, 2008. In the same period all determinations of the international normalised ratio (INR) were collected. The parameters evaluated were anticoagulation control and adherence to VKA treatment.The survey showed that only 47.9% and 56.3% of INR determinations, in VKA naïve and established patients respectively, were into the recommended range (2.0-3.0). Moreover, the percentage of INR determination below the recommended range was higher than the percentage of INR determination above the recommended range for both naïve and established patients. Moreover, adherence to VKA treatment was poor both in naïve and established patients and, consequently, anticoagulation control is poor. Also in patients with the highest adherence to VKA treatment, only about 60% of INR determinations were into the recommended range. Our findings evidence that the anticoagulation control in clinical practice settings is still unsatisfactory and it is necessary to evaluate interventions to increase the amount of time at which patients’ INR are within the recommended range.

Benefits of double reading of screening mammograms: retrospective study on a consecutive series

The purpose of this study was to assess the performance of delayed second reading of screening mammograms when added to real-time reading plus immediate assessment. The study setting was the mammography screening programme of an Italian Local Health Unit. Recall rate and cancer detection rate at first reading or informed second reading only were assessed in a cohort of 23,629 women aged 50-69 years screened during 2007-2008. Incremental recall rate, incremental cancer detection rate and incremental cost of second reading were determined. Recall rate was 13.0% at first and 2.7% at second reading (incremental recall rate +21.1%). Overall, recalls were more frequent in the younger decade and in the presence of denser breasts. Cancer detection rate was 7.06‰ (n=167) at first and 0.93‰ (n=22) at second reading (incremental cancer detection rate +13.1%). Compared with first reading, second reading detected more cancers depicted as isolated microcalcifications and distortions (40.9% vs. 16.2%, p=0.02) and at a lower stage (stage 0-I 81.8% vs. 69.5%, p=0.34). The cost of adding delayed second reading was + <euro> 3.65 per screened individual or <euro> 3,926.61 per incremental cancer detected. The study confirms the efficacy of second reading, even as an adjunct to real-time single reading plus immediate assessment. Incremental recall rate is acceptable in view of the incremental cancer detection rate, and both figures are within the range of literature reports on double-reading performance.

Surveillance of perceptions, knowledge, attitudes and behaviors of the Italian adult population (18–69 years) during the 2009–2010 A/H1N1 influenza pandemic

Monitoring perceptions, knowledge, attitudes and behaviors of populations during pandemic flu outbreaks is important as it allows communication strategies to be adjusted to meet emerging needs and assessment to be made of the effects of recommendations for prevention. The ongoing Italian Behavioral Risk Factor Surveillance System (PASSI) offered the setting for investigating people's opinions and behaviors regarding the A/H1N1 pandemic. PASSI surveillance is carried out in 126/148 Italian Local Health Units (LHU) through monthly telephone interviews administered by public health staff to a random sample of the resident population 18-69 years. In fall 2009 additional questions exploring issues related to the A/H1N1 flu were added to the standard questionnaire. The pandemic module was administered on a voluntary basis by the 70 participating LHUs from November 2nd, 2009 to February 7th, 2010; 4 047 interviews were collected. Overall 33% of respondents considered it likely that they would catch flu, 26% stated they were worried, 16% reported having limited some daily activities out of home and 22% said they would accept vaccination if offered. All these indicators showed a decreasing trend across the four-month period of observation. The most trusted sources of information were family doctors (81%). Willingness to be vaccinated was associated with worry about pandemic, age, sex, having a chronic disease and timing of the interview. The surveillance allowed us to gather relevant information, crucial for devising appropriate public health interventions. In future disease outbreaks, systems monitoring people's perceptions and behaviors should be included in the preparedness and response plans.

Social determinants effects from the Italian risk factor surveillance system PASSI

To offer examples on how risk factor surveillance systems can help in providing useful information on social determinants effects and health inequalities. The Italian risk factor surveillance system (PASSI) collects monthly information from most of the Italian Local Health Units (over 85% of the Italian population is covered) on major health-related behaviours together with information on health practices, attitudes and opinions. Multivariate analysis of associations with possible indicators of social determinants collected by the system, offers important indications on the value that the system has in providing useful information on the effects of social determinants. Social determinants, although measured through very simple indicators, have major influence on health outcomes (in the example here, depression), geographical disparities in health (efficacy of smoking ban), and access to preventive services (pap test in our analysis). Risk factor surveillance can offer valuable information for monitoring social determinants effects and inequalities, and, when considering data over time, for evaluating the gross impact of future interventions and policies aimed at reducing them.

Analisi di minimizzazione dei costi degli agenti stimolanti l’eritropoiesi nel trattamento dell’anemia indotta da chemioterapia

Administration of Erythropoietin Receptor Agonists (ERAs) is indicated as standard of care for treatment of anaemia in cancer patients. Considering the Italian setting, only limited information is available on the economic impact of ERAs epoetin alfa, epoetin beta and darbepoetin alfa in the treatment of anaemic cancer patients. So, this analysis was conducted to compare cost per patient of each of these agents. Data for this retrospective study were derived from the administrative database of a middle-sized (half a million beneficiaries) Local Health Unit in Northern Italy. A sample was built by selecting all patients who, between 2005 and 2006, had a cancer diagnosis and had received at least two prescription for ERA. The study evaluated durations of treatments and weekly costs associated with either treatment. The original sample consisted of 322 patients (mean age: 65.6 years, 52.5% females). The mean duration of treatment was 7.52 weeks for epoetin alfa and 8.68 weeks for darbepoetin alfa (p = 0.16). The annual mean cost of treatment was €2,413.23/patient treated with epoetin alfa and €3,492.23/patient (+45%) treated with darbepoetin alfa (p < 0.001). Based on data from an Italian Local Health Unit, we performed an analysis focused on the use of ERAs in the treatment of anemia in cancer patients. Analysis results were interesting, particularly as attempt to estimate the annual mean cost of treatment between epoetin alfa and darbepoetin alfa, which resulted consistent with a previous European study. This evaluation showed that epoetin is a cost-saving strategy compared with darbepoetin alfa in the treatment of cancer patients anaemia. An important limitation was that patient records did not provide an indicator of disease severity.

Hospital discharge planning and continuity of care for aged people in an Italian local health unit: does the care-home model reduce hospital readmission and mortality rates?

BackgroundHospital discharge planning is aimed to decrease length of stay in hospitals as well as to ensure continuity of health care after being discharged. Hospitalized patients in Turin, Italy, who are in need of medical, social and rehabilitative care are proposed as candidates to either discharge planning relying on a care-home model (DPCH) for a period of about 30 days, or routine discharge care. The aim of this study was to evaluate whether a hospital DPCH that was compared with routine care, improved patients' outcomes in terms of reduced hospital readmission and mortality rates in patients aged 64 years and older.MethodsIn a retrospective observational cohort study a sample of 380 subjects aged 64 years and over was examined. Participants were discharged from the hospital S.Giovanni Bosco in Turin, Italy from March 1st, 2005 to February 28th, 2006. Of these subjects, 107 received routine discharge care while 273 patients were referred to care-home (among them, 99 received a long-term care intervention (LTCI) afterwards while 174 did not). Data was gathered from various administrative and electronic databases. Cox regression models were used to evaluate factors associated with mortality and hospital readmission.ResultsWhen socio-demographic factors, underlying disease and disability were taken into account, DPCH decreased mortality rates only if it was followed by a LTCI: compared to routine care, the Hazard Ratio (HR) of death was 0.36 (95% Confidence Interval (CI): 0.20 – 0.66) and 1.15 (95%CI: 0.77 – 1.74) for DPCH followed by LTCI and DPCH not followed by LTCI, respectively. On the other hand, readmission rates did not significantly differ among DPCH and routine care, irrespective of the implementation of a LTCI: HRs of hospital readmission were 1.01 (95%CI: 0.48 – 2.24) and 1.18 (95%CI: 0.71 – 1.96), respectively.ConclusionThe use of DPCH after hospital discharge reduced mortality rates, but only when it was followed by a long-term health care plan, thus ensuring continuity of care for elderly participants.

Drug utilisation profile in the Italian paediatric population

In order to evaluate the prescribing pattern in the Italian paediatric population, prescriptions involving 923,353 children under 14 years old and dispensed during 2006 by the retail pharmacies of 22 Italian local health units were analysed. A total of 561,237 children (61%) received at least one drug prescription. The prescription prevalence rate was highest in children 3 years of age (78%), decreased with increasing age and was higher in boys than in girls (chi(2)=655; p<<0.001). Each treated child received an average of 3.2 prescriptions and 4.8 boxes. Antibiotics and anti-asthmatics were the more prescribed therapeutic classes and represented 80% of prescriptions. Amoxicillin+clavulanic acid was the most prescribed drug (24% of the overall population; 17% of all boxes), followed by inhaled beclometasone and amoxicillin. A total of 620 different drugs were prescribed and the ten leading drugs represented 64% of the prescribed boxes. Six of the ten most prescribed drugs were the same in all age groups. Wide differences were found in the prevalence rate between the different local health units; these ranged between 50.1 and 68.4% (p<<0.001). The prescription prevalence increased in the 2000-2002 period (from 62.2 to 68.3%) and slightly decreased afterwards. Despite some limitations, the systematic monitoring of prescriptions is a valuable tool for evaluating the appropriateness of the care.

Evaluation of the prescription and utilization patterns of statins in an Italian local health unit during the period 1994–2003

The prescription pattern of statins in the Local Health Unit (LHU) of Treviso (northern Italy) over a 10-year period was evaluated, with the aim of evaluating the persistence with and adherence to therapy. Data on 21,393 subjects who received at least one prescription for statins during the period between January 1, 1994 and December 31, 2003 were retrieved from the LHU database in order to track the pharmacological history of individual patients. The data included age, sex, drug formulation, strength, number of drug packages prescribed, and prescription date. The adopted indicators for drug utilization included the Defined Daily Dose (DDD), the Received Daily Dose (RDD), and a surrogated Prescribed Daily Dose (sPDD), extrapolated from available prescription data. An Adherence to Therapy Index (ATI) was calculated from the ratio between the amount of drug actually prescribed and the amount of sPDD. Based on the ATI, patients were grouped into non-adherent, poor-adherent, and good-adherent groups. The distribution of adherence level among patient-age classes and statin-prescribed patients in primary or secondary prevention was evaluated. All drug-utilization indicators showed an increase in statin use over the study period in terms of both the number of prescribed patients and the sPDD. Persistence with and adherence to therapy remained low, with a 50% discontinuation rate in the first year, and persistent patients did not follow the therapy regularly. Patients in secondary prevention were the most adherent to their drug regimen, although only 41% of these had a good compliance. Our findings suggest an increase in statin use which is, however, accompanied by poor patient persistence with and adherence to statin therapy.

Neonatal polycythaemia

Nonalcoholic steatohepatitis (NASH) may progress to advanced liver disease (AdvLD). This study characterized comorbidities, healthcare resource utilization (HCRU) and associated costs among hospitalized patients with AdvLD due to NASH in Italy.Adult nonalcoholic fatty liver disease (NAFLD)/NASH patients from 2011 to 2017 were identified from administrative databases of Italian local health units using ICD-9-CM codes. Development of compensated cirrhosis (CC), decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC), or liver transplant (LT) was identified using first diagnosis date for each severity cohort (index-date). Patients progressing to multiple disease stages were included in >1 cohort. Patients were followed from index-date until the earliest of disease progression, end of coverage, death, or end of study. Within each cohort, per member per month values were annualized to calculate all-cause HCRU or costs(€) in 2017.Of the 9,729 hospitalized NAFLD/NASH patients identified, 97% were without AdvLD, 1.3% had CC, 3.1% DCC, 0.8% HCC, 0.1% LT. Comorbidity burden was high across all cohorts. Mean annual number of inpatient services was greater in patients with AdvLD than without AdvLD. Similar trends were observed in outpatient visits and pharmacy fills. Mean total annual costs increased with disease severity, driven primarily by inpatient services costs.NAFLD/NASH patients in Italy have high comorbidity burden. AdvLD patients had significantly higher costs. The higher prevalence of DCC compared to CC in this population may suggest challenges of effectively screening and identifying NAFLD/NASH patients. Early identification and effective management are needed to reduce risk of disease progression and subsequent HCRU and costs.

Inappropriate use of anti-asthmatic drugs in the Italian paediatric population.

To evaluate anti-asthmatic drug prescriptions in a large Italian paediatric population. Prescriptions involving 417,559 children younger than 14 years old dispensed during 2000 by the retail pharmacies of 17 Italian local health units participating in the ARNO project were analysed. In the study, 92,890 children (22.2%) received at least one anti-asthmatic drug prescription. The prevalence of prescriptions was higher in children less than 1 year old, significantly decreased with increasing age, and was higher in boys than in girls. Of children treated with anti-asthmatic drugs, 71.5% received prescriptions of less than three boxes. Beclomethasone, salbutamol, flunisolide and fluticasone were the most prescribed drugs. Beclomethasone and flunisolide were prescribed mostly as nebulised suspension. The data suggest that anti-asthmatic drugs are often prescribed for diseases different from asthma and that many children are exposed to treatments for which there is no evidence of efficacy.

Survival of patients with recurrent malignant glioma treated with temozolomide: a retrospective observational study.

To assess whether the survival of patients with recurrent malignant glioma receiving temozolomide in everyday practice is comparable to that reported in previous studies. We conducted a retrospective observational study that included patients with recurrent malignant glioma who where treated with temozolomide. The study was based on prospective clinical databases managed by the Italian Local Health Units; the databases are required by Italian Law 648/96 for patients treated with temozolomide before drug approval by the reimbursement agency of the Italian Ministry of Health. 201 patients who had received temozolomide during the qualifying period of Law 648/96 for this drug (from 11 March 1998 to 30 September 2000) were included in our study. The clinical indications for temozolomide were glioblastoma multiforme (n = 123), anaplastic astrocytoma (n = 49) or other indications (n = 28). One patient did not have an indication reported. The median survival for patients with glioblastoma multi-forme and anaplastic astrocytoma was 13 and 20.3 months, respectively (with survival rates at 6 months of 81% and 78%, respectively). In our group of 49 patients with anaplastic astrocytoma, the survival plateau observed between 22 and 37 months (with no fatalities over this long time interval) suggested a favourable outcome, although restricted to a small subgroup. The 123 patients with glioblastoma multiforme showed a slightly better survival than that reported previously, but all patients died before 32 months. This observational study extends the previous information regarding the efficacy of temozolomide and provides survival data from patients treated in everyday practice.

Reactogenicity in the elderly of nine commercial influenza vaccines: results from the Italian SVEVA study

A 10-fold increase of reported adverse events following influenza vaccination in the 1995–1996 campaign was reported. To evaluate the relative reactogenicity of different influenza vaccines a prospective observational study was conducted in 72 Italian local health units (LHU) in the period October–December 1996. Of the 16,637 enrolled individuals aged 65 or more, 27.4% reported the occurrence of at least one adverse event within 72 h of vaccination. The odds ratios, adjusted through a multivariate logistic model, were highest for whole vaccine recipients. Most of the observed events were of moderate clinical severity and were mainly represented by local symptoms. None of the products was found to show an unusual or concerning reactogenicity profile, and no severe events associated with immunization were reported.