Incidence, associated disease burden and healthcare utilization due to Staphylococcus aureus prosthetic joint infection in European hospitals: the COMBACTE-NET ARTHR-IS multi-centre study.

BACKGROUND: The aim of this study was to estimate the incidence, associated disease burden and healthcare utilization due to Staphylococcus aureus prosthetic joint infections (SA-PJI) after primary hip and knee arthroplasty in European centres. METHODS: This study was conducted in patients who underwent primary hip and knee arthroplasty in 19 European hospitals between 2014 and 2016. The global incidence of PJI and SA-PJI was calculated. The associated disease burden was measured indirectly as infection-related mortality plus loss of function. For healthcare utilization, number and duration of hospitalizations, number and type of surgical procedures, duration of antibiotic treatments, and number of outpatient visits were collected. Subgroup and regression analyses were used to evaluate the impact of SA-PJI on healthcare utilization, controlling for confounding variables. RESULTS: The incidence of PJI caused by any micro-organism was 1.41%, and 0.40% for SA-PJI. Among SA-PJI, 20.7% were due to MRSA with substantial regional differences, and were more frequent in partial hip arthroplasty (PHA). Related deaths and loss of function occurred in 7.0% and 10.2% of SA-PJI cases, respectively, and were higher in patients with PHA. Compared with patients without PJI, patients with SA-PJI had a mean of 1.4 more readmissions, 25.1 more days of hospitalization, underwent 1.8 more surgical procedures, and had 5.4 more outpatient visits, controlling for confounding variables. Healthcare utilization was higher in patients who failed surgical treatment of SA-PJI. CONCLUSIONS: This study confirmed that the SA-PJI burden is high, especially in PHA, and provided a solid basis for planning interventions to prevent SA-PJI.

The relative burden of diabetes complications on healthcare costs: The population-based CINECA-SID ARNO Diabetes Observatory.

BACKGROUND AND AIMS: In the present population-based study, we aimed to describe the per patient annual healthcare cost of people with diabetes in 2007-2012, to assess the relative burden of diabetes complications and other potential determinants on healthcare costs in the 2012 cohort, and to describe and analyse the determinants of the cost of incident cases diagnosed in 2012. METHODS AND RESULTS: We analysed data from a retrospective cohort of residents in four Italian areas that were served by Local Health Units participating in the ARNO Observatory. Per patient annual healthcare costs (Euros) were estimated as the sum of all the resources supplied during that year (drugs, outpatient care, and hospitalisations). The mean per patient annual healthcare cost increased from €2752 in 2007 to €3191 in 2010, before decreasing to €2791 in 2012. The largest component of these costs was represented by hospitalisations (around €1550, on average; 51.7% of total cost), followed by outpatient care (€422; 14.6%) and drugs (€973; 33.7%). In 2012, the most relevant cost determinants were chronic diabetes complications, with an additional cost due to nephropathy/end stage renal disease (€4683), amputations (€5042), lower extremity revascularization (€4808), and cerebrovascular diseases (€3861). Costs associated with incidence cases were higher than those associated with prevalent. CONCLUSION: The present study provides evidence on the excess of healthcare costs due to diabetes complications in both prevalent and incident cases.

Adherence to alendronic or risedronic acid treatment, combined or not to calcium and vitamin D, and related determinants in Italian patients with osteoporosis.

PURPOSE: Osteoporosis is a chronic disease and an important health and social burden due to its worldwide prevalence. Literature and clinical experience report incomplete adherence to the therapy. This retrospective observational study aimed at assessing the adherence to first-line antiosteoporosis drugs (AODs; reimbursed by the National Health System, according to the Italian Medicine Agency recommendation number 79), alendronate or risedronate, with or without calcium and/or vitamin D supplements, in a real, Italian clinical setting. PATIENTS AND METHODS: Analyses were carried out on data present in the ARNO Observatory, a population-based patient-centric Italian database. From a population of 5,808,832 inhabitants with available data, a cohort of 3.3 million of patients aged ≥40 years was selected. New users of first-line AODs as monotherapy (accrual period, 2007-2009) were followed up over 3 years to assess adherence at 6, 12, and 36 months to AODs and to supplements and related determinants. RESULTS: Approximately 40,000 new users were identified: mostly women, aged on average (standard deviation) 71±10 years. Alendronate was the most prescribed (38.2% of patients), followed by risedronate (34.9%) and alendronate with colecalciferol as a fixed-dose combination (25.8%). Adherence at the 6-month follow-up was 54%, and this constantly and significantly decreased after 1 year to 46%, and after 3 years to 33% (P<0.01). Adherence to the fixed-dose combination was higher than to plain alendronate throughout the follow-up period. Similarly, adherence to supplements constantly decreased with the duration of treatment. Women and patients aged >50 years were more likely to adhere to treatment regimen (P<0.001). The use of drugs for peptic ulcer and gastroesophageal reflux disease and of corticosteroids for systemic use were significantly associated with high adherence at different times. Polytherapy (>5 drugs), cardiovascular, and neurological therapies were significantly associated with low adherence throughout the follow-up period. CONCLUSION: In a huge clinical practice sample, this study highlights suboptimal adherence to first-line AODs and to supplements and important determinants, such as concomitant therapies.

Oral antidiabetic therapy in a large Italian sample: drug supply and compliance for different therapeutic regimens.

OBJECTIVES: To define the main features of patients treated with oral antidiabetics, evaluating monotherapy (MT), loose-dose combination therapy (LDCT) and fixed-dose combination therapy (FDCT); to describe medication adherence to the different therapies; and to evaluate the differences in compliance with the prescribed therapy regimen among prevalent and incident patient cohorts. STUDY DESIGN: This study was a retrospective cohort analysis based on the ARNO database, a national record that tracks reimbursable prescription claims submitted from selected pharmacies to the Italian national health system. In total, 169,375 subjects, from an overall population of 4,040,624 were included in this study. The patients represented 12 different local health units. Each patient had at least one oral antidiabetic prescription claim (A10B ATC code). METHODS: Patients were divided into four groups according to their treatment regimen during the recruitment period (1 January 2008-31 December 2008): MT, FDCT, LDCT and switching therapy. A timespan of 5 years was considered, from 4 years before to 1 year after the index date (i.e. date of the prescription selected in the recruitment period). A medication possession ratio (MPR) with a cut-off value of 80% was used to measure medication adherence. Descriptive statistics and multiple logistic regression were used to define the objectives, while P < 0.05 was considered to indicate significance. RESULTS: The median age of patients (n = 169,375, prevalence 4.2%) was 70 years [interquartile range (IQR) 17], and 49.1% were females. Considering the entire sample, the median MPRs for the treatment regimens were: MT, 0.73 (IQR 0.53; 43.9% compliant); FDCT, 1 (IQR 0.29, 68,5% compliant); and LDCT, 0.89 (IQR 0.33, 60.3% compliant). FDCT and LDCT were significantly correlated with MPR. Compliance was 48.9% in the prevalent patient cohort (i.e. patients prescribed oral antidiabetic therapy in both prerecruitment and recruitment periods); median MPRs for the treatment regimens were: MT, 0.73 (IQR 0.52); FDCT, 1 (IQR 0.28); and LDCT, 0.90 (IQR 0.32). Compliance was 43.0% in the incident patient cohort (i.e. patients who were first prescribed oral antidiabetic therapy in the recruitment period); median MPRs for the treatment regimens were: MT, 0.70 (IQR, 0.58); FDCT, 1 (IQR 0.34); and LDCT, 0.64 (IQR 0.39). CONCLUSIONS: Compliance was better for FDCT than the other therapeutic regimens in the study population. The same trend was observed in both the prevalent and incident patient cohorts. As type 2 diabetes is a chronic lifelong pathology, and multiple agents are often required to achieve glycaemic control, the preference for FDCT in the population, when clinically applicable, could be an effective strategy for functional administration of clinical outcome and sources. Evaluation of specific population fractions (age, sex, compliance, etc.) and specific agents or drug combinations could also be relevant in order to reach the healthcare objectives.

Hospitalized patients with atrial fibrillation compared to those included in recent trials on novel oral anticoagulants: a population-based study.

BACKGROUND: Nonvalvular atrial fibrillation is associated with a substantial risk of stroke. Novel oral anticoagulants (NOACs) with predictable anticoagulant effect and no need for routine coagulation monitoring have recently shown good results when compared with warfarin in phase III clinical trials. OBJECTIVE: To describe clinical features and pharmacological treatments of a population-based cohort of patients with nonvalvular atrial fibrillation and ascertain whether they are comparable with those included in the three main phase III clinical trials on NOACs. RESULTS: Of the 2,862,264 subjects considered for this study 13,360 patients (0.47%) were recently discharged from the hospital with a diagnosis of nonvalvular atrial fibrillation. Mean age was 76.3 (SD 10.7), 49.8% were men and 64.6% were ≥75 years of age. 50% of patients were treated with warfarin and 44.1% with antiplatelet agents. The proportion of patients on antiplatelet therapy increased with age up to a rate of 54.3% in subjects ≥85 years. 92.9% of the studied cohort was on polypharmacy (mean 8 drugs/patient). Around 20% of the entire cohort was treated with amiodarone, a drug potentially interfering with NOACs, and 3.6% from a subgroup analysis had renal failure, which is an exclusion criterion in trials on NOACs. CONCLUSION: In patients recently discharged from the hospital with the diagnosis of nonvalvular AF, warfarin use decreases and aspirin treatment increases with patients' age. These patients are older, more frequently female, and on multiple medications. The benefit of NOACs in these subjects needs to be confirmed in phase IV clinical studies.

[Solitary small bowel metastasis after resection of bile duct carcinoma]. / Metastasi ileale solitaria da neoplasia biliare extraepatica precedentemente resecata.

Small bowel solitary metastases are a very rare occurrence and are more frequently recognized only in the presence of a severe complication, such as intestinal hemorrhage or occlusion. We report the case of a 75 year-old man who was admitted with a recent history of mechanical ileus developed one year after the surgical removal of an endoscopically intubated carcinoma of the extrahepatic biliary tree (pT3 pN0 Mx). A solitary metastasis of the small bowel, 30 cm from the ileo-cecal valve, was excised during the emergency laparotomy and a side-to-side anastomosis was performed to reconstruct the intestinal continuity. Patient was, thereafter, discharged in the 9th postoperative day. Local recurrence and intrabdominal dissemination are often observed in patients treated for bilio-pancreatic carcinoma. Preoperative invasive (ERCP, FNA, PTBD, etc.) diagnostic procedures and surgical tumor manipulation are associated with a greater risk of metastasis implantation and intraabdominal dissemination. In accordance to the literature, the authors propose, in cases with resectable bilio-pancreatic neoplasms, the use of standard external low dose radiotherapy prior to any invasive diagnostic procedure and/or surgical removal.