An overview of Clinical Quality Registries (CQRs) on gynecological oncology worldwide.

INTRODUCTION: Clinical Quality Registries (CQRs) were initiated in order to compare clinical outcomes between hospitals or regions within a country. To get an overview of these CQRs worldwide the aim of this study was to identify these CQRs for gynecological oncology and to summarize their characteristics, processes and QI's and to establish whether it is feasible to make an international comparison in the future. METHODS: To identify CQRs in gynecological oncology a literature search in Pubmed was performed. All papers describing the use of a CQR were included. Administrative, epidemiological and cancer registries were excluded as these registries do not primarily serve to measure quality of care through QI's. The taskforce or contact person of the included CQR were asked to participate and share information on registered items, processes and indicators. RESULTS: Five nations agreed to collaborate: Australia, Denmark, Italy, the Netherlands and Sweden. Denmark, Netherlands and Sweden established a nationwide registry, collecting data on multiple tumor types, and various QI's. Australia and Italy included patients with ovarian cancer only. All nations had a different process to report feedback results to participating hospitals. CONCLUSION: CQRs serve the same purpose to improve quality of care but vary on different aspects. Although similarities are observed in the topics measured by the QI's, an international comparison was not feasible as numerators or denominators differ between registries. In order to compare on an international level it would be useful to harmonize these registries and to set an international standard to measure the quality of care with similar indicators.

Bilateral nephrectomy as an extreme measure management for methicillin-resistant staphylococcus aureus (MRSA): A case report.

Methicillin-resistant Staphylococcus aureus (MRSA) infections are cases of urgent management that often leads to hospitalizations in intensive care and prolonged management of antibiotic therapy. In this occasion, we present the case of a 38-year-old female patient with sepsis secondary to banal dermal infection due MRSA that complicates with infectious thrombus of the left renal vein associated with multiple foci of bilateral renal abscesses. As an extreme and exceptional measure, emergency bilateral radical nephrectomy was performed to save the patient's life.

The non-euphoric phytocannabinoid cannabidivarin counteracts intestinal inflammation in mice and cytokine expression in biopsies from UC pediatric patients.

Patients with ulcerative colitis (UC) using marijuana have been reported to experience symptomatic benefit. Cannabidivarin (CBDV) is a safe non-psychoactive phytocannabinoid able to activate and desensitize TRPA1, a member of the TRP channels superfamily, which plays a pivotal role in intestinal inflammation. Here, we have investigated the potential intestinal anti-inflammatory effect of CBDV in mice and in biopsies from pediatric patients with active UC. Colonic inflammation was induced in mice by dinitrobenzenesulfonic acid (DNBS). The effect of orally administered CBDV on macroscopic and microscopic damage, inflammatory parameters (i.e. myeloperoxidase activity, intestinal permeability and cytokine production) and faecal microbiota composition, was evaluated 3 days after DNBS administration. TRPA1 expression was studied by RT-PCR in inflamed colons of mice as well as in mucosal colonic biopsies of children with active UC, whose response to incubation with CBDV was also investigated. CBDV attenuates, in a TRPA1-antagonist sensitive manner, DNBS-induced signs of inflammation including neutrophil infiltration, intestinal permeability, and cytokine (i.e. IL-1ß, IL-6 and the chemokine MCP-1) production. CBDV also alters the dysregulation of gut microbiota associated to colitis. Finally, CBDV lessens cytokine expression in colonic biopsies from pediatric patients with ulcerative colitis, a condition in which TRPA1 was up-regulated. Our preclinical study shows that CBDV exerts intestinal anti-inflammatory effects in mice via TRPA1, and in children with active UC. Since CBDV has a favorable safety profile in humans, it may be considered for possible clinical trials in patients with UC.

NADPH oxidase 2 inhibitors CPP11G and CPP11H attenuate endothelial cell inflammation & vessel dysfunction and restore mouse hind-limb flow.

First described as essential to the phagocytic activity of leukocytes, Nox2-derived ROS have emerged as mediators of a range of cellular and tissue responses across species from salubrious to deleterious consequences. Knowledge of their role in inflammation is limited, however. We postulated that TNFα-induced endothelial reactive oxygen species (ROS) generation and pro-inflammatory signaling would be ameliorated by targeting Nox2. Herein, we in silico-modelled two first-in-class Nox2 inhibitors developed in our laboratory, explored their cellular mechanism of action and tested their efficacy in in vitro and mouse in vivo models of inflammation. Our data show that these inhibitors (CPP11G and CPP11H) disrupted canonical Nox2 organizing factor, p47phox, translocation to Nox2 in the plasma membrane; and abolished ROS production, markedly attenuated stress-responsive MAPK signaling and downstream AP-1 and NFκB nuclear translocation in human cells. Consequently, cell adhesion molecule expression and monocyte adherence were significantly inhibited by both inhibitors. In vivo, TNFα-induced ROS and inflammation were ameliorated by targeted Nox2 inhibition, which, in turn, improved hind-limb blood flow. These studies identify a proximal role for Nox2 in propagated inflammatory signaling and support therapeutic value of Nox2 inhibitors in inflammatory disease.

Diagnostic accuracy and cost-effectiveness of different strategies to triage women with adnexal masses: a prospective study.

OBJECTIVE: Transvaginal sonography (TVS) and serum biomarkers are used widely in clinical practice to triage women with adnexal masses, but the effectiveness of current biomarkers is weak. The aim of this study was to determine the best method of diagnosing patients with adnexal masses, in terms of diagnostic accuracy and economic costs, among four triage strategies: (1) the International Ovarian Tumor Analysis group's simple rules (SR) for interpretation of TVS with subjective assessment (SA) by an experienced ultrasound operator when TVS results are inconclusive (referred to hereafter as SR ± SA), (2) SR ± SA and cancer antigen 125 (CA 125), (3) SR ± SA and human epididymis protein 4 (HE4) and (4) SR ± SA and the risk of malignancy algorithm (ROMA). Our main hypothesis was that the addition of the biomarkers to SR ± SA could improve triaging of these patients in terms of diagnostic accuracy (i.e. malignant vs benign). As secondary analyses, we estimated the cost effectiveness of the four strategies and the diagnostic accuracy of SR ± SA at the study hospitals. METHODS: Between February 2013 and January 2015, 447 consecutive patients who were scheduled for surgery for an adnexal mass at the S. Anna and Mauriziano Hospitals in Turin were enrolled in this multicenter prospective cohort study. Preoperative TVS was performed and preoperative CA 125 and HE4 levels were measured. Pathology reports were used to assess the diagnostic accuracy of the four triage strategies and the cost of each strategy was calculated. RESULTS: A total of 391 patients were included in the analysis: 57% (n = 221) were premenopausal and 43% (n = 170) were postmenopausal. The overall prevalence of malignancy was 21%. SR were conclusive in 89% of patients and thus did not require SA; the overall performance of SR ± SA showed a sensitivity of 82%, specificity of 92% and positive and negative predictive values and positive and negative likelihood ratios of 74%, 95%, 10.5 and 0.19, respectively. In premenopausal women, mean cost among the four triage strategies varied from €36.41 for SR ± SA to €70.12 for SR ± SA + ROMA. The addition of biomarkers to SR ± SA showed no diagnostic advantage compared with SR ± SA alone and was more costly. Among postmenopausal women, mean cost among the four triage strategies varied from €39.52 for SR ± SA to €73.23 for SR ± SA + ROMA. Among these women, SR ± SA + CA 125 and SR ± SA + ROMA had a higher sensitivity (both 92% (95% CI, 85-99%)) than SR ± SA (81% (95% CI, 71-91%)), but SR ± SA had a higher specificity (84% (95% CI, 77-91%)). SR ± SA + CA 125 and SR ± SA + ROMA improved diagnostic accuracy, each diagnosing a third more malignant adnexal masses. In postmenopausal women, compared with SR ± SA alone, SR ± SA + CA 125 showed a net reclassification improvement (NRI) of 28.8% at an extra cost of €13.00, while the extra cost for SR ± SA + ROMA was €33.71, with a comparable gain, in terms of NRI, as that of SR ± SA + CA 125. CONCLUSIONS: In our study sample, SR ± SA seems to be the best strategy to triage women with adnexal masses for surgical management. Among postmenopausal women, SR ± SA + CA 125 increased the NRI at a reasonable extra cost. Our data do not justify the use of HE4 and ROMA in the initial triage of women with adnexal masses. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

Incidence, prevalence, costs and quality of care of type 1 diabetes in Italy, age 0-29 years: The population-based CINECA-SID ARNO Observatory, 2002-2012.

BACKGROUND AND AIMS: To assess temporal trend in incidence (2003-12) and prevalence (2002-12) of type 1 diabetes in children and young adults, direct costs and selected indicators of quality of care under the coverage of the universalistic Italian National Health System (NHS). METHODS AND RESULTS: The ARNO Observatory, a healthcare monitoring system based on administrative data, identified a population-based multiregional cohort of subjects aged 0-29 years. Type 1 diabetes was defined by at least two prescriptions of insulin over 12 months and continuous insulin-treatment in the following year. Indicators of quality of care and directs costs were assessed in persons with diabetes and in people without diabetes, individually matched for age, gender and health unit (1:4 ratio). We identified 2357 incident cases of type 1 diabetes aged 0-29 years (completeness of ascertainment, 99%). Incidence rates were similar in ages 0-14 (15.8, 95% CI 14.9-16.8) and 15-29 years (16.3, 15.4-17.2), with no significant trend. Prevalence increased from 137 to 166.9/100,000, particularly in the age 15-29 years. Direct costs accounted for € 2117 in persons with diabetes and € 292 in control individuals. A statistically significant decreasing trend in hospitalization for acute complications was evident (p < 0.001), which was almost completely due to ketoacidosis. People with at least one HbA1c measurement over the year were 48.5%. CONCLUSION: We showed high incidence and increasing prevalence of type 1 diabetes in young adults in Italy, which impact on direct costs under the universalistic coverage of the NHS.

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.

Bone substitutes in orthopaedic surgery: from basic science to clinical practice.

Bone substitutes are being increasingly used in surgery as over two millions bone grafting procedures are performed worldwide per year. Autografts still represent the gold standard for bone substitution, though the morbidity and the inherent limited availability are the main limitations. Allografts, i.e. banked bone, are osteoconductive and weakly osteoinductive, though there are still concerns about the residual infective risks, costs and donor availability issues. As an alternative, xenograft substitutes are cheap, but their use provided contrasting results, so far. Ceramic-based synthetic bone substitutes are alternatively based on hydroxyapatite (HA) and tricalcium phosphates, and are widely used in the clinical practice. Indeed, despite being completely resorbable and weaker than cortical bone, they have exhaustively proved to be effective. Biomimetic HAs are the evolution of traditional HA and contains ions (carbonates, Si, Sr, Fl, Mg) that mimic natural HA (biomimetic HA). Injectable cements represent another evolution, enabling mininvasive techniques. Bone morphogenetic proteins (namely BMP2 and 7) are the only bone inducing growth factors approved for human use in spine surgery and for the treatment of tibial nonunion. Demineralized bone matrix and platelet rich plasma did not prove to be effective and their use as bone substitutes remains controversial. Experimental cell-based approaches are considered the best suitable emerging strategies in several regenerative medicine application, including bone regeneration. In some cases, cells have been used as bioactive vehicles delivering osteoinductive genes locally to achieve bone regeneration. In particular, mesenchymal stem cells have been widely exploited for this purpose, being multipotent cells capable of efficient osteogenic potential. Here we intend to review and update the alternative available techniques used for bone fusion, along with some hints on the advancements achieved through the experimental research in this field.

[Pseudotumoral pulmonary AL amyloidosis]. / Amylose AL pulmonaire de forme pseudo-tumorale.

INTRODUCTION: Thoracic involvement in amyloidosis is rare. An isolated pseudotumor without extra-thoracic disease suggests a malignant process. We present the case of a patient with pseudonodular AL amyloidosis, confirmed by lobar lung resection. CASE REPORT: A 57-year-old woman, with a 25-pack-year smoking history, presented with a nodular opacity on chest x-ray. Physical examination was normal. Thoracic CT-scan revealed an isolated spiculated nodule in the right upper lobe. A whole body positron emission tomography (PET) scan revealed high FDG activity in this nodule, without evidence of metastatic disease. Bronchoscopy was negative. Lobectomy revealed lambda L-chain amyloidosis. Investigation for systemic extension was negative. Follow up has been unremarkable. CONCLUSION: A spiculated lung nodule on conventional imaging (radiography, scanner) is cancer until proven otherwise. The use of PET scan in this context is sensitive but not specific. Definitive diagnosis must be obtained by histological examination. Nodular lung amyloidosis must be included in the differential diagnosis of lung nodules and false-positive FDG PET.

Prediction of mortality and macrovascular complications in type 2 diabetes: validation of the UKPDS Outcomes Model in the Casale Monferrato Survey, Italy.

AIMS/HYPOTHESIS: The United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model can be used to estimate the lifetime occurrence of major diabetes-related complications in order to calculate health economic outcomes. The aim of the study was to assess the performance of the model by comparing the predicted and observed mortality and the incidence of macrovascular complications in an Italian population-based cohort with type 2 diabetes. METHODS: We used data from the Casale Monferrato Survey, a cohort enrolled in 1988 and surveyed in 1991 (n = 1,967) to assess the prevalence of cardiovascular risk factors. In 2000, a new survey included all the members of the original cohort who were still alive (n = 860), and in addition all individuals identified with a new diagnosis of type 2 diabetes since 1993 (n = 2,389). We compared the mortality predicted by the model for the 1991 survey over the subsequent 17-year period with the observed risk. The following outcomes were analysed in the 2000 survey: myocardial infarction (MI), other ischaemic heart disease, stroke, congestive heart failure (CHF) and amputation. RESULTS: For all-cause mortality, the predictions from the model at 5 and 10 years (23% and 47%, respectively) were identical to the observed risks. At 15 years, the risk of death was slightly overestimated (an estimate of 67% vs 64% observed, 95% CI 61%, 66%). The performance of the model was best for patients with a recent history of disease (duration <6 years). Among the complications, the predicted cumulative incidences of MI and CHF were very close to those observed. CONCLUSIONS/INTERPRETATION: External validation is essential to assess the accuracy of simulation models. The UKPDS Outcomes Model satisfactorily predicted a set of actual incidences of mortality and complications in an Italian diabetes cohort up to a duration of approximately 12 years. The longer term performance of such models should be carefully evaluated.

Collatamp sponges in the management of open fractures.

Open fractures are at high risk of infection and the prompt treatment of these injuries is critical to the success and is crucial to reduce the rate of complications. The basic steps of treatment include the immediate administration of systemic antibiotics, early surgical stabilization of the fracture associated with copious irrigation and radical debridement of the site of exposure, and when possible adequate soft tissue coverage. The systemic antibiotic therapy significantly improves the prognosis and reduces the occurrence of complications. However, in order to ensure adequate and sustained local concentration of antibiotic agent, high doses and for a long time are necessary. This increases the risk of side effects and bacterial resistance. The introduction of the antibiotic-loaded collagen sponges offers the advantages of a high local concentrations of antibiotic carrier delivering system with reduced systemic drug diffusion (less risk of side effects and resistance rate). Sponges are also biodegradable and fully resorbable and do not require additional surgery for their removal.

Bioplasty for vertebral fractures: preliminary results of a pre-clinical study on goats using autologous modified skin fibroblasts.

The debate is still ongoing about the long term effects of the mininvasive vertebral augmentation techniques and their usefulness in treating more complex cases where a bone inducing effect more than a merely bone substitution would be suitable, such as the vertebral fractures in young patients. We previously developed a clinically relevant gene therapy approach using modified dermal fibroblasts for inducing bone healing and bone formation in different animal models. The aim of this study is to show the feasibility of a minimally invasive percutaneous intrasomatic ex vivo gene therapy approach to treat thoracolumbar vertebral fractures and anterior column bone defects in a goat model.

The use of collatamp in total hip arthroplasty.

Total Hip Arthroplasty (THA) is one of the most common orthopedic operations in the world. The number of THA is expected to grow and with it the number of associated complications. Although improved surgical technique and the development of more scrupulous asepsis has decreased the incidence of periprosthetic joint infection (PJI), it remains one of the most feared complications of joint arthroplasty. The purpose of this study is to present the use of antibiotic-loaded collagen sponges (Collatamp EG) in the prophylaxis and treatment of PJI. For this scope a case report is described. The advantages offered by the antibiotic loaded sponges in terms of high and sustained concentration of antibiotic at the site of infection, diffused by the fully reabsorbable carrier, showed to be a an important adjuvant therapy in the treatment of PJI. Low systemic concentration of the drug and a wide versatility in surgical application are other advantages of this dispositive.

A decision-tree model to estimate the impact on cost-effectiveness of a venous thromboembolism prophylaxis guideline.

BACKGROUND AND OBJECTIVE: The impact of clinical guidelines (GL) on venous thromboembolism (VTE) prophylaxis was evaluated in a large Italian hospital with a before/after study. GL were effective in increasing the appropriateness of prophylaxis and in reducing VTE. Following this study, the aim was to estimate the impact of the adopted GL on costs and benefits through a cost-effectiveness analysis. METHODS: A decision-tree model was used to compare prophylaxis costs and effects before and after GL implementation. All patients were classified into four risk profiles (low, moderate, high, very high). Outcomes considered were: no event, asymptomatic VTE, symptomatic VTE, fatal pulmonary embolism and major bleeding. Patient risks and the probability of receiving prophylaxis were defined using data from the previous study. Outcome probabilities were derived from the literature. Regional Drg reimbursements and hospital figures were used for costing the events. RESULTS: Despite a marked increase in the number of patients receiving some form of prophylaxis, it was estimated that the introduction of GL reduced the average cost per patient related to VTE from euro210 to euro181 (-14%), with a parallel absolute decrease in VTE complications (-5%). Results are particularly relevant in the very-high-risk group. Sensitivity analysis confirmed the overall cost savings and gains in effectiveness. CONCLUSIONS: The implementation of locally adapted GL on VTE prophylaxis may lead to a benefit in terms of both costs and effects, especially for the highest-risk patients.

A biological role for the gonadotrophin-releasing hormone (GnRH) metabolite, GnRH-(1-5).

Gonadotrophin-releasing hormone (GnRH) was first isolated in the mammal and shown to be the primary regulator of the reproductive system through its initiation of pituitary gonadotrophin release. Subsequent to its discovery, this form of GnRH has been shown to be one of many structural variants found in the brain and peripheral tissues. Accordingly, the original form first discovered and cloned in the mammal is commonly referred to as GnRH-I. In addition to the complex regulation of GnRH-I synthesis, release and function, further evidence suggests that the processing of GnRH-I produces yet another layer of complexity in its activity. GnRH-I is processed by a zinc metalloendopeptidase EC 3.4.24.15 (EP24.15), which cleaves the hormone at the covalent bond between the fifth and sixth residue of the decapeptide (Tyr(5)-Gly(6)) to form GnRH-(1-5). It was previously thought that the cleavage of GnRH-I by EP24.15 represents the initiation of its degradation. Here, we review the evidence for the involvement of GnRH-(1-5), the metabolite of GnRH-I, in the regulation of GnRH-I synthesis, secretion and facilitation of reproductive behaviour.

Appropriateness of early breast cancer management in relation to patient and hospital characteristics: a population based study in Northern Italy.

Administrative data may provide valuable information for monitoring the quality of care at population level and offer an efficient way of gathering data on individual patterns of care, and also to shed light on inequalities in access to appropriate medical care. The aim of the study was to investigate the role of patient and hospital characteristics in the initial treatment of early breast cancer using administrative data. Incident breast cancer patients were identified from hospital discharge records and linked to the radiotherapy outpatient database during 2000-2004 in the Piedmont region of Northwestern Italy. Women treated with breast-conserving surgery followed by radiotherapy (BCS + RT) were compared to those treated with BCS without radiotherapy (BCS w/o RT) or mastectomy using multinomial logistic regression models. Out of 16,022 incident cases, 46.2% received BCS + RT, 20.3% received BCS w/o RT, and 33.5% received a mastectomy. Compared to BCS + RT, the factors associated with BCS w/o RT were: increased age (OR = 1.54; 95% CI = 1.29-1.85, for ages 70-79 vs. <50), being unmarried (1.24; 1.13-1.36), presence of co-morbidities (1.32; 1.10-1.58), being treated at hospitals with low surgical volume (1.31; 1.07-1.60 for hospitals with less than 50 vs. > or =150 interventions/year), and living far from radiotherapy facilities (1.75; 1.39-2.20 for those at a distance of >45 min). These same factors were also associated with mastectomy. During the 5-year period observed, there was a trend of reduced probability of receiving a mastectomy (0.70; 0.56-0.88 for 2004 vs. 2000). The presence or absence of nodal involvement was positively associated with mastectomy (2.28; 1.83-2.85) and negatively associated with BCS w/o RT (0.65; 0.56-0.76). After adjustment for potential confounders, education level did not show any association with the type of treatment. Social and geographical factors, in addition to hospital specialization, should be considered to reduce inappropriateness of care for breast cancer.

The cost of foreign body injuries in the upper aero-digestive tract: need for a change from a clinical to a public health perspective?

OBJECTIVE: This paper addressed the impact in terms of direct costs of the injuries in children due to foreign bodies in the upper aero-digestive tract. METHODS: Two thousand one hundred and three consecutive cases were collected from 2000 to 2002 in 16 European hospitals, 1 hospital for each participating country, and referred to children aged until 14 who had FB injuries. Costs were based on the extraction of the FB procedures and on hospitalization length, based on DRGs. Determinants of costs and of length of stay (LOS) were analyzed using a multilevel model. RESULTS: The major cost of the treatment of FB injuries is covered by the ENT Departments, which are usually the first choice of referral, directly from the patients. Children had a mean LOS of 2.13 days (95% C.I. 1.99-2.29). Treatment of the FB was associated with a mean cost of euro 1017.37 (95% C.I. 963.27-1073.51). In the multivariable analysis higher costs are related to the modality of arrival to the hospital by walk, to the site of the injury (ICD-933, ICD-934, ICD-935 in particular) and to the use of surgery in removing the FB. DISCUSSION: Foreign bodies injuries are posing a great threat not only with regards to the clinical aspects but also from the public health perspective, their treatment being associated with high costs, in particular when surgery is needed.

Evaluating hospital costs in type 2 diabetes care: does the choice of the model matter?

BACKGROUND: Awareness of the economic burden of diabetes has led to a number of studies on economic issues. However, comparison among cost-of-illness studies is problematic because different methods are used to arrive at a final cost estimate. OBJECTIVE: The aim of the study is to show how estimates of hospitalisation costs for diabetic patients can vary significantly in relation to the statistical method adopted in the analysis. RESEARCH DESIGN AND METHODS: The study analyses diabetic patients' costs as a function of demographic and clinical covariates, by applying the following statistical survival models: the parametric survival model assuming Weibull distribution, the Cox proportional hazard (PH) model and the Aalen additive regression for modelling costs. The Aalen approach is robust both for the non proportionality in hazard and for departures from normality. In addition it is able to easily model the effect of covariates on the extreme costs. This cost analysis is based on data collected for a retrospective observational study analysing repeated hospitalisations (N = 4816) in a cohort of 3892 diabetic patients. RESULTS: There is agreement in all models with the effects of the considered covariates (age, sex, duration of disease and presence of other pathologies). An effect of over- or under-estimation, according to the chosen model due to arguably inappropriate model fitting, was observed, being more evident for some specific profiles of the patients, and overall accounting for as much as 20% of the estimated effect. The Aalen model was able to cope with all the other models in furnishing unbiased estimates with the advantage of a greater flexibility in representing the covariates' effect on the cost process. CONCLUSIONS: An appropriate choice of the model is crucial in avoiding misinterpretation of cost determinants of type 2 diabetes care. For our data set the Aalen model proved itself to be a realistic and informative way to characterise the effect of covariates on costs.

Epidemiology of meningococcal disease in Switzerland, 1999-2002.

In Switzerland, immunisation against serogroup C meningococcal disease is recommended for persons at increased risk but is not included in the national vaccination programme. The aim of this study was to present the nationwide surveillance data on invasive meningococcal disease collected from 1999 to 2002, emphasising the evolution in the absence of extended vaccination. The number of reported cases of meningococcal disease peaked at 178 cases in 2000 (incidence rate of 2.5/100,000 person-years), with 61% of all cases attributed to serogroup C meningococci (incidence rate, 1.5/100,000 person-years). Since 2001, a spontaneous decrease in the reported cases was observed, resulting in an overall incidence rate of 1.4/100,000 person-years in 2002 (serogroup C cases, 0.8/100,000 person-years). On the other hand, the case-fatality rate of serogroup C cases increased to 18% in 2002, leading to an increase in the overall case-fatality rate from 8% to 14% (P>0.05). The small sample size reduces the interpretability of this observation. However, when the introduction of a generalised vaccination against serogroup C meningococcal disease is discussed, the fluctuations in the number of vaccine-preventable deaths should receive greater attention.

An economic evaluation of the optimal workload in treating surgical patients in a breast unit.

A breast unit is a cancer centre specialised in the diagnosis and treatment of patients with breast cancer. The high level of specialised skills involved in running a breast unit makes it an expensive pattern of care. The European Society of Mastology (EUSOMA) recommends a minimum caseload of 150 cases sufficient to maintain expertise for each team member and to ensure cost-effective working of the breast unit. Specific economic analysis evaluating main diagnostic services (radiology and pathology) and treatment are needed. The present study assesses the activity level at which the breast unit represents good value for money in surgically-treated patients. Cost assessment is realised by defining a cost function according to the following assumptions: cost function input is personnel costs and technical equipment and output is the number of newly diagnosed cases of primary breast cancer admitted to the breast care unit each year. The increase from 50 new cancer cases per year to 100 will reduce average costs by almost 50%. Cost reduction is important up to a volume of 200 new cases per year. For economic investment to be justified, it is desirable that intake rises to at least 200 new cases per year. Our result is in-line with the EUSOMA recommendation.