The Urbino Charter: a Declaration for the well-being of working people.

Abstract: The "Urbino Charter" is a document aimed at promoting the well-being of the working person that the Olympus Observatory of the University of Urbino Carlo Bo and the Rubes Triva National Foundation, a joint body in the field of environmental hygiene, presented in Bilbao at a public conference in March 2023. The Charter has the objective of stimulating reflection on the issues related to prevention while drawing attention to the essential values for the effective protection of workers' health, safety and well-being. This commentary has the aim of presenting the 10 statements of the Chart, from a perspective of Occupational health and safety.

Certification and prescription in the diabetology field: occupational and medico-legal aspects.

Abstract: Diabetes mellitus is an ever-increasing disease and is defined as a "social disease" due to the significant economic damage it causes to the affected individuals and the community involved in its care. This paper presents the process of certification of diabetic disease and the application for invalidity in order to obtain welfare and economic benefits provided by law; it, also, describes the prescription process and the appropriateness of therapeutic prescription for the diabetic patient in terms of clinical-prescriptive appropriateness and economic-prescriptive appropriateness. Finally, it reports on the side effects of the most common antidi-abetics, the off-label use of metformin and the physician's responsibili-ties in the light of the Gelli-Bianco law.

What to remove from the work environment: the sick worker or the cause of his sickness? Workplace bullying, a form of violence that causes sickness.

Abstract: Although there are many different definitions of workplace bullying in the scientific literature, it can be defined as a form of psychological and relational violence conducted systematically and continuously by one or more individuals, towards another individual, with the aim of causing him physical and mental harm and exclude him from the workplace. The elements common to all definitions are the work context, the duration for at least six months, the frequency of bullying actions, which must occur at least once a week, the evolution in phases and the power differential between aggressor and victim. The purpose of this article is not only to provide the most important definitions of workplace bullying and to identify the common elements, but also to report the most recent findings concerning gender and personality differences of both victim and aggressor, to report the most investigated professional sectors, to describe the causes and the consequences on both the worker and the organization and to present the legislative framework. Workplace bullying can be considered an emerging public health problem that requires preventive interventions. Secondary and tertiary prevention interventions are important, but the aim is to prevent the phenomenon when it has not yet developed. Primary prevention interventions promote a healthy work environment that reduces the development of work-related violence, including workplace bullying.

Outcomes and costs of autologous stem cell mobilization with chemotherapy plus G-CSF vs G-CSF alone.

Chemotherapy plus G-CSF (C+G) and G-CSF alone are two of the most common methods used to mobilize CD34(+) cells for autologous hematopoietic SCT (AHSCT). In order to compare and determine the real-world outcomes and costs of these strategies, we performed a retrospective study of 226 consecutive patients at 11 medical centers (64 lymphoma, 162 multiple myeloma), of whom 55% of lymphoma patients and 66% of myeloma patients received C+G. Patients with C+G yielded more CD34(+) cells/day than those with G-CSF alone (lymphoma: average 5.51 × 10(6) cells/kg on day 1 vs 2.92 × 10(6) cells/kg, P=0.0231; myeloma: 4.16 × 10(6) vs 3.69 × 10(6) cells/kg, P<0.00001) and required fewer days of apheresis (lymphoma: average 2.11 vs 2.96 days, P=0.012; myeloma: 2.02 vs 2.83 days, P=0.0015), although nearly all patients ultimately reached the goal of 2 × 10(6) cells/kg. With the exception of higher rates of febrile neutropenia in myeloma patients with C+G (17% vs 2%, P<0.05), toxicities and other outcomes were similar. Mobilization with C+G cost significantly more (lymphoma: median $10,300 vs $7300, P<0.0001; myeloma: $8800 vs $5600, P<0.0001), although re-mobilization adds $6700 for drugs alone. Our results suggest that although both C+G and G-CSF alone are effective mobilization strategies, C+G may be more cost-effective for patients at high risk of insufficient mobilization.

Cost-effectiveness of oxaliplatin in the adjuvant treatment of colon cancer in Canada.

OBJECTIVE: The cost-effectiveness of oxaliplatin in combination with 5-fluorouracil/leucovorin (5FU/LV)-the FOLFOX regimen-was compared with that of 5FU/LV alone as adjuvant therapy for patients with stage III colon cancer, from the perspective of the Cancer Care Ontario New Drug Funding Program. In the mosaic (Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer) trial, the FOLFOX regimen significantly improved disease-free survival. The mosaic trial formed the basis of the present analysis. METHODOLOGY: Extrapolated patient-level data from the mosaic trial were used to model patient outcomes from treatment until death. Utilities were obtained from the literature. Resource utilization data were derived from the mosaic trial and supplemented with data from the literature. Unit costs were obtained from the Ontario Ministry of Health and Long-Term Care, the London Health Sciences Centre, and the literature. RESULTS: Lifetime incremental cost-effectiveness ratios for FOLFOX compared with 5fu/lv were CA$14,266 per disease-free year, CA$23,598 per life-year saved, and CA$24,104 per quality adjusted life-year (QALY) gained, discounting costs and outcomes at 5% per annum. These results were stable for a wide range of inputs; only utility values associated with relapse seemed to influence the cost-effectiveness ratios observed. CONCLUSIONS: With an incremental cost of CA$24,104 per QALY gained, FOLFOX is a cost-effective adjuvant treatment for stage iii colon cancer. Compared with 5fu/lv alone, this regimen offers better clinical outcomes and provides good value for money.

Greater first year effectiveness drives favorable cost-effectiveness of brand risedronate versus generic or brand alendronate: modeled Canadian analysis.

UNLABELLED: The RisedronatE and ALendronate (REAL) study provided a unique opportunity to conduct cost-effectiveness analyses based on effectiveness data from real-world clinical practice. Using a published osteoporosis model, the researchers found risedronate to be cost-effective compared to generic or brand alendronate for the treatment of Canadian postmenopausal osteoporosis in patients aged 65 years or older. INTRODUCTION: The REAL study provides robust data on the real-world performance of risedronate and alendronate. The study used these data to assess the cost-effectiveness of brand risedronate versus generic or brand alendronate for treatment of Canadian postmenopausal osteoporosis patients aged 65 years or older. METHODS: A previously published osteoporosis model was populated with Canadian cost and epidemiological data, and the estimated fracture risk was validated. Effectiveness data were derived from REAL and utility data from published sources. The incremental cost per quality-adjusted life-year (QALY) gained was estimated from a Canadian public payer perspective, and comprehensive sensitivity analyses were conducted. RESULTS: The base case analysis found fewer fractures and more QALYs in the risedronate cohort, providing an incremental cost per QALY gained of $3,877 for risedronate compared to generic alendronate. The results were most sensitive to treatment duration and effectiveness. CONCLUSIONS: The REAL study provided a unique opportunity to conduct cost-effectiveness analyses based on effectiveness data taken from real-world clinical practice. The analysis supports the cost-effectiveness of risedronate compared to generic or brand alendronate and the use of risedronate for the treatment of osteoporotic Canadian women aged 65 years or older with a BMD T-score < or =-2.5.

Cost-effectiveness of nucleic acid test screening of volunteer blood donations for hepatitis B, hepatitis C and human immunodeficiency virus in the United States.

BACKGROUND AND OBJECTIVES: The aim of this study was to examine the cost-effectiveness of adding nucleic acid testing (NAT) to serological (antibody and antigen) screening protocols for donated blood in the United States (US) with the purpose of reducing the risks of transfusion-transmission of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). MATERIALS AND METHODS: The costs, health consequences and cost-effectiveness of adding either minipool or individual-donor NAT to serological screening (SS) testing were estimated using a decision-analysis model. RESULTS: With the given modelling assumptions, adding minipool NAT would avoid an estimated 37, 128 and eight cases of HBV, HCV and HIV, respectively, and save approximately 53 additional years of life and 102 additional quality adjusted life years (QALYs) compared with SS, at a net cost of $154 million. SS + minipool NAT - p24 compared with SS alone resulted in an incremental cost-effectiveness ratio of $1.5 million per QALY gained (range in sensitivity analysis $1.0-2.1 million per QALY gained) in this US analysis. CONCLUSIONS: The cost effectiveness of adding NAT screening is outside the typical range for most healthcare interventions, but not for established blood safety measures.

Clinical and economic impacts of latanoprost 0.005% in first-line treatment of open-angle glaucoma and ocular hypertension in France.

PURPOSE: To assess the cost-effectiveness of treatment strategies that utilize first-line latanoprost compared to those based on initial beta-blocker therapy in patients with open-angle glaucoma (OAG) or ocular hypertension (OH) in France. METHODS: The study was based on a decision-analytic model that was populated with data from a retrospective chart review. A hypothetical cohort of patients newly diagnosed with OAG and/or OH was assessed over a period of 2 and 3 years. For each treatment strategy 10,000 patients were assumed. RESULTS: First-line latanoprost therapy was significantly more effective than initial treatment with a beta-blocker, providing more days of intraocular pressure (IOP) control primarily due to its longer time until initial treatment failure. Latanoprost's higher acquisition cost was largely offset by reductions in costs associated with surgical procedures. The additional cost for latanoprost was estimated at approximately 41 Euro and 27 Euro over 2 and 3 years, respectively. The incremental cost per day of IOP control when latanoprost was used as first-line strategy compared to the first-line beta-blocker strategy was 0.82 Euro and 0.36 Euro over 2 and 3 years, respectively. CONCLUSIONS: These results provide compelling evidence that first-line latanoprost therapy can provide superior clinical outcomes at a small additional cost in actual clinical practice.

Challenges for model-based economic evaluations of postmenopausal osteoporosis interventions.

Assessing the cost-effectiveness of long-term treatment for osteoporosis requires use of mathematical models to estimate health effects and costs for competing interventions. The primary motivations for model-based analyses include the lack of long-term clinical trial outcome data and the lack of data comparing all relevant treatments within randomized clinical trials. We report on specific modeling challenges that arose in the development of a model of the natural history of postmenopausal osteoporosis that is suitable for assessing the cost-effectiveness of osteoporosis interventions among various population subgroups in diverse countries. These include choice of modeling changes in bone mineral density (BMD) or in fracture rate, definition of health states, modeling mortality and costs of long-term care following fracture, incorporation of health utility, and model validation. This report should facilitate future postmenopausal osteoporosis model development and provide insight for decision-makers who must evaluate model-based economic analyses of postmenopausal osteoporosis interventions.

Cost and health related quality of life consequences of multiple sclerosis.

OBJECTIVES: To (i) quantify the cost of multiple sclerosis (MS) to the Canadian health care system and society; (ii) measure health utility in MS patients, and (iii) examine the influence of disability on patient utility and health care costs. MATERIALS AND METHODS: A comprehensive patient survey and chart review of relapsing MS patients in remission, relapse and recalling a relapse. RESULTS: Annual remission costs increased with EDSS level ($7596 at EDSS 1, $33 206 at EDSS 6). At all EDSS levels the largest costs were due to inability to work, which increased with EDSS. The average relapse cost for all EDSS levels was $1367. An inverse correlation was found between EDSS level and patient utility for patients in remission and relapse. The decrease in remission health utility from EDSS 1 to 6 was 0.24, which is 25% greater than the difference in health status between an average 25 and 85 year-old. CONCLUSIONS: This study demonstrates that MS produces substantial health care costs and reductions in patient quality of life and ability to work, losses that can be avoided or delayed if disease progression is slowed. These data provide health-care decision-makers with the opportunity to consider the full impact of MS when faced with budget allocation decisions.

Cost effectiveness of multi-therapy treatment strategies in the prevention of vertebral fractures in postmenopausal women with osteoporosis.

OBJECTIVE: The aim of this study was to evaluate the cost effectiveness of multi-therapy treatment strategies in the prevention of vertebral fractures in postmenopausal women with osteoporosis. DESIGN: A retrospective, incremental cost-effectiveness analysis was conducted from a societal perspective. It compared 9 treatment strategies over 3 years and incorporated the willingness of patients to initiate and continue each therapy. MAIN OUTCOME MEASURES AND RESULTS: Four nondominated strategies formed the efficient frontier in the following order: (i) calcium-->no therapy; (ii) ovarian hormone therapy (OHT)-->calcium-->no therapy [166 Canadian dollars ($Can)]; (iii) OHT-->etidronate-->calcium-->no therapy ($Can2331); and (iv) OHT-->alendronate-->calcium-->no therapy ($Can40,965). The figures in parentheses are the incremental costs per vertebral fracture averted to move to that strategy from the previous strategy for patients who had undergone a hysterectomy. CONCLUSIONS: We identified 4 efficient multi-therapy strategies for the treatment of vertebral osteoporosis in postmenopausal women, 2 of which were consistent with the practice guidelines of the Osteoporosis Society of Canada. Decision-makers may select from among these efficient strategies on the basis of incremental cost effectiveness.

The total process cost of parenteral antibiotic therapy: beyond drug acquisition cost.

Intravenous antibiotic therapy represents a considerable expense to hospital pharmacy budgets; however, when evaluating the cost of these therapies one needs to look beyond acquisition cost and consider the total "process" cost of treatment. These additional costs include the personnel time and the materials required for drug preparation and administration, maintenance of intravenous access, waste disposal, and therapeutic drug monitoring. This paper provides an examination of the daily process costs of intravenous therapy with cefazolin, cefotaxime, ceftazidime, once-daily ceftriaxone, cefuroxime, or aminoglycoside (tobramycin or gentamicin) combination therapy, where the aminoglycoside is given once daily or in divided doses. This analysis demonstrates that the costs associated with drug preparation and administration can equal or exceed drug acquisition costs and are highly dependent on dosing frequency. On this basis, ceftriaxone, at $52.21, is the least expensive of these antibiotic regimens in terms of total daily process cost, followed by the remaining cephalosporins at $53.29 to $94.57, aminoglycoside once-daily combinations at $93.44 to $99.65, and aminoglycoside multidose combinations at $103.26 to $111.42, respectively (values are given in constant 1995 Canadian dollars). Once-daily ceftriaxone offers the potential for cost savings compared with other antibiotic regimens whose pharmacokinetics require multiple daily doses, due largely to the reduced resources required for ceftriaxone preparation and administration.

Lipocortin 2 (annexin 2) is a major substrate for constitutive tyrosine kinase activity in chondrocytes.

Treatment of cultured bovine articular chondrocytes with 100 microM orthovanadate, in the absence of serum, results in the production of a single major tyrosine phosphorylated protein with an apparent molecular mass of 36 kDa (p36). Chondrocytes were found to contain proteins reactive with anti-lipocortin 1, 2, and 5 antibodies. p36 comigrated on SDS-polyacrylamide gels with lipocortin 2, but not with other members of the lipocortin family. The distribution of p36 between the particulate and soluble cell fractions was also similar to that of lipocortin 2. p36 that was purified on an anti-phosphotyrosine immunoaffinity column cross-reacted with anti-lipocortin 2 antibodies. Similarly, lipocortin 2 purified on an anti-lipocortin 2 immunoaffinity column reacted with anti-phosphotyrosine antibodies. Furthermore, cyanogen bromide cleavage fragments of purified lipocortin 2 and p36 were similar. These data demonstrate that the major constitutively tyrosine phosphorylated protein, in chondrocytes, is lipocortin 2. Tyrosine phosphorylated p36 required SDS buffers for extraction due to a loss of the tyrosine phosphate group under other solubilization conditions using Triton X-100 or sodium cholate. This study provides a system for the study of the effects of tyrosine phosphorylation on lipocortin 2 function. What role lipocortin 2 plays in chondrocyte biology remains to be determined.