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There is unmet need in patients suffering from chronic pain, yet innovation may be impeded by the difficulty of justifying economic value in a field beset by data limitations and methodological variability. A systematic review was conducted to identify and summarise the key areas of variability and limitations in modelling approaches in the economic evaluation of treatments for chronic pain. The results of the literature review were then used to support the development of a fully flexible open-source economic model structure, designed to test structural and data assumptions and act as a reference for future modelling practice. The key model design themes identified from the systematic review included: time horizon; titration and stabilisation; number of treatment lines; choice/ordering of treatment; and the impact of parameter uncertainty (given reliance on expert opinion). Exploratory analyses using the model to compare a hypothetical novel therapy versus morphine as first-line treatments showed cost-effectiveness results to be sensitive to structural and data assumptions. Assumptions about the treatment pathway and choice of time horizon were key model drivers. Our results suggest structural model design and data assumptions may have driven previous cost-effectiveness results and ultimately decisions based on economic value. We therefore conclude that it is vital that future economic models in chronic pain are designed to be fully transparent and hope our open-source code is useful in order to aspire to a common approach to modelling pain that includes robust sensitivity analyses to test structural and parameter uncertainty. [ABSTRACT FROM AUTHOR]

The purpose of this paper is to describe the impact of exposure to influenza on hospitalizations and deaths in the elderly residents of long-term care facilities (LTCFs). An observational, longitudinal, prospective, multicenter, cohort study collected influenza and influenza-like cases, diseases, hospitalizations, and deaths of dependant elderly residents of French LTCFs during the 2004–2005 seasonal influenza epidemic. A total of 8,041 residents of 98 participating LTCFs were included. The mean age was 85 ± 9 years; 93% were vaccinated against influenza and 64% of the residents were exposed to influenza during the epidemic. Exposure to influenza increased both the all-cause risk of hospitalization (9.2% of the residents exposed vs. 7.4% of the residents not exposed) (relative risk, RR [95% confidence interval, CI] = 1.24 [1.05; 1.47]) and the all-cause risk of death (5.8% vs. 4.3%) (RR [95% CI] = 1.36 [1.10; 1.70]). Exposure to influenza increased the risks of death and hospitalization. Additional measures should be taken to avoid influenza exposure and apply recommendations more thoroughly in the particularly susceptible population of elderly LTCF residents. [ABSTRACT FROM AUTHOR]

The objective of this study was to estimate the unit costs of non-vertebral osteoporotic fractures in five European countries based on the results of the SOTI and TROPOS clinical trials in postmenopausal osteoporotic women. The information recorded in the Case Report Forms was used. The perspective of third party payers was adopted. Hip fracture unit cost was the highest. The ranges of costs among countries was narrow for hip from 8,346€ (Italy) to 9,907€ (France), but wider for other fractures: 890€ (Spain) to 2,022€ (Italy) for wrist, 1,167€ (Spain) to 3,268€ (Italy) for pelvis, 837€ (Spain) to 2,116€ (Italy) for sternum/clavicle, 565€ (Spain) to 908€ (France) for rib, 1,518€ (Spain) to 3,651€ (Belgium) for humerus, 1,805€ (Spain) to 3,521€ (Italy) for leg. The costs of those fractures should be considered when estimating the cost of osteoporosis. [ABSTRACT FROM AUTHOR]

OBJECTIVE:: Nutritional status and lifestyle can have profound effects on health. To analyse behaviour patterns in population subgroups of public health importance, we compared lifestyle, dietary intake of energy and selected nutrients, and nutritional biomarkers of type 1 diabetes (T1DM) patients and nondiabetic first-degree relatives against control subjects with no family history of T1DM. DESIGN:: A cross-sectional study. SETTING:: Department of Internal Medicine, University of Pisa, Italy. SUBJECTS:: A total of 209 individuals including 38 type 1 patients, 76 relatives, and 95 healthy subjects. INTERVENTIONS:: We used the European Prospective Investigation of Cancer and Nutrition questionnaires to assess dietary intake and lifestyle. Anthropometric indices and nutritional biomarkers (such as plasma levels of albumin, iron, lipids, homocysteine, vitamin B9 and vitamin B12 as well as urinary outputs of nitrogen, sodium and potassium) were evaluated. RESULTS:: Emerging health issues:(1) In total, 45%of controls were overweight. Increasing age was associated with increasing body mass and decreasing activity in sport in front of an unchanged energy intake.(2) The distribution of energy sources was incorrect. The proportion of caloric intake derived from total fat and cholesterol did not match general guidelines. Total dietary fibre consumption was assessed to be adequate (25?g/day) in only 27%of all the participants.(3) Estimated daily intakes of water-soluble vitamin B9 and fat-soluble vitamin D and vitamin E were deficient in comparison with dietary reference intakes.(4) The prevalence of adoption and maintenance of healthful eating and physical activity habits was higher in women and T1DM patients (probably as a consequence of the medical educational intervention). On the contrary, supportiveness of the family in term of changing the undesirable behaviours at home seemed to fail. CONCLUSIONS:: This study provides first evidence indicating unhealthy dietary behaviours, which could even predispose to the development of diabetes and cardiovascular complications, in subjects living in Pisa. The combination of vitamin B9 and vitamin E deprivation could be deleterious for endothelial function, since these antioxidants have been implicated in the modulation of nitric oxide and eicosanoid signalling. SPONSORSHIP:: This study was supported by a grant from the Ministry of Education, University and Research, Italy.European Journal of Clinical Nutrition (2005) 59, 114-122. doi:10.1038/sj.ejcn.1602047 Published online 1 September 2004 [ABSTRACT FROM AUTHOR]

Few studies have assessed the actual costs associated with failure of initial empiric antibiotic therapy administered to patients with community-acquired intra-abdominal infections. The goals of this study were (i) to determine the frequency of unsuccessful initial empiric therapy in a real-world setting and (ii) to determine the associated impact on medical costs. Thus, a retrospective chart review was performed at four acute-care university hospitals in France. A total of 292 patients hospitalized for community-acquired intra-abdominal infection were included. The mean age of the cohort was 51 years, and 42% of the patients were female. The most commonly administered empiric regimens were intravenous amoxicillin/clavulanate alone (69 patients) or in combination with other antibiotics (n=87) and piperacillin/tazobactam alone (n=24) or in combination (n=48). Other regimens included broad-spectrum penicillin, cephalosporins, and fluoroquinolones administered alone or in combination (n=64). Empiric therapy was successful in 189 (65%) patients and unsuccessful in 103 (35%). Among the 292 patients with community-acquired infection, 15 died of the infection, 8 required reoperation and 80 required second-line antibiotic therapy. Patients with unsuccessful initial empiric therapy had significantly more parenteral antibiotic days (10.3 vs. 7.6 days) and a longer length of stay (16.2 vs. 12.8 days) compared to those with successful initial empiric therapy. A better selection of initial empiric antibiotic therapy may significantly influence the medical costs associated with patients who are hospitalized with community-acquired intra-abdominal infections. [ABSTRACT FROM AUTHOR]

Objective: To assess the cost effectiveness of emedastine, a new antihistamine, versus levocabastine in the treatment of acute allergic conjunctivitis (AAC) in Belgium, France, Germany, The Netherlands, Norway, Portugal and Sweden.Design and Setting: Randomised double-blind multicountry clinical trial followed by economic modelling from the treatment provider perspective.Patients: A total of 221 patients (109 emedastine, 112 levocabastine) with AAC were included.Methods: The clinical trial compared the efficacy and safety of emedastine 0.05% and levocabastine 0.05%, both twice daily, for 42 days, using ocular redness, itching, days without symptoms and clinical failure as outcome measures. The cost of first-line treatment failure, including visits, drugs and laboratory examinations, was established in each country from a panel of ophthalmologists and general practitioners. Full sensitivity analyses were conducted.Results: From day 7 to 42, patients treated with emedastine had less itching (p < 0.001) and less redness (p < 0.001). The failure rate was 10% less (p < 0.02) with emedastine and patients treated with emedastine had an incremental 8.5 days (p < 0.01) without symptoms. Emedastine and levocabastine were equally well tolerated. In all European countries, the cost of failure was lower with emedastine. Emedastine was found to be economically dominant relative to levocabastine, i.e. more effective and less expensive, in Belgium, Germany, Portugal and Sweden; in France, The Netherlands and Norway the incremental cost was low (less than 1 euro per additional symptom-free day).Conclusion: Through a model based on a randomised clinical trial and cost estimates of treatment failure derived from practitioner interviews, emedastine is a cost-effective treatment of AAC. [ABSTRACT FROM AUTHOR]

Objectives: To perform an evaluation from the societal perspective of the cost of treatment with enoxaparin sodium versus unfractionated heparin (UFH) in patients with unstable angina and non-Q wave myocardial infarction in France.Design: Four complementary cost-minimisation analyses based on the results of the Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q wave Coronary Events (ESSENCE) international trial were conducted. We assessed differences in medical resource consumption and in duration of hospital stay in the whole study population (n = 3171) and for the French patients (n = 133).Results: Results were consistent for the study group as a whole and for the French subgroup. Among patients treated with enoxaparin sodium, there was a statistically significant reduction in the use of angiography and percutaneous transluminal coronary angioplasty (whole group study: p = 0.024 and 0.006, respectively) and a trend towards shorter lengths of hospital stay. The differences in angiography and angioplasty rates led to estimated average net cost savings with enoxaparin sodium of French Francs (FF)1555 per treated patient (whole study population) and FF9993 (French subgroup) [1996 values]. The analyses based on the duration of hospital stay resulted in estimated net cost savings with enoxaparin sodium of between FF1014 per treated patient (whole study population) and FF2804 (French subgroup).Conclusion: Our study confirmed earlier results which show that enoxaparin sodium is cost saving in the treatment of unstable angina. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To estimate the direct medical costs associated with obesity in France. DESIGN: Analysis of the French 1991-1992 National Household Survey database comprising a representative sample of 14,670 individuals aged 18 y and over. A subgroup of subjects with a body mass index (BMI) ≥30 kg/m² was compared with a control group of normal-weight individuals (BMI 18.5-25 kg/m²) matched on age, gender and education level. MEASUREMENTS: Self-reported weight and height used to calculate individual body mass index and health expenditures in a 3 month period, and morbidity as declared by respondents to the national household survey and verified on medical records. RESULTS: The direct cost attributable to obesity (BMI ≥ 30 kg/m²) was estimated to be in the range 4.2-8.7 billion French Francs (FF) in 1992 value, that is between 0.7 and 1.5% of total health expenditures. CONCLUSION: These results were of the same order of magnitude as similar estimates obtained by a top-down approach for the same year and setting. [ABSTRACT FROM AUTHOR]

We study the dynamics of expansive cellular automata. We prove that a cellular automaton is expansive if and only if it is topologically conjugate to an appropriate one-sided subshift. We define a large class of expansive cellular automata in terms of the permutivity of the local rule on which they are based. We prove that each cellular automaton of this class is topologically conjugate to a onesided full shift. Since one-sided full shifts are widely recognized as the paradigm of chaotic systems, we conclude that the above mentioned cellular automata are chaotic according to any reasonable definition of chaos. We provide a technique to construct expansive cellular automata which are topologically conjugate to onesided full shifts but do not belong to the above defined class. Finally, we investigate connections between expansivity, topological transitivity, and surjectivity. [ABSTRACT FROM AUTHOR]

Objective: Recurrent infectious rhinitis (RIR) is a frequent disease among adults and constitutes an economic burden for National Sickness Funds (NSF) that might be prevented by immunostimulant therapy. Cost effectiveness of preventive methods should be documented. The aim of this study was to determine whether the cost of treating patients with ribosomal vaccine (Ribomunyl), an immunostimulant therapy, could be offset by the savings associated with avoided RIR episodes.Design and Setting: Using a 'piggy-back' approach, an economic analysis was conducted based on a placebo-controlled clinical trial of 327 patients with at least 3 episodes of RIR in the past year. Patients were recruited during September and October 1994 through 50 French and 2 Belgian specialists (ear, nose and throat; ENT) and were randomised to receive ribosomal vaccine or placebo for a 6-month period covering the entire winter season. Two economic perspectives were analysed: (i) the French NSF; and (ii) the patient (i.e., considering copayments which are not reimbursed by the NSF).Main Outcome Measures and Results: The placebo-controlled clinical trial demonstrated a significant decrease (p < 0.001) of more than 30% in the cumulative number of RIR episodes with ribosomal vaccine during the 6-month study period. In general, patients receiving the active treatment tolerated it well. Data were collected on the use of medical services (e.g. number of physician visits), antibacterial and other drug courses, as well as the number of sick-leave days for the study participant. Patients treated with ribosomal vaccine visited their general practitioner (GP) less frequently (mean reduction of 33%), had fewer days of antibacterial use (mean reduction of 3.5 days) and took fewer sick-leave days (mean reduction of 6.3%).Conclusions: Overall, the cost of prevention with ribosomal vaccine was offset by the savings to both the French NSF and to patients (in terms of out-of-pocket expense). Indeed, ribosomal vaccine was deemed to be a cost-saving agent in the prevention of RIR in the French healthcare setting, provided that it is prescribed only for patients who are expected to develop at least 2 episodes of RIR in the coming year. [ABSTRACT FROM AUTHOR]

This 9-month pragmatic study compared 2 therapeutic regimens in the management of osteoarthritis of the hip and knee. Patients received either diacerein 100 mg/day plus standard osteoarthritic therapy for 6 months, followed by a 3-month monitoring period without diacerein, or standard therapy alone for the entire 9-month period. A total of 207 patients with osteoarthritis of the knee and hip were enrolled. Improvements in Lequesne's functional index and quality-of-life scores (revised Arthritis Impact Measurement Scales Health Status Questionnaire and Nottingham Health Profile), and decreases in nonsteroidal anti-inflammatory drug and analgesic consumption were significantly greater with diacerein plus standard therapy than with standard therapy alone. The overall assessment of therapy by patients was good or excellent for 60% of those who received diacerein plus standard therapy, compared with 26% who received standard therapy alone. Medical and paramedical procedures carried out in addition to those stipulated in the protocol (medical consultations, physiotherapy, nursing, etc.), osteoarthritisrelated, were fewer and less costly in the diacerein plus standard therapy group than in the standard therapy group. The average outpatient cost (in 1995 French francs) of osteoarthritis treatment in the standard therapy group was FF2272 compared with FF2360 in the diacerein plus standard therapy group. The cost-effectiveness ratios per point scored on Lequesne's index were FF1893 for the standard therapy group and FF1072 for the diacerein plus standard therapy group, leading to a saving of 43% with diacerein plus standard therapy. The marginal cost (additional cost corresponding to the clinical benefit obtained by adding diacerein to standard treatment) was FF88 per point scored on Lequesne's index. [ABSTRACT FROM AUTHOR]

The risk of late-occurring deep vein thrombosis and pulmonary embolism after total hip replacement persists for at least 3 weeks after hospital discharge. Recent clinical trials have demonstrated that prolonged prophylaxis with enoxaparin, a low-molecular-weight heparin (LMWH), significantly reduces this risk. We used a decision-analysis model to determine the incremental outcomes associated with the routine use of such prophylaxis, administered during hospitalisation for total hip replacement and for 3 weeks after discharge, instead of short term prophylaxis administered only during hospitalisation. For a hypothetical cohort of 100 000 patients undergoing hip surgery, prolonged LMWH prophylaxis saved between 601 and 783 additional lives compared with prophylaxis stopped at discharge. This was obtained at a net direct marginal cost ranging from 1118 to 1300 French francs (F) per patient. The cost-effectiveness ratio ranged from F11 158 to F34 591 per life-year saved and from F23 532 to F35 268 per venous thromboembolic event (routinely diagnosed and treated) avoided. Prolonged LMWH anticoagulant prophylaxis with enoxaparin is more effective in routine practice after elective hip surgery than conventional short term perioperative prophylaxis in terms of the number of deaths or thromboembolic events avoided. Such prophylaxis also appears to be clearly cost effective, using French cost data. [ABSTRACT FROM AUTHOR]