A clinical tool to determine the necessity of spine radiography in postmenopausal women with osteoporosis presenting with back pain.

BACKGROUND: Vertebral fractures are underdiagnosed, although the resulting mortality and morbidity in postmenopausal women with osteoporosis is now recognised. In a population of postmenopausal women with osteoporosis and back pain, symptoms may be related to vertebral fractures or degenerative changes of the spine. AIM: To evaluate a population of postmenopausal women presenting with back pain and factors associated with vertebral fractures which were assessable in a clinical setting in order to determine the necessity for spine radiography. METHODS: Patient questioning and physical examination were carried out and spinal radiographic data collected from 410 postmenopausal women with osteoporosis, with an average age of 74 years, who consulted a rheumatologist for back pain. Of these, 215 (52.4%) patients were diagnosed with at least one vertebral fracture. Logistic regression was used to identify the most relevant clinical features associated with existing vertebral fractures, and to derive a quantitative index of risk. RESULTS: The model included six parameters: age, back pain intensity, height loss, history of low trauma non-vertebral fractures, thoracic localisation of back pain and sudden occurrence of back pain. The scoring system, or the quantitative index, had a maximal score of 16. For a score >or=7, the probability of existing vertebral fracture was >or=43%. The correlation between this quantitative index and the logistic model probability was 0.98, suggesting an excellent and highly significant approximation of the original prediction equation. CONCLUSIONS: From six clinical items, an index was built to identify women with osteoporosis and back pain who should have spine radiography. This simple tool may help clinicians to optimise vertebral fracture diagnosis and to make a proper therapeutic decision.

Cost-minimization study comparing Simulect vs. Thymoglobulin in renal transplant induction.

PURPOSE: Based on the data of clinical trial CHI-F-02 comparing the efficacy and safety of basiliximab (Simulect) vs. anti-thymocyte globulin (Thymoglobulin) in renal transplant induction, we carried out an economic evaluation. METHOD: This pharmacoeconomic study was a cost-minimization study, i.e. given the equivalent efficacy of the products, the strategy that minimized the cost of care was considered better. The cost of care was analyzed from the hospital perspective. MATERIAL: This 'piggyback' study of 100 patients estimated the direct medical costs incurred over 6 months of use of two strategies for renal transplant induction therapy. Direct medical costs are those of utilized medical resources: medications, hospital stays, dialysis, and physician visits and investigations not scheduled in the protocol. RESULTS: In the Simulect arm, significant reductions were found in the initial hospital stay duration and number of infectious episodes. Therefore, although the average cost of treatment was slightly higher with Simulect) than with Thymoglobulin (2964 vs. 2298 Euros), the cost of the initial hospitalization was significantly lower in the Simulect arm (10 907 vs. 11 967 Euros; p = 0.02). Furthermore the mean cost of infectious episodes was significantly lower in the Simulect arm (1056 vs. 1790 Euros, p = 0.03). Cytomegalovirus infection accounted for a significantly smaller proportion of this cost in the Simulect arm than in the Thymoglobulin arm (30% vs. 53%, p = 0.001). CONCLUSION: This study showed direct medical cost savings of 1159 Euros per patient in the Simulect arm, which more than compensated for the higher price of this immunosuppressive drug.

The burden cost of French patients suffering from irritable bowel syndrome.

BACKGROUND: The impact of irritable bowel syndrome (IBS) on health-care resource use in France is evaluated, and explanatory variables determined. METHODS: A questionnaire comprising socio-demographic characteristics, symptoms, consumption of resources, quality of life and impact of IBS on productivity was administered by telephone to a sample of 253 French adults with IBS recruited from the general population, and diagnosed with IBS using several well-known diagnostic criteria. The medical costs were estimated on a monthly basis and included medication(s), physicians' consultations, investigations and hospitalizations. RESULTS: Mean age was 48.3 years and 75% of subjects were women (192). Thirty-six percent of subjects had suffered from IBS for more than 10 years; 77% had consulted a general practitioner and 43% a gastroenterologist. Twenty-nine percent of subjects had undergone an investigation and 25% reported hospitalization; 61% of patients reported that they were taking medication. The average monthly medical costs was 71.8 euros (95% CI = [57.6-86.0]) with an asymmetric distribution (median = 28.1 euros) because of a high proportion of subjects (27%) who reported receiving no care at all. The two principal cost components were investigations (39%), and hospitalizations (22%). The highest medical costs were associated with subjects who were very elderly or suffered from severe symptoms (very severe pain), and were correlated with the lowest quality of life scores. CONCLUSION: IBS has a major impact on resource consumption and the productivity of patients. Determination of the variables to explain medical costs showed that advanced age, severe pain and deterioration in quality of life could be predictive of high medical costs.

[Factors predicting the severity and the degree of symptom control of asthma in a recently diagnosed cohort of adult patients (A.S.M.A study)]. / Facteurs liés à la sévérité et au contrôle de l'asthme récemment diagnostiqué dans une cohorte de patients adultes.

INTRODUCTION: The aim of this cohort study was to describe the evolution of recently diagnosed (<12 months) asthma, and to identify outcome predictive factors. This paper describes the evolution of an adult cohort and the factors related to asthma severity and control. METHODS: In 1995, 251 chest specialists from throughout France, recruited 347 asthmatic adults (subjects with severe asthma were excluded). 220 eligible patients were examined every four months over a three year period. Data (socio-demographic characteristics, asthma history, results of atopy testing and lung function tests, treatment, drug compliance, respiratory infections, changes in lifestyle and environment, and major life events) were collected by means of detailed standardised questionnaires completed by physicians. Asthma severity, recorded one year after study inclusion, and asthma control, assessed at each follow-up visit in the second and third year, were defined according to the international guidelines. RESULTS: The clinical status of these adult patients generally improved rapidly. Asthma severity correlated closely with allergy, with a history of childhood asthma and with sensitisation to indoor allergens. After adjusting for severity, poor asthma control was associated with poor compliance, with respiratory infections, and, to a lesser extent, with animals inside the home. CONCLUSIONS: This cohort study highlights the association of asthma severity with allergy, and of poor asthma control with poor compliance and respiratory infections.

What criteria for pharmaceuticals reimbursement? An empirical analysis of the evaluation of "medical service rendered" by reimbursable drugs in France.

The criteria for the registration of new drugs may differ from the criteria for drug reimbursement. In 2000 the French government entrusted the French Medicines Agency with determining the "medical service rendered" (MSR) for each reimbursable drug. The goal was to determine which drugs could be classified with an "insufficient" MSR and therefore should be taken out of the scope of health insurance. We analyze the concepts and methods used for this evaluation and the kind of results that are obtained. We collected data on the result of MSR classification and the criteria used to perform this classification (efficacy-security, severity of the disease,place in the therapeutic strategy, existence of therapeutic alternative, public health value) for a sample of 1453 drugs belonging to five therapeutic areas. We used statistical analysis to determine what were the most influential criteria. Only two criteria - efficacy and disease severity - suffice to very largely explain the MSR classification. The other criteria contribute little added value. Some of these criteria clearly suffer from a lack of clarification, leading to different interpretations according to therapeutic class or even according to drug or drug family. The evaluation procedure differs between therapeutic classes, at least at intermediate MSR levels. Analysis of the French experience with MSR shows that the evaluation procedure has not succeeded in completely breaking away from the traditional logic of the marketing authorization and registration, as witnessed by the importance of the "efficacy/safety" criterion, the absence of an economic criterion, and the vagueness of the "public health value" criterion, which one would have thought would instead be decisive.

Short-term health effects of particulate and photochemical air pollution in asthmatic children.

In a previous panel study in Paris, France, detrimental effects of moderately high levels of winter air pollution on the symptoms and lung function of asthmatic children were demonstrated. A new study was conducted, with the aim of assessing the short-term effects of photo-oxidant and particulate air pollution on childhood asthma during spring and early summer in Paris. Eighty-two medically diagnosed asthmatic children were followed up for 3 months. Outcomes included the incidence and prevalence of asthma attacks, nocturnal cough, supplementary use of beta2-agonists, symptoms of airway irritation, and peak expiratory flow (PEF) value and its variability. The statistical methods controlled for the lack of independence between daily health outcomes, temporal trends and pollen and weather conditions. Black smoke and nitrogen dioxide (NO2) were associated with increases in the occurrence of nocturnal cough and respiratory infections. Ozone (O3) was associated with an increase in the occurrence of asthma attacks and respiratory infections and with changes in lung function, as shown by an increase in PEF variability and a decrease in PEF. Statistically significant interactions were demonstrated between O3 and temperature and between O3 and pollen count for asthma attacks. O3 levels had a greater effect on additional bronchodilator use and on irritations of the eyes, nose and throat on days on which no steroids were used. Particulate matter was associated with eye irritation only. This study showed that, although within international air quality standards, the prevailing levels of photo-oxidant and particulate pollution in spring and early summer had measurable short-term effects on children with mild-to-moderate asthma.

Asthma in adults: comparison of adult-onset asthma with childhood-onset asthma relapsing in adulthood.

The prevalence of asthma in children and young adults is rising. Although the general features of asthma are similar in children and adults, there are several differences. Studies of the differences between childhood- and adult-onset asthma may provide new insight into the phenotypic heterogeneity of asthma. The aim of this cross-sectional study was to compare the characteristics of asthmatic adults who reported having (n = 84) or not having (n = 235) asthma in childhood. The participating patients were recruited by chest specialists throughout France and were examined from March to November 1995. The specialists completed a standardized questionnaire, and carried out a clinical examination and spirometric tests. Male sex; greater severity, particularly lower spirometry values related to small airways; greater severity and earlier onset of allergy; and maternal history of atopic dermatitis and perennial rhinitis were found to be associated with reported childhood asthma. This study exhibits highly internally consistent results and indicates that subjects who did have childhood asthma and relapse in adulthood appeared to have a potentially more severe form of asthma.