[COPD and quality of life: impact of the disease in primary care in France]. / BPCO et qualité de vie : impact de la maladie en médecine générale en France.

In Europe, there are few data on the impact of chronic obstructive pulmonary disease (COPD) on patients' quality of life. This study, within primary care, addressed health-related quality of life in patients according to stage of COPD severity. The objective was to estimate the impact of the COPD on the quality of life of the patients in seven European countries (France, Belgium, Germany, Italy, the Netherlands, Spain and the United Kingdom) in 2430 patients among whom 573 patients were in France. This cross-sectional, epidemiological and non-randomized study was realized by using two generic quality of life questionnaires and two disease-specific ones. The results in the French subgroup showed an impact on patients' health occurring even in the mild stage of the disease. The differences between the severity stages, as appreciated by the general practitioners, are clinically significant with a strong dispersal of the scores of quality of life within every stage. The impact of COPD on patients' daily activities is a key feature of the disease and it is essential that this is evaluated systematically and recognized as a target for management as much as other manifestations of the disease.

The burden associated with ocular symptoms in allergic rhinitis.

BACKGROUND: Ocular symptoms remain widely neglected while they concern the majority of subjects with allergic rhinitis (AR) and impair their daily activities. We describe the characteristics of ocular symptoms in subjects suffering from AR in the French INSTANT study and their impact on daily activities. METHODS: This cross-sectional observational survey was carried out in November 2006 using face-to-face interviews. RESULTS: 31.7% of the population-based sample (n = 4,019) suffered from AR and 52.0% of AR subjects (n = 663) described ocular symptoms. Men had significantly less ocular symptoms than women (odds ratio 0.71, 95% CI 0.57-0.89). 57.5% of subjects suffered from ocular symptoms for >5 years, 30.2% for >6 months in the past 12 months, and 92.2% during the pollen season. The troublesome ocular symptoms were itching eyes (51.1%), watery eyes (38.6%), red eyes (6.6%) and swollen eyelids (3.6%). The trigger factors were pollens (51.3%), household dust and mites (34.8%), pets (12.2%) and air pollution (3.8%). Ocular symptoms had a negative impact on daily activities (blurred sight 47.8%, reduction in daily activities 38.8%, reduction in efficacy at work 25.8%, sleep disturbances 16.3%, and sick leave 12.9%). They were diagnosed in 38.9% of subjects and followed up in 34.8%. Treatment for ocular symptoms was prescribed to 35.4% of subjects and to 61.9% of subjects with a regular follow-up care. CONCLUSIONS: This survey confirms the impact of ocular symptoms on AR patients' lives and suggests that they are still neglected and undertreated.

[The costs of asthma in France and the economic implications of its level of control]. / Le coût de l'asthme en France et les implications économiques du niveau de contrôle.

INTRODUCTION: The prevalence of asthma is increasing in France and the proportion of patients with poorly controlled or uncontrolled asthma remains significant. The economic impact of this public health issue is still poorly documented and this is addressed in the present literature review. STATE OF THE ART: Older identified studies aimed to estimate the use of asthma-related health care resources according to the asthma severity. Only more recent studies have taken into account the level of control of the disease as well. A consistent finding was that asthma-related medical costs were highly dependent both on the degree of severity and level of control. PERSPECTIVES: Studies identified in this review used the recommendations current at the time of their publication to define severity or levels of control in connection to asthma-related medical consumption, which leads to important methodological variation among them. Economic evaluation which is generally based on annual consumption estimates is hampered by the fact that the level of control reflects only a short-term situation. CONCLUSIONS: Although data in the literature are consistent in showing that improved control of the disease significantly reduces the costs of its management, there is a need for economic studies based on recent definitions of control and using appropriate methodology.

[Phenotype of asthmatic patients according to a score derived from the Asthma Control Test]. / Phénotype des patients asthmatiques selon le score dérivé de l'Asthma Control Test.

UNLABELLED: Today the control of asthma is a key element of national and international guidelines. The ER'Asthma survey, created in 2003, measured the control of asthma and its determinants in a primary care population. The aim of the current analysis of the ER'Asthma database was to characterize the phenotype of asthmatic patients according to three levels of control by using a score derived from the Asthma Control Test (ACT). METHOD: An ancillary descriptive analysis of a cross-sectional epidemiological survey of 15,534 asthmatic patients. A score derived from the ACT was calculated for each patient by using an algorithm applied to five questions from the ER'Asthma questionnaire and similar to those of the ACT. The analysis looked for association between the patients' characteristics and the different levels of control. RESULTS: The uncontrolled patients were more likely to be obese, smokers, older, treated by a single drug, non-compliant and to have a poorer quality of life. CONCLUSION: The use of a validated three-level score has confirmed the phenotypes of poorly controlled patients. ACT not only evaluates asthma control but could also be the starting point of a discussion with the patients on the correction of modifiable risk-factors and the necessary compliance with treatment.

[Validation study of the BDI/TDI scores in chronic obstructive pulmonary disease]. / Etude de validation de l'échelle BDI/TDI dans la bronchopneumopathie chronique obstructive.

BACKGROUND: The Baseline and Transition Dyspnoea Indices (BDI/TDI) provide measurements of breathlessness and of its impact on activities of daily living. OBJECTIVES: To assess, in France, the measurement characteristics of the BDI/TDI scores. METHOD: A multicentric cohort of 103 patients with mild to severe COPD was questioned by both a medical and a paramedical investigator at enrollment and again 6 months later. RESULTS: Concordance between investigators was good for all the sub-scores of the BDI, but less satisfactory for the TDI score. The BDI score was significantly correlated with all spirometric data. Conversely, the TDI score only correlated significantly with change in the FEV1. Both scores correlated highly with the modified Medical Research Council score, the St George Respiratory Questionnaire and with their evolution. The average TDI score was close to 0 in stable patients indicating good reproducibility of this Index. Changes in the TDI score were closely associated with changes in global health assessment by physicians, less so when assessed by patients. CONCLUSION: The BDI-TDI scores appear to be valid instruments for the measurement of dyspnoea in COPD patients and, less significantly, for measurement of its change over time.

Lack of eosinophilia can predict remission in wheezy infants?

BACKGROUND: Early wheezing in infants is a potential risk factor for persistence of asthma into adulthood. Moreover, a personal or familial history of atopy are risk factors associated with persistence of pre-existing wheezing during childhood. However, their relative importance remains unclear. OBJECTIVES: Firstly to determine the critical thresholds of common biological markers of atopy in wheezy infants associated with persistence of wheezing into childhood and secondly to rank these biological markers together with clinical parameters according to the strength of their association with wheezing persistence. METHODS: A cohort of infants less than 30 months old with recurrent wheezing was established in order to assess severity of respiratory symptoms and to look for the presence of atopy. At the age of 6 years, they were re-evaluated regarding remission of wheezing over the previous 12-months period. RESULTS: Data were available for 219 subjects. In 27% of them, wheezing persisted at 6 years of age. Critical biological thresholds associated with the risk of wheezing persistence were: (1) a blood eosinophilia count >or=470/mm(3) (defining eosinophilia), and (2) a total serum IgE level >or=45 IU/mL (defining elevated IgE) during infancy. A multiple component factorial analysis identified a dimension associating eosinophilia, elevated IgE and allergic sensitization on the one hand with persistent wheezing at 6 years of age on the other (lambda=0.15). According to a segmentation analysis, the main discriminative parameter of wheezing persistence was eosinophilia. Thus a lack of eosinophilia alone could account for 91% of infants in remission, and when combined with absence of allergic sensitization, remission was correctly discriminated in 96.9% of the study population. CONCLUSION: Our data strongly suggest that the lack of eosinophilia in wheezy infants without ongoing infection could predict future remission of wheezing in a large majority of cases.

[Asthma control level in asthmatic children followed in general practice medicine in France: results of ER'ASTHME study]. / Niveau de contrôle de l'asthme chez l'enfant en médecine générale en France: résultats de l'étude ER'ASTHME.

UNLABELLED: Little information is available on asthma control level in children in France in general practice medicine although such control is 1 of the essential goals of treatment. The ER'Asthme survey has been set up to assess asthma control among asthmatic patients visiting their general practitioner and to determine the clinical and therapeutic associated factors. METHODS: Cross-sectional ancillary study carried out in 1410 asthmatic children aged 6 to 14 years old (B/G 65/35%), with asthma diagnosed at least 12 months earlier and visiting spontaneously their GP. It collected data on self-assessed health status, asthma control (assessed by 3-level composite score based on the Canadian consensus criteria as adapted by Anaes: optimal, acceptable and unacceptable), and compliance (PMAQ3w questionnaire) during the last 4 weeks. RESULTS: Children (or their parents) answered the question about their asthma control as follow: 62% "excellent" or "fine", 31% "not very good" and 7% "poor". GPs, however, assessed asthma control as optimal in 27% of children, acceptable in 7% and unacceptable in 66%. Eighty-four per cent of children had taken a maintenance treatment. Only 57% of patients reported complete compliance with their maintenance treatment (60% in 6-12 years old vs 52% in 13-14 years old, P=0.0089). Asthma control level was significantly associated to the asthma severity (P=0.0063), type of maintenance treatment (P<0.0001) and to treatment compliance (P=0.0005). CONCLUSION: Asthmatic children aged 6 to 14 years old (or their parents) overestimate their asthma control, which remains inadequate. Severity of asthma, compliance level and the type of maintenance treatment influence the level of asthma control.

[Asthma control in general practice: a cross-sectional survey of 16,580 patients]. / ER'Asthme, contrôle de l'asthme chez 16580 patients suivis en médecine générale.

INTRODUCTION: Little information is available about asthma control in patients followed by general practitioners care in France, although such control is one of the essential aims of their treatment. OBJECTIVES: The ER'Asthme survey sought to assess asthma control among patients visiting their general practitioner (GP) and to determine the factors associated with it. METHODS: This cross-sectional included patients with asthma diagnosed at least 12 months earlier, aged more than 6 years, and followed by a GP. It collected data on self-assessed health status, asthma control (assessed by a 3-level composite score based on the Canadian consensus criteria as adapted by ANAES: optimal, acceptable and unacceptable), and compliance. RESULTS: The study included 16,580 patients; 85% were older than 20 years, and 54% were male. Patients answered the question about their asthma control as follows: 53% "excellent" or "fine", 39% "not very good" and 8% "poor". GPs, however, assessed asthma control as optimal in 21% of patients, acceptable in 7% and unacceptable in 72%. Concordance between these two assessments was thus poor: Kappa coefficient 34.5% (95% CI [33.5%; 35.5%]). Only 59% of patients reported complete compliance with their maintenance treatment. Factors associated with optimal control were: use of fixed combination therapy (inhaled corticosteroid+long-acting beta-agonist) (OR: 3.7; 95%CI [3.5; 4.2]) normal BMI (OR: 2.4; 95%CI [2.0; 2.9]), non-smoker status (OR: 2.4; 95%CI [2.1; 2.8]), age<50 (OR: 2.3; 95%CI [2.1; 2.6]) and good compliance (OR: 1.6; 95%CI [1.5; 1.8]). CONCLUSION: Patients with asthma overestimate their asthma control, which often remains inadequate. Maintenance treatment with a fixed combination, BMI, smoking, age and compliance all influence the level of asthma control.

[Economic burden of COPD: the SCOPE study]. / Impact economique de la BPCO en France: etude SCOPE.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is a major health problem. Few data about COPD economic burden are available. METHODS: SCOPE was an observational economical retrospective and prospective study conducted in France in 2001, by 114 general practitioners (GPs) and 57 lung specialists. The aim was to describe the burden of COPD patients and to estimate the annual cost according to severity stages. Health resource utilization was collected by questionnaires over a 12-month period for 285 patients. RESULTS: It was a cost-of-illness analysis. COPD patients followed by a lung specialist were more severe than patients followed by a GP and had a higher level of medical resource consumption. The COPD disease and its complications explained 66% of the total cost. The main cost drivers were inpatient care (35%, or 1509,9 euros/year/patient) and prescription medications (31%, or 1340,6 euros/year/patient). The direct total cost varied according to COPD severity on account of inpatient care and respiratory assistance. DISCUSSION: This study confirmed the economic burden of COPD in France. Actions allowed to slow down the disease's evolution and to anticipate the exacerbation could reduce the cost.

Characteristics of intermittent and persistent allergic rhinitis: DREAMS study group.

BACKGROUND: In the Allergic Rhinitis and its Impact on Asthma (ARIA) classification, intermittent and persistent rhinitis were proposed to replace seasonal and perennial allergic rhinitis (AR). AIM: To better understand the ARIA classification of rhinitis. METHODS: A cross-sectional study was carried out in 591 patients consulting ENT or allergy specialists for AR and 502 control subjects. The diagnosis of AR was based on a score for allergic rhinitis (SFAR) > or =7. Patients were classified according to the four ARIA classes (mild intermittent, mild persistent, moderate/severe intermittent and moderate/severe persistent). Allergen sensitization (skin prick tests (SPTs) or specific IgE) and co-morbidities were examined according to the ARIA classes. RESULTS: Ten percent of patients had mild intermittent rhinitis, 14% mild persistent rhinitis, 17% moderate/severe intermittent rhinitis and 59% moderate/severe persistent rhinitis. Most patients with intermittent rhinitis had a pollen sensitivity, but 5% had a single house dust mite (HDM) sensitization. Over 50% of patients with persistent rhinitis were allergic to pollens or HDM. Asthma was present in 24% of rhinitis patients and in only 2% of the control population (P<0.0001). Patients with moderate/severe persistent rhinitis had the highest asthma prevalence (33%). DISCUSSION: Intermittent and persistent rhinitis are not synonymous of seasonal and perennial rhinitis. Most patients consulting specialists have severe rhinitis. Asthma prevalence increases with duration and severity of rhinitis supporting the ARIA major recommendation that patients with persistent rhinitis should be evaluated for asthma.

Prevalence of nasal polyposis in France: a cross-sectional, case-control study.

BACKGROUND: The prevalence of nasal polyposis (NP) has never been established in France due to the lack of diagnostic tools for population-based studies. METHODS: Using a recently validated questionnaire/algorithm (90% specificity and sensitivity) in a population-based random sample, the present cross-sectional, case-control study allowed to determine NP prevalence and describe the principal aspects of NP epidemiology. A total of 10 033 subjects (>/=18 years) were screened. After identification of subjects with NP and those without, another questionnaire was submitted to NP patients only for further data collection. Controls were individuals without NP, matched by gender and age to NP patients. RESULTS: Nasal polyposis prevalence was 2.11% (95% CI 1.83-2.39). NP patients (n = 212, 45% males) were aged 49.4 +/- 17.6 years. No gender preponderance was observed, but NP tended to increase with age. Mean duration of nasal symptoms was 22.4 +/- 15.7 years. Among the 145 patients having already seen a doctor for their symptoms, 77.2% have been referred to a specialist, and 18.6% had a diagnosis of NP. Rhinorrhoea was reported by 39.9% of NP patients, blocked nose by 30.8%, and anosmia by 28.9%. Only 6.9% reported facial discomfort while 24.6% complained about general discomfort. Most NP patients (61.3%) had a pharmacological treatment, a nasal spray for the major part (76.9%). CONCLUSION: The present study provides valuable and reliable information on NP epidemiology in France; the collected information are in accordance with most published international data.

The SCOPE study: health-care consumption related to patients with chronic obstructive pulmonary disease in France.

OBJECTIVE: The main objective of the SCOPE study was to estimate the total direct medical costs of patients with treated chronic obstructive pulmonary disease (COPD) in France according to severity stages. METHODS: Total medical resources consumption of a sample of COPD patients was collected over a 12-month period through a national physician survey (including both general practitioners and lung specialists). This survey was completed for 255 patients. Data were then extrapolated to all patients with diagnosed and treated COPD in France. Average total medical resources consumption of a COPD patient per year was 4366 euros. Among this cost 41% was directly related to COPD follow-up, 25% to COPD-related complications (mainly exacerbations), and 34% to other diseases. More than one-third of the total direct COPD cost was related to hospitalizations and 31% to drug consumption. COPD-related costs increased markedly with severity based on FEV1 (but data suggested the existence of a threshold effect). SCOPE data did not show any evidence of a significant relationship between direct medical cost and patient age, sex, addiction to tobacco, or duration of COPD. The total medical consumption of COPD patients in France was 3.5 billion euros and accounted for 3.5% of the total medical expenditures (prevalence of COPD was estimated 1.3% in the general population). RESULTS: The SCOPE study revealed the high level of medical resources consumption of patients with COPD. CONCLUSIONS: The burden of COPD itself and its complications appeared to be of considerable magnitude in France especially for severe COPD.

[A model-based comparison of cost effectiveness of imiquimod versus podophyllotoxin for the treatment of external anogenital warts in France]. / Comparaison coût-efficacité par modélisation de l'imiquimod et de la podophyllotoxine dans le traitement du condylome acuminé externe en France.

OBJECTIVES: For the National health scheme, to compare the costs and the efficacy of treatment of external anogenital warts with imiquimod and podophyllotoxin and laser therapy in the case of failure or relapse. PATIENTS AND METHODS: A model simulating the two successive treatments was built. In the first phase, the two topical treatments applied by the patients: podophyllotoxin for 4 weeks and imiquimod for 16 weeks were compared. In the case of failure or relapse, laser therapy that is widely used in France in this indication and, was applied. The efficacy of the topical treatments was assessed after reanalysis of the results of two controlled clinical trials versus placebo. These two trials were retained because they were comparable in method and had been recently published at the same time. A review of the literature assessed the results of laser therapy. A survey was conducted to collect the medical resources consumed by the different treatments. RESULTS: Imiquimod provided a clearance rate of 49.5 p. 100, i.e., the disappearance of the lesions at 16 weeks, greater than that of podophyllotoxin (28.3 p. 100) at 4 weeks. The relapse rate was lowest with imiquimod (13.3 p. 100) than with podophyllotoxin (30.9 p. 100). The remission rate without relapse 3 months after the end of treatment was, including the laser, of 62 p. 100 following imiquimod and of 47 p. 100 following podophyllotoxin. The costs per patient cured was of 668 Euros for imiquimod and of 689 Euros for podophyllotoxin. CONCLUSION: Imiquimod, because of its greater initial efficacy, is at least as cost-effective as podophyllotoxin the treatment of external genital warts.

The burden of COPD in France: results from the Confronting COPD survey.

Chronic obstructive pulmonary disease (COPD) is an obstructive lung disorder characterized by progressive airflow limitation that is not reversible or only partially reversible, including chronic bronchitis and emphysema. Confronting COPD in North America and Europe was the first large-scale international survey to attempt to quantify the country-specific burden of the disease, collecting data on clinical outcomes, healthcare resource utilization, and lost productivity, from patients and physicians in France and seven other countries. The economic analysis of the French survey results showed that patients with COPD required considerable utilization of healthcare resources, with annual direct costs estimated at Euro 530 per patient In addition, COPD-related illness or disability prevented many patients from working, with an estimated annual indirect cost of Euro 1078 per patient The survey suggested underdiagnosis and undertreatment of COPD by healthcare professionals, and patients reported poor symptom control. The cost of unscheduled care (Euro 151) was almost double the cost of scheduled visits to healthcare professionals (Euro 82). This suggests that improving the long-term management of chronic symptoms by healthcare professionals could reduce the burden of disease. As in other countries, the clinical management of COPD in France may be improved by following guideline recommendations for COPD treatment. These include smoking cessation at all stages of the disease, regular treatment of chronic symptoms with bronchodilators in dyspnoeic patients, and pulmonary rehabilitation. The results of the survey also showed that the societal cost of COPD was considerably greater in patients with severe disease (Euro 2882) compared with mild COPD (Euro 289). This suggests that interventions that could help delay the progression of COPD to the advanced stages of the disease (such as smoking cessation) could be of economic benefit.

Budget impact model for determining the costs of introducing inhaled salmeterol/fluticasone propionate combination for the management of persistent asthma in France.

A budget impact model was used to estimate the effect of introducing inhaled salmeterol/fluticasone propionate combination on asthma drug-related costs in France. The model is based on disease prevalence, drug use, drug acquisition cost and sales forecasting data specific to France. It takes the perspective of social security and has a time horizon of 1 year. All drug acquisition costs are adjusted for the average rate of reimbursement of asthma medications in France (77.3%). All costs are expressed in euros. The model shows that if patients receiving concurrent salmeterol plus fluticasone propionate (or budesonide plus formoterol switch to combined salmeterol/fluticasone propionate, the anticipated annual savings would be 2,691,580 and 1,916,966 euros, respectively. On a fixed budget 4067 additional patients could be treated if salmeterol/fluticasone propionate is substituted for concurrent salmeterol plus fluticasone propionate and an additional 2939 patients if the combination is used to replace concurrent budesonide plus formoterol. Overall, using sales forecasting data to estimate how many patients will switch to the new combination from their current therapy, it is estimated that the introduction of salmeterol/fluticasone propionate will increase the national expenditure in France on asthma medications by a maximum of 3%. This budget impact model shows that the introduction of inhaled salmeterol/fluticasone propionate combination is likely to have minimal impact on asthma-related medication costs in France. Moreover, the available data on the salmeterol/fluticasone propionate combination suggest that it is clinically effective, cost-effective and affordable to the French healthcare system.

[Medical resources consumption of type 2 diabetics in France in 1998]. / Consommation de soins et de biens médicaux des diabétiques de type 2 en France en 1998.

The research objective of CODE-2 study was to estimate the total direct medical resources use of type 2 diabetes in France and in Europe. Only French data are provided in this paper. Total medical resources consumption of type 2 diabetics on a 6 months retrospective period were collected through a national practitioner survey (including both general practitioners and diabetology/endocrinology specialists). This survey was completed for 751 patients. Data collected were then extrapolated to be representative of all type 2 diabetics in France. Average medical resources consumption of a type 2 diabetic per year is 3 350 US$ (1 US$ =6FF). This figure is a minimum because some costs were underestimated in the study. Extrapolated to all diagnosed and treated type 2 diabetics in France, this expenditure is 4.3 billion US$ and accounts for 3.8 % of the total medical resources consumption in France (prevalence of type 2 diabetes reaches 2.5 % in the general population). Among this consumption, 24.1 % is directly related to diabetes, 26.7 % to potential related diabetes complications and 49.2 % to other diseases. Time since diagnosis, current treatment type and complications are the main factors which increase such consumption. CODE-2 study reveals the high level of medical resources consumption associated with type 2 diabetes complication. It confirms that more efficient therapeutical strategies are needed to avoid these complications.

Obesity morbidity and health care costs in France: an analysis of the 1991-1992 Medical Care Household Survey.

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. International Journal of Obesity (2000) 24, 151-155

Economic assessment of a maintenance treatment strategy in prevention of recurrent depressive disorder.

OBJECTIVE: To compare the 12-month cost-effectiveness of milnacipran in maintenance treatment of depression to that of medical follow-up without antidepressant. METHOD: A Markov model with transition probabilities from a double blind clinical trial demonstrating the prophylactic efficacy of milnacipran was used. Other parameters were obtained from published sources. RESULTS: Base-case incremental cost for preventive treatment was 1,191 FF. It was reduced to 685 FF when using a 25% hospitalization rate in case of recurrence. Patients with a high initial response had extra cost of 191 FF and cost-utility was estimated to be 23,875 FF per QALY gained. For those patients, using a 25% hospitalization rate in case of recurrence, costs were lower at 1,174 FF and preventive strategy was dominating. CONCLUSION: Cost of maintenance therapy is partially balanced by the gain from recurrence prevention. It should be focused on patients with few residual symptoms or a high probability of hospitalization in case of recurrence.