Public Health Impact and Cost-Effectiveness Analysis of 4-Component Meningococcal Serotype B Vaccination for Infants in France.

BACKGROUND AND OBJECTIVES: In France, meningococcal serogroup B (MenB) is the most common serogroup causing invasive meningococcal disease (IMD) in infants and young children. Our objective was to illustrate the impact of model choices on health outcomes and the cost-effectiveness of infant vaccination with the multicomponent meningococcal serogroup B vaccine (4CMenB) versus no vaccine in France. METHODS: A previously published dynamic transmission-based cost-effectiveness model was adapted for the French context using updated, French-specific demographic, epidemiological, and cost data. IMD incidence and long-term sequelae were derived through analysis of French healthcare and surveillance databases. A collective perspective over a 100-year time horizon was adopted, with a discount rate of 2.5%, reduced to 1.5% after the first 30 years. Deterministic and probabilistic sensitivity and scenario analyses were performed. RESULTS: In the base case analysis, infant vaccination with 4CMenB avoided 3101 MenB IMD cases in infants aged < 1 year (- 54%) and 6845 cases in all age groups (- 21%). The estimated incremental cost-effectiveness ratio was €316,272/quality-adjusted life-year (QALY) but was highly sensitive to the types of sequelae included, MenB incidence, vaccine effectiveness parameters, and consideration of life-expectancy in IMD survivors (range: €65,272/QALY to €493,218/QALY). CONCLUSIONS: Using economic models compliant with French methodology guidelines, 4CMenB does not seem cost-effective; however, results are sensitive to model choices and 4CMenB immunization is an effective strategy to prevent MenB IMD cases and to improve quality of life and economic burden associated with MenB IMD treatment, especially with regard to long-term sequelae.

Invasive meningococcal disease (IMD) is rare but can lead to lifelong disabilities and death. It is caused by a type of bacteria called Neisseria meningitidis. IMD is most common in infants and young children, and in this group it is mostly caused by Neisseria serogroup B bacteria. We analyzed the number of IMD cases caused by serogroup B in France, as well as sequelae (long-time effects of the disease), using data from national healthcare databases. The most common sequelae observed were epilepsy, severe neurological disorders, and anxiety, occurring in approximately 5% of patients. We then calculated the costs and benefits of the multicomponent meningococcal serogroup B vaccine (4CMenB) vaccine for infants and young children in France. The results showed that 4CMenB vaccination can reduce the number of IMD cases due to serogroup B by 3101 cases (− 54%) in infants under 1 year and by 6845 cases (− 21%) in all age groups. Over 100 years, vaccination could prevent over 2000 cases of IMD that result in disabilities and 438 deaths. The estimated cost-effectiveness ratio was high. However, costs per health benefit gained decreased when focusing on long-term health benefits. In France, there is no threshold for the cost-effectiveness ratio and the French Health Authority has included 4CMenB in its vaccination schedule. This recommendation reflects results from our study, which highlights the considerable burden on families and patients, mostly because of IMD-related disabilities. Early vaccination is a good way to protect infants and young children against this serious disease.

Care pathways in invasive meningococcal disease: a retrospective analysis of the French national public health insurance database.

Invasive meningococcal disease (IMD) carries a high burden in terms of mortality, long-term complications, and cost, which can be significantly reduced by vaccination. The objectives of this case-control study were to document the care pathways of patients with IMD before, during, and after hospitalization and to assess in-hospital complications and long-term sequelae. Cases consisted of all people hospitalized for IMD in France between 2012 and 2017. Controls were matched by age, gender, and district of residence. Data were extracted from the French national public health insurance database on demographics, hospitalizations, mortality and potential sequelae of IMD. Overall, 3,532 cases and 10,590 controls were assessed and followed up for 2.8 years (median). During hospitalization, 1,577 cases (44.6%) stayed in an intensive care unit, 1,238 (35.1%) required mechanical ventilation, and 43 (1.2%) underwent amputation; 293 cases (8.3%) died in hospital and a further 163 (4.6%) died following discharge; 823 cases (25.4% of survivors) presented ≥1 sequela and 298 (9.2%) presented multiple sequelae. The most frequently documented sequelae were epilepsy (N = 205; 5.8%), anxiety (N = 196; 5.5%), and severe neurological disorders (N = 193; 5.5%). All individual sequelae were significantly more frequent (p < .0001) in cases than controls. Hearing/visual impairment and communication problems were conditions that presented the highest risk for cases compared to controls (risk ratios >20 in all cases). In conclusion, this study highlights the importance of providing optimal medical care for patients with IMD, of minimizing the delay before hospitalization, and of effective prevention through comprehensive vaccination programs.

Benefits of providing optimal medical care for IMD patients.Importance of minimising the delay before hospitalization.IMD remains challenging to diagnose, and vaccination is the most efficient way to prevent the disease and its complications.

Healthcare Resource Consumption and Cost of Invasive Meningococcal Disease in France: A Study of the National Health Insurance Database.

INTRODUCTION: Invasive meningococcal disease (IMD) is an uncommon but serious infectious disease. Its economic burden is known to be high but is poorly characterised. The objective of this study was to determine costs, as captured in the healthcare claims database, incurred by all patients hospitalised for IMD in France over a 6-year period. METHODS: This case-control study was performed using the French national public health insurance database (SNDS). Cases comprised all individuals hospitalised with acute IMD in France between 2012 and 2017 inclusive. For each case, three controls were identified, matched for age, gender and region of residence. All healthcare resource consumption by cases and controls during the follow-up period was documented. Costs were analysed for the index hospitalisation in cases, 1 year following the index date and then for 5 years following the index date. Costs were assigned from national tariffs. The analysis was performed from a societal perspective. IMD sequelae were identified from hospital discharge summaries. RESULTS: A total of 3532 cases and 10,590 controls were evaluated. The mean per capita cost of the index IMD hospitalisation was €11,256, and increased with age and with the presence of sequelae. In the year following the index date, mean per capita direct medical costs were €6564 in cases and €2890 in controls. Annual costs were €4254 in cases without sequelae, €10,799 in cases with one sequela and €20,096 in cases with more than one sequela. In the fifth year of follow-up, mean per capita costs were €2646 in cases and €1478 in controls. The excess cost in cases was principally due to the management of sequelae. Amputation, skin scarring and mental retardation generated per capita costs in excess of €20,000 in the first year and in excess of €10,000 for subsequent years. CONCLUSION: The economic burden of IMD in France is high and, over the long-term, is driven by sequelae management.

Risk factors for invasive meningococcal disease: a retrospective analysis of the French national public health insurance database.

Vaccination of at-risk populations against Neisseria meningitidis is an important strategy to prevent invasive meningococcal disease (IMD). The objective of this study was to characterize preexisting risk factors in patients with IMD and to compare their relative importance. This case-control analysis was performed in the French national public health insurance database (SNDS). Cases consisted of all people hospitalized for IMD in France over a six-year period (2012-2017). Controls were matched by age, gender, and district of residence. Medical risk factors were identified from ICD-10 codes in the SNDS. Socioeconomic risk factors studied were low household income and social deprivation of the municipality of residence. Associations of these risk factors with hospitalization for IMD were quantified as odds ratios (ORs) between cases and controls with their 95% confidence intervals (95%CI). The medical risk factors showing the most robust associations were congenital immunodeficiency (OR: 39.1 [95%CI: 5.1-299], acquired immunodeficiency (10.3 [4.5-24.0]) and asplenia/hyposplenia (6.7 [3.7-14.7]). In addition, certain chronic medical conditions, such as autoimmune disorders (5.4 [2.5-11.8]), hemophilia (4.7 [1.8-12.2]) and severe chronic respiratory disorders (4.3 [3.1-6.2]) were also strongly associated, as was low household income (1.68 [1.49-1.80]). In conclusion, this study has documented potential risk factors associated with hospitalization for IMD in a large and comprehensive sample of individuals with IMD in France. Several of the risk factors identified may help identify groups who could benefit from targeted prevention measures (such as vaccination) in order to reduce the burden of IMD.

Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme.

BACKGROUND: Mepolizumab was available in France as part of an early access programme for patients with severe eosinophilic asthma (nominative autorisation temporaire d'utilisation [temporary use authorisation] (nATU)) before its commercialisation. This study aimed to characterise patients who received mepolizumab in the nATU. METHODS: This retrospective, observational study analysed data from the hospital medical records of patients up to 24 months after treatment initiation. Study objectives were to describe patient baseline characteristics, the evolution of disease severity and treatment modifications during follow-up; safety was also investigated. FINDINGS: Overall, 146 patients who received ≥1 dose of mepolizumab were included. At inclusion, patients had a mean age of 58.2 years with a mean severe asthma duration of 13.4 years, and 37.0% had respiratory allergies. Patients experienced, on average, 5.8 exacerbations per patient per year at baseline, 0.6 and 0.5 of which required hospitalisation and emergency department visits, respectively. These values improved to 0.6, 0.1 and 0.1 exacerbations per patient per year, respectively, at 24 months of follow-up. Most patients (92.8%) were using oral corticosteroids at baseline, compared with 34.7% by 24 months of follow-up. Moreover, mean blood eosinophil counts improved from 722 cells·µL-1 at baseline to 92 cells·µL-1 at 24 months of follow-up; lung function and asthma control followed a similar trend. INTERPRETATION: Results confirm findings from clinical trials, demonstrating that mepolizumab is associated with important improvements in several clinically meaningful outcomes and has a favourable safety profile in a population with severe eosinophilic asthma, outside of the controlled environment of a clinical trial.

Clinical and economic burden of severe asthma: A French cohort study.

OBJECTIVE: To describe the clinical and economic burden of severe asthma in France over 12 months. METHODS: Data were retrieved from the observational, prospective "Cohorte Obstruction Bronchique et Asthme" (COBRA) cohort, which has enrolled nearly 1000 asthma patients since 2007 from throughout France. Patients undergoing treatment with GINA step-4 or 5 medications uninterruptedly for 12 months (thus defining "severe asthma") were identified and their clinical data used to describe the clinical burden of asthma (exacerbations, symptoms outside exacerbations, and level of asthma control). Patients' utilization of healthcare resources was described and used to estimate the direct medical costs incurred to treat severe asthma. RESULTS: 155 patients were included in the present study. Over the 12-month period of interest, 128 (83%) patients experienced at least one asthma exacerbation, 22 (14%) patients were hospitalized for asthma, 133 (86%) patients experienced continuous symptoms outside exacerbations, and 77 (50%) patients experienced important limitations in daily life activities. The median number of asthma-related drugs used was 4. The mean estimated annual asthma-related cost was 8,222 euros (standard deviation, SD = 11,886), including 7,229 euros (SD = 11,703) for controller medications. CONCLUSION: Symptoms outside exacerbation periods are highly prevalent in severe asthma patients, for whom the main driver of medical costs is controller medication.

Defining the "Frequent Exacerbator" Phenotype in COPD: A Hypothesis-Free Approach.

BACKGROUND: The COPD "frequent exacerbator" phenotype is usually defined by at least two treated exacerbations per year and is associated with a huge impact on patient health. However, existence of this phenotype and corresponding thresholds still need to be formally confirmed by statistical methods analyzing exacerbation profiles with no specific a priori hypothesis. The aim of this study was to confirm the existence of the frequent exacerbator phenotype with an innovative unbiased statistical analysis of prospectively recorded exacerbations. METHODS: Data from patients with COPD from the French cohort in Exacerbations of COPD Patients (EXACO) were analyzed using the KmL method designed to cluster longitudinal data and receiver operating characteristic (ROC) curve analysis to determine the best threshold to allocate patients to identified clusters. Univariate and multivariate analyses were performed to study characteristics associated with different clusters. RESULTS: Two clusters of patients were identified based on exacerbation frequency over time, with 2.89 exacerbations per year on average in the first cluster (n = 348) and 0.71 on average in the second cluster (n = 116). The best threshold to distinguish these clusters was two moderate to severe exacerbations per year. Frequent exacerbators had more airflow limitation, symptoms, and health-related quality of life impairment. A simple clinical score was derived to help identify patients at risk of exacerbations. CONCLUSIONS: These analyses confirmed the existence and clinical relevance of a frequent exacerbator subgroup of patients with COPD and the currently used threshold to define this phenotype.

Limited treatment adaptation despite poor asthma control in asthma patients treated with inhaled corticosteroids.

OBJECTIVE: Current asthma guidelines recommend use of inhaled corticosteroids (ICS) in patients with persistent disease. This study was designed to investigate (1) the proportion of patients prescribed ICS-containing maintenance treatment who achieve asthma control, (2) determinants of control and (3) how physicians adapt treatment to the level of control. METHODS: General practitioners (GPs) and chest physicians (CPs) in France recruited patients consulting for asthma and prescribed an ICS. Over a 2-year follow-up period, asthma symptoms in the previous 3 months and treatments prescribed were documented at each visit. Variables independently associated with asthma control were determined by multiple logistic regression. RESULTS: Data were available for 924 patients recruited by GPs and 455 recruited by CPs. Asthma control was acceptable in only 24% of patients at inclusion, and in 33.6% at the last follow-up visit. Five factors were independently associated with asthma control: age (or time since diagnosis), gender, smoking status, allergic aetiology of asthma and treatment. Most patients (56.3%) were prescribed the same ICS dose regimen at the end of follow-up as at inclusion. The intensity of controller therapy had been increased in only 12.2% of patients unacceptably controlled at inclusion. CONCLUSIONS: Asthma was unacceptably controlled in most patients receiving ICS-containing maintenance treatment and remained so during follow-up. Despite this, treatment adaptations by GPs and CPs were very infrequent. This unsatisfactory situation may be improved by adopting a more dynamic approach to tailoring controller therapy to the needs of the patient.

The daily cost of ICU patients: A micro-costing study in 23 French Intensive Care Units.

OBJECTIVES: To estimate the daily cost of intensive care unit (ICU) stays via micro-costing. METHODS: A multicentre, prospective, observational, cost analysis study was carried out among 21 out of 23 French ICUs randomly selected from French National Hospitals. Each ICU randomly enrolled 5 admitted adult patients with a simplified acute physiology II score ≥ 15 and with at least one major intensive care medical procedure. All health-care human resources used by each patient over a 24-hour period were recorded, as well as all medications, laboratory analyses, investigations, tests, consumables and administrative expenses. All resource costs were estimated from the hospital's perspective (reference year 2009) based on unitary cost data. RESULTS: One hundred and four patients were included (mean age: 62.3 ± 14.9 years, mean SAPS II: 51.5 ± 16.1, mean SOFA on the study day: 6.9 ± 4.3). Over 24 hours, 29 to 186 interventions per patient were performed by different caregivers, leading to a mean total time spent for patient care of 13:32 ± 05:00 h. The total daily cost per patient was € 1425 ± € 520 (95% CI = € 1323 to € 1526). ICU human resources represented 43% of total daily cost. Patient-dependent expenses (€ 842 ± € 521) represented 59% of the total daily cost. The total daily cost was correlated with the daily SOFA score (r = 0.271, P = 0.006) and the bedside-time given by caregivers (r = 0.716, P < 0.0001). CONCLUSION: The average cost of one day of ICU care in French National Hospitals is strongly correlated with the duration of bedside-care carried out by human resources.

Real-life use of fluticasone propionate/salmeterol in patients with chronic obstructive pulmonary disease: a French observational study.

BACKGROUND: In Europe, administration of an inhaled corticosteroid (ICS) combined with a long-acting ß2 agonist is approved in chronic obstructive pulmonary disease (COPD) patients with a pre-bronchodilator FEV1 < 60% predicted normal, a history of repeated exacerbations, and who have significant symptoms despite regular bronchodilator therapy. Minimal data are available on the use of the fluticasone propionate/salmeterol xinafoate combination (FSC) in the real-life COPD setting and prescription compliance with the licensed specifications. METHODS: A French observational study was performed to describe the COPD population prescribed with FSC, prescription modalities, and the coherence of prescription practices with the market authorized population. Data were collected for patients initiating FSC treatment (500 µg fluticasone propionate, 50 µg salmeterol, dry powder inhaler) prescribed by a general practitioner (GP) or a pulmonologist, using physician and patient questionnaires. RESULTS: A total of 710 patients were included, 352 by GPs and 358 by pulmonologists. Mean age was over 60 years, and 70% of patients were male. More than half were retired, and overweight or obese. Approximately half were current smokers and one-third had cardiovascular comorbidities. According to both physician evaluation and GOLD 2006 classification, the majority of patients (>75%) had moderate to very severe COPD. Strict compliance by prescribing physicians with the market-approved population for dry powder inhaler SFC in COPD was low, notably in ICS-naïve patients; all three conditions were fulfilled in less than a quarter of patients with prior ICS and less than 7% of ICS-naïve patients. CONCLUSIONS: Prescription of dry powder inhaler SFC by GPs and pulmonologists has very low conformity with the three conditions defining the licensed COPD population. Prescription practices need to be improved and systematic FEV1 evaluation for COPD diagnosis and treatment management should be emphasized.

The association between asthma control, health care costs, and quality of life in France and Spain.

BACKGROUND: Current asthma management guidelines are based on the level of asthma control. The impact of asthma control on health care resources and quality of life (QoL) is insufficiently studied. EUCOAST study was designed to describe costs and QoL in adult patients according to level of asthma control in France and Spain. METHODS: An observational cost of illness study was conducted simultaneously in both countries among patients age greater or equal to 18 with a diagnosis of asthma for at least 12 months. Patients were recruited prospectively by GPs in 2010 in four waves to avoid a seasonal bias. Health care resources utilization of the three months before the inclusion was collected through physician questionnaires. Asthma control was evaluated using 2009 GINA criteria over a 3-month period. QoL was assessed using EQ-5D-3L®. RESULTS: 2,671 patients (France: 1,154; Spain: 1,517) were enrolled. Asthma was controlled in 40.6% [95% CI: 37.7%-43.4%] and 29.9% [95% CI: 27.6%-32.3%] of French and Spanish patients respectively.For all types of costs, the percentage of patients using health care resources varied significantly according to the level of asthma control. The average cost (euros/3-months/patient) of controlled asthma was €85.4 (SD: 153.5) in France compared with €314.0 (SD: 2,160.4) for partially controlled asthma and €537.9 (SD: 2,355.7) for uncontrolled asthma (p<0.0001). In Spain, the corresponding figures were €152.6 (SD: 162.1), €241.2 (SD: 266.8), and €556.8 (SD: 762.4). EQ-5D-3L® score was higher (p<0.0001) in patients with controlled asthma compared to partially controlled and uncontrolled asthma in both countries (respectively 0.88; 0.78; 0.63 in France and 0.89; 0.82; 0.69 in Spain). CONCLUSIONS: In both countries, patients presenting with uncontrolled asthma had a significantly higher asthma costs and lower scores of Qol compared to the others.

Impact of innate and environmental factors on wheezing persistence during childhood.

BACKGROUND: Persistent asthma in adults starts often early in childhood and is associated with alterations in respiratory function that occur early in life. OBJECTIVES: The aim of this study was to evaluate the importance of innate and environmental factors associated with occurrence of asthma during childhood in a population of recurrent wheezing infants followed prospectively. 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 and environmental risk factors. At the age of 6 years, they were reevaluated with respect to remission or persistence of wheezing over the previous 12-month period. RESULTS: Data were available for 219 subjects aged 15 +/- 5 months. In 27% of the infants with recurrent wheeze, wheezing persisted until the age of 6 years. In multivariate analysis, stepwise logit analysis showed that the risk factors for persistent wheezing are eosinophilia >or=470/mm(3), allergenic sensitization, and a father with asthma. Environmental factors present during the first year of life that protect from persistence of wheezing are ( 1 ) breastfeeding for longer than 3 months, ( 2 ) pets at home, and ( 3 ) >or=3 siblings. The detection rate for persistent wheezing in this model is 72%. The persistence score showed good specificity 91% but low sensitivity 35%. CONCLUSION: This study confirms the role of atopic host factors on wheezing persistence during childhood and detected protective environmental factors.

[INSTANT: national survey of allergic rhinitis in a French adult population based-sample]. / Un tiers des adultes ont une rhinite allergique en France (enquête INSTANT).

OBJECTIVE: To assess the prevalence of allergic rhinitis (AR) (according to the SFAR, Score For Allergic Rhinitis and the ARIA Allergic Rhinitis and its Impact on Asthma classification) in the French adult general population and to describe its impact on quality of life, quality of sleep and prevalence of associated ocular symptoms. METHODS: This cross-sectional survey was carried out in 2006 in a French population-based sample. The data were collected by a polling organization in 3 waves using face-to-face interviews at home. Subjects answered to questionnaires of AR management, quality of life (SF-12), quality of sleep (MOS-Sleep) and daytime sleepiness (Epworth). Statistical analysis was performed using SAS software. RESULTS: Among the 10, 038 interviewed subjects, (mean age: 43 years), the overall prevalence of AR was 31%, with regional variations (from 26% in South West to 37% in the Mediterranean area). The prevalence was higher in younger subjects (39% in 18-25 years, 35% in 26-35 years, vs. 22% in >65 years, p<0.001) and in women (36% vs. 25% in men, p<0.001). Among the 2005 subjects of the 1st wave, the first 601 subjects with a SFAR> or =7 constituted the AR group and 706 subjects with SFAR<7 the Control group. According to the ARIA classification, 44 % of individuals had a moderate to severe persistent AR, 6% a mild persistent AR, 43.5% a moderate to severe intermittent AR and 6.5% a mild intermittent AR. Asthma (26%) and eczema (14%) were the most frequent allergic conditions associated with AR. Ocular symptoms were present in 52% of AR subjects. Quality of life and of sleep did not differ significantly between the intermittent and the persistent forms of AR (or according to the length...) but were more significantly deteriorated in the AR group compared to the Control group (summary psychic score of SF-12: 45.5 vs. 49, p<0.001 and index 1 of MOS-Sleep: 34 vs. 25; p<0.01). The Epworth sleepiness score was also higher in the AR group than in the Control group (6.9 vs. 5.5, p<0.01). Furthermore, sleepiness was more frequent in the AR persistent form than in the AR intermittent form (MOS-sleep scores: 28.5 vs. 33, p<0.05). CONCLUSION: This national survey confirmed the elevated prevalence of AR as assessed using the SFAR and associated ocular symptoms at the general population level and highlighted the important negative impact of AR on quality of life and sleep.

Asthma patients' perception of their ability to influence disease control and management.

BACKGROUND: Patients' perception of their ability to influence their asthma symptoms has not been sufficiently addressed. OBJECTIVE: To study the relationship between patients' perceived ability to self-care, as approached by internal locus of control (LOC) orientation, and concomitant level of asthma control. METHODS: A cross-sectional study was conducted from May 19, 2004, through July 7, 2005. Asthma patients receiving inhaled corticosteroids and supervised in primary care were identified. Asthma control was measured with the Asthma Control Test. Patients reported their LOC orientation on a 100-mm visual analog scale (0%, "I have absolutely no influence on asthma change," to 100%, "this change only depends on me"). Asthma therapy was obtained from a prescription database. The risk of an internal LOC of less than 50% was studied. RESULTS: Among the 163 patients with documented LOC (mean age, 52 years; 58% female), 72 (44.2%) had an internal LOC of less than 50%. Asthma control was inadequate for 65 of the 157 patients with available data on the global score of the Asthma Control Test (41.4%). Patients with inadequately controlled asthma had a higher risk of a LOC of less than 50% (odds ratio, 2.68; 95% confidence interval, 1.23-5.81). A 3-fold increased risk also appeared for patients older than 65 years compared with those younger than 45 years. Conversely, no association was identified with sex, asthma severity markers, or therapy. CONCLUSIONS: Asthma control was related to internal LOC orientation (ie, perceived ability to self-care). Improved self-care efficiency is a target for adequate disease management.

Asthma patients' self-reported behaviours toward inhaled corticosteroids.

BACKGROUND: Patient adherence to recommended use of ICS is questionable in asthma, with irregular use or interruptions occurring frequently. Factors explaining discontinuation of controller therapy could orientate interventions. The characteristics of patients with interruptions of inhaled corticosteroids (ICSs), intentional or accidental, were investigated. METHODS: Asthma patients regularly prescribed ICS by GPs (Cegedim network) were included. Patients' characteristics and behaviours toward ICS (accidental/intentional interruptions, less frequent use of ICS and change in dosing) were identified from self-report questionnaires, and linked to data prescription database. Interrelations between declared behaviours toward ICS were studied with a Multiple Component Analysis (MCA) and the correlates of ICS interruptions were identified. RESULTS: During the past 3 months, 31.6% of 204 patients (mean age: 53.8 years, females: 59.3%) intentionally interrupted ICS when feeling better, 25.4% forgot ICS and 18.3% deliberately changed the doses. A quarter of patients considered constant use of respiratory medicines as unhealthy. MCA revealed that intentional, accidental interruptions and less frequent use of ICS were closely correlated. Risk of intentional interruption was increased when patients considered constant use of respiratory therapy to be unhealthy (OR=3.36, 95%CI=[1.47-7.66]). Conversely, risk was significantly lower when ICS was associated or combined with another controller (OR=0.24, 95%CI=[0.08-0.73]), compared to ICS in monotherapy. Less frequent interruptions were observed in patients older than 65 (OR=0.35, 95%CI=[0.13-0.89]). CONCLUSIONS: Our study suggests that discontinuation of use of controllers is associated with other inadequate behaviours or beliefs about inhaled controllers. Efforts should be targeted at patients' perceptions and behaviours toward controller therapy.

Control of asthma in children: still unacceptable? A French cross-sectional study.

BACKGROUND: The goal of asthma management focuses on adequate control of asthma, although little is known about the optimal level of asthma control to be reached. The ELIOS study was conducted in France to address this lack of information. METHODS: Cross-sectional study of asthmatic children (4-15 years) visiting their medical practitioner. The primary objective was to assess the level of asthma control with a 3-level composite score based on French (ANAES) guidelines criteria (optimal, acceptable, and unacceptable). RESULTS: Asthma control was assessed in 3431 children and classified as optimal (26%), acceptable (41.3%), and unacceptable (32.7%). When PEFR was studied, asthma control was optimal in 23.0%, acceptable in 35.8% and unacceptable in 41.2% (p<0.001) of children. Unacceptable asthma control was significantly associated with higher BMI (p=0.002), more recent diagnosis of asthma (p=0.008), passive exposure to parental tobacco smoke (p<0.001), number of associated allergic diseases (p<0.001), frequent respiratory tract infections (p<0.001) and low socioeconomic status (p<0.001). Multivariate analysis identified presence of respiratory tract infections (p<0.0001), passive exposure to parental tobacco smoke (p=0.009) and low socioeconomic status (p=0.042) as variables associated with unacceptable asthma control. CONCLUSIONS: There is room for improvement in France as only 25% of asthmatic children are optimally controlled. Public health strategies should increase awareness among physicians and parents about the importance of using asthma control tools, eliminating exposure to tobacco smoke and treating associated allergic diseases.

[Difficulties in the assessment of dyspnea and respiratory function in general practice]. / Difficultés de l'évaluation de la dyspnée et de la fonction respiratoire en médecine générale.

BACKGROUND: Dyspnea is one of the principal signs of chronic respiratory diseases. OBJECTIVE AND METHODS: To determine the appropriate questions and tests for recognizing dyspnea, 295 general practitioners questioned 1991 patients with or at risk of COPD in this cross-sectional study. After a brief training session, the physicians were asked to assess respiratory function with a small electronic spirometer. RESULTS: A questionnaire with a six-point semi-quantitative scale of dyspnea detected more dyspneic patients (78.1%) than the single question "Are you usually short of breath?" (68.6%), which in turn detected this symptom more often than simply listening for spontaneous complaints (33.7%). Even when dyspnea was reported only for substantial exertion, it was associated with impairment of all domains of quality of life. Only half the spirometry results met the minimal criteria of validity and reproducibility. DISCUSSION AND CONCLUSIONS: These results underline the importance of a specific, systematic assessment of dyspnea in patients at risk, and the need for sufficient training and practice before the use of electronic spirometers in general practice.

Allergic rhinitis and its consequences on quality of sleep: An unexplored area.

BACKGROUND: Allergic rhinitis (AR) is common and has been shown to impair social life and sleep. Patients with severe symptoms may have more sleep disturbances than those with a mild form of the disease, but this has never been assessed using a validated tool. The objective of our study was to assess, in patients with AR, whether duration and severity of AR are associated with sleep impairment. METHODS: A nationwide controlled cross-sectional epidemiological study was carried out. A representative sample of 260 French ear, nose, and throat and allergy specialists enrolled 591 patients with AR of at least 1 year's duration. Sleep disorders, sleep quality, and AR were assessed using validated tools (Sleep Disorders Questionnaire, Epworth Sleepiness Scale, and Score for Allergic Rhinitis). The severity of AR was assessed using the Allergic Rhinitis and its Impact on Asthma classification. RESULTS: All dimensions of sleep were impaired by AR, particularly by the severe type. Sleep was significantly more impaired in patients with severe AR than in those with the mild type. The duration of AR (intermittent or persistent) had no effect on sleep. CONCLUSION: These data underline the close relationship between AR and sleep and highlight the need for clinicians, particularly general practitioners, to be attentive in this respect.

Nasal polyposis in France: impact on sleep and quality of life.

The prevalence of nasal polyposis (NP) in France (2.11 per cent) and its epidemiology (detection, medical management, patients' characteristics, risk factors, associated diseases, etc.) were determined in a population-based, cross-sectional, case-control study of 10 033 adults carried out in 2002. The impact of this disease on daily living was also studied, by the analysis of potential sleep disorders (validated questionnaire) and quality of life (QOL, SF-36 questionnaire) of NP patients, in a comparison with a matched-control group of individuals without NP. A quarter of NP patients (24.6 per cent) reported a feeling of general discomfort due to their nasal condition, during the day as well as the night in most of these cases (61.2 per cent). Compared with controls, NP patients have a two-fold higher risk of suffering sleep disturbance (odds ratio [OR]: 2.25, 95 per cent confidence interval [95% CI] [1.54; 3.29]). Snoring was reported by 50.5 per cent of NP patients vs 35.7 per cent of controls (p < 0.001). All scores from the SF-36 questionnaire demonstrated a significant negative impact of NP on the different aspects of QOL. The current study underlines the negative impact of NP on QOL and sleep, two dimensions that are rarely considered in its pathology. In addition to the discomfort and lowered QOL experienced by patients with this disease, a significant increase in sleep disorders was shown, suggesting a risk of suffering further chronic diseases and complications.

Evaluation of a diagnostic questionnaire for nasal polyposis: an observational, cross-sectional study.

Nasal polyposis (NP) represents actually a matter of concern for most ear, nose and throat (ENT) specialists. In France, we lack data on NP prevalence due to the unavailability of a validated diagnostic questionnaire easily usable in population-based studies. The present study tested the sensitivity and specificity of an 11-item questionnaire for NP diagnosis from which an algorithm of diagnosis decision was inferred. Outpatients from 3 ENT departments were asked to complete the questionnaire prior to their visit. After the visit, the investigator had to write his final diagnosis (FD) on the envelope containing the questionnaire, without reading the patient's responses. Data from 406 patients showed a good specificity and sensitivity of most items. Awareness of NP, previous cortisone therapy for nasal pathology, and history of nasal surgery were shown to be the most discriminating items. An algorithm was elaborated by aggregation of the different items; its specificity and sensitivity were close to 90%. These diagnostic questionnaire and algorithm, although not substitutable to a clinical diagnosis, should be very useful for population-based studies.