A methodological comparison of two European primary care databases and replication in a US claims database: inhaled long-acting beta-2-agonists and the risk of acute myocardial infarction.

PURPOSE: Results from observational studies on inhaled long-acting beta-2-agonists (LABA) and acute myocardial infarction (AMI) risk are conflicting, presumably due to variation in methodology. We aimed to evaluate the impact of applying a common study protocol on consistency of results in three databases. METHODS: In the primary analysis, we included patients from two GP databases (Dutch-Mondriaan, UK-CPRD GOLD) with a diagnosis of asthma and/or COPD and at least one inhaled LABA or a "non-LABA inhaled bronchodilator medication" (short-acting beta-2-agonist or short-/long-acting muscarinic antagonist) prescription between 2002 and 2009. A claims database (USA-Clinformatics) was used for replication. LABA use was divided into current, recent (first 91 days following the end of a treatment episode), and past use (after more than 91 days following the end of a treatment episode). Adjusted hazard ratios (AMI-aHR) and 95 % confidence intervals (95 % CI) were estimated using time-dependent multivariable Cox regression models stratified by recorded diagnoses (asthma, COPD, or both asthma and COPD). RESULTS: For asthma or COPD patients, no statistically significant AMI-aHRs (age- and sex-adjusted) were found in the primary analysis. For patients with both diagnoses, a decreased AMI-aHR was found for current vs. recent LABA use in the CPRD GOLD (0.78; 95 % CI 0.68-0.90) and in Mondriaan (0.55; 95 % CI 0.28-1.08), too. The replication study yielded similar results. Adjusting for concomitant medication use and comorbidities, in addition to age and sex, had little impact on the results. CONCLUSIONS: By using a common protocol, we observed similar results in the primary analysis performed in two GP databases and in the replication study in a claims database. Regarding differences between databases, a common protocol facilitates interpreting results due to minimized methodological variations. However, results of multinational comparative observational studies might be affected by bias not fully addressed by a common protocol.

[Results of the French cohort of the European observational study FINDER: quality of life of patients treated with antidepressants]. / Résultats de la cohorte française de l'étude observationnelle européenne FINDER : qualité de vie de patients traités par antidépresseurs.

OBJECTIVES: To describe health-related quality of life (HRQoL), pain, clinical outcomes and treatment patterns in French patients with depression treated by general practitioners and psychiatrists. METHODS: Factors Influencing Depression Endpoints Research (FINDER) is a European longitudinal observational, naturalistic, multicentre study to determine the HRQoL (SF-36 and EQ-5D) and to assess outcomes of depression and anxiety (Hospital Anxiety and Depression Scale [HADS]), and pain (VAS) in a population of depressed patients initiating antidepressant treatment. Clinical diagnosis of depression was based on physician's clinical judgment. Physicians decided at their own discretion and clinical practice to initiate pharmacological treatment for depression. Adult patients with a first or new episode of depression were enrolled between May 2004 and September 2005, and followed up for 6 months. Across Europe, 437 physicians observed 3468 patients. RESULTS: In France, 606 patients (approximately 17% of the whole sample) were enrolled by 57 psychiatrists and 46 general practitioners. These patients were (mean ± SD) 45.6 ± 13.0 years old, 69% female and 39% having had a previous depressive episode in the last 2 years. According to the patient-rated HADS score greater or equal to 11, most patients (75%) were classified as cases of depression as well as cases of anxiety (84%); 51% of patients rated their overall pain severity (based on VAS cut-off of 30 mm) as moderate/severe, with 65% of these patients reporting no medical explanation for their pain. The majority (81%) of the patients were prescribed selective serotonin reuptake inhibitors (SSRI). During the 6-month follow-up, the majority of the patients (73%) remained on the same antidepressant at the same dose during the course of treatment. Between baseline and 6-month endpoint, French patients improved their mean scores (SD) on the SF-36 physical score by+3.5 (9.0) (P<0.001) and mental score by+20.6 (14.2) (P<0.001); on the EQ-5D Health State Index by+0.37 (0.32) (P<0.001) and the EQ-5D VAS by+32.3 (25.0) (P<0.001); on the HADS depression score by-8.1 (6.0) (P<0.001) and HADS anxiety score by-6.9 (5.0) (P<0.001). Patients with moderate/severe pain at baseline improved their overall pain on a mean VAS score by-34.1 (28.7) (P<0.001). CONCLUSIONS: More than half of the French patients enrolled in the study experienced pain associated with depression. During follow-up, patients improved all of their outcome measurements (physical and mental SF-36 scores, depression and anxiety HADS scores, pain VAS, EQ-5D Health State Index and VAS) and most patients remained on the same antidepressant at the same dose.

[The European Schizophrenia Outpatient Health Outcomes Study: observational study over 36 months of the French cohort of schizophrenic outpatients treated with antipsychotics]. / Etude Schizophrenia Outpatient Health Outcomes (SOHO) France : étude observationnelle à 36 mois d'une cohorte de patients schizophrènes ambulatoires traités par antipsychotiques.

BACKGROUND: Studies describing long-term continuous care of outpatients with schizophrenia are relatively scarce. The prospective European Schizophrenia Outpatient Health Outcomes study (SOHO) provides data on a cohort of schizophrenic patients over a period of three years. METHODS: Prospective, long-term, observational study including outpatients who initiate therapy or change to a new antipsychotic. The study was designed to provide two patient groups of approximately equal size: treated either with olanzapine or a non-olanzapine antipsychotic. Sociodemographic, clinical and disease characteristics at baseline were described. Clinical severity of symptoms was assessed at each visit using the Clinical Global Impression scale (CGI). Treatment outcomes were analyzed as treatment discontinuation, remission and relapse rates. RESULTS: French results are presented in this report. Nine hundred and thirty-three patients (62% males) were recruited between March and December 2001. The mean age was 37.1+/-11.5 years. The mean time since first consultation for schizophrenia was 8.0+/-9.3 years. At study baseline, one quarter had paid employment, less than one third had a spouse or partner and more than half of them had an independent housing. Thirty percent of patients reported a previous suicide attempt. The mean CGI was 4.5+/-1.0 at admission. Overall, medication discontinuation for any cause occurred for 42% of patients. A remission (defined by a CGI

Patterns of prescription of four major antipsychotics: a retrospective study based on medical records of psychiatric inpatients.

PURPOSE: (1) To identify factors associated with the choice among the three atypical antipsychotics available in France (amisulpride, olanzapine, risperidone) and the typical antipsychotic of reference: (haloperidol), (2) to compare psychotropic co-prescription rates according to antipsychotic. METHODS: All antipsychotic prescriptions including at least one of the four antipsychotics (n=421) for all inpatients (n=372) hospitalized 24 hours or more in the 6 months previous to the start of the study were included (2003). Data were obtained from medical records and psychiatrist interviews. Of the prescriptions, 13.3% included amisulpride, 39.4% olanzapine, 27.3% risperidone, and 20.0% haloperidol. Mean dosages were 142 mg (amisulpride), 15 mg (olanzapine), 4.5 mg (risperidone), and 19.5 mg (haloperidol). RESULTS: Differences between antipsychotics were observed in relation to patients' age (younger patients prescribed amisulpride and olanzapine, p=0.04), diagnoses (affective disorders more frequently prescribed olanzapine and risperidone, p=0.005), and mode of hospitalization (admissions under constraint more frequently prescribed haloperidol, p<0.001). Antidepressant and anxiolytic-hypnotic co-prescription rates were lower with haloperidol than with atypicals. Mood-stabilizer co-prescription rates were higher for olanzapine and risperidone than for haloperidol and amisulpride. Anticholinergic co-prescription was higher with haloperidol than with atypicals (p<0.001). CONCLUSIONS: Haloperidol was prescribed to a minority and targeted male patients hospitalized under constraint, using high dosages. Type and rate of co-prescriptions varied considerably between haloperidol and atypicals.

Multidrug-resistant bacteria infection control: study of compliance with isolation precautions in a Paris university hospital.

Isolation practices in a university hospital were analyzed for 137 patients with multidrug-resistant bacteria. Isolation was ordered in writing by physicians for 40% and instituted by nurses for 60%; 74% were isolated. Compliance depended on physician ordering in writing (odds ratio, 36.3; 95% confidence interval, 4.8-274.9). Nurses complied best with hand washing.

Differences between burns in rural and in urban areas: implications for prevention.

This study aimed to identify typical features of burns in rural areas and to improve their prevention by comparing the characteristics of burnt patients and their burns in rural and urban areas. A cross-sectional survey was conducted in 19 of the 23 French burns units over one year, using a structured questionnaire. We analysed the resulting database. Of the 1422 patients, excluding 188 burnt in unclassified areas, 420 (34%) were burnt in rural areas. Burns were more frequent in rural than in urban areas. Occupational burns were more frequent in rural than in urban areas. The characteristics of patients and burns did not differ between the areas. Patients burnt during everyday activities were older and more frequently had predisposing factors in rural than in urban areas. Burns occurred outdoors more often in rural than in urban areas and were frequently due to flames or explosions or to the use of barbecues or open fires. The hands and perineum were burnt more frequently in rural than in urban areas. Rural burns were more severe than urban burns: they were deeper, involved a larger body surface area and caused more deaths. Preventive measures in rural areas should take into account occupation and everyday activities. They should be specifically adapted to the profiles of burnt patients.