Risk of pacemaker implantation after radiotherapy for breast cancer: A study based on French nationwide health care database sample.

BACKGROUND: Among cardiac complications of breast cancer radiotherapy (BC RT), there are very limited data on arrhythmia and conduction disorders, in particular severe cases requiring permanent pacemaker implantation (PPMI). Therefore, this exploratory study aimed to evaluate the risk of PPMI for BC patients treated with RT, compared with the general population and with BC patients not treated with RT. METHODS: The study was performed on a 1/97 representative sample of the French health care database (EGB database). Adult women with a first BC treated with or without RT between 2008 and 2016 were included, followed until 2018, and de novo PPMI were identified. We compared the PPMI incidence in BC cohort relative to the general population with standardized incidence ratio (SIR) and evaluated the risk of PPMI in RT patients compared to patients without RT with a competing risk survival analysis. RESULTS: A total of 3853 BCE patients were included. Among BC patients treated with RT, 28 PPMI cases were observed compared with 13 expected cases, corresponding to a SIR of 2.18 [95% CI: 1.45-3.06]. For BC patients not treated with RT, the SIR was 1.01 [95% CI: 0.40-1.90]. Patients treated with RT showed a borderline significant higher risk of PPMI compared with those not treated with RT (subdistribution Hazard Ratio = 2.08, 95% CI 0.87-4.97, p = 0.09). CONCLUSIONS: Our exploratory findings indicate that, over the last decade in France, BC patients treated with RT appeared to be at higher risk of PPMI than general population. Further studies are needed to expand on this topic.

Diabetes Remission and Relapse After Bariatric Surgery: a Nationwide Population-Based Study.

PURPOSE: The long-term impact of bariatric surgery on the remission of type 2 diabetes (T2DM) remains to be clarified through large nationally representative cohorts. The objectives were to determine the incidence of T2DM remission and relapse after bariatric surgery, to determine the factors associated with remission and to establish a profile for patients at risk for relapse. MATERIALS AND METHODS: We conducted a population-based cohort study using data from the French national health insurance database (Systeme national des données de santé [SNDS]). We had access to exhaustive regional data between 2013 and 2017 and to a national representative sample of the French population (EGB) from 2008 to 2018. Patients were included if they were adults and diabetics with incidental bariatric surgery. RESULTS: This study shows that 50% of patients are in remission from diabetes after bariatric surgery within a median of 2 to 4 months. Diabetes relapse was observed in 13-20% within 10 years. The factors favouring remission already described were noted (non-insulin-dependent diabetes) and original factors were also identified, in particular the advantage of bypass surgery over sleeve gastrectomy, with more remissions and fewer relapses. CONCLUSION: This study highlights a 50% prevalence of remission and a low prevalence of relapse. There are non-modifiable risk factors for remission and relapse (characteristics of diabetes, age, lipid-lowering therapy) and modifiable factors (type of surgery). Identifying these factors is essential for optimal management of patients. Additional data are essential to confirm the results of our analysis of the factors associated with relapse.

[Insufficient influenza vaccination coverage in giant cell arteritis. A French population-based study]. / Couverture vaccinale anti grippale insuffisante dans l'artérite à cellules géantes.

PURPOSE: To evaluate the rate of seasonal influenza vaccination coverage (IVC) in incident giant cell arteritis (GCA) patients compared with controls. METHODS: The vaccination rate was estimated from vaccine dispensation. IVC was compared between GCA and their controls using longitudinal multivariate Poisson regression. RESULTS: During the influenza campaigns from 2005-2006 to 2010-2011, the IVC rates in the GCA group and the control group ranged from 60.8 to 74.7% vs. 56.6 to 70.4%, respectively. Incident GCA influenza vaccination rate was 20% higher than controls (RR=1.20 ; IC 1.09 to 1.32, P<0.001). CONCLUSION: Although suboptimal, IVC in incident GCA was statistically better than controls.

Fear of cancer recurrence in Non- and Hodgkin lymphoma survivors during their first three years of survivorship among French patients.

The aim of this study was to measure the prevalence of FCR among a sample of French lymphoma survivors and to determine factors associated with clinical levels of FCR. The study was conducted with two cross-sectional measures: sociodemographic and anxiety, depression as well as health-related quality of life (HRQoL) scores were measured at the baseline of the post-cancer period and FCR was evaluated during the first 3 years of survivorship. The prevalence of clinical levels of FCR (≥13) was evaluated by the Fear of Cancer Recurrence Inventory - Short Form (FCRI-SF) among non- and Hodgkin lymphoma survivors undergoing prior first-line chemotherapy. Among 108 lymphoma survivors with an average follow-up of 1.6 years (range 0.3-3.0 years), clinical levels of FCR (≥13) were observed for 44.4% (n = 48). Multivariate analysis indicated that baseline anxiety and low quality of life were related to clinically significant FCR levels.

Risk factors for bleeding, including platelet count threshold, in newly diagnosed immune thrombocytopenia adults.

Essentials Risk factors of bleeding in adult immune thrombocytopenia are not known. This multicenter study assessed risk factors of bleeding at immune thrombocytopenia onset. Platelet count thresholds associated with bleeding were < 20 × 109 L-1 and < 10 × 109 L-1 . Exposure to anticoagulants was a major risk factor of severe bleeding. SUMMARY: Background The aim of this cross-sectional study was to assess risk factors for bleeding in immune thrombocytopenia (ITP) adults, including the determination of platelet count thresholds. Methods We selected all newly diagnosed ITP adults included in the Cytopénies Auto-immunes Registre Midi-PyrénéEN (CARMEN) register and at the French referral center for autoimmune cytopenias. The frequencies of any bleeding, mucosal bleeding and severe bleeding (gastrointestinal, intracranial, or macroscopic hematuria) at ITP onset were assessed. Platelet count thresholds were assessed by the use of receiver operating characteristic curves. All potential risk factors were included in logistic regression models. Results Among the 302 patients, the frequencies of any, mucosal and severe bleeding were 57.9%, 30.1%, and 6.6%, respectively. The best discriminant threshold of platelet count for any bleeding was 20 × 109 L-1 . In multivariate analysis, factors associated with any bleeding were platelet count (< 10 × 109 L-1 versus ≥ 20 × 109 L-1 , odds ratio [OR] 48.2, 95% confidence interval [CI] 20.0-116.3; between 10 × 109 L-1 and 19 × 109 L-1 versus ≥ 20 × 109 L-1 , OR 5.2, 95% CI 2.3-11.6), female sex (OR 2.6, 95% CI 1.3-5.0), and exposure to non-steroidal anti-inflammatory drugs (NSAIDs) (OR 4.8, 95% CI 1.1-20.7). A low platelet count was also the main risk factor for mucosal bleeding. Exposure to anticoagulant drugs was associated with severe bleeding (OR 4.3, 95% CI 1.3-14.1). Conclusions Platelet counts of < 20 × 109 L-1 and < 10 × 109 L-1 were thresholds for major increased risks of any and mucosal bleeding. Platelet count, female sex and exposure to NSAIDs should be considered for assessment of the risk of any bleeding. Exposure to anticoagulant drugs was a major risk factor for severe bleeding.

[Propensity score: Interests, use and limitations. A practical guide for clinicians]. / Score de propension : intérêts, utilisation et limites. Un guide pratique pour le clinicien.

Propensity scores have been proposed in the early 1980s, and are increasingly used in epidemiology since the 2000s. They are is used to minimize the selection bias in observational studies, leading to a comparability between the exposure groups close to that observed in randomized trials. However, they have important limitations. Besides, new statistical techniques to improve the propensity score performances are more and more complex, while the build and the use of propensity score require a strict methodology to avoid bias, imprecision and non-reproducibility. This overview, designed for clinicians, is aimed at describing the advantages, techniques of use and limitations of propensity scores. A reading grid is provided in order to help interpreting studies using propensity scores.

[Epidemiology and pharmacoepidemiology of immune thrombocytopenia]. / Épidémiologie et pharmacoépidémiologie du purpura thrombopénique immunologique.

During the last decade, the development of large clinical and population-based cohorts led to new findings in the epidemiology and the pharmacoepidemiology of immune thrombocytopenia (ITP). The incidence is estimated to 3-4 for 105 inhabitants/year, with a slight female predominance and peaks in children and patients after 60 years. The incidence rate is 9 for 105 inhabitants/year in males after 75 years. Variations across ethnic groups are discussed. In France, there is a North-South gradient and a peak of incidence during winter suggesting the role of viruses in ITP pathophysiology. Myelodysplastic syndromes are an emergent cause of secondary ITP. The incidence of intracranial bleeding is about 1% by year and the risk increases with aging. Exposure to splenectomy decreases while rituximab and thrombopoietin receptor agonists (TPO-RA) are the most used second-line drugs for persistent ITP. Mortality is slightly increased in primary ITP as compared with the general population. ITP patients have an increased risk of infection, thrombosis and hemorrhage. Aging, lung diseases, splenectomy, corticosteroids and rituximab are risk factors for infection while influenza and pneumococcal vaccines are associated with a 50% decrease of infection risk. Aging, cardiovascular risk factors, lupus anticoagulant and splenectomy are risk factors for thrombosis. The risk of thrombosis associated with corticosteroids and TPO-RAs must be further investigated.

Infections in non-splenectomized persistent or chronic primary immune thrombocytopenia adults: risk factors and vaccination effect.

Essentials The risk factors for infection in immune thrombocytopenia are not well known. We conducted a national pharmacoepidemiological study. Pulmonary disease, corticosteroids and rituximab were the main risk factors for infections. Pneumococcal and influenza vaccines were protective against infections. SUMMARY: Introduction Risk factors for infection and protective effect of vaccines in immune thrombocytopenia (ITP) patients in the era of rituximab therapy are unknown. Objectives To assess the risk factors for serious and non-serious infections (respectively, SIs and NSIs) in non-splenectomized adults treated for persistent or chronic primary ITP, including the effect of pneumococcal and influenza vaccines. Patients/Methods The population was the 2009-2012 FAITH cohort (n = 1805), which is the cohort of all incident (newly diagnosed) primary ITP adults treated > 3 months in France built into the national health insurance database (SNIIRAM). SIs were hospitalizations with any infection as the primary diagnosis code. NSIs were identified using out-of-hospital antibiotic dispensing. Cox models were performed. Results Incidence rates were 6.3/100 patient-years (95% confidence interval [CI], 5.4-7.4) for SIs (lower respiratory tract in 42.8% of the cases) and 100.5/100 patient-years (95% CI, 95.0-106.3) for NSIs. In multivariate analyses, increasing age and chronic pulmonary disease were associated with both SI and NSI occurrence. The hazard ratios (HRs) for corticosteroids and rituximab were, respectively, 3.83 (95% CI, 2.76-5.31) and 2.60 (95% CI, 1.67-4.03) for SIs and 2.46 (95% CI, 2.19-2.76) and 1.49 (95% CI, 1.28-1.74) for NSIs. Pneumococcal vaccine showed a protective effect for both SIs and NSIs (0.38 [95% CI, 0.20-0.73] and 0.52 [95% CI, 0.43-0.65], respectively), as did influenza vaccine (0.42 [95% CI, 0.27-0.64] and 0.49 [95% CI, 0.41-0.59], respectively). Conclusions Chronic pulmonary disease, corticosteroids and rituximab are the main risk factors for infections, whereas pneumococcal and influenza vaccines are protective against SIs and NSIs.

[Relationship between defense mechanism and therapeutic alliance]. / Relation entre mécanismes de défense et alliance thérapeutique.

INTRODUCTION: The therapeutic alliance can be defined as a collaborative relationship between the patient and the practitioner. It represents an essential component of the psychotherapeutic process (Ambresin et al., 2007; Cungi, 2006; Martin et al., 2000). Some authors suggest that a good alliance can have a favorable impact on the therapeutic success (Barber et al., 2000; Hubble, Duncan, & Miller 1999; Horvath & Luborsky, 1993; Horvath & Symonds, 1991). This alliance can be influenced by psychological and behavioral factors (Cungi, 2006) Thus, some defense mechanisms could prevent change or, on the contrary could facilitate adaptation (Ambresin et al., 2007) and have an impact on the therapeutic success (Muris & Merckelbach, 1996). However, the relationship between therapeutic alliance and defense mechanisms represents an insufficiently explored field (Ambresin et al., 2007; Cungi, 2006). The aim of the present study was to examine the relationship between therapeutic alliance and twenty defense mechanisms in a sample of French psychiatric patients, by differentiating results in men and women. We also examined the positive and the negative therapeutic alliance. METHOD: Sixty patients aged from 18 to 58 (M=41.50; SD=11.03) completed the French versions of the Defense Style Questionnaire-40 (DSQ-40) and the Helping Alliance questionnaire-II (HAq-II). RESULTS: Therapeutic alliance was significantly associated with each defense style: mature (0.62), neurotic (0.45) P<0.01and immature (0.27) p<0.05. The mature defense style was a significant predictor of therapeutic alliance (R(2) adj=36, F=12.39, ß=0.65, P<0.01) and of positive therapeutic alliance (R(2) adj=36, F=12.34, ß=0.62, P<0.001). Among women, positive therapeutic alliance was significantly associated with all mature defenses, three neurotic defenses (reaction formation, pseudo-altruism, idealization) and four immature defenses (splitting, denial, somatization, passive aggression). Among men, three mature defenses were associated (anticipation, humor, sublimation), four neurotic (reaction formation, pseudo-altruism, idealization and undoing) and two immature (somatization and denial). The negative therapeutic alliance, in our total sample, was associated with two immature defenses (denial and dissociation). Among men, displacement was the only defense associated with negative alliance, among women no defenses was significant. DISCUSSION: These results highlight the relationship between therapeutic alliance and some defense mechanisms, like some authors have suggested (Ambresin et al., 2007; Bond & Perry, 2004; Bond, 2004). Moreover, some defenses appeared to be more associated with a positive or a negative therapeutic alliance, and could depend on the patient gender. CONCLUSION: The present study confirms the importance of taking into account the gender in the study of defense mechanisms, and to increase our knowledge about the relationship between therapeutic alliance and defense mechanisms.

Detection of signals of abuse and dependence applying disproportionality analysis.

INTRODUCTION: Prescription drug abuse and dependence is a widespread phenomenon in many countries. The use of disproportionality measures in drug abuse surveillance is rarely performed. PURPOSE: The aim of this study is to determine the occurrence of signals of abuse and dependence for different psychoactive drugs in real-life settings. METHODS: Disproportionality analysis was realised from a database specifically constructed for the monitoring of drug abuse and dependence. This database provides information on approximately 5000 patients and 8000 consumption modalities for more than 100 distinct psychoactive medications for 2010 and 2011. Proportional reporting ratio (PRR) was computed in two population groups: subjects under an opiate maintenance treatment (OMT) versus those not under OMT, and focused on four types of behaviours: abuse and dependence, illegal acquisition, diverted route of administration and concomitant alcohol use. RESULTS: Among the 100 psychoactive drugs for which a signal could be detected, those presenting the highest signals were the following: flunitrazepam, clonazepam, methylphenidate, ketamine, morphine sulfate, codeine and buprenorphine. CONCLUSIONS: The present study shows an innovative application of disproportionality measures for drug abuse monitoring based on two cross-national, annual studies. The disproportionality analysis provided the opportunity to reveal and compare the magnitude of signals between 100 psychoactive drugs. This approach helps to compare the magnitude of abuse and dependence behaviours for a large number of drugs, and allows prioritizing actions in a context where such events are usually underreported.

[Mental health service utilization among borderline personality disorder patients inpatient]. / Utilisation des services de soin par les patients hospitalisés, présentant un trouble de personnalité borderline en Midi-Pyrénées.

BACKGROUND: Borderline personality disorder (BPD) is characterized by a pervasive pattern of instability and impulsivity. Several North American prospective studies support the high level of mental health care utilization in this population. There is little data in other systems of health organization, such as France. Furthermore, little is known on the variables associated with the mental health service utilization among BPD patients. OBJECTIVE: The main objective was to compare the utilization of mental health care among BPD patients, to the general population and patients with another personality disorder (PD) and to describe the demographic and clinical factors associated with the group of patients who use the most health care. METHOD: A multi-center (5 public and private centers), epidemiological study. Data were collected prospectively (database of an insurance fund covering 80% of the population) and viewed, retrospectively. We used the data collected during the five years previously to the inclusion. Inclusion criteria were age (18-60 years) and membership in the health insurance fund targeted. Patients on legal protection, forced hospitalization, with a chronic psychotic disorder, manic, mental retardation, or not reading French were excluded. First, four groups were composed: BPD, other PD, control groups for PD and other PD. The first two groups were recruited from a screening of inpatients including a self-administered questionnaire (Personality Disorder Questionnaire 4+). Assessment by a psychologist including the Structured Interview for DSM-IV Personality Disorders (SIDP-IV) was given straight to those who had a score above 28. This questionnaire allowed us to distinguish one group of subjects with BPD and a group with other PD (without BPD). Clinical evaluation included Axis I (MINI), Axis II (SIDP-IV), psychopathological features (YSQ-I, DSQ-40), demographic variables and therapeutic alliance (Haq-II). Matched controls (age, sex) composed the 3rd and 4th group (BPD control and other PD control). They were randomly chosen in the health database insurance previously used. RESULTS: One hundred and thirty-seven (95.8%) screened patients agreed to answer the psychological assessment. In this sample, 44 (32.1%) had BPD, 39 (28.5%) other PD and another 39 (28.5%) did not have PD. The BPD group was compared to a sample of 165 matched subjects and the other group PD to a sample of 123 matched controls. There was no difference between BPD and other PD groups regarding the mental health utilization. However, there was an increased use of hospitalizations and deliverances of nervous system drugs in both clinical groups compared to their controls. The analysis of drugs supplied in pharmacies for BPD patients showed that the first two drugs were opiate substitutes (12.3% methadone, buprenorphine 6.7%). No anticonvulsants or atypical antipsychotics appear in the top 20 of treatments delivered. A composite variable (hospitalization for more than 6 months during previous five years and 500 supplied drugs) allowed the discrimination of two groups among patients with BPD: heavy users of care and low care users. No variables (demographics, Axis I, Axis II, self-aggressiveness, DSQ-40, Haq-II, YSQ-I) could discriminate the two groups except the number of previous psychotherapies (heavy users: n=0.4 (SD 0.5) vs low users: n=1.8 (SD 2.1) P=0.0054). CONCLUSION: This study confirms the important use of the service of BPD patients in France, as well as the possible moderating role of psychotherapy. We found a mismatch between these uses and recommendations.

French health insurance databases: What interest for medical research?

French health insurance databases are organized since 2003 into a huge digital data warehouse, the Système national d'information inter-régime de l'assurance maladie (SNIIR-AM). It covers the entire French population (65 million inhabitants). In order to facilitate studies on more frequent conditions, a random sample of 1/97th of national health system beneficiaries has been built since 2005, called the échantillon généraliste des bénéficiaires (EGB). The aim of this article is to describe the main characteristics of the SNIIR-AM and the EGB, to detail their accessibility according to French law, and to present their strengths and limits. It is illustrated with the most recent studies conducted in these databases. These databases include demographic, out-hospital reimbursement (including drug dispensing), medical (costly long-term diseases, occupational diseases, sick-leaves…), and in-hospital data. All these data are prospectively recorded, individualized, made anonymous and linkable. Consequently, the SNIIR-AM is a very useful data source for epidemiological, pharmacoepidemiological and health economics studies, particularly for rare diseases. The EGB is appropriate for long-term research on more frequent diseases.

Multimorbidity type, hospitalizations and emergency department visits among nursing home residents: a preliminary study.

BACKGROUND: The burden of multimorbidity in institutionalized elderly is poorly investigated. We examined the associations of the type of multimorbidity (i.e., physical, mental or both) with the number of hospitalizations and emergency department (ED) visits in nursing home (NH) residents. METHODS: This is a cross-sectional study among NH residents. Information on residents' health, number of hospitalizations in the last 12 months and hospital department of admission (having been seen in ED vs. non) was recorded by NH staff of 175 French NHs (data was collected in 2011). Participants were screened for the presence of several mental (e.g., dementia) and physical conditions (e.g., diabetes). RESULTS: Data on hospitalization was available for 6076 NH residents. Compared to having no diseases, the concomitant presence of ≥ 2 physical conditions was the multimorbidity type more strongly associated with both the number of hospitalizations (incidence rate ratio (IRR) =1.93; 95% confidence interval (CI) =1.57 - 2.37) and ED visits (odds ratio (OR)= 1.79; 95% CI=1.24 - 2.58). The presence of a mental condition appeared to moderate the associations between physical conditions and hospitalizations, since the estimate effects were lower among people who had both physical and mental conditions, compared to those with only physical conditions. For example, compared to people with ≥ 2 physical conditions, those with multiple physical and mental conditions had lower IRR (IRR = 0.84; 95% CI=0.75 - 0.95) for the number of hospitalizations. CONCLUSIONS: Mental diseases in very old and multimorbid NH residents probably moderate the associations between physical diseases and hospitalizations. To what extent this represents either a mirror of better clinical practice in NHs or the under-recognition from the NH staff of symptoms leading to justifiable hospitalizations remains unclear.

Healthcare cost impact of biological drugs compared with traditional systemic treatments in psoriasis: a cohort analysis in the French insurance database.

BACKGROUND: Biological drugs have dramatically improved the management of moderate to severe psoriasis. Little is known about their economic impact in daily clinical practice. OBJECTIVE: The aim of this study was to estimate the costs of biological drugs, in term of health resources consumption, and to compare it with costs induced by traditional systemic treatments. METHODS: This cohort study was built from the French health insurance database in the Midi Pyrénées area (2.8 million inhabitants, South West of France). We compared health care costs between 'exposed' patients treated with biological drugs (adalimumab, etanercept, infliximab or ustekinumab) and 'unexposed' patients defined as patients who received traditional systemic treatments (phototherapy, acitretin, methotrexate or cyclosporin) during a 6-month period. RESULTS: A total of 1924 patients met the inclusion criteria. Sixty-nine patients were 'exposed', whereas 1855 patients were 'unexposed'. 'Exposed' patients had a mean total healthcare cost of 8107€ vs. 1678€ (P < 0.001) for 'unexposed' patients. They had higher costs concerning inpatient admission, medication and consultations including dermatology consultations, laboratory, non-medical care and transportation. Biological drug prescription was associated with an increase in the use of anti-infective drugs and with a reduction in the use of psychoactive drugs. CONCLUSION: The mean total health care expenditure in patients treated with biological drugs was five times higher as compared with patients treated with traditional systemic treatments. The limitation of the study is the short duration of follow-up comprising a loading dose period for some biological drugs. This may have contributed to an overestimation of drug-related costs.

Drug treatment for diabetes in nursing home residents.

AIMS: The aim of this study was to describe drug treatment for diabetes in a large sample of nursing home residents and to compare subjects' health outcomes according to the anti-diabetic agents used. METHODS: The cross-sectional data of 6275 residents [average age 86 years (± 8.2); 73.7% women] from 175 nursing homes in France were analysed. Participants were divided into one of the following four groups: diabetes non-drug treatment, diabetes hypoglycaemic (e.g. insulins, sulphonylurea) treatment, diabetes non-hypoglycaemic (e.g. metformin) treatment and no diabetes. Group comparisons were made on functional ability (activities of daily living score) and on the prevalence of the following variables (yes vs. no): emergency department visits, falls and fractures. RESULTS: Of the participants, 1076 (17.1%) had diabetes: 222 participants in the non-drug treatment group, 722 in the hypoglycaemic group and 132 in the non-hypoglycaemic group. The remaining 5199 participants made up the group without diabetes. Insulin and metformin were used by 549 and 185 participants, respectively. Activities of daily living scores differed across the four groups, with those in the non-drug treatment group being the most disabled. Adjusted multivariate analyses showed that, compared with the group without diabetes, those in the hypoglycaemic group had a higher probability of emergency department visits (odds ratio 1.26, 95% CI 1.03-1.54) and increased the incidence rate ratios (1.02, 95% CI 1.00-1.04) of disability (activities of daily living score), whereas the non-hypoglycaemic group was not significantly associated with these outcomes. CONCLUSIONS: The use of hypoglycaemic drugs was associated with poor health outcomes in nursing home residents. Therefore, more attention must be paid to adapting anti-diabetic treatment in this complex population.

A multicentric individually-tailored controlled trial of education and professional support to nursing home staff: research protocol and baseline data of the IQUARE study.

BACKGROUND: Whilst the number of people living in nursing homes (NH) is expected to rise, research on NH quality is scarce. The purpose of this article is to describe the research protocol of the IQUARE study and to present its baseline data. METHODS AND DESIGN: IQUARE is a 18-month multicentric individually-tailored controlled trial of education and professional support to NH staff. The main purposes of IQUARE are to improve the quality of the health care provided in NHs and to reduce the risk of functional decline among residents. Data on internal organisation and residents' health for the 175 participating NHs were recorded by NH staff at baseline. NHs were allocated to either a light intervention group (LIG, n = 90 NHs, totalising 3 258 participants) or a strong intervention group (SIG, n = 85 NHs, totalising 3 017 participants). Intervention for LIG consisted at delivering to NH staff descriptive statistics on indicators of quality regarding their NH and the NHs from their sub-region of health and region; whereas for SIG, NH staff received the same information that LIG, but quality indicators were discussed by a cooperative work (two half-day meetings) between a hospital geriatrician and NH staff. Strategies for overcoming NH's weaknesses were then traced; the efficacy of strategies is evaluated at a 6-month period. RESULTS: Baseline data showed high levels of dependence, comorbidities, psychological disturbances and medication's consumption among NH residents. Large discrepancies among NHs were observed. CONCLUSIONS: IQUARE is one of the largest controlled trials in NHs developed in France. Results from IQUARE may constitute the basis for the development of new work modalities within the French health system, and serve as a model of a feasible research approach in NHs.

Estimated magnitude of diversion and abuse of opioids relative to benzodiazepines in France.

INTRODUCTION: Prescription drug abuse is a major concern in several countries. France appears to be particularly prone to the abuse of opiate maintenance treatment (OMT) opioids and benzodiazepines (BZD), whereas the abuse of opioid analgesics (OA) is less commonly reported. To estimate the extent of psychoactive drug abuse, the French drug agency relies on different methods measuring various diversion indicators used as proxies for the detection of abuse/misuse: suspicion of abuse/dependence, illegal acquisition by patients seen in specialized care centers, prescription forgery and doctor shopping. The main objectives of the present study are to analyse the abuse and diversion of opioids (both OA and OMT), in comparison with those of BZDs, through the concurrent use of three different data sources. METHODS: Diversion and abuse of opioids were analysed using indicators of abuse and diversion derived from three data sources over the period 2006-2008. Then, opioids were compared to BZDs for the year 2008 using the same indicators. RESULTS: The analysis suggests that BZDs are more commonly dispensed than OAs and OMTs but that abuse and diversion are related mainly to OMT (particularly to buprenorphine), morphine and BZDs and less to OAs (except for morphine). CONCLUSION: This study presents an original approach, based on the use of multiple data sources, to evaluate and compare the estimated abuse and diversion of opioids and benzodiazepines. It provides health authorities with a global, comparative and summarized overall view of the importance of different patterns of diversion and abuse for different prescription drugs.

Statin-induced lupus: a case/non-case study in a nationwide pharmacovigilance database.

Statin use has been advocated to prevent atheromatous complications in lupus patients and may be widely prescribed for these patients in future. Statin-induced lupus has also been described, though the risk is not confirmed. The goal of this study was to detect a safety signal regarding statin-induced lupus. We conducted a case/non-case study in the French PharmacoVigilance Database from January 2000 until December 2010. Cases were drug-induced lupus reports. Non-cases were all reports of other adverse drug reactions (ADRs). Exposure to statins at the time of ADR was screened in each report. Among 235,147 ADR reports, 232 were drug-induced lupus. Exposure to statins was present in 17 (7.3%) cases and in 10,601 (4.7%) non-cases. Reporting odds ratio (ROR) for statin exposure associated with lupus erythematosus was 1.67 (95% confidence interval 1.02-2.74). The ROR was > 1 for each statin but fluvastatin. This pharmacoepidemiological study suggests a link between statin exposure and lupus induction. The benefit-to-risk ratio of statin therapy in lupus patients should be evaluated through randomized controlled trials.