Choice of Systemic Drugs for the Management of Moderate-to-severe Psoriasis: A Cross-country Comparison Based on National Health Insurance Data.

Current management of moderate-to-severe psoriasis may be heterogeneous between European countries, probably due to differences in the organization of care. The aim of this study was to compare the utilization of systemic treatments for psoriasis between 2 coun-tries. All adults with psoriasis who were registered in the French (SNDS) and the Dutch (VEKTIS) national health insurance databases between 2012 and 2016 were eligible for inclusion. In France, 105,035 (15%) of 684,156 patients and, in the Netherlands, 37,405 (28.6%) of 130,822 patients received at least a systemic agent. In France, the proportion of patients treated with systemic agents was constant, while the type of drugs dispensed shifted from non-biological to biological agents. In the Netherlands, the first systemic treatment was methotrexate and, in France, acitretin. In France, the choice of the first biologic was much more variable than it was in the Netherlands, where a large proportion of patients were dispensed ustekinumab. This study highlights discrepancies between France and the Netherlands concerning the choice of first non-biologic agent and first biologic agent for patients with psoriasis. These discrepancies may be due to differences in the healthcare systems between the 2 countries.

Development of an algorithm to identify pregnancy episodes and related outcomes in health care claims databases: An application to antiepileptic drug use in 4.9 million pregnant women in France.

PURPOSE: Access to claims databases provides an opportunity to study medication use and safety during pregnancy. We developed an algorithm to identify pregnancy episodes in the French health care databases and applied it to study antiepileptic drug (AED) use during pregnancy between 2007 and 2014. METHODS: The algorithm searched the French health care databases for discharge diagnoses and medical procedures indicative of completion of a pregnancy. To differentiate claims associated with separate pregnancies, an interval of at least 28 weeks was required between 2 consecutive pregnancies resulting in a birth and 6 weeks for terminations of pregnancy. Pregnancy outcomes were categorized into live births, stillbirths, elective abortions, therapeutic abortions, spontaneous abortions, and ectopic pregnancies. Outcome dates and gestational ages were used to calculate pregnancy start dates. RESULTS: According to our algorithm, live birth was the most common pregnancy outcome (73.9%), followed by elective abortion (17.2%), spontaneous abortion (4.2%), ectopic pregnancy (1.1%), therapeutic abortion (1.0%), and stillbirth (0.4%). These results were globally consistent with French official data. Among 7 559 701 pregnancies starting between 2007 and 2014, corresponding to 4 900 139 women, 6.7 per 1000 pregnancies were exposed to an AED. The number of pregnancies exposed to older AEDs, comprising the most teratogenic AEDs, decreased throughout the study period (-69.4%), while the use of newer AEDs increased (+73.4%). CONCLUSIONS: We have developed an algorithm that allows identification of a large number of pregnancies and all types of pregnancy outcomes. Pregnancy outcome and start dates were accurately identified, and maternal data could be linked to neonatal data.

Severe intestinal malabsorption associated with olmesartan: a French nationwide observational cohort study.

OBJECTIVES: Severe sprue-like enteropathy associated with olmesartan has been reported, but there has been no demonstration of an increased risk by epidemiological studies. AIM: To assess, in a nationwide patient cohort, the risk of hospitalisation for intestinal malabsorption associated with olmesartan compared with other angiotensin receptor blockers (ARB) and ACE inhibitors (ACEIs). DESIGN: From the French National Health Insurance claim database, all adult patients initiating ARB or ACEI between 1 January 2007 and 31 December 2012 with no prior hospitalisation for intestinal malabsorption, no serology testing for coeliac disease and no prescription for a gluten-free diet product were included. Incidence of hospitalisation with a discharge diagnosis of intestinal malabsorption was the primary endpoint. RESULTS: 4 546 680 patients (9 010 303 person-years) were included, and 218 events observed. Compared with ACEI, the adjusted rate ratio of hospitalisation with a discharge diagnosis of intestinal malabsorption was 2.49 (95% CI 1.73 to 3.57, p<0.0001) in olmesartan users. This adjusted rate ratio was 0.76 (95% CI 0.39 to 1.49, p=0.43) for treatment duration shorter than 1 year, 3.66 (95% CI 1.84 to 7.29, p<0.001) between 1 and 2 years and 10.65 (95% CI 5.05 to 22.46, p<0.0001) beyond 2 years of exposure. Median length of hospital stay for intestinal malabsorption was longer in the olmesartan group than in the other groups (p=0.02). Compared with ACEI, the adjusted rate ratio of hospitalisation for coeliac disease was 4.39 (95% CI 2.77 to 6.96, p<0.0001) in olmesartan users and increased with treatment duration. CONCLUSIONS: Olmesartan is associated with an increased risk of hospitalisation for intestinal malabsorption and coeliac disease.

Compliance with pregnancy prevention plan recommendations in 8672 French women of childbearing potential exposed to acitretin.

PURPOSE: Acitretin is an oral synthetic aromatic analogue of retinoic acid available in most European countries since 1988. It is mainly used to treat severe psoriasis. Like all systemic retinoids, acitretin is teratogenic. Strict pregnancy prevention is required in women of childbearing potential who use acitretin. This study assessed compliance with Pregnancy Prevention Plan (PPP) recommendations, specifically looking at compliance with pregnancy testing (PT) and pregnancy occurrence. METHODS: A cohort of 8672 women aged 15-49 years initiating acitretin treatment from 1 January 2007 through 31 December 2013 was identified using French SNIIRAM (administrative claims data) and PMSI (hospitalisations data) databases. Pregnancy tests (PTs) were identified from reimbursed serum ßHCG and urine laboratory PTs. To satisfy PT criteria, patients who started treatment had to undergo a PT within 3 days before acitretin was dispensed. Pregnancies were identified by a pregnancy-related hospital stay or an outpatient medical abortion. RESULTS: A PT was performed in only 12% of women starting treatment and was rarely performed during treatment or during the 24 months following discontinuation of treatment. Compliance with PPP recommendations although poor appeared to be better among private dermatologists, as a PT was performed for 16% of treatment initiations (vs. 4% for general practitioners, p < 0.001). Moreover, 470 pregnancies were reported corresponding to 27 pregnancies per 1000 person-years at risk of teratogenicity. CONCLUSIONS: This study highlights poor compliance with acitretin PPP recommendations in France. Physicians and pharmacists must more rigorously apply the acitretin PPP recommendations, and patients must be better informed about acitretin's risk of teratogenicity.

Exposure of the French paediatric population to ionising radiation from diagnostic medical procedures in 2010.

BACKGROUND: Medical examination is the main source of artificial radiation exposure. Because children present an increased sensitivity to ionising radiation, radiology practices at a national level in paediatrics should be monitored. OBJECTIVE: This study describes the ionising radiation exposure from diagnostic medical examinations of the French paediatric population in 2010. MATERIALS AND METHODS: Data on frequency of examinations were provided by the French National Health Insurance through a representative sample including 107,627 children ages 0-15 years. Effective doses for each type of procedure were obtained from the published French literature. Median and mean effective doses were calculated for the studied population. RESULTS: About a third of the children were exposed to at least one examination using ionising radiation in 2010. Conventional radiology, dental exams, CT scans and nuclear medicine and interventional radiology represent respectively 55.3%, 42.3%, 2.1% and 0.3% of the procedures. Children 10-15 years old and babies from birth to 1 year are the most exposed populations, with respectively 1,098 and 734 examinations per 1,000 children per year. Before 1 year of age, chest and pelvis radiographs are the most common imaging tests, 54% and 32%, respectively. Only 1% of the studied population is exposed to CT scan, with 62% of these children exposed to a head-and-neck procedure. The annual median and mean effective doses were respectively 0.03 mSv and 0.7 mSv for the exposed children. CONCLUSION: This study gives updated reference data on French paediatric exposure to medical ionising radiation that can be used for public health or epidemiological purposes. Paediatric diagnostic use appears much lower than that of the whole French population as estimated in a previous study.

Predicted cancer risks induced by computed tomography examinations during childhood, by a quantitative risk assessment approach.

The potential adverse effects associated with exposure to ionizing radiation from computed tomography (CT) in pediatrics must be characterized in relation to their expected clinical benefits. Additional epidemiological data are, however, still awaited for providing a lifelong overview of potential cancer risks. This paper gives predictions of potential lifetime risks of cancer incidence that would be induced by CT examinations during childhood in French routine practices in pediatrics. Organ doses were estimated from standard radiological protocols in 15 hospitals. Excess risks of leukemia, brain/central nervous system, breast and thyroid cancers were predicted from dose-response models estimated in the Japanese atomic bomb survivors' dataset and studies of medical exposures. Uncertainty in predictions was quantified using Monte Carlo simulations. This approach predicts that 100,000 skull/brain scans in 5-year-old children would result in eight (90 % uncertainty interval (UI) 1-55) brain/CNS cancers and four (90 % UI 1-14) cases of leukemia and that 100,000 chest scans would lead to 31 (90 % UI 9-101) thyroid cancers, 55 (90 % UI 20-158) breast cancers, and one (90 % UI <0.1-4) leukemia case (all in excess of risks without exposure). Compared to background risks, radiation-induced risks would be low for individuals throughout life, but relative risks would be highest in the first decades of life. Heterogeneity in the radiological protocols across the hospitals implies that 5-10 % of CT examinations would be related to risks 1.4-3.6 times higher than those for the median doses. Overall excess relative risks in exposed populations would be 1-10 % depending on the site of cancer and the duration of follow-up. The results emphasize the potential risks of cancer specifically from standard CT examinations in pediatrics and underline the necessity of optimization of radiological protocols.

Epidemiologic features and outcomes associated with caustic ingestion among adults admitted in intensive care unit from 2013 to 2019: a French national observational study.

PURPOSE: Caustic ingestion is a potential life-threatening condition associated with high morbidity and mortality. Data on patients admitted to Intensive Care Unit (ICU) for severe caustic ingestion are lacking. We aimed to describing epidemiological features and outcomes of patients admitted to ICU for caustic ingestion in France. METHODS: In a retrospective, observational, and multicenter study, data from the national French Programme de Médicalisation des Systèmes d'Informations (PMSI) database were analysed from 2013 to 2019. In-hospital mortality rate (primary outcome) and in-ICU complications (secondary outcomes) were reported and analysed. RESULTS: 569 patients (289 males (50.8%), with median age of 49 years [interquartile (26-62)] were admitted in 65 French ICU for severe caustic ingestion. Five hundred and thirteen patients (90%) were admitted for intentional caustic ingestion. The median length of stay in ICU was 14.0 [4.0-31.0] days. In-hospital mortality occurred in 56 patients (9.8%). In multivariate analysis, age and simplified acute physiology score II were associated with in-hospital mortality age of 40-59 years [OR = 15.3 (2.0-115.3)], age of 60-79 years [OR = 23.6 (3.1-182.5)], and age > 80 years [OR = 37.0 (4.2-328.6)] and SAPS 2 score [OR = 1.0018 (1.003-1.033), p < 0.001]. During ICU stay, 423 complications (74%) were reported in 505 patients (89%). Infectious (244 (42.9%)), respiratory (207 (36.4%)), surgical 62 (10.9%), haemorrhagic (64 (11.2%)) and thrombo-embolic and (35 (6.2%)) complications were the most frequently reported during ICU stay. CONCLUSION: ICU admission for severe caustic ingestion is associated with 9.8% mortality and 74% complications. Age > 40 years and SAPS 2 score were independently associated with mortality.

Intensive Care Unit activity in France from the national database between 2013 and 2019: More critically ill patients, shorter stay and lower mortality rate.

BACKGROUND: Knowledge of the occurrence and outcome of admissions to Intensive Care Units (ICU) over time is important to inform healthcare services planning. This observational study aims at describing the activity of French ICUs between 2013 and 2019. METHODS: Patient admission characteristics, organ dysfunction scores, therapies, ICU and hospital lengths of stay and case fatality were collected from the French National Hospital Database (population-based cohort). Logistic regression models were developed to investigate the association between age, sex, SAPS II, organ failure, and year of care on in-ICU case fatality. FINDINGS: Among 1,594,801 ICU admissions, the yearly ICU admission increased from 3.3 to 3.5 per year per 1000 inhabitants (bed occupancy rate between 83.4 and 84.3%). The mean admission SAPS II was 42 ± 22, with a gradual annual increase. The median lengths of stay in ICU and in hospital were 3 (interquartile range (IQR) = [1-7]) and 11 days (IQR = [6-21]), respectively, with a progressive decrease over time. The in-ICU and hospital mortality case fatalities decreased from 18.0% to 17.1% and from 21.1% to 19.9% between 2013 and 2019, respectively. Male sex, age, SAPS II score, and the occurrence of any organ failure were associated with a higher case fatality rate. After adjustment on age, sex, SAPS II and organ failure, in-ICU case fatality decreased in 2019 as compared to 2013 (adjusted Odds Ratio = 0.87 [95% confidence interval, 0.85-0.89]). INTERPRETATION: During the study, an increasing incidence of ICU admission was associated with higher severity of illness but lower in-ICU case fatality.

French multicentre observational study on SARS-CoV-2 infections intensive care initial management: the FRENCH CORONA study.

AIM: Describing acute respiratory distress syndrome patterns, therapeutics management, and outcomes of ICU COVID-19 patients and indentifying risk factors of 28-day mortality. METHODS: Prospective multicentre, cohort study conducted in 29 French ICUs. Baseline characteristics, comorbidities, adjunctive therapies, ventilatory support at ICU admission and survival data were collected. RESULTS: From March to July 2020, 966 patients were enrolled with a median age of 66 (interquartile range 58-73) years and a median SAPS II of 37 (29-48). During the first 24 h of ICU admission, COVID-19 patients received one of the following respiratory supports: mechanical ventilation for 559 (58%), standard oxygen therapy for 228 (24%) and high-flow nasal cannula (HFNC) for 179 (19%) patients. Overall, 721 (75%) patients were mechanically ventilated during their ICU stay. Prone positioning and neuromuscular blocking agents were used in 494 (51%) and 460 (48%) patients, respectively. Bacterial co-infections and ventilator-associated pneumonia were diagnosed in 79 (3%) and 411 (43%) patients, respectively. The overall 28-day mortality was 18%. Age, pre-existing comorbidities, severity of respiratory failure and the absence of antiviral therapy on admission were identified as independent predictors of 28-day outcome. CONCLUSION: Severity of hypoxaemia on admission, older age (> 70 years), cardiovascular and renal comorbidities were associated with worse outcome in COVID-19 patients. Antiviral treatment on admission was identified as a protective factor for 28-day mortality. Ascertaining the outcomes of critically ill COVID-19 patients is crucial to optimise hospital and ICU resources and provide the appropriate intensity level of care.