Weight telemonitoring of heart failure versus standard of care in a real-world setting: Results on mortality and hospitalizations in a 6-month nationwide matched cohort study.

AIMS: Evaluating the benefit of telemonitoring in heart failure (HF) management in real-world settings is crucial for optimizing the healthcare pathway. The aim of this study was to assess the association between a 6-month application of the telemonitoring solution Chronic Care Connect™ (CCC) and mortality, HF hospitalizations, and associated costs compared with standard of care (SOC) in patients with a diagnosis of HF. METHODS AND RESULTS: From February 2018 to March 2020, a retrospective cohort study was conducted using the largest healthcare insurance system claims database in France (Système National des Données de Santé) linked to the CCC telemonitoring database of adult patients with an ICD-10-coded diagnosis of HF. Patients from the telemonitoring group were matched with up to two patients from the SOC group based on their high-dimensional propensity score, without replacement, using the nearest-neighbour method. A total of 1358 telemonitored patients were matched to 2456 SOC patients. The cohorts consisted of high-risk patients with median times from last HF hospitalization to index date of 17.0 (interquartile range: 7.0-66.0) days for the telemonitoring group and 27.0 (15.0-70.0) days for the SOC group. After 6 months, telemonitoring was associated with mortality risk reduction (hazard ratio [HR] 0.71, 95% confidence interval [CI] 0.56-0.89), a higher risk of first HF hospitalization (HR 1.81, 95% CI 1.55-2.13), and higher HF healthcare costs (relative cost 1.38, 95% CI 1.26-1.51). Compared with the SOC group, the telemonitoring group experienced a shorter average length of overnight HF hospitalization and fewer emergency visits preceding HF hospitalizations. CONCLUSION: The results of this nationwide cohort study highlight a valuable role for telemonitoring solutions such as CCC in the management of high-risk HF patients. However, for telemonitoring solutions based on weight and symptoms, consideration should be given to implement additional methods of assessment to recognize imminent worsening of HF, such as impedance changes, as a way to reduce mortality risk and the need for HF hospitalizations. Further studies are warranted to refine selection of patients who could benefit from a telemonitoring system and to confirm long-term benefits in high-risk and stable HF patients.

Real-world effectiveness of long-acting injectable antipsychotic treatments in a nationwide cohort of 12,373 patients with schizophrenia-spectrum disorders.

This mirror-image study aimed to evaluate the real-life effectiveness of long-acting injectable antipsychotics (LAI) in schizophrenia. Patients with schizophrenia initiating LAIs January 2015-December 2016 were enrolled from the French National Health Data System (SNDS). Standardized mean differences (SMD > 0.1 deemed clinically significant) were calculated for psychiatric healthcare resource utilization measures assessed one year before (during oral AP treatment) and one year after LAI initiation. LAI effectiveness was analyzed overall and by age group, gender and compliance to oral AP, defined as exposure to an AP for at least 80% of the year before LAI initiation. 12,373 patients were included. LAIs were more frequently initiated in men (58.1%), young (18-34 years, 42.0%) and non-compliant (63.7%) patients. LAI initiation was effective in reducing the number and duration of psychiatric hospitalizations and psychiatric emergency department (ED) admissions in non-compliant patients (SMD = -0.19, -0.26 and -0.12, respectively), but not in compliant patients. First-generation LAIs, paliperidone and aripiprazole LAIs reduced psychiatric hospitalizations (SMD = -0.20, -0.24, -0.21, respectively) and ED admissions (SMD = -0.15, -0.13, -0.15, respectively). No differences in effectiveness were found for age or gender. In compliant patients, only aripiprazole LAI reduced the number of psychiatric hospitalizations (SMD = -0.13). Risperidone and paliperidone LAIs increased hospitalization duration (SMD = 0.15 and 0.18, respectively). The prescription of LAIs (except risperidone) should be recommended in all non-compliant patients, even in women and patients aged 35 or older. The lower frequency of administration of LAIs than of oral APs may improve compliance and hence reduce the risk of relapse. Aripiprazole LAI may represent a treatment of choice for compliant patients that should be further investigated.

How can we improve the care of patients with schizophrenia in the real-world? A population-based cohort study of 456,003 patients.

An important step to improve outcomes for patients with schizophrenia is to understand treatment patterns in routine practice. The aim of the current study was to describe the long-term management of patients with schizophrenia treated with antipsychotics (APs) in real-world practice. This population-based study included adults with schizophrenia and who had received ≥3 deliveries of an AP from 2012-2017, identified using a National Health Data System. Primary endpoints were real-life prescription patterns, patient characteristics, healthcare utilization, comorbidities and mortality. Of the 456,003 patients included, 96% received oral APs, 17.5% first-generation long-acting injectable APs (LAIs), and 16.1% second generation LAIs. Persistence rates at 24 months after treatment initiation were 23.9% (oral APs), 11.5% (first-generation LAIs) and 20.8% (second-generation LAIs). Median persistence of oral APs, first-generation LAIs and second-generation LAIs was 5.0, 3.3, and 6.1 months, respectively. Overall, 62.1% of patients were administered anxiolytics, 45.7% antidepressants and 28.5% anticonvulsants, these treatments being more frequently prescribed in women and patients aged ≥50 years. Dyslipidemia was the most frequent metabolic comorbidity (16.2%) but lipid monitoring was insufficient (median of one occasion). Metabolic comorbidities were more frequent in women. Standardized patient mortality remained consistently high between 2013 and 2015 (3.3-3.7 times higher than the general French population) with a loss of life expectancy of 17 years for men and 8 years for women. Cancer (20.2%) and cardiovascular diseases (17.2%) were the main causes of mortality, and suicide was responsible for 25.4% of deaths among 18-34-year-olds. These results highlight future priorities for care of schizophrenia patients. The global persistence of APs used in this population was low, whereas rates of psychiatric hospitalization remain high. More focus on specific populations is needed, such as patients aged >50 years to prevent metabolic disturbances and 18-34-year-olds to reduce suicide rates.

Epidemiology of Lyme Borreliosis in France in Primary Care and Hospital Settings, 2010-2019.

Introduction: Lyme borreliosis (LB) is a growing public health concern requiring accurate and comprehensive epidemiological knowledge to inform health care interventions. This study compared the epidemiology of LB in primary care and hospital settings, using for the first time in France three sources of data, and highlighted specific populations at higher risk of developing LB. Methods: This study analyzed data from general practitioner networks (i.e., Sentinel network, Electronic Medical Records [EMR]) and the national hospital discharge database to describe the LB epidemiology from 2010 to 2019. Results: The average annual incidence rates of LB in primary care increased from 42.3 cases/100,000 population in 2010-2012 to 83.0/100,000 in 2017-2019 for the Sentinel Network and 42.7/100,000 to 74.6/100,000 for the EMR, following a marked rise in 2016. The annual hospitalization rate remained stable from 2012 to 2019 fluctuating between 1.6 and 1.8 hospitalizations/100,000. Women were more likely to present with LB in primary care setting compared with men (male-to-female incidence rate ratio [IRR] = 0.92), whereas men were predominant among hospitalizations (IRR = 1.4), with the largest discordance among adolescents aged 10-14 years (IRR = 1.8) and adults aged 80 years and older (IRR = 2.5). In 2017-2019, the average annual incidence rate peaked among persons aged 60-69 years in primary care (>125/100,000) and aged 70-79 years among hospitalized patients (3.4/100,000). A second peak occurred in children aged 0-4 or 5-9 years depending on sources. Incidence rates in Limousin and the north-eastern regions were the highest for both primary care and hospital settings. Conclusions: Analyses showed disparities in the evolution of incidence, sex-specific incidence rates, and predominant age groups between primary care and hospital settings that merit further exploration.

Adverse drug reactions induced by cotrimoxazole: Still a lot of preventable harm.

Owing to a broad spectrum and low cost antimicrobial, cotrimoxazole is largely prescribed. However, its use is associated with various adverse drug reactions (ADRs) that warrant to ensure rational prescribing. This study aimed to describe spontaneous reports of cotrimoxazole ADRs and to evaluate the quality of prescription in patients who had ADRs. Suspected cotrimoxazole-induced ADRs cases reported to the Bordeaux regional pharmacovigilance center (France) during a 5-year period were described. Seriousness was assessed according to international criteria. Quality of prescription was assessed by compliance with the Summary of Product Characteristics (SPC) and relevance of cotrimoxazole indication. Then, an ADR was considered as preventable if the cotrimoxazole indication was not relevant, or potentially preventable if indication was relevant but the prescription was not compliant with the SPC. A total of 96 cases were analyzed: median age was 60.5 years (range: 4-94); 59.4% of patients were male. ADRs were mostly cutaneous disorders (n = 46) and hematological disorders (n = 25). A total of 60 serious ADRs occurred in 55 patients. Prescribers complied with all SPC recommendations in 21.9% of cases. Indication of cotrimoxazole was relevant or highly relevant in 41 cases. In 58% of cases, the occurrence of a cotrimoxazole-induced ADR would have been preventable or potentially preventable. In a context of increasing interest for this antibiotic to treat infections due to resistant bacteria, physicians should be more aware of the potential consequences of inappropriate prescribing cotrimoxazole and reserve its use when there is no alternative and under suitable monitoring.

Diagnostic accuracy of the International Classification of Diseases, Tenth Revision, codes of heart failure in an administrative database.

PURPOSE: Heart failure (HF) is a common, serious, and still poorly known illness, which might benefit from studies in claims databases. However, to provide reliable estimates, HF patients must be adequately identified. This validation study aimed to estimate the diagnostic accuracy of the International Classification of Diseases, Tenth Revision (ICD-10) codes I50.x, heart failure, in the French hospital discharge diagnoses database. METHODS: This study was performed in two university hospitals, comparing recorded discharge diagnoses and electronic health records (EHRs). Patients with discharge ICD-10 codes 150.x were randomly selected. Their EHRs were reviewed to classify HF diagnosis as definite, potential, or miscoded based on the European Society of Cardiology diagnostic criteria, from which the codes' positive predictive value (PPV) was computed. To estimate sensitivity, patients with an EHR HF diagnosis were identified, and the presence of the I50.x codes was sought for in the hospital discharge database. RESULTS: Two hundred possible cases of HF were selected from the hospital discharge database, and 229 patients with an HF diagnosis were identified from the EHR. The PPV of I50.x codes was 60.5% (95% CI, 53.7%-67.3%) for definite HF and 88.0% (95% CI, 83.5%-92.5%) for definite/potential HF. The sensitivity of I50.x codes was 64.2% (95% CI, 58.0%-70.4%). PPV results were similar in both hospitals; sensitivity depended on the source of EHR: Departments of cardiology had a higher sensitivity than had nonspecialized wards. CONCLUSIONS: Diagnosis codes I50.x in discharge summary databases accurately identify patients with HF but fail to capture some of them.

Previous Drug Exposure in Patients Hospitalised for Acute Liver Injury: A Case-Population Study in the French National Healthcare Data System.

INTRODUCTION: Acute liver injury (ALI) is a major reason for stopping drug development or removing drugs from the market. Hospitalisation for ALI is relatively rare for marketed drugs, justifying studies in large-scale databases such as the nationwide Système National des Données de Santé (SNDS), which covers 99% of the French population. METHODS: SNDS was queried over 2010-2014 for all hospital admissions for acute toxic liver injuries not associated with a possible other cause, using a case-population approach. Exposures of interest were drugs dispensed from 7 to 60 days before date of admission. Individual drugs were analysed by their frequency (if five or more cases) and by the ratio of exposed cases to the number of exposed subjects and to exposed patient-time in the general population over the same timeframe. RESULTS: Over 5 years, 4807 cases of ALI were identified, mean age 54.5, 59% women, 76% exposed to at least one of 249 different drugs. Drugs most commonly identified were non-overdose paracetamol (31% of cases), esomeprazole or omeprazole (18%), phloroglucinol, domperidone, co-amoxiclav, furosemide, and atorvastatin (more than 250 cases each). When compared to population exposures, the highest per-person risks were observed with antimycobacterial antibiotics, with one case for 1000 or fewer users, followed by colestyramine and erythromycin (around 1/5300), antiepileptic drugs, anticoagulants, and anti-Alzheimer drugs (1/6000-1/10,000 users). When a person-time approach was considered, the drugs with the highest per-tablet risk were still the antituberculosis drugs, followed by a number of other antibiotics. CONCLUSIONS: This nationwide study describes drugs associated with ALI, according to absolute population burden and per-patient and per-tablet risk. Some of these associations may be spurious, others causal, and others yet were unexpected. Systematic analysis of drug classes will look for outliers within each class that could raise signals of unexpected hepatic toxicity.