COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals.

Background: The Global COVID Vaccine Safety (GCoVS) Project, established in 2021 under the multinational Global Vaccine Data Network™ (GVDN®), facilitates comprehensive assessment of vaccine safety. This study aimed to evaluate the risk of adverse events of special interest (AESI) following COVID-19 vaccination from 10 sites across eight countries.

Methods: Using a common protocol, this observational cohort study compared observed with expected rates of 13 selected AESI across neurological, haematological, and cardiac outcomes.

Background rates of adverse events of special interest for COVID-19 vaccines: A multinational Global Vaccine Data Network (GVDN) analysis.

Background: The Global COVID Vaccine Safety (GCoVS) project was established in 2021 under the multinational Global Vaccine Data Network (GVDN) consortium to facilitate the rapid assessment of the safety of newly introduced vaccines. This study analyzed data from GVDN member sites on the background incidence rates of conditions designated as adverse events of special interest (AESI) for COVID-19 vaccine safety monitoring.

Methods: Eleven GVDN global sites obtained data from national or regional healthcare databases using standardized methods.

Using LASSO Regression to Estimate the Population-Level Impact of Pneumococcal Conjugate Vaccines.

Pneumococcal conjugate vaccines (PCVs) protect against diseases caused by Streptococcus pneumoniae, such as meningitis, bacteremia, and pneumonia. It is challenging to estimate their population-level impact due to the lack of a perfect control population and the subtleness of signals when the endpoint-such as all-cause pneumonia-is nonspecific. Here we present a new approach for estimating the impact of PCVs: using least absolute shrinkage and selection operator (LASSO) regression to select variables in a synthetic control model to predict the counterfactual outcome for vaccine impact inference.

Statin Use and Incidence of Parkinson's Disease in Women from the French E3N Cohort Study.

Background: Statins represent candidates for drug repurposing in Parkinson's disease (PD). Few studies examined the role of reverse causation, statin subgroups, and dose-response relations based on time-varying exposures.

Objectives: We examined whether statin use is associated with PD incidence while attempting to overcome the limitations described previously, especially reverse causation.

Identifying Protective Drugs for Parkinson's Disease in Health-Care Databases Using Machine Learning.

Background: Available treatments for Parkinson's disease (PD) are only partially or transiently effective. Identifying existing molecules that may present a therapeutic or preventive benefit for PD (drug repositioning) is thus of utmost interest.

Objective: We aimed at detecting potentially protective associations between marketed drugs and PD through a large-scale automated screening strategy.

High-Dimensional Propensity Score-Adjusted Case-Crossover for Discovering Adverse Drug Reactions from Computerized Administrative Healthcare Databases.

Introduction: Increasing availability of medico-administrative databases has prompted the development of automated pharmacovigilance signal detection methodologies. Self-controlled approaches have recently been proposed. They account for time-independent confounding factors that may not be recorded.

Estimation of mid-and long-term benefits and hypothetical risk of Guillain-Barre syndrome after human papillomavirus vaccination among boys in France: A simulation study.

Background: The burden of human papillomavirus (HPV) infection can be substantially reduced through vaccination of girls, and gender-neutral policies are being adopted in many countries to accelerate disease control among women and expand direct benefits to men. Clinical direct benefit of boys HPV vaccination has been established for ano-genital warts and anal cancer. HPV vaccines are considered safe, but an association with Guillain-Barre syndrome has been found in French reimbursement and hospital discharge data.

Early exposure of pregnant women to non-steroidal anti-inflammatory drugs delivered outside hospitals and preterm birth risk: nationwide cohort study.

Objective: To assess the risk of preterm birth associated with nonsteroidal anti-inflammatory drugs (NSAIDs), focusing on early exposure in the period from conception to 22 weeks of gestation (WG).

Design: National population-based retrospective cohort study.

Setting: The French National Health Insurance Database that includes hospital discharge data and health claims data.

Accounting for indirect protection in the benefit-risk ratio estimation of rotavirus vaccination in children under the age of 5 years, France, 2018.

Background Rotavirus is a major cause of severe gastroenteritis in children worldwide. The disease burden has been substantially reduced in countries where rotavirus vaccines are used. Given the risk of vaccine-induced intussusception, the benefit–risk balance of rotavirus vaccination has been assessed in several countries, however mostly without considering indirect protection effects.

Identifying Drugs Inducing Prematurity by Mining Claims Data with High-Dimensional Confounder Score Strategies.

Background: Pregnant women are largely exposed to medications. However, knowledge is lacking about their effects on pregnancy and the fetus.

Objective: This study sought to evaluate the potential of high-dimensional propensity scores and high-dimensional disease risk scores for automated signal detection in pregnant women from medico-administrative databases in the context of drug-induced prematurity.

Seasonal influenza vaccine and Guillain-Barré syndrome: A self-controlled case series study.

Objective: To evaluate the risk of Guillain-Barré syndrome (GBS) following seasonal influenza vaccination based on French nationwide data.

Methods: All cases of GBS occurring in metropolitan France between September 1 and March 31 from 2010 to 2014 were identified from the French national health data system. Data were analyzed according to the self-controlled case series method.

Asthma prevalence and risk factors in school children: The RESPIR longitudinal study.

Objectives: To analyze the incidence of wheezing in the first six years of life; the prevalence of asthma at six years of age; and the associated risk factors, in a population from Valencia, Spain.

Methods: A prospective longitudinal study was made of a cohort of 636 newborn infants, with follow-up of the clinical records and the completion of questionnaires up to the age of six years.

Results: The prevalence of asthma at six years of age was 12.

Instrumental variable analysis in the context of dichotomous outcome and exposure with a numerical experiment in pharmacoepidemiology.

Background: In pharmacoepidemiology, the prescription preference-based instrumental variables (IV) are often used with linear models to solve the endogeneity due to unobserved confounders even when the outcome and the endogenous treatment are dichotomous variables. Using this instrumental variable, we proceed by Monte-Carlo simulations to compare the IV-based generalized method of moment (IV-GMM) and the two-stage residual inclusion (2SRI) method in this context.

Methods: We established the formula allowing us to compute the instrument's strength and the confounding level in the context of logistic regression models.

A benefit-risk analysis of rotavirus vaccination, France, 2015.

IntroductionTwo vaccines available for protection against rotavirus gastroenteritis (RVGE), Rotarix and RotaTeq, have contributed to a large decrease in the incidence of paediatric diarrhoea in countries where they have been used. However, they have also led to a small increase in the risk of intussusception. We compare the number of prevented hospitalisations for RVGE to the number of vaccine-induced hospitalised intussusceptions in France.

Prescription drug use during pregnancy in France: a study from the national health insurance permanent sample.

Purpose: To provide an up-to-date account of drug prescription during pregnancy in France from 2011 to 2014 using the permanent sample of the French national computerized healthcare database and with a focus on recommended supplementations, fetotoxic drugs and teratogenic drugs.

Methods: All pregnancies identified by the International Classification of Diseases, 10th Revision codes list in the hospitalization database, lasting more than 9 weeks of amenorrhea and whose delivery occurred between 01/01/2011 and 12/31/2014, were included. Drugs delivered between the trimester before and until the end of the pregnancy were included.

Executive function after severe childhood traumatic brain injury - Age-at-injury vulnerability periods: The TGE prospective longitudinal study.

Background: Executive function (EF) impairment is a major predictor of overall outcome after traumatic brain injury (TBI). TBI severity is a factor of poor outcome, but most studies include a majority of children with mild and moderate TBI. The aims of this study were to estimate EF impairment after severe childhood TBI and to explore factors predicting EF outcome.

Mefloquine Versus Sulfadoxine-Pyrimethamine for Intermittent Preventive Treatment in Pregnancy: A Joint Analysis on Efficacy and Tolerability.

Since there is no ideal candidate to replace sulfadoxine-pyrimethamine (SP) for intermittent preventive treatment (IPTp), alternatives need to be evaluated on basis of their benefit-risk ratio. We reanalyzed the first Beninese trial on mefloquine (MQ) versus SP for IPTp using a multiple outcome approach, which allowed the joint assessment of efficacy and tolerability. Overall superiority of MQ to SP was defined as superiority on at least one efficacy outcome (low birth weight [LBW], placental malaria, or maternal anemia), non-inferiority on all of them as well as on tolerability defined as cutaneous or neuropsychiatric adverse events (AEs) or low compliance with the treatment.

Short-term exposure to environmental parameters and onset of ST elevation myocardial infarction. The CARDIO-ARSIF registry.

Background: Environmental parameters have been reported to be triggers of acute myocardial infarction (MI). However, the individual role of each parameter is unknown. We quantified the respective association of climate parameters, influenza epidemics and air pollutants with the onset of ST elevation MI (STEMI) in Paris and the surrounding small ring.

Intussusception risk after RotaTeq vaccination: evaluation from worldwide spontaneous reporting data using a self-controlled case series approach.

The increased risk of intussusception after vaccination with the rhesus-human reassortant rotavirus vaccine Rotashield led to its withdrawal in 2005. We assess the risk of intussusception following the pentavalent rotavirus vaccine (RV5) on the basis of worldwide reports to the manufacturer up to May 2014, using a self-controlled case series. The method had to be modified to account for the under-reporting, a specific feature of pharmacovigilance spontaneous reports.

Resistance of M. leprae to quinolones: a question of relativity?

Unlabelled: Multidrug resistant leprosy, defined as resistance to rifampin, dapsone and fluoroquinolones (FQ), has been described in Mycobacterium leprae. However, the in vivo impact of fluoroquinolone resistance, mainly mediated by mutations in DNA gyrase (GyrA2GyrB2), has not been precisely assessed. Our objective was to measure the impact of a DNA gyrase mutation whose implication in fluoroquinolone resistance has been previously demonstrated through biochemical studies, on the in vivo activity of 3 fluoroquinolones: ofloxacin, moxifloxacin and garenoxacin.

Validation of the French national health insurance information system as a tool in vaccine safety assessment: application to febrile convulsions after pediatric measles/mumps/rubella immunization.

In the French national health insurance information system (SNIIR-AM), routine records of health claimed reimbursements are linked to hospital admissions for the whole French population. The main focus of this work is the usability of this system for vaccine safety assessment programme. Self-controlled case series analyses were performed using an exhaustive SNIIR-AM extraction of French children aged less than 3 years, to investigate the relationship between MMR immunization and children hospitalizations for febrile convulsions, a well-documented rare adverse event, over 2009-2010.

A new self-controlled case series method for analyzing spontaneous reports of adverse events after vaccination.

In this paper, we propose new methods for analyzing cases of vaccine adverse events spontaneously reported to a surveillance database. The methods use the self-controlled case series approach, extended in several ways with parametric and nonparametric assumptions to account for the specific features of the data (large amount of underreporting and variation of reporting with time since vaccination). This work was motivated by the documented risk of intussusception after RotaShield vaccination (Wyeth-Lederle Vaccines, Radnor, Pennsylvania) and used worldwide spontaneous reports of intussusception occurring after Rotarix vaccination (GlaxoSmithKline Biologics, Research Triangle Park, North Carolina) collected between January 2004 and February 2010.

Changes in reperfusion strategy over time for ST segment elevation myocardial infarction in the Greater Paris Area: results from the e-MUST Registry.

Background: ESC guidelines recommend a shorter (90 min) delay for the use of primary percutaneous intervention (pPCI) in patients presenting within the first 2h of pain onset. Using registry data on STEMI patients in the Greater Paris Area, we assessed changes between 2003 and 2008 in the rates of pPCI, pre-hospital fibrinolytic therapy (PHF) and time delays in patients presenting within 2h of STEMI pain onset.

Methods: The Greater Paris Area was divided in 3 regions: Paris, the small and large rings.

Misspecification of the covariance structure in generalized linear mixed models.

When fitting marginal models to correlated outcomes, the so-called sandwich variance is commonly used. However, this is not the case when fitting mixed models. Using two data sets, we illustrate the problems that can be encountered.

Main air pollutants and myocardial infarction: a systematic review and meta-analysis.

Context: Short-term exposure to high levels of air pollution may trigger myocardial infarction (MI), but this association remains unclear.

Objective: To assess and quantify the association between short-term exposure to major air pollutants (ozone, carbon monoxide, nitrogen dioxide, sulfur dioxide, and particulate matter ≤10 μm [PM(10)] and ≤2.5 μm [PM(2.