The Effect of Different Algorithms on Prevalence of Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder in Secondary Healthcare Data in Five European Countries: A Contribution from the ConcePTION Project.

To assess the effect on prevalence estimates of using different algorithms to identify children with attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) in healthcare data. Three algorithms were developed and run on administrative/research data in Finland, France (Haute Garonne), Italy (Emilia Romagna), Norway and Wales: (1) ≥ 1 ADHD or ASD diagnoses recorded in specialist settings, (2) ≥ 2 ADHD or ASD diagnoses recorded in primary care and (3) ≥ 1 prescription for medication to manage ADHD. Prevalence rates per 1000 children for each algorithm were calculated.

Statin use in pregnancy and risk of congenital malformations: a Norwegian nationwide study.

Background And Aims: Statins and other lipid-modifying agents (LMAs) have traditionally been contraindicated during pregnancy due to concerns about harmful fetal effects; however, the risks associated with exposure to statins and other LMAs in human pregnancies remain unclear. Therefore, this study aimed to examine the associations between statin and LMA exposure in pregnancy and congenital malformations in offspring, while updating a 2022 meta-analysis with the results from the present study.

Methods: National registry data were linked for all pregnant women in Norway in 2005-18.

Trajectories of Selective Serotonin Reuptake Inhibitor Use in Pregnancy and Perinatal Outcomes: A Longitudinal Register Study.

Objective: We examined the possible impact of selective serotonin reuptake inhibitor (SSRI)-trajectories describing the timing of different SSRI dosages on adverse perinatal outcomes.

Design: Longitudinal register study.

Setting: Study from Kuopio University Hospital Birth Register.

Methods of estimating prevalence of multiple sclerosis in six European healthcare data sources: a contribution from the ConcePTION project.

Multiple sclerosis (MS) is a chronic autoimmune condition primarily affecting women and often diagnosed during childbearing years. This study assessed the impact of the lookback period and calculation method on MS prevalence in three healthcare data sources including women of childbearing age (from Italy, Norway and Wales) and three data sources including pregnant women (from France, Finland and Spain). Women aged 15 to 49 years from 2005 to 2019 were included, data from pregnant women were collected around the pregnancy period.

Advancing Health Equity in Europe: Explore, Tailor, Implement, and Evaluate (ETIE)-A Framework of Diversity and Fairness in Pharmacoepidemiologic Research.

Pharmacoepidemiology should represent and benefit populations equitably, embracing diversity and equity, and ensuring fairness. This article describes equity and fairness in pharmacoepidemiology, depicts key diversity domains, and provides an operational framework and call for action to implement diversity and fairness in pharmacoepidemiologic research. To ensure fairness, studies should address diversity and inclusion while providing equal opportunities and benefits for everyone in the target population.

Identifying multiple sclerosis in women of childbearing age in six European countries: a contribution from the ConcePTION project.

Prevalence of Multiple Sclerosis (MS) has increased over the last decades, primarily among women of childbearing age. Several algorithms for identifying MS have been described in the literature, providing heterogeneous prevalence estimates. We compared five algorithms to identify MS in women of childbearing age and estimated MS prevalence by time period and age-group.

Predicting Drug Transfer Into Human Milk With the Simcyp Simulator: A Contribution From the ConcePTION Project.

Physiologically-based pharmacokinetic (PBPK) modeling can support decision-making on maternal medication use during breastfeeding. This study aimed to enhance lactation PBPK models in two ways. First, the utility of integrating permeability- versus perfusion-limited distribution to human milk was explored using the Simcyp Simulator.

Longitudinal Methods Versus Multiple Imputation to Infer Missing Maternal Data in Registry-Based Pregnancy Studies.

Background: In birth registries, incomplete recording of information leads to missing values. Multiple imputation (MI) by chained equations is a widely used method for analysing datasets with missing data. It is unknown whether using registry records from multiple pregnancies contributed by the same woman could potentially give more accurate values when resolving missing data.

Initiating antidepressant treatment in pregnancy: Timing, intensity, and influential maternal and familial factors.

Objective: To describe the timing and intensity of antidepressant initiation in pregnancy using longitudinal trajectories of antidepressant prescription fills to identify associated sociodemographic, lifestyle, somatic, mental health, pregnancy, and paternal factors.

Methods: This population-based cohort within the Norwegian Mother, Father and Child Cohort study linked to MoBa Genetics and the Prescribed Drug Registry included 1879 women with a new episode of self-reported depression/anxiety during pregnancy. Antidepressants were measured by week and average daily dose.

Clusters of post-acute COVID-19 symptoms: a latent class analysis across 9 databases and 7 countries.

Objective: Prior evidence has suggested the multisystem symptomatic manifestations of post-acute COVID-19 condition (PCC). Here we conducted a network cluster analysis of 24 World Health Organization-proposed symptoms to identify potential latent subclasses of PCC.

Study Design And Setting: Individuals with a positive test of or diagnosed with SARS-CoV-2 after September 2020 and with at least 1 symptom within ≥90 to 365 days following infection were included.

Identifying Maternal Conditions Leading to Gabapentinoid Prescriptions in Pregnancy Using Electronic Health Records from Six European Countries: A Contribution from the IMI ConcePTION Project.

Introduction And Objective: Given the recent increase in the prescription and dispensation of gabapentinoids (gabapentin and pregabalin) and the importance of controlling for underlying maternal illnesses in drug safety studies, we aimed to develop algorithms for identifying maternal conditions leading to gabapentinoid prescribing among pregnant women using data from six electronic healthcare data sources across Europe.

Methods: The study was conducted in Finland, France (Haute-Garonne), Italy (Emilia Romagna), Norway, Spain (Valencian region), and Wales (UK), covering three million pregnancies from 2006 to 2020. Algorithms were developed to detect epilepsy, neuropathic pain, and generalized anxiety disorder (GAD) (approved indications for gabapentinoids by the European Medicines Agency, with the exception of gabapentin for GAD) using data ± 1 year around the gabapentinoid prescription date.

Maternal hormonal contraceptive use and childhood central nervous system tumor risk in a large Scandinavian cohort.

An association between maternal hormonal contraception use and childhood central nervous system (CNS) tumors has been suggested, but findings are inconclusive. This population-based cohort study includes Scandinavian nationwide registry data on liveborn children (1996-2018). Children were followed from birth until CNS tumor (<20 years) or censoring (other cancer, emigration, death, 20th birthday, or end of follow-up in 2017-2020).

Association of Prenatal Exposure to Triptans, Alone or Combined With Other Migraine Medications, and Neurodevelopmental Outcomes in Offspring.

Background And Objectives: The long-term reproductive safety of migraine medications remains uncertain. This study sought to examine the effect of different intensities and durations of prenatal exposure to triptans, alone and combined with other preventive migraine medications, on neurodevelopmental disorders (NDDs) in children.

Methods: This nationwide health registry study in Norway included pregnancies of women with migraine before pregnancy and followed up their children up to 14 years of age.

Exposure to Systemic Antimicrobials During Pregnancy and Risk of Miscarriage: A Population-Based Registry Study.

Objective: To estimate miscarriage risk following gestational antimicrobial exposure while addressing biases that have affected previous studies.

Design: Population-based cohort study.

Setting: Linkage of four nationwide registries: Medical Birth Registry of Norway (MBRN), Norwegian Prescribed Drug Registry (NorPD), Norwegian Patient Registry (NPR) and Norwegian Control and Payment of Health Reimbursements Database (KUHR).

Agreement Between Parental Self-Reported Antiseizure Medication Use and Dispensed Prescription Records From a National Prescription Database.

Purpose: Accurate measurement of medication exposure is crucial for studying the safety of antiseizure medications (ASMs) during pregnancy. Pregnancy safety studies of ASMs frequently rely on secondary data from drug prescription registries to assess potential teratogenic effects and impact on fetal development. This study aimed to evaluate the agreement between dispensed prescriptions registered in a national database and self-reported ASM use by parents.

Prenatal exposure to psychotropics and analgesics on cognitive, linguistic and educational outcomes - a scoping review with focus on validity and reliability of outcome measures.

Objective: To provide an overview of the observational studies on child's cognitive, linguistic, and educational outcomes following prenatal exposure to psychotropics and analgesics, including reporting of outcome measure validity and reliability.

Study Design: We searched four databases, MEDLINE, Embase, PsycINFO, and PubMed from inception to September 2023. We included all original studies involving participants less than 18 years old, who were prenatally exposed to psychotropics and/or analgesics with cognitive, linguistic, and/or educational outcomes and excluded those lacking comparison groups.

Epidemiological outcomes and policy implementation in the Nordic countries during the COVID-19 pandemic.

Background: During the initial phase of the COVID-19 pandemic, there was an intensive debate on which strategies would be most effective to minimize the negative societal impact of the pandemic. This study aimed to provide an overview of key epidemiological outcome measures of the disease in the Nordic countries and the subsequent policy implementation that were undertaken to curb the outbreak.

Methods: Time trends in test-positive infections, hospitalizations, and intensive care unit (ICU) admissions due to COVID-19 as well as COVID-19 mortality and excess mortality were compared between Denmark, Finland, Iceland, Norway, and Sweden.

Use of signal detection methods to identify associations between prenatal medication exposure and subsequent childhood cancers: a Nordic hypothesis-generating registry-based study.

Background: Childhood cancer is an important contributor to childhood mortality in high-income countries. Information on associations between childhood cancer and in-utero exposure is absent or limited for most medications. Signal detection methods identify medications where research should be focused but have not been applied to datasets containing prenatal medication exposures and childhood cancers.

Maternal use of hormonal contraception and risk of childhood leukemia: A Scandinavian population-based cohort study.

Background: Maternal hormonal contraception use has been associated with childhood leukemia risk. However, studies are few and often based on self-reported information.

Methods: Using registry data from Denmark, Norway, and Sweden, we identified 3,183,316 children (born 1996-2018) and followed them from birth until leukemia diagnosis, censoring (death, emigration, other cancer, 20th birthday) or study closure (December 31st, 2017, 2018 or 2020).

Incidence of post-acute COVID-19 symptoms across healthcare settings in seven countries: an international retrospective cohort study using routinely-collected data.

Background: The World Health Organisation (WHO) has identified a range of symptomatic manifestations to aid in the clinical diagnosis of post-COVID conditions, herein referred to as post-acute COVID-19 symptoms. We conducted an international network cohort study to estimate the burden of these symptoms in North American, European, and Asian populations.

Methods: A federated analysis was conducted including 10 databases from the United Kingdom, Netherlands, Norway, Estonia, Spain, France, South Korea, and the United States, between September 1st 2020 and latest data availability (which varied from December 31st 2021 to February 28th 2023), covering primary and secondary care, nationwide registries, and claims data, all mapped to the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM).

Incidence of severe and non-severe SARS-CoV-2 infections in children and adolescents: a population-based cohort study using six healthcare databases from Italy, Spain, and Norway.

Unlabelled: We aim to estimate the incidence rates (IRs) of SARS-CoV-2 infections stratified by disease severity and comorbidities in pediatric population and to describe the COVID-19 vaccination coverage in children with and without comorbidities. A population-based cohort study was conducted in 6 electronic healthcare records databases from Italy, Spain, and Norway. The study lasted from 1 January 2020 to the latest databases' available data in each site, i.

Paternal metformin use and risk of congenital malformations in offspring in Norway and Taiwan: population based, cross national cohort study.

Objective: To evaluate the association between paternal metformin use and risk of congenital malformations in offspring.

Design: Population based, cross national cohort study.

Setting: Norway and Taiwan.

Neonatal outcomes after in utero exposure to antipsychotics: a systematic review and meta-analysis.

Adverse neonatal outcomes following in utero antipsychotic exposure remain unclear. This systematic review and meta-analysis aimed to investigate associations between in utero first- and second-generation antipsychotic exposure and various neonatal outcomes. The primary outcome was small for gestational age.