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• Alcalde-Herraiz, Marta; Du, Mike; Sanchez-Parada, Aina; Duarte-Salles, Talita; Palomar-Cros, Anna & Giuliodori, Agustina [Show all 13 contributors for this article] (2026). The effectiveness of HPV vaccination against invasive cervical cancer and related precancerous lesions: a multinational target trial emulation study. The Lancet Primary Care. 2(3). doi: 10.1016/j.lanprc.2026.100114. Full text in Research Archive Show summary

  Background Human Papillomavirus (HPV) vaccines prevent HPV infection and related disease. 15 years after the first HPV vaccination programmes were launched in Europe, their long-term effectiveness can now start to be assessed. We designed a target trial emulation study to estimate the effectiveness of HPV vaccination in preventing invasive cervical cancer and high-grade precancerous lesions using three primary care databases. Methods In this target trial emulation study, we analysed primary care records from the UK (Clinical Practice Research Datalink; data from Sept 9, 1987 to Dec 15, 2023), primary care records linked to hospital records from Catalonia, Spain (Sistema d’Informació per al Desenvolupament de la Investigació en Atenció Primària; Jan 1, 2006 to June 30, 2023), and nationwide linked health registry (including primary care, secondary care, and other health data) in Norway (Norwegian Linked Health Registry; Jan 1, 2018 to Dec 31, 2023), all standardised to the Observational Medical Outcomes Partnership common data model. We included women aged 15 years or younger in 2008, coinciding with the start of public vaccination programmes. Exposure was defined as receiving one or more HPV vaccine doses by age 15 years. The main outcomes included high-grade cervical intraepithelial neoplasia (CIN2+), invasive cervical cancer, and conisation (as a proxy for CIN2+ diagnosis). Vaccinated and unvaccinated cohorts were sequentially matched on an annual basis by year of birth, location, and propensity scores, with up to five vaccinated people matched to an unvaccinated individual. Vaccine effectiveness, based on incidence rate ratios after 15 years of follow-up, were calculated using Poisson regression. Results across databases were meta-analysed using fixed-effects. The specified primary analysis in the original protocol was designed to assess exposure by HPV brand versus unvaccinated populations; however, due to the low number of events by brand, the study was underpowered and the primary analysis was amended to assess HPV vaccination exposure overall (any brand) versus unvaccinated. Findings After two-step matching, our analysis included 81 863 vaccinated and 46 357 unvaccinated women from the UK; 148 214 vaccinated and 39 952 unvaccinated from Spain; and 14 885 vaccinated and 4073 unvaccinated from Norway. Fewer than five cervical cancers were observed per cohort, precluding vaccine effectiveness estimation for this outcome. Meta-analytic vaccine effectiveness at 15 years was 42% (95% CI 6–64) against CIN2+ and 58% (6–82) against conisation. Interpretation Our estimates of vaccine effectiveness against CIN2+ and conisation in Europe align with estimates from previous systematic reviews of randomised controlled trials. We also observed an increased health-seeking behaviour among vaccinated individuals, suggesting that our study might have underestimated vaccine effectiveness. Further studies with longer follow-up are needed to estimate vaccine effectiveness against cervical cancer.

• Nguyen, Nhi H.; Le, Hieu; Tang, An Q.; Nguyen, Hang T.H.; Tran, Ha N. & Nguyen, Tuyen T. [Show all 12 contributors for this article] (2026). Prediction model of thrombocytopenia on patients using linezolid: a ranked-based covariate selection with multi-center data. Frontiers in Pharmacology. 17, p. 1–12. doi: 10.3389/fphar.2026.1802397. Full text in Research Archive Show summary

  Background: Thrombocytopenia is a common adverse reaction of linezolid, often leading to severe complications. It is challenging to externally validate directly apply developed in other countries. We aim to develop and validate a risk prediction model of linezolid-associated thrombocytopenia (LAT) tailored to Vietnamese setting and to construct a simplified risk score calculation to support clinical decision-making.Materials and Methods: Data was collected retrospectively from three large hospitals in Northern Vietnam. We selected inpatients treated with linezolid from November 2019 to March 2023. Potential predictors were chosen based on literature review and clinical experts’ opinions. Final predictors were selected using Bayesian model selection. Thrombocytopenia was defined as platelet count value ≤112.5 G/L and a decrease more than 25% from the baseline. A multivariable logistic regression model was constructed to predict the occurrence of LAT. The final model was further validated using internal-external cross-validation.Results: Of 776 patients included, 247 patients (31.8%) developed LAT. Logistic regression model selection indicated that the risk predictors were age, duration of linezolid ≥14 days, baseline platelet count, creatinine clearance, sepsis, cirrhosis, continuous renal replacement therapy (CRRT) and heparin use. The model had moderate discrimination, with area under the curve (AUC) of 0.77 (95% confidence interval (CI): 0.72–0.83). Model calibration was good, with calibration-in-the-large and calibration slope of 0.00 (−0.38 to 0.38), and 0.92 (0.59–1.26) respectively. A risk score scale was established, with the optimal cut-off value being 23 points. Patients were categorised based on this score into three groups: low risk (−1 to 13 points), moderate risk (14–22 points) and high risk (≥23 points).Conclusion: Our newly developed risk prediction model demonstrated moderate discriminatory ability in predicting the occurrence of LAT. From there, a simplified risk score was constructed to facilitate its applicability in clinical practice.

• Trinh, Nhung; Fukasawa, Toshiki; Yanai, Takanori; Okura, Takayuki; Takayama, Atsushi & Sakai, Takamasa [Show all 9 contributors for this article] (2026). Paediatric outpatient antibiotic utilization patterns and use of healthcare services before, during and after the COVID-19 pandemic: interrupted time series analysis using data from Norway and Japan. Journal of Antimicrobial Chemotherapy. ISSN 0305-7453. 81(7). doi: 10.1093/jac/dkag217. Full text in Research Archive
• Chatha, Zeenat Fatima; Trinh, Nhung; Rostami, Sina; Bergink, Veerle; Carson, Alexis Christine & Magnus, Per [Show all 7 contributors for this article] (2026). Timing of antidepressant initiation postpartum and maternal mental health outcomes up to 18 months after childbirth. The European Journal of Psychiatry. ISSN 0213-6163. 40(2). doi: 10.1016/j.ejpsy.2026.100352. Full text in Research Archive
• Trinh, Nhung; Rostami, Sina; Pedroncelli, Michele; Cheesman, Rosa Catherine Gillespie; Magnus, Per Minor & Johansson, Stefan [Show all 8 contributors for this article] (2026). Prenatal antidepressant use and longitudinal differences in BMI up to 8 years of age in the offspring born to mothers with depression/anxiety in the Norwegian Mother, Father and Child Cohort Study. Journal of Affective Disorders. ISSN 0165-0327. 405. doi: 10.1016/j.jad.2026.121552. Full text in Research Archive Show summary

  Background: No study has explored how prenatal antidepressant exposure affects offspring body mass index (BMI) throughout childhood. Methods: We used data from the Norwegian Mother, Father, and Child Cohort Study (MoBa) linked to the Medical Birth Registry of Norway and the MoBa Genetics. We included 6084 pregnancy-child dyads (singleton, liveborn) with child BMI data up to 8 years, born to women with pre-pregnancy depression/anxiety. Prenatal antidepressant exposure groups include continued antidepressants in pregnancy (n = 626), discontinued antidepressants proximal to pregnancy (n = 412), or unexposed to antidepressants (n = 5046). Mean BMI differences over time between groups were calculated using multilevel mixed-effect linear models. Results: Children born to continuers had comparable childhood BMIs with those born to unexposed mothers or mothers who discontinued antidepressant, in overall and in both sexes. However, higher BMI was observed up to 3 years among male offspring of continued mothers compared to discontinuers in those exposed to selective-serotonin-reuptake-inhibitor before pregnancy (β = 0.334; 95% CI: 0.081 to 0.588 at baseline). Lower BMI was seen among female offspring born to continued vs. discontinued mothers with larger gap over time, especially between low-moderate use of antidepressant vs. discontinuation during pregnancy. Analyses integrating parental genetic liability for depression, BMI, and antidepressant response using polygenic risk scores in (n = 1913) suggests potential influence of the genetic component on the longitudinal differences in BMI in some strata. Conclusion: The childhood BMI of children born to mothers with pre-pregnancy depression/anxiety did not differ across prenatal antidepressant trajectories. Exploratory analyses revealed differences at specific timeframes which are sex-specific and potentially influenced by genetic liability profiles.

• López-Güell, Kim; Català, Martí; Dedman, Daniel; Duarte-Salles, Talita; Kolde, Raivo & López-Blasco, Raúl [Show all 38 contributors for this article] (2025). Clusters of post-acute COVID-19 symptoms: a latent class analysis across 9 databases and 7 countries. Journal of Clinical Epidemiology. ISSN 0895-4356. 185. doi: 10.1016/j.jclinepi.2025.111867. Full text in Research Archive
• Zidan, Mahmoud; Trinh, Nhung; Desalegn, Anteneh Assefa; Smith, Louisa H.; Gelder, Marleen van & Nordeng, Hedvig Marie Egeland [Show all 7 contributors for this article] (2025). BNT162b2 mRNA COVID-19 vaccine effectiveness in pregnancy: Emulating trial NCT04754594 using observational data from Norwegian health registries. Vaccine. ISSN 0264-410X. 68. doi: 10.1016/j.vaccine.2025.127908. Full text in Research Archive
• Wijk, Emma van; Zugic, Milica; Rostami, Sina; Gelder, Marleen van; Ahmad, Ashi Sarfraz & Sitras, Vasilis [Show all 9 contributors for this article] (2025). Gestational weight gain and postpartum weight retention: What is the role of perinatal antidepressant use? Journal of Affective Disorders. ISSN 0165-0327. 394(A). doi: 10.1016/j.jad.2025.120521. Full text in Research Archive Show summary

  Background: Little is known about the association between perinatal antidepressant use and gestational weight gain (GWG) and postpartum weight retention (PPWR). Methods: We used data from the Norwegian Mother, Father and Child Cohort Study (MoBa), linked to the Medical Birth Registry of Norway (MBRN) and the Norwegian Prescribed Drug Registry (LMR). We included singleton, live birth pregnancies with pre-pregnancy depression/anxiety. Prenatal and perinatal antidepressant use trajectories were constructed using longitudinal k-means clustering. GWG and PPWR at 6/18 months postpartum were calculated using self-reported data. We estimated weighted relative risks (wRR) and 95 % confidence intervals (CI) using modified Poisson regression with robust variance estimators and overlap weights. For a sub- population with available genetics data, we used polygenic risk scores (PRSs) to partially account for confounding by genetic component. Results: Among 3365 pregnancies included, we observed six prenatal and perinatal antidepressant use trajectories: non-users, pre-pregnancy discontinuers, early pregnancy discontinuers, late pregnancy discontinuers, continuers, and post-pregnancy initiators. Pre-pregnancy discontinuers had increased risk of inadequate GWG compared to non-users (wRR 1.34, 95 % CI 1.03–1.73). Early pregnancy discontinuers (wRR 0.89, 95 % CI 0.78–1.02), late pregnancy discontinuers (wRR 0.88, 95 % CI 0.76–1.01), and continuers (wRR 0.86, 95 % CI 0.71–1.05) had a borderline decreased risk of excessive PPWR at 6 months postpartum compared to non-users. We observed no other associations between antidepressant use trajectories and GWG or PPWR. Conclusion: These results enhance knowledge on weight-related safety concerns of antidepressant use in the prenatal and perinatal period, specifically regarding GWG and PPWR.

• Carson, Alexis Christine; Trinh, Nhung; Nordeng, Hedvig Marie Egeland; Liu, Xiaoqin; Munk-Olsen, Trine & Eberhard-Gran, Malin [Show all 8 contributors for this article] (2025). Initiating antidepressant treatment in pregnancy: Timing, intensity, and influential maternal and familial factors. Journal of Affective Disorders. ISSN 0165-0327. 388. doi: 10.1016/j.jad.2025.119726. Full text in Research Archive Show summary

  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. Results: There were 87 initiators, from which we identified three prescription fill trajectories: Early-pregnancy initiators with rapid discontinuation (n = 41, 47.1 %), Early-pregnancy initiators with mid-pregnancy discontinuation (n = 30, 34.5 %), and Early-mid pregnancy initiators with continuation (n = 16, 18.4 %) and three dose trajectories: Low dose with discontinuation (n = 45, 51.7 %), High dose with discontinuation (n = 26, 29.9 %), and Medium dose with continuation (n = 16, 18.4 %). Thyroid disorder was associated with Early initiators with rapid discontinuation (adjusted relative risk ratios (aRRR): 4.15, 95 % CI: 1.56–11.03) compared to Unmedicated. Other psychotropics pre-pregnancy increased the likelihood of being Early initiators with mid-pregnancy discontinuation and High dose discontinuers compared to Unmedicated. Higher maternal genetic liability for depression was strongly associated with Early initiators with mid-pregnancy discontinuation (aRRR = 8.57, 95 % CI: 3.09–23.74), High dose discontinuers and Medium dose continuers across comparisons. Adverse reproductive history, immigration and alcohol pre-pregnancy emerged as important factors. Conclusions: Approximately 5 out of 100 women with a new episode of depression/anxiety initiated an antidepressant during pregnancy, predominantly in early pregnancy, with most discontinuing early to mid-pregnancy. Identified factors can be utilized by clinicians to provide personalized treatment guidance.

• Zugic, Milica; Trinh, Nhung; Rostami, Sina; Nordeng, Hedvig Marie Egeland; Ystrøm, Eivind & Bulik, Cynthia M [Show all 10 contributors for this article] (2025). Antenatal depressive and anxiety symptoms in women with eating disorders who continue or discontinue antidepressant treatment in pregnancy. Journal of Affective Disorders Reports. 22, p. 1–10. doi: 10.1016/j.jadr.2025.100985. Full text in Research Archive Show summary

  Background Limited evidence on antidepressant effectiveness in pregnant women with eating disorders (ED) challenges pharmacotherapy management. We examined antenatal depressive and anxiety symptoms with continued antidepressant use in women with ED. Methods We used data from the Norwegian Mother, Father and Child Cohort Study (MoBa) linked to the Medical Birth Registry of Norway and MoBa Genetics. MoBa questionnaires at weeks 17 (early) and 30 (mid-late pregnancy) measured antidepressant exposure and symptoms of depression and anxiety using the 5-item Hopkins Symptom Checklist. We fitted generalised linear models and adjusted for confounding. In a subsample, we stratified analyses by polygenic-score tertiles for antidepressant response. Results We identified 5920 pregnancies in women with ED, mainly binge-eating disorder (BED) (84.0 %) and bulimia nervosa (BN) (12.4 %). Of these, 48 (0.8 %) continued antidepressants into early pregnancy, 93 (1.6 %) discontinued during, and 85 (1.4 %) discontinued before pregnancy. At early pregnancy only, continued antidepressant was associated with lower severity of depressive and anxiety symptoms relative to discontinuation. Among women with BED, this was specific to lower anxiety symptoms (β:-0.43, 95 %CI:-0.84, -0.02). This association was not observed in women with BN. In women with higher antidepressant-response polygenic-score continued antidepressant was associated with lower symptom severity relative to discontinued (range of β:-0.86 to -1.35). Conclusions Continuing antidepressants in early but not mid-late pregnancy is associated with lower severity of depressive and anxiety symptoms in women with BED. The association observed in women with higher antidepressant-response polygenic-score calls for larger studies on personalized treatment in perinatal ED.

• Abellan, Alicia; Burn, Edward; Trinh, Nhung; Burkard, Theresa; Callahan, Alison & Fernández-Bertolín, Sergio [Show all 12 contributors for this article] (2025). Expanding the OMOP Common Data Model to Support Perinatal Research in Network Studies. Pharmacoepidemiology and Drug Safety. ISSN 1053-8569. 34(2). doi: 10.1002/pds.70106. Full text in Research Archive
• Xie, Junqing; López-Güell, Kim; Dedman, Daniel; Duarte-Salles, Talita; Kolde, Raivo & López-Blasco, Raúl [Show all 38 contributors for this article] (2024). Incidence of post-acute COVID-19 symptoms across healthcare settings in seven countries: an international retrospective cohort study using routinely-collected data. EClinicalMedicine. 77. doi: 10.1016/j.eclinm.2024.102903. Full text in Research Archive Show summary

  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). We defined two cohorts for the main analyses: a SARS-CoV-2 infection cohort [positive polymerase chain reaction (PCR) or rapid lateral flow test (LFT) result or clinical COVID-19 diagnosis] and a general population cohort. Individuals with less than 365 days of prior history or 120 days of follow-up were excluded. We estimated incidence rates (IRs) of the 25 WHO-proposed post-acute COVID-19 symptoms, considering symptoms that occurred ≥90 and ≤365 days after index date, excluding individuals with the respective symptoms 180 days prior to the index event. Stratified analyses were conducted by age and sex. Incidence rate ratios (IRRs) were calculated comparing rates in the infected cohort versus the general population. Results from the different databases were combined using random-effects meta-analyses. Findings 3,019,408 individuals were included in the infection cohort. 1,585,160 of them were female and 1,434,248 of them male. 929,351,505 individuals were included in the general population group. 461,195,036 of them were female and 466,022,004 of them male. The 1-year IR of any post-acute COVID-19 symptom in the COVID-19 infection cohort varied significantly across databases, from 4.4 (95% CI 3.8–5.1) per 100 person-years to 103.9 (95% CI 103.2–104.7). The five most common symptoms were joint pain (from 1.6 (95% CI 1.3–1.9) to 14.3 (95% CI 14.1–14.6)), abdominal pain (from 0.3 (95% CI 0.1–0.5) to 9.9 (95% CI 9.7–10.1)), gastrointestinal issues (from 0.6 (95% CI 0.4–0.9) to 13.3 (95% CI 13.1–13.6)), cough (from 0.3 (95% CI 0.2–0.5) to 9.1 (95% CI 8.9–9.3)), and anxiety (from 0.8 (95% CI 0.6–1.2) to 11.4 (95% CI 11.2–11.6)); whereas muscle spasms (from 0.01 (95% CI 0.008–0.2) to 1.7 (95% CI 1.6–1.8)), pins and needles (from 0.05 (95% CI 0.03–0.0.9) to 1.5 (95% CI 1.4–1.6)), memory issues (from 0.03 (95% CI 0.02–0.06) to 0.8 (95% CI 0.7–0.8)), cognitive dysfunction (from 0.007 (95% CI 0.004–0.01) to 0.6 (95% CI 0.4–0.8)), and altered smell and/or taste (from 0.04 (95% CI 0.03–0.04) to 0.7 (95% CI 0.6–0.8)) were least common. Incidence rates of any post-acute COVID-19 symptoms generally increased with age, with certain symptoms peaking in middle-aged adults (anxiety, depressive disorders, headache, altered smell and taste) and others in pre-school children (gastrointestinal issues and cough). Females had higher incidence rates for most symptoms. Based on the random-effects model, the infected cohort had a higher incidence of any post-acute COVID-19 symptom than the general population, with a meta-analytic incidence rate ratio (meta-IRR) of 1.4 (1–2). A similar pattern was seen for all individual symptoms. The highest meta-IRRs were depressive disorder, 2.6 (1.7–3.9); anxiety, 2.3 (1.4–3.8); allergy, 2.1 (1.7–2.8) and sleep disorders, 2.1 (1.5–2.6). The meta-IRR for altered smell and/or taste was 1.9 (1.3–2.8). Interpretation Post-acute COVID-19 symptoms, as listed by the WHO, were commonly observed following COVID-19 infection. However, even after standardising research methods, there was significant heterogeneity in the incidence rates from different healthcare settings and geographical locations. This is the first international study of the epidemiology of post-acute COVID-19 symptoms using the WHO-listed symptoms. Its findings contibute to understand the epidemiology of this condition from a multinational approach. Limitations of this study include the lack of consensus of the post-acute COVID-19 definition, as well as the difficulty to capture the impact on daily life of the post-acute COVID-19 symptoms in the available datasets. Funding This work has been funded by the European Health Data Evidence Network (EHDEN) through an Evidence Generation Fund Grant and by the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Centre (BRC).

• Fusaroli, Michele; Salvo, Francesco; Begaud, Bernard; AlShammari, Thamir M.; Bate, Andrew & Battini, Vera [Show all 34 contributors for this article] (2024). The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration. Drug Safety. ISSN 0114-5916. doi: 10.1007/s40264-024-01423-7. Full text in Research Archive
• Elyass, Jovan; Desalegn, Anteneh Assefa; Trinh, Nhung; Orangzeb, Saima; Zidan, Mahmoud & Nordeng, Hedvig Marie Egeland [Show all 7 contributors for this article] (2024). Individual and familial factors associated with mRNA COVID-19 vaccine uptake in pregnancy: A large-scale registry-based linkage study. Vaccine. ISSN 0264-410X. 42(21). doi: 10.1016/j.vaccine.2024.126171. Full text in Research Archive Show summary

  The association between maternal COVID-19 vaccination in pregnancy and factors such as high risk for severe COVID-19, pre-existing asthma, prior adverse reproductive history, or paternal COVID-19 vaccination during pregnancy, remains unclear. The aim of this study is two-fold: (i) to describe uptake of COVID-19 vaccine during pregnancy by maternal risk for severe COVID-19 and asthma, and (ii) to comprehensively examine individual and familial factors associated with vaccine uptake during pregnancy in Norway. Based on nation-wide registry-linkage data in Norway, we included 101,659 deliveries with gestational length ≥12 weeks, in 2021–2022. Our outcome measure was uptake of at least one dose of mRNA COVID-19 vaccine during pregnancy, using a narrow (first ever dose) and broad (any dose) definition. We fit univariate and multivariate modified Poisson regression models, clustered by county of residency and adjusted for calendar time, to estimate risk ratios (RR) with 95 % Confidence Intervals (CIs). Gestational uptake of any COVID-19 vaccine dose increased from <1 % before mid Aug-2021, to 38.8 % in the rest of 2021, and 48.9 % in 2022. Only 28.8 % and 33.9 % pregnant individuals with high risk for severe COVID-19 or asthma, respectively, received at least one COVID-19 vaccine dose. Paternal COVID-19 vaccination was strongly associated with greater vaccine uptake by pregnant individuals (adjusted RR: 7.2, 95 % CI: 6.8–7.5). Maternal SARS-CoV-2 infection pre-pregnancy (adjusted RR: 0.31, 95 % CI: 0.26, 0.37), familial and individual migrant status were associated with a considerable decreased likelihood of vaccine uptake in pregnancy. History of miscarriage or pregnancy with congenital anomaly were not associated with vaccine uptake. Despite rising COVID-19 vaccine rates in pregnancy, uptake remained low for high-risk individuals. Paternal vaccination, pre-pregnancy infection, migration status, and maternal citizenship were strongly associated with prenatal vaccine uptake. This knowledge can inform tailoring of future vaccination campaigns.

• Orangzeb, Saima; Desalegn, Anteneh Assefa; Trinh, Nhung; Zhao, Jing; Nordeng, Hedvig Marie Egeland & Lupattelli, Angela (2024). COVID-19 vaccine uptake among children and adolescents in Norway: A comprehensive registry-based cohort study of over 800,000 individuals. Vaccine. ISSN 0264-410X. 42(15), p. 3420–3428. doi: 10.1016/j.vaccine.2024.04.039. Full text in Research Archive Show summary

  Factors related with COVID-19 vaccine uptake in children and adolescents in Norway remain unclear, despite this being useful knowledge for future pandemic preparedness. This study aimed to comprehensively examine individual and familial factors associated with vaccine uptake in children and adolescents in Norway. We utilized nationwide registry-data from various health registries and Statistics Norway, encompassing all children and adolescents living in Norway during the pandemic, until 31-Dec-2022. Vaccine uptake is defined as receiving at least one dose of COVID-19 vaccine. We employed a forward stepwise logistic regression model and a random forest machine-learning algorithm to explore the relationship between vaccine uptake and socio-cultural, demographic, and health-related factors. We included 423,548 5–11-year-olds, 269,830 12–15-year-olds, and 120,854 16–17-year-olds. Vaccine uptake in these three groups was respectively 2.6 %, 73.3 %, and 87.3 %. Factors associated with vaccine uptake varied by age group. In youngest children, immigrant background (Odds-ratio (OR) = 1.58, 95 % confidence interval (CI) (1.14–2.19)), born extremely preterm (OR = 2.38, 95 % CI (1.60–3.54)), having risk of severe COVID-19 (OR = 5.40, 95 % CI (4.69–6.23) and maternal COVID-19 vaccination (OR = 6.34, 95 % CI (5.35–7.53)) were positively associated with vaccine uptake. The latter two factors were also strongly, positively associated with vaccine uptake in 12–15-year-olds, while previous SARS-CoV-2 infection was negatively associated (OR = 0.12, 95 % CI (0.11–0.14). Similar findings were observed in 16–17-year-olds. COVID-19 vaccine uptake differed markedly by age group, and major associated factors included socio-demographics and parental COVID-19 vaccination status, prior SARS-CoV-2 infection, but also being born premature and having moderate or high risk of severe COVID-19.

• Liu, Xiaoqin; Trinh, Nhung; Wray, Naomi R.; Lupattelli, Angela; Albiñana, Clara & Agerbo, Esben [Show all 9 contributors for this article] (2024). Impact of genetic, sociodemographic, and clinical features on antidepressant treatment trajectories in the perinatal period. European Neuropsychopharmacology. ISSN 0924-977X. 81, p. 20–27. doi: 10.1016/j.euroneuro.2024.01.010. Full text in Research Archive
• Mercadé-Besora, Núria; Li, Xintong; Kolde, Raivo; Trinh, Nhung; Sanchez-Santos, Maria T. & Man, Wai Yi [Show all 16 contributors for this article] (2024). The role of COVID-19 vaccines in preventing post-COVID-19 thromboembolic and cardiovascular complications. Heart. ISSN 1355-6037. 110(9). doi: 10.1136/heartjnl-2023-323483. Full text in Research Archive Show summary

  Objective To study the association between COVID-19 vaccination and the risk of post-COVID-19 cardiac and thromboembolic complications. Methods We conducted a staggered cohort study based on national vaccination campaigns using electronic health records from the UK, Spain and Estonia. Vaccine rollout was grouped into four stages with predefined enrolment periods. Each stage included all individuals eligible for vaccination, with no previous SARS-CoV-2 infection or COVID-19 vaccine at the start date. Vaccination status was used as a time-varying exposure. Outcomes included heart failure (HF), venous thromboembolism (VTE) and arterial thrombosis/thromboembolism (ATE) recorded in four time windows after SARS-CoV-2 infection: 0–30, 31–90, 91–180 and 181–365 days. Propensity score overlap weighting and empirical calibration were used to minimise observed and unobserved confounding, respectively. Fine-Gray models estimated subdistribution hazard ratios (sHR). Random effect meta-analyses were conducted across staggered cohorts and databases. Results The study included 10.17 million vaccinated and 10.39 million unvaccinated people. Vaccination was associated with reduced risks of acute (30-day) and post-acute COVID-19 VTE, ATE and HF: for example, meta-analytic sHR of 0.22 (95% CI 0.17 to 0.29), 0.53 (0.44 to 0.63) and 0.45 (0.38 to 0.53), respectively, for 0–30 days after SARS-CoV-2 infection, while in the 91–180 days sHR were 0.53 (0.40 to 0.70), 0.72 (0.58 to 0.88) and 0.61 (0.51 to 0.73), respectively. Conclusions COVID-19 vaccination reduced the risk of post-COVID-19 cardiac and thromboembolic outcomes. These effects were more pronounced for acute COVID-19 outcomes, consistent with known reductions in disease severity following breakthrough versus unvaccinated SARS-CoV-2 infection.

• Visme, Sophie de; Korevaar, Daniel A.; Guen, Christèle Gras-Le; Flamant, Alix; Bevacqua, Martina & Stanzelova, Anna [Show all 17 contributors for this article] (2024). Inconsistency Between Pictures on Baby Diaper Packaging in Europe and Safe Infant Sleep Recommendations. Journal of Pediatrics. ISSN 0022-3476. 264. doi: 10.1016/j.jpeds.2023.113763. Full text in Research Archive
• Català, Martí; Mercadé-Besora, Núria; Kolde, Raivo; Trinh, Nhung; Roel, Elena & Burn, Edward [Show all 15 contributors for this article] (2024). The effectiveness of COVID-19 vaccines to prevent long COVID symptoms: staggered cohort study of data from the UK, Spain, and Estonia. The Lancet Respiratory Medicine. ISSN 2213-2600. 12(3), p. 225–236. doi: 10.1016/S2213-2600(23)00414-9. Full text in Research Archive Show summary

  Background Although vaccines have proved effective to prevent severe COVID-19, their effect on preventing long-term symptoms is not yet fully understood. We aimed to evaluate the overall effect of vaccination to prevent long COVID symptoms and assess comparative effectiveness of the most used vaccines (ChAdOx1 and BNT162b2). Methods We conducted a staggered cohort study using primary care records from the UK (Clinical Practice Research Datalink [CPRD] GOLD and AURUM), Catalonia, Spain (Information System for Research in Primary Care [SIDIAP]), and national health insurance claims from Estonia (CORIVA database). All adults who were registered for at least 180 days as of Jan 4, 2021 (the UK), Feb 20, 2021 (Spain), and Jan 28, 2021 (Estonia) comprised the source population. Vaccination status was used as a time-varying exposure, staggered by vaccine rollout period. Vaccinated people were further classified by vaccine brand according to their first dose received. The primary outcome definition of long COVID was defined as having at least one of 25 WHO-listed symptoms between 90 and 365 days after the date of a PCR-positive test or clinical diagnosis of COVID-19, with no history of that symptom 180 days before SARS-Cov-2 infection. Propensity score overlap weighting was applied separately for each cohort to minimise confounding. Sub-distribution hazard ratios (sHRs) were calculated to estimate vaccine effectiveness against long COVID, and empirically calibrated using negative control outcomes. Random effects meta-analyses across staggered cohorts were conducted to pool overall effect estimates. Findings A total of 1 618 395 (CPRD GOLD), 5 729 800 (CPRD AURUM), 2 744 821 (SIDIAP), and 77 603 (CORIVA) vaccinated people and 1 640 371 (CPRD GOLD), 5 860 564 (CPRD AURUM), 2 588 518 (SIDIAP), and 302 267 (CORIVA) unvaccinated people were included. Compared with unvaccinated people, overall HRs for long COVID symptoms in people vaccinated with a first dose of any COVID-19 vaccine were 0·54 (95% CI 0·44–0·67) in CPRD GOLD, 0·48 (0·34–0·68) in CPRD AURUM, 0·71 (0·55–0·91) in SIDIAP, and 0·59 (0·40–0·87) in CORIVA. A slightly stronger preventative effect was seen for the first dose of BNT162b2 than for ChAdOx1 (sHR 0·85 [0·60–1·20] in CPRD GOLD and 0·84 [0·74–0·94] in CPRD AURUM). Interpretation Vaccination against COVID-19 consistently reduced the risk of long COVID symptoms, which highlights the importance of vaccination to prevent persistent COVID-19 symptoms, particularly in adults.

• Trinh, Nhung; Houghtaling, Jared; Bernal, Fabian Leonardo Martinez; Hayati, Saeed; Maglanoc, Luigi & Lupattelli, Angela [Show all 8 contributors for this article] (2024). Harmonizing Norwegian registries onto OMOP common data model: Mapping challenges and opportunities for pregnancy and COVID-19 research. International Journal of Medical Informatics. ISSN 1386-5056. 191. doi: 10.1016/j.ijmedinf.2024.105602. Full text in Research Archive Show summary

  Objective Norwegian health registries covering entire population are used for administration, research, and emergency preparedness. We harmonized these data onto the Observational Medical Outcomes Partnership common data model (OMOP CDM) and enrich real-world data in OMOP format with COVID-19 related data. Methods Data from six registries (2018–2021) covering birth registrations, selected primary and secondary care events, vaccinations, and communicable disease notifications were mapped onto the OMOP CDM v5.3. An Extract-Transform-Load (ETL) pipeline was developed on simulated data using data characterization documents and scanning tools. We ran dashboard quality checks, cohort generations, investigated differences between source and mapped data, and refined the ETL accordingly. Results We mapped 1.5 billion rows of data of 5,673,845 individuals. Among these, there were 804,277 pregnancies, 483,585 mothers together with 792,477 children, and 472,948 fathers. We identified 382,516 positive tests for COVID-19 in 380,794 patients. These figures are consistent with results from source data. In addition to 11 million source codes mapped automatically, we mapped 237 non-standard codes to standard concepts and introduced 38 custom concepts to accommodate pregnancy-related terminologies that were not supported by OMOP CDM vocabularies. A total of 3,700/3,705 (99.8%) checks passed. The 5 failed checks could be explained by the nature of the data and only represent a small number of records. Discussion and conclusion Norwegian registry data were successfully harmonized onto OMOP CDM with high level of concordance and provides valuable source for federated COVID-19 related research. Our mapping experience is highly valuable for data partners with Nordic health registries.

• Fusaroli, Michele; Salvo, Francesco; Begaud, Bernard; AlShammari, Thamir M.; Bate, Andrew & Battini, Vera [Show all 34 contributors for this article] (2024). The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement. Drug Safety. ISSN 0114-5916. doi: 10.1007/s40264-024-01421-9. Full text in Research Archive
• Bruckner, Tim A.; Trinh, Nhung; Lelong, Nathalie; Madani, Kaveh; Slama, Rémy & Given, Joanne [Show all 7 contributors for this article] (2024). Climate Change and Congenital Anomalies: A Population-Based Study of the Effect of Prolonged Extreme Heat Exposure on the Risk of Neural Tube Defects in France. Birth Defects Research. 116(9). doi: 10.1002/bdr2.2397. Full text in Research Archive
• Lupattelli, Angela; Trinh, Nhung & Nordeng, Hedvig Marie Egeland (2023). Association of maternal personality traits with medication use during pregnancy to appraise unmeasured confounding in long-term pharmacoepidemiological safety studies. Frontiers in Pharmacology. 14. doi: 10.3389/fphar.2023.1160168. Full text in Research Archive Show summary

  Maternal personality is a possible confounder on the association between prenatal medication exposure and long-term developmental outcomes in offspring, but it is often unmeasured. This study aimed to (i) estimate the association between five maternal personality traits and prenatal use of acetaminophen (including extended use), opioid analgesics, antidepressants, benzodiazepines/z-hypnotics, and antipsychotics; (ii) evaluate, using an applied example, whether unmeasured confounding by maternal neuroticism would make the association between prenatal antidepressant-child ADHD null, using the E-value framework. We used data from 8,879 pregnant women and recent mothers who participated in the Multinational Medication Use in Pregnancy Study, a web-based cross-sectional study performed within the period from 1-Oct-2011 to 29-Feb-2012 in Europe, North America and Australia. Medication use in pregnancy was self-reported by the women. Personality was assessed with the Big Five Inventory, capturing the dimensions of neuroticism, extraversion, openness, agreeableness, and conscientiousness. Adjusted logistic regression analyses were conducted for each trait-medication pair, using the survey weighting. There was a strong association between having high neuroticism and prenatal use of antidepressants (Odds Ratio (OR): 5.63, 95% Confidence Interval (CI): 3.96-8.01), benzodiazepines/z-hypnotics (OR: 6.66, 95% CI: 4.05-10.95), and analgesic opioids (OR: 2.24, 95% CI: 1.41-3.56), but not with antipsychotics. Among women with mental illness, this association attenuated for benzodiazepines/z-hypnotics, but decreased to the null for antidepressants. High neuroticism (OR: 1.31, 95% CI: 1.08-1.59) and high openness (OR: 0.77, 95% CI: 0.64-0.93) were associated with extended use of acetaminophen. The E-value for the Hazard Ratio 1.93 in the applied example was 3.27. If the example study was conducted using a population comparison group, high maternal neuroticism could have explained away the association antidepressant-ADHD. Because the example study included only women with a mental illness, this risk of bias was assessed as minimal. Various personality dispositions in the mother are associated, with a different degree, to prenatal use of medication. The strength of these association can aid researchers in evaluating the influence of uncontrolled confounding by maternal personality in long-term safety studies in pregnancy, using the E-value. This assessment should always be performed in addition to a rigorous study design using approaches to triangulate the evidence.

• Lupattelli, Angela; Corrao, Giovanni; Gatti, Chiara; Rea, Federico; Trinh, Nhung & Cantarutti, Anna (2023). Antidepressant continuation and adherence in pregnancy, and risk of antenatal hospitalization for unipolar major depressive and/or anxiety disorders. Journal of Affective Disorders. ISSN 0165-0327. 339, p. 502–510. doi: 10.1016/j.jad.2023.07.066. Full text in Research Archive Show summary

  Background Knowledge about the effectiveness of antidepressants in pregnancy is limited. We aimed to evaluate the association of antidepressant continuation in pregnancy and adherence with the risk of antenatal hospitalization for depression/anxiety. Methods In a population-based study based on the healthcare databases of the Lombardy region, Italy (2010–2020), we included 17,033 live-birth pregnancies within 16,091 women with antidepressant use before pregnancy. Antidepressant exposure was classified as continued in pregnancy versus discontinued proximal to pregnancy. Outcome measure was antenatal hospitalization for depression/anxiety. Propensity score matching analysis was performed to control for measured confounding. Stratification by pre-pregnancy antidepressant adherence based on the proportion of days covered (PDC) with antidepressants served to address confounding by disease severity. We applied 60 days lag-time for antidepressant exposure to minimize the risk of protopathic bias. Results There were 362 (2.1 %) antenatal hospitalizations for depression/anxiety. Among the matched pairs, the cumulative incidence was 3.5 (continued antidepressant) versus 2.1 (discontinued antidepressant) per 1000 person-months, yielding a hazard ratio (HR) of 1.76 (95 % confidence interval (CI): 1.34–2.33)). The HR declined to the null (1.02, 95 % CI: 0.62–1.69) in the stratified analysis of pregnancies with moderate-high adherence pre-pregnancy. Moderate-high adherence in pregnancy was associated with 85 % greater risk of the antenatal outcome, but the HR decreased with the 60 days lag-time (HR: 1.40, 95 % CI: 0.79–2.50). Limitations Lack of information regarding antidepressant dosage. Conclusion We found no difference in risk for antenatal hospitalization for depression/anxiety with antidepressant continuation or higher adherence in pregnancy, relative to discontinuation or lower adherence.

• Kostka, Kristin; Roel, Elena; Trinh, Nhung; Mercadé-Besora, Núria; Delmestri, Antonella & Mateu, Lourdes [Show all 11 contributors for this article] (2023). The burden of post-acute COVID-19 symptoms in a multinational network cohort analysis. Nature Communications. 14(1). doi: 10.1038/s41467-023-42726-0. Full text in Research Archive Show summary

  Abstract Persistent symptoms following the acute phase of COVID-19 present a major burden to both the affected and the wider community. We conducted a cohort study including over 856,840 first COVID-19 cases, 72,422 re-infections and more than 3.1 million first negative-test controls from primary care electronic health records from Spain and the UK (Sept 2020 to Jan 2022 (UK)/March 2022 (Spain)). We characterised post-acute COVID-19 symptoms and identified key symptoms associated with persistent disease. We estimated incidence rates of persisting symptoms in the general population and among COVID-19 patients over time. Subsequently, we investigated which WHO-listed symptoms were particularly differential by comparing their frequency in COVID-19 cases vs. matched test-negative controls. Lastly, we compared persistent symptoms after first infections vs. reinfections.Our study shows that the proportion of COVID-19 cases affected by persistent post-acute COVID-19 symptoms declined over the study period. Risk for altered smell/taste was consistently higher in patients with COVID-19 vs test-negative controls. Persistent symptoms were more common after reinfection than following a first infection. More research is needed into the definition of long COVID, and the effect of interventions to minimise the risk and impact of persistent symptoms.

• Gauffin, Oskar; Brand, Judith S.; Vidlin, Sara Hedfors; Sartori, Daniele; Asikainen, Suvi & Català, Martí [Show all 34 contributors for this article] (2023). Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study. Drug Safety. ISSN 0114-5916. 46, p. 1335–1352. doi: 10.1007/s40264-023-01353-w. Full text in Research Archive Show summary

  Introduction Individual case reports are the main asset in pharmacovigilance signal management. Signal validation is the first stage after signal detection and aims to determine if there is sufficient evidence to justify further assessment. Throughout signal management, a prioritization of signals is continually made. Routinely collected health data can provide relevant contextual information but are primarily used at a later stage in pharmacoepidemiological studies to assess communicated signals. Objective The aim of this study was to examine the feasibility and utility of analysing routine health data from a multinational distributed network to support signal validation and prioritization and to reflect on key user requirements for these analyses to become an integral part of this process. Methods Statistical signal detection was performed in VigiBase, the WHO global database of individual case safety reports, targeting generic manufacturer drugs and 16 prespecified adverse events. During a 5-day study-a-thon, signal validation and prioritization were performed using information from VigiBase, regulatory documents and the scientific literature alongside descriptive analyses of routine health data from 10 partners of the European Health Data and Evidence Network (EHDEN). Databases included in the study were from the UK, Spain, Norway, the Netherlands and Serbia, capturing records from primary care and/or hospitals. Results Ninety-five statistical signals were subjected to signal validation, of which eight were considered for descriptive analyses in the routine health data. Design, execution and interpretation of results from these analyses took up to a few hours for each signal (of which 15–60 minutes were for execution) and informed decisions for five out of eight signals. The impact of insights from the routine health data varied and included possible alternative explanations, potential public health and clinical impact and feasibility of follow-up pharmacoepidemiological studies. Three signals were selected for signal assessment, two of these decisions were supported by insights from the routine health data. Standardization of analytical code, availability of adverse event phenotypes including bridges between different source vocabularies, and governance around the access and use of routine health data were identified as important aspects for future development. Conclusions Analyses of routine health data from a distributed network to support signal validation and prioritization are feasible in the given time limits and can inform decision making. The cost–benefit of integrating these analyses at this stage of signal management requires further research.

• Trinh, Nhung; Semark, Birgitte Dige; Munk-Olsen, Trine; Liu, Xiaoqin; Thapa, Suraj Bahadur & Yilmaz, Zeynep [Show all 8 contributors for this article] (2023). Antidepressant treatment in pregnancy: a Danish registry linkage study in pregnant women with pre-existing obsessive‐compulsive disorder. Translational Psychiatry. 13(1). doi: 10.1038/s41398-023-02516-0. Full text in Research Archive Show summary

  Abstract The association between antidepressant continuation during pregnancy and postpartum mental health in women with obsessive-compulsive disorder (OCD) is uncertain. We identified 1317 women with live-birth singleton pregnancies and having outpatient/inpatient visits for OCD in the 4 years pre-pregnancy from the Danish registries. We defined three groups based on antidepressant prescriptions filled in the 2 years before pregnancy to delivery: (i) unexposed ( n  = 449); (ii) discontinuers ( n  = 346), i.e., with pre-pregnancy antidepressant fills only; (iii) continuers ( n  = 522), i.e., with antidepressant fills before and during pregnancy. We estimated crude and propensity score weighted hazard ratio (HRs) of postpartum visit for OCD and mood/anxiety disorders using Cox proportional hazard models. In weighted analyses, we found no difference in the probability of a postpartum visit for OCD or MADs with antidepressant continuation compared to unexposed and discontinuers. The likelihood of a postpartum OCD visit was higher in pregnancies having only one prescription fill during pregnancy compared to unexposed (HR = 3.44, 95% CI: 1.24, 9.54) or discontinuers (HR = 2.49, 95% CI: 0.91, 6.83). Continuers in pregnancy without antidepressant fill in the first three months postpartum had higher probability for postpartum visit for mood/anxiety disorders compared to discontinuers (HR = 3.84, 95% CI: 1.49, 9.92). Among pregnant women with pre-existing OCD, we found similar probabilities of a postpartum visit for OCD or mood/anxiety disorders in antidepressant continuers compared to unexposed and discontinuers. Continuers with a single prescription fill during pregnancy or no fill postpartum may have higher risks for these outcomes. Our findings highlight the importance of continuity of treatment throughout the perinatal period.

• Trinh, Nhung; Munk-Olsen, Trine; Wray, Naomi R.; Bergink, Veerle; Nordeng, Hedvig Marie Egeland & Lupattelli, Angela [Show all 7 contributors for this article] (2023). Timing of Antidepressant Discontinuation During Pregnancy and Postpartum Psychiatric Outcomes in Denmark and Norway. JAMA psychiatry. ISSN 2168-6238. 80(5), p. 441–450. doi: 10.1001/jamapsychiatry.2023.0041. Full text in Research Archive
• Tran, Ha N.; Nguyen, Tien N. T.; Tran, Ngan T. K.; Nguyen, Ly T.; Vu, Hoa D. & Nguyen, Anh H. [Show all 7 contributors for this article] (2023). Preventability of Adverse Drug Reactions Related to Antibiotics: An Assessment Based on Spontaneous Reporting System. Therapeutic Innovation and Regulatory Science. ISSN 2168-4790. 57(5), p. 1104–1112. doi: 10.1007/s43441-023-00552-y. Full text in Research Archive
• Trinh, Nhung; Nordeng, Hedvig Marie Egeland; Bandoli, Gretchen; Eberhard-Gran, Malin Marie Cecilia & Lupattelli, Angela (2022). Antidepressant and mental health care utilization in pregnant women with depression and/or anxiety: An interrupted time-series analysis. Journal of Affective Disorders. ISSN 0165-0327. 308, p. 458–465. doi: 10.1016/j.jad.2022.04.101. Full text in Research Archive Show summary

  Background Little is known about mental health care utilization patterns in pregnant women with depression/anxiety in Norway according to antidepressant fill trajectories in pregnancy. Method We conducted a registry-linkage cohort study of pregnancies within women having outpatient visit for depression/anxiety and antidepressant fills prior to pregnancy identified from four national registries of Norway (2009–2018). Number of consultations for depression/anxiety per 100 pregnancies as proxy of mental health care utilization was modelled using interrupted time-series analysis with first month into pregnancy and first month after delivery as interruption points. We investigated the time window spanning from six months prior to one year postpartum. Antidepressant fill trajectories in the corresponding time window were identified using longitudinal k-means trajectory modelling. Results The cohort included 8460 pregnancies within 8062 women with depression/anxiety. We observed reduced mental health care utilization when pregnant women entered the course of pregnancy (negative slopes during pregnancy for psychiatric specialists and psychologists). The declines were observed for all antidepressant fill trajectories (i.e., discontinuers and continuers) except interrupters (i.e., discontinued then resumed treatment). We found increased mental health care utilization in the postpartum year, notably in interrupters (positive slopes in consultation rates with specialists of outpatient clinics and public-contracted psychiatrists). Limitations It was not possible to measure directly the use of psychosocial interventions and psychotherapy. Conclusions Pregnancy was associated with reduced mental health care utilization regardless of whether antidepressant treatment was maintained during pregnancy or not. Increases in mental health care utilization were observed in the postpartum year, especially in interrupters.

• Burvenich, Ruben; Dillen, Hannelore; Trinh, Nhung; Freer, Joseph; Wynants, Laure & Heytens, Stefan [Show all 8 contributors for this article] (2022). Antibiotic use in ambulatory care for acutely ill children in high-income countries: A systematic review and meta-analysis. Archives of Disease in Childhood. ISSN 0003-9888. 107, p. 1088–1094. doi: 10.1136/archdischild-2022-324227. Full text in Research Archive
• Trinh, Nhung; Nordeng, Hedvig Marie Egeland; Bandoli, Gretchen; Palmsten, Kristin; Eberhard-Gran, Malin & Lupattelli, Angela (2022). Antidepressant Fill and Dose Trajectories in Pregnant Women with Depression and/or Anxiety: A Norwegian Registry Linkage Study. Clinical Epidemiology. 14, p. 1439–1451. doi: 10.2147/CLEP.S379370. Full text in Research Archive Show summary

  Background: Few studies investigated longitudinal antidepressant exposure during pregnancy and included dosage in the assessment. Methods: We conducted a nationwide, registry-linkage study in Norway using data on antidepressant prescription fills in pregnancies lasting ≥ 32 weeks in women with a delivery between 2009 and 2018 who had a depression/anxiety diagnosis and antidepressant fills prior to pregnancy. Information on antidepressant exposure by week (measured by filled prescriptions) and prescribed average daily dose was used in longitudinal k-means trajectory modelling for a 108-week time window from six months prior to pregnancy to one year after delivery. Factors associated with trajectory group membership were examined using multinomial logistic regression models. Results: We included 8,460 pregnancies in 8,092 women. Four antidepressant fill trajectories were identified based on filled antidepressant prescriptions: two distinct discontinuing patterns, one at around the start of pregnancy (30.4%) and one around the end of pregnancy (33.8%); one continuing pattern (20.6%); and one interrupting pattern (15.2%). Using average usual daily dose, we identified low dose discontinuing (60.3%), medium dose reducing (20.6%) and high dose continuing (15.2%) patterns. The multinomial logistic regressions showed that the fill trajectory group membership was strongly associated with: antidepressant type and dose prior to pregnancy and co-medication prior to pregnancy, maternal age, marital status, parity, previous pregnancy loss, and pregnancy planning. Conclusion: Longitudinal trajectory modelling revealed distinct antidepressant fill and dosage patterns in the period around pregnancy. Knowledge about factors associated with utilization trajectories might be useful for health-care personnel counselling women about antidepressant use in pregnancy.

• Trinh, Nhung; Semark, Birgitte Dige; Munk-Olsen, Trine; Liu, Xiaoqin; Rø, Øyvind & Bulik, Cynthia M. [Show all 9 contributors for this article] (2022). Psychiatric visits during the postpartum year in women with eating disorders who continue or discontinue antidepressant treatment in pregnancy. International Journal of Eating Disorders. ISSN 0276-3478. 56(3), p. 582–594. doi: 10.1002/eat.23877. Full text in Research Archive Show summary

  Objective To determine the association between continued antidepressant use in pregnancy and postpartum psychiatric visits for eating (ED) or mood/anxiety disorders in women with preexisting ED. Method Using Danish health registry data (1998–2015), we identified 3529 pregnancies in women with ED prepregnancy: (i) 564 with continued antidepressant use before and during pregnancy; (ii) 778 with discontinued antidepressants before pregnancy; (iii) 2137 unexposed. Outpatient and inpatient postpartum visits for an ED or a mood/anxiety disorder constituted the outcome measures. We estimated hazard ratios (HRs) and 95% confidence intervals (CI) using Cox regression with inverse probability of treatment weighting, and performed stratified analyses by antidepressant prescription filling in the first 3 months postpartum. Results The weighted cumulative incidence for an ED visit at end of follow-up was 4.5% (continued) and 4.8% (discontinued). We found no association between continued antidepressant and postpartum ED visit, relative to discontinued (HR: 0.89, 95% CI: 0.52–1.52). The HR for postpartum mood/anxiety disorder visit was 1.27 (95% CI: 0.68–2.36) with continued antidepressants versus discontinued but decreased if more than two antidepressant prescriptions were refilled. Continued antidepressant use was associated with a 57% reduced likelihood of a postpartum ED visit versus discontinued use in pregnancies with antidepressant prescription refills in the early postpartum. Conclusion Among women with preexisting ED, there was no association between continued antidepressant use during pregnancy and the likelihood of postpartum psychiatric visits, relative to discontinued antidepressants before pregnancy. Continuation of treatment into the early postpartum is associated with reduced likelihood of postpartum ED visit. Public Significance Based on data from the Danish registries, we identified 3529 pregnancies among women with preexisting eating disorders before pregnancy. Women with continued antidepressant treatment both before and during pregnancy did not have a lower probability of having postpartum psychiatric visits for an eating disorder or for mood/anxiety disorders (often coexisting with eating disorders), relative to those who discontinued antidepressants before pregnancy. Further continuation of antidepressant treatment into the early postpartum is associated with improved maternal postpartum outcomes. However, residual confounding by disease severity limits confidence in this conclusion.

• Trinh, Thi Hong Nhung; Andersen, Sarah Hjorth & Nordeng, Hedvig Marie Egeland (2021). Use of interrupted time-series analysis to characterise antibiotic prescription fills across pregnancy: A Norwegian nationwide cohort study. BMJ Open. 11(12). doi: 10.1136/bmjopen-2021-050569. Full text in Research Archive Show summary

  Objectives Antibiotics are the most frequently prescribed medications for pregnant and breastfeeding women. We applied interrupted time-series analysis (ITSA) to describe antibiotic prescription fills patterns in pregnant women and examined recurrent antibiotic fills in subsequent pregnancies. Designs A population-based drug utilisation study. Setting Norwegian primary care. Participants 653 058 pregnancies derived from Medical Birth Registry of Norway linked to the Norwegian Prescription Database (2006–2016). Main outcome measure Proportion of pregnancies exposed to antibiotics aggregated by week in pregnancy time windows. Statistical analyses We descriptively analysed antibiotic prescription fills patterns and components in pregnant women. The changes in antibiotic fills in pregnancy time windows were assessed using ITSA. Interruptions points at week 4 to week 7 into pregnancy and delivery were used. Factors associated with antibiotic fills during pregnancy were identified using generalised estimating equations for Poisson regression. Recurrent antibiotic use was estimated using proportion of women who filled antibiotic prescription in a subsequent pregnancy. Results Antibiotics were filled in 27.6% pregnancies. The ITSA detected an immediate decrease of 0.07 percentage points (95% CI −0.13 to –0.01) in the proportion of exposed pregnancies at 4 weeks after conception, mainly among women taking folic acid before pregnancy. This proportion increased shortly after delivery (immediate change=1.61 percentage points (95% CI 0.31 to 2.91)) then decreased gradually afterwards (change in slope=−0.19 percentage points, 95% CI −0.34 to –0.05)). The strongest factor associated with antibiotic fills during pregnancy was having recurrent urinary tract infections (adjusted OR=2.65, 95% CI 2.59 to 2.72). Women who had filled antibiotics during a pregnancy were up to three times more likely to fill antibiotics in the subsequent pregnancies. Conclusions ITSA highlighted important impact of pregnancy and delivery on antibiotic fillings. Having antibiotic fills in a pregnancy was associated with recurrent antibiotic fills in subsequent ones.

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• Lupattelli, Angela & Trinh, Nhung (2024). Sars-cov-2 Infection Incidence And Severity In Immunocompromised Children: A Population-based Study In Italy And Norway. Full text in Research Archive
• Lupattelli, Angela & Trinh, Nhung (2024). Assessing neonatal outcomes across prenatal exposure trajectories to antidepressant. Full text in Research Archive
• Lupattelli, Angela; Trinh, Nhung & Nordeng, Hedvig Marie Egeland (2024). Psychiatric outcomes and their progression across different states in children and adolescents following prenatal exposure to antidepressants. Full text in Research Archive
• Lupattelli, Angela; Trinh, Nhung & Chatha, Zeenat Fatima (2024). Timing of Antidepressant Initiation Postpartum and Maternal Mental Health Outcomes up to 18 Months after Childbirth. Full text in Research Archive
• Lupattelli, Angela & Trinh, Nhung (2024). Time-dependent effect of prenatal antidepressant exposure on symptoms of eating, depressive, and anxiety disorders in children at 14 years of age. Full text in Research Archive
• Trinh, Nhung; Jödicke, Annika M; Català, Martí; Mercadé-Besora, Núria; Hayati, Saeed & Lupattelli, Angela [Show all 8 contributors for this article] (2024). Effectiveness of COVID-19 vaccines to prevent long COVID: data from Norway. The Lancet Respiratory Medicine. ISSN 2213-2600. 12(5), p. e33–e34. doi: 10.1016/S2213-2600(24)00082-1. Full text in Research Archive
• Nordeng, Hedvig Marie Egeland; Pedersen, Elisabeth; Hurley, Eimir; Zhao, Jing; Trinh, Nhung & Lupattelli, Angela (2022). EU-COVID-19 - a multinational registry-based study with focus on risk and protective factors, clinical outcomes and mental health. Full text in Research Archive
• Lupattelli, Angela & Trinh, Nhung (2022). Polysubstance Exposure During Pregnancy and Attention-Deficit/Hyperactivity Disorder in Offspring—Methodological Challenges and Opportunities for Future Research. JAMA Network Open. 5(3), p. e221964–e221964. doi: 10.1001/jamanetworkopen.2022.1964. Full text in Research Archive

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