Kicking off 2025 with new publications!

PharmaSafe Research Group is kicking off 2025 with 4 new publications! Read below about the research we have contributed to:

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

  • Authors: Reddy AS, Fawad F, Leite MA, Olstad EW, Gervin K, Kanduri C, Sandve GK, Brandlistuen R, Lupattelli A, von Koss Torkildsen J, Nordeng HME.
  • The scoping review aimed to summarize observational studies on cognitive, linguistic, and educational outcomes in children exposed prenatally to psychotropics and analgesics, paying particular attention to the validity and reliability of outcome measures. It identified 80 studies, with the majority focusing on the effects of antiepileptics like valproate, which was consistently linked to a higher risk of neurodevelopmental disorders, whereas other medications showed inconsistent results. Many studies used psychometric assessments or diagnostic codes but often lacked rigorous validation of these measures, affecting the reliability of their conclusions. The authors highlight the need for future research to prioritize robust assessment methods to accurately evaluate the long-term safety of prenatal medication exposure.

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

  • Authors: Hallberg A, Aakjaer M, Aaltonen K, Andersen M, Pedersen E, Hajiebrahimi M, Nordeng H, Nyberg F, Samuelsen PJ, Wettermark B.
  • This study examined the epidemiological outcomes and policy implementations in the Nordic countries during the COVID-19 pandemic, comparing test-positive infections, hospitalizations, ICU admissions, and mortality among Denmark, Finland, Iceland, Norway, and Sweden. Sweden experienced higher rates of infections and hospitalizations in the first three waves, whereas Denmark surpassed Sweden during the fourth wave. The countries implemented varying degrees of policy stringency, with Iceland maintaining the lowest and Sweden the highest average stringency index. Despite diverse approaches in managing the pandemic, the long-term impact on excess mortality was similar across these nations, highlighting potential learning opportunities from their differing strategies.

3. Expanding the OMOP Common Data Model to Support Perinatal Research in Network Studies.

  • Authors: Abellan A, Burn E, Trinh NTH, Burkard T, Callahan A, Fernández-Bertolín S, Hurley E, Rodriguez C, Segundo E, Morales DR, Nordeng HME, Duarte-Salles T.
  • This article describes the development and implementation of a perinatal expansion for the Observational Medical Outcomes Partnership common data model (OMOP-CDM) to enhance its support for perinatal research in network studies. The expansion includes a pregnancy table and an infant table, featuring both required and optional standardized variables, tested using the SIDIAP and Norwegian databases. Quality assessments confirmed the accurate capture of perinatal data, with descriptive analyses providing insights into pregnancy characteristics and outcomes, such as stillbirth rates, gestational lengths, and birth weights. This expansion aims to facilitate more comprehensive perinatal research across networks and includes a diagnostic package for evaluating data quality and completeness in OMOP-CDM-mapped databases.

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

  • Authors: Johnson H, Hjorth S, Morris J, Pottegård A, Leinonen M, Norby U, Nordeng H.
  • This study applied and evaluated four signal detection methods—odds ratios (OR), the information component (IC), sequential probability ratio testing (SPRT), and Bayesian hierarchical models (BHM)—to identify associations between prenatal medication exposure and childhood cancers using Nordic registry data. Among the methods tested, the odds ratio demonstrated the highest sensitivity, while the information component showed the highest specificity. The research emphasizes that while IC may be most suitable for identifying signals, these findings only suggest potential associations and require further investigation to account for confounding factors before drawing causal conclusions.
Published Mar. 14, 2025 4:21 PM - Last modified Mar. 14, 2025 4:21 PM