Pharmacoepidemiology and Drug Safety最新文献

{"title":"First-Recorded Alcohol Use Disorder Diagnosis as an Ascertainment Outcome: Implications for GLP-1 Target Trial Emulations.","authors":"Chien-Huei Sung, Lien-Chung Wei","doi":"10.1002/pds.70472","DOIUrl":"10.1002/pds.70472","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 9","pages":"e70472"},"PeriodicalIF":2.6,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13520804/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148831378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association Between Proton Pump Inhibitor Use and Malnutrition Risk in the US General Population Using the GLIM Framework (NHANES 1999-2020).","authors":"F Orsini, A Novella, L Pasina","doi":"10.1002/pds.70451","DOIUrl":"10.1002/pds.70451","url":null,"abstract":"<p><strong>Background: </strong>Proton pump inhibitors (PPIs) are the global gold standard for acid-related disorders; however, their proliferation into long-term, often non-indicated use raises significant concerns regarding qualitative nutrient depletion.</p><p><strong>Objective: </strong>This study primarily aimed to evaluate the independent association between PPI use and malnutrition risk according to the Global Leadership Initiative on Malnutrition (GLIM) criteria in a nationally representative US population.</p><p><strong>Methods: </strong>We conducted a cross-sectional analysis of 23 363 adults from the NHANES 1999-2020 database. Malnutrition was operationalized via the GLIM approach, integrating phenotypic criteria (weight loss, low BMI, or DXA-derived reduced muscle mass) with etiologic criteria (inflammation or reduced calorie intake). Robust Poisson regression models estimated relative risks (RRs) for general malnutrition, while logistic regression estimated odds ratios (ORs) for severe malnutrition. Models were adjusted for sociodemographics, food security, comorbidities, and appetite-affecting medications.</p><p><strong>Results: </strong>The prevalence of malnutrition was 18.9% (95% CI: 18.4%-19.4%) and PPI use was associated with a 10% increased risk of malnutrition (RR 1.10; 95% CI: 1.01-1.19; p = 0.031) in the adjusted model. For severe malnutrition, PPI exposure was a robust independent predictor (OR 1.36; 95% CI: 1.13-1.63; p = 0.001). Notably, sex-stratified analysis revealed a RR associated with PPIs was significantly more pronounced in females (RR 1.37; 95% CI: 1.06-1.79; p = 0.018) than in males (RR 1.07; p = 0.11). In the geriatric population (≥ 65 years), chronic PPI use increased the odds of severe malnutrition by 57% (OR 1.57; 95% CI: 1.15-2.14; p = 0.004).</p><p><strong>Conclusion: </strong>Prolonged iatrogenic hypochlorhydria may represent an important contributor to malnutrition, particularly to its more severe forms and among older adults. These findings support the need for regular medication reviews to identify and discontinue unnecessary long-term PPI therapy. Preserving metabolic and nutritional health may therefore require the implementation of non-pharmacological approaches as first-line management options for acid-related disorders whenever clinically appropriate. Such strategies may help reduce unnecessary long-term PPI exposure and its potential adverse effects on nutritional status.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 9","pages":"e70451"},"PeriodicalIF":2.6,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13529924/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148866038","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unsupervised Ensemble Learning for Active Drug-Induced Liver Injury Surveillance: Integrating Pharmacokinetic Burden With Enzyme Trajectories.","authors":"Thawatchai Nakkaratniyom, Sanita Hirunrassamee, Thapana Boonchoo, Cha-Oncin Sooksriwong","doi":"10.1002/pds.70471","DOIUrl":"10.1002/pds.70471","url":null,"abstract":"<p><strong>Purpose: </strong>Traditional drug-induced liver injury (DILI) surveillance relying on static laboratory thresholds frequently misses early kinetic evolution. To address this, a fundamentally drug-agnostic unsupervised ensemble framework, integrating pharmacokinetic (WCEDR) and polypharmacy (HAMPIS) features, was developed for early DILI detection. Antiepileptic drugs (AEDs) were utilised as a proof-of-concept validation cohort.</p><p><strong>Methods: </strong>Using Thailand's national electronic health record database (2021-2024), a multi-view ensemble (Isolation Forest, Local Outlier Factor, One-Class Support Vector Machine) evaluated longitudinal physiological deviations. Feature engineering prioritised acute kinetic volatility to mitigate irregular sampling intervals. Diagnostic performance was benchmarked against standard criteria (ALT > 3 × ULN) and validated through blinded expert adjudication of 140 clinical episodes.</p><p><strong>Results: </strong>From 616 425 treatment episodes, the framework isolated 86 high-probability anomalies. Benchmarking revealed the model captured 80.2% of rule-based positives while proactively identifying 17 AI-only sub-threshold episodes (19.8%) exhibiting distinct enzymatic velocity; over half (52.9%) were clinically confirmed as DILI. Blinded adjudication yielded a clinical plausibility rate of 69.8% and a negative predictive value of 92.6%. Operationally, the framework achieved a number needed to review (NNR) of 1.43, substantially optimising triage efficiency. Digital phenotyping stratified alerts into three distinct archetypes: complex polypharmacy, atypical pharmacokinetic burden, and active idiosyncratic injury.</p><p><strong>Conclusion: </strong>By prioritising kinetic volatility and multidimensional pharmacological context, the unsupervised ensemble functions as a high-precision, complementary surveillance tool. It successfully detects early-onset idiosyncratic reactions frequently overlooked by rigid static thresholds, offering a scalable blueprint for proactive pharmacovigilance.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 9","pages":"e70471"},"PeriodicalIF":2.6,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13525449/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148850599","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dementias in Older Women With Early-Stage HER2-Negative Breast Cancer Treated With Anthracycline Plus Taxane Versus Taxane-Based Chemotherapy Regimens.","authors":"Nguyen Le, Nirupama Anne, Chan Shen, Ratnakishore Pallapothu, Yan Liu, Chanhyun Park","doi":"10.1002/pds.70457","DOIUrl":"10.1002/pds.70457","url":null,"abstract":"<p><strong>Background: </strong>Anthracycline plus taxane (ATAX) regimens are associated with improved survival in HER2-negative breast cancer (HBC) compared to taxane-based (TAX) regimens. However, anthracyclines are known for their cardiotoxicity, which could increase the risk of neurocognitive deficits, raising concerns about neurocognitive safety, particularly in older adults. Limited evidence exists comparing neurocognitive outcomes between these two regimens.</p><p><strong>Objective: </strong>To compare the incidence of Alzheimer's disease and related dementias (ADRD) between ATAX and TAX regimens in neoadjuvant (Trial #1) and adjuvant (Trial #2) settings among older women with early-stage HBC.</p><p><strong>Methods: </strong>Using SEER-Medicare data (2010-2021), we identified women aged ≥ 66 years with newly diagnosed HBC and no prior neurocognitive conditions between 2011 and 2021. Patients were longitudinally tracked, and their eligibility for each regimen was evaluated. We applied the clone-censor-weight method and used weighted pooled logistic regression to estimate the 10-year risks of ADRD, Alzheimer's disease (AD), and vascular dementia (VD).</p><p><strong>Results: </strong>We identified 14 079 and 9321 eligible individuals in Trial #1 and Trial #2, respectively. For ADRD outcome, the 10-year risk difference (RD) was -6.91% (95% CI: -15.60% to 0.91%) for HR+/HER2- cohort and -2.14% (95% CI: -9.57% to 5.46%) for TNBC cohort in Trial #1. The 10-year RD was -1.42% (95% CI: -9.33% to 6.98%) for HR+/HER2- cohort and -2.91% (95% CI: -9.54% to 7.86%) for TNBC cohort in Trial #2.</p><p><strong>Conclusion: </strong>Our findings suggest that ATAX regimens were not associated with increased risks of ADRD, AD, and VD compared to TAX regimens in older women with HBC. However, the risks of AD and VD should be interpreted with caution due to sparse events. These findings may support the continued use of ATAX regimens in this population, while also informing more personalized, risk-adapted treatment strategies.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 9","pages":"e70457"},"PeriodicalIF":2.6,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13525236/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148851297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Process of Deprescribing in Older Adults With Potentially Inappropriate Medication or Polypharmacy: A Scoping Review.","authors":"Mengnan Zhao, Zhaoyan Chen, Ying Zhang, Fangyuan Tian","doi":"10.1002/pds.70467","DOIUrl":"10.1002/pds.70467","url":null,"abstract":"<p><strong>Objectives: </strong>Deprescribing is increasingly recognized as an effective strategy for reducing potentially inappropriate medication (PIM) use and polypharmacy in older adults. However, existing deprescribing frameworks often lack detailed operational guidance, which may hinder their routine implementation in clinical practice. To systematically map and characterize the reported deprescribing processes in older adults with PIM use or polypharmacy and identify gaps in their operationalization.</p><p><strong>Methods: </strong>PubMed, Embase (Ovid), and Web of Science were comprehensively searched for studies describing deprescribing processes in older adults with PIM use or polypharmacy. The reported processes were evaluated against Reeve's patient-centered deprescribing framework, which comprises five sequential steps.</p><p><strong>Results: </strong>A total of 92 studies describing deprescribing processes were included. Although 91 studies (98.91%) provided at least a partial description of the deprescribing process, only 1 study reported all five steps of Reeve's framework in detail. The step of planning and initiating medication withdrawal was the most frequently and thoroughly described (63/92, 68.97%). In contrast, operational guidance for determining whether a medication could be ceased and prioritizing medications for discontinuation was rarely reported, with only 7 studies (7.61%) providing sufficient detail. Patient involvement in developing the deprescribing plan was also inconsistently reported, with nearly half of the studies inadequately addressing this aspect.</p><p><strong>Conclusions: </strong>Deprescribing processes are incompletely and inconsistently operationalized in the literature. In particular, guidance on cessation decisions, medication prioritization, and patient engagement remains limited. Future deprescribing frameworks should provide explicit, stepwise, and patient-centered operational guidance to facilitate consistent implementation in routine clinical practice.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 9","pages":"e70467"},"PeriodicalIF":2.6,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13508765/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148819282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corticosteroid Use and In-Hospital Mortality in Patients With Brain Abscess: A Target Trial Emulation.","authors":"Takayuki Anno, Toshiki Fukasawa, Koji Kawakami","doi":"10.1002/pds.70468","DOIUrl":"10.1002/pds.70468","url":null,"abstract":"<p><strong>Purpose: </strong>Corticosteroids are sometimes administered to patients with severe brain edema associated with brain abscess. However, no studies have used methods that appropriately account for time-varying covariates and immortal time to evaluate the impact of intravenous corticosteroid use on in-hospital mortality. Therefore, we aimed to address these limitations and estimate the impact on in-hospital mortality using a target trial emulation framework.</p><p><strong>Methods: </strong>We identified patients admitted with brain abscess, not caused by head trauma or neurosurgical interventions, from two large-scale hospital-based databases in Japan between 2014 and 2024. We compared two treatment strategies: Strategy 1 was initiation of intravenous dexamethasone or betamethasone administration within 7 days after admission and continuing for at least 3 consecutive days; Strategy 2 was no intravenous corticosteroid use throughout hospitalization. Using a clone-censor-weight approach, we estimated the 60-day in-hospital mortality.</p><p><strong>Results: </strong>A total of 627 patients met the eligibility criteria. Overall, 34 patients (5.4%) died within 60 days. The estimated total effect of treatment strategy on 60-day all-cause in-hospital death was 4.8% (95% CI, 1.1-9.2) for Strategy 1, and 4.6% (95% CI, 2.9-6.6) for Strategy 2, corresponding to a risk ratio of 1.04 (95% CI, 0.26-2.08) and risk difference of 0.2% (95% CI, -3.3 to 4.3).</p><p><strong>Conclusions: </strong>No clear difference in 60-day in-hospital mortality between the two treatment strategies; however, the wide confidence intervals indicate that clinically important benefit or harm could not be excluded. This study's framework may guide future studies using more granular data.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 9","pages":"e70468"},"PeriodicalIF":2.6,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13522999/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148840944","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of Heart Failure Hospitalization Associated With Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors Versus Erythropoiesis-Stimulating Agents: A Nationwide Claims-Based Cohort Study.","authors":"Yuki Kunitsu, Keiko Ikuta, Daiki Hira, Shunsaku Nakagawa, Tomohiro Terada","doi":"10.1002/pds.70453","DOIUrl":"10.1002/pds.70453","url":null,"abstract":"<p><strong>Purpose: </strong>Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) are increasingly used to treat renal anemia in patients with chronic kidney disease (CKD). We evaluated the risk of heart failure associated with HIF-PHIs compared with erythropoiesis-stimulating agents (ESAs) in routine clinical practice.</p><p><strong>Methods: </strong>We conducted a nationwide, retrospective, active-comparator cohort study using a Japanese claims database. We included adults with non-dialysis CKD and heart failure initiating HIF-PHIs or ESAs alongside diuretic therapy between August 2020 and March 2025. The primary outcome was heart failure hospitalization. Secondary outcomes included emergency heart failure hospitalization and hospitalization requiring intravenous diuretics. Baseline characteristics were balanced using inverse probability of treatment weighting (IPTW) based on propensity scores. Hazard ratios (HRs), 95% confidence intervals (CIs), and sensitivity analyses were evaluated in predefined subgroups using Cox proportional hazards models.</p><p><strong>Results: </strong>The cohorts comprised 14 995 HIF-PHI and 22 889 ESA users with baseline characteristics well balanced after IPTW adjustment. Heart failure hospitalization incidence rates per 1000 person-years (PY) were 157.8 for HIF-PHIs and 177.0 for ESAs. HRs were 0.93 [95% CI 0.87-1.01] for heart failure hospitalization, 0.94 [95% CI 0.84-1.03] for emergency heart failure, and 0.87 [95% CI 0.81-0.94] for intravenous diuretic administration. Results were generally consistent across subgroup and sensitivity analyses.</p><p><strong>Conclusions: </strong>Although residual confounding cannot be excluded because of the observational study design, HIF-PHIs were not associated with evidence of an increased risk of heart failure hospitalization in patients with heart failure.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 9","pages":"e70453"},"PeriodicalIF":2.6,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13525448/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148849924","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Postpartum Psychotropic Treatment Patterns and Breastfeeding: Nationwide Clustering Study.","authors":"Anders Hviid, Anna Laksafoss, Elisabeth O'Regan, Poul Videbech, Ingrid Bech Svalgaard","doi":"10.1002/pds.70470","DOIUrl":"10.1002/pds.70470","url":null,"abstract":"<p><strong>Introduction: </strong>Postpartum psychotropic medication use is heterogeneous, comprising continuation of prenatal treatment, initiation, transient use and complex polypharmacy. Prior studies have reported the prevalence of potential infant exposure to psychotropics via breast milk, but characterisations better capturing the heterogeneity of this exposure are lacking. We aimed to identify distinct postpartum psychotropic treatment patterns using hierarchical clustering accounting for medication type, timing and polypharmacy, and to describe breastfeeding characteristics across these patterns.</p><p><strong>Methods: </strong>Population-based cohort study of mothers using psychotropics during the first postpartum year using linked Danish national registers 2012-2023. From a source population of 659 866 mother-child pairs with live-born singleton births, 38 528 mothers redeemed at least one psychotropic prescription during the first postpartum year and comprised the study cohort. Weekly psychotropic use was defined by redeemed prescriptions using prescribed daily dose assumptions. Hierarchical agglomerative clustering (tame R package) identified distinct treatment patterns based on medication type, timing and polypharmacy. The number of patterns was determined from interpretability, size and examination of the hierarchical dendrogram. Exclusive breastfeeding prevalence and duration were described across patterns among pairs with recorded breastfeeding habits (64%).</p><p><strong>Results: </strong>Eight distinct treatment patterns were identified, differing in psychotropic type, timing and polypharmacy. Three SSRI-dominated patterns (24 225 pairs, 63%) ranged from increasing SSRI use (Pattern I; n = 11 731), through continued SSRI use with high persistence (Pattern II; n = 7167), to mixed use involving SSRIs and other psychotropics (Pattern III; n = 5327; 48% using three or more medications). The remaining five patterns (14 303 pairs, 37%) were dominated by benzodiazepine-related drugs, other antidepressants, centrally acting sympathomimetics, antipsychotics or complex mixed use, ranging from late-initiated benzodiazepine-related use (Pattern IV; median initiation Week 27; persistence 13%) to early-initiated, highly persistent mixed use (Pattern VIII; median initiation Week 4; persistence 94%). Exclusive breastfeeding duration varied across patterns, with long-duration exclusive breastfeeding (181 days or more) highest in the SSRI-continued pattern (Pattern II, 10.6%) and lowest in the mixed-use-increasing and antipsychotics-sporadic patterns (Patterns III and VII, 5.1% and 5.2%).</p><p><strong>Conclusion: </strong>Postpartum psychotropic treatment patterns are clinically heterogeneous and exclusive breastfeeding practices differ across treatment patterns.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 9","pages":"e70470"},"PeriodicalIF":2.6,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13526646/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148860600","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identifying Pregnancies in Population-Based Data Sources: Development and Application of the ConcePTION Pregnancy Algorithm.","authors":"Giorgio Limoncella, Anna Girardi, Claudia Bartolini, Giulia Hyeraci, Giuseppe Roberto, Olga Paoletti, Davide Messina, Felipe Villalobos, Carlo Alberto Bisacco, Jesse van den Berg, Eline Houben, Katia Santacà, Ylenia Ingrasciotta, Gianluca Trifirò, Giorgia Pellegrini, Valentina Ientile, Vjola Hoxhaj, Carlos Durán, Judit Riera-Arnau, Patricia García-Poza, Mar Martín-Pérez, Ana Llorente-García, Lucia Cea-Soriano, Consuelo Huerta-Álvarez, Francisco Sánchez-Sáez, Gabriel Sanfélix-Gimeno, Clara L Rodríguez-Bernal, Jérémy Jové, Marie-Agnès Bernard, Nicolas H Thurin, Sue Jordan, Daniel Thayer, Hywel Turner Evans, Alex-Ioan Coldea, Marco Manfrini, Marleen van Gelder, Michele Tari, Romin Pajouheshnia, Ana Sofia Afonso Maciel, Maryline Le Noan-Lainé, Ditte Mølgaard-Nielsen, Marianne Cunnington, Caitlin Dodd, Leonardo Grilli, Constanza L Andaur Navarro, Miriam Sturkenboom, Hedvig Nordeng, Rosa Gini","doi":"10.1002/pds.70438","DOIUrl":"10.1002/pds.70438","url":null,"abstract":"<p><strong>Purpose: </strong>In 2019, the Innovative Medicines Initiative funded the ConcePTION project to enhance monitoring of medication safety in pregnancy and breastfeeding. This paper describes how the ConcePTION Pregnancy Algorithm (PA) identified pregnancies in 10 diverse European electronic healthcare data sources and estimated their duration.</p><p><strong>Methods: </strong>Data sources from six European countries were mapped to the ConcePTION Common Data Model. Any pregnancy-related record was retrieved from various available data banks, including birth register, primary care records, and hospital records, and reconciled into episodes of pregnancy (starting between 01/2015 and 12/2019), each with start date, end date, and type of end. A random forest model was used to estimate missing gestational ages for incomplete records. Parameters were tailored to data sources to address local variations in data availability, collection, and governance. Model performance was evaluated using cross-validated Root Mean Squared Error (RMSE).</p><p><strong>Results: </strong>The PA identified ~2.7 million pregnancies, in over 2.2 million individuals. Most ended in live births (50%-83%), 1%-15% in elective terminations, and 4%-10% in spontaneous abortions, depending on data sources. Pregnancies with unknown type of end were also retrieved (2%-34%). Gestational age was predicted for 6%-89% of records (RMSE: 17-50 days). The median gestational age at first identified pregnancy record ranged from 47 to 280 days.</p><p><strong>Conclusions: </strong>We developed an open-source algorithm to identify and date pregnancies, including early-stage pregnancies with unknown end and/or ongoing at the time of data extraction. This algorithm may facilitate multinational studies, improving generation of timely real-world evidence about use and safety of medicinal products in pregnancy.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 8","pages":"e70438"},"PeriodicalIF":2.6,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13453551/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148701911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Abstracts of ISPEs 2026, 42nd International Conference, August 29-September 2, 2026, Milan.","authors":"","doi":"10.1002/pds.70409","DOIUrl":"https://doi.org/10.1002/pds.70409","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 Suppl 3 ","pages":"e70409"},"PeriodicalIF":2.6,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148850664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}