Pharmacoepidemiology and Drug Safety最新文献

{"title":"Factors Associated With Self-Medication to Mitigate Vaccine Reactions After COVID-19 Vaccination: A Prospective Cohort Study.","authors":"Maximilian Blattner, Ingmar Schäfer, Yvonne Nestoriuc, Christian Büchel, Martin Scherer, Jan Hendrik Oltrogge-Abiry","doi":"10.1002/pds.70372","DOIUrl":"10.1002/pds.70372","url":null,"abstract":"<p><strong>Objective: </strong>Management of vaccine reactions with analgesics/antipyretics can enhance acceptance and adherence to future vaccinations. However, inappropriate self-medication may pose health risks, particularly for individuals with chronic conditions. The aim of this study was to identify demographic, clinical, and psychosocial factors associated with self-medication behavior after COVID-19 vaccinations.</p><p><strong>Methods: </strong>Monocentric prospective cohort study at a vaccination center in Germany between August 16 and 28, 2021 with adults receiving a second dose of mRNA-based COVID-19 vaccines. We used linear regression analyses to examine the association of self-reported factors with the amount of self-medication after vaccination.</p><p><strong>Results: </strong>A total of 1616 participants (median age 34 years, 52% females) were included, with 536 (33.2%) reporting the use of self-medication. Used substances were nonsteroidal anti-inflammatory drugs n = 345 (21.3%), paracetamol n = 186 (11.5%), acetylsalicylic acid n = 48 (3.0%), and metamizole n = 18 (1.1%). The highest intake of any analgesic/antipyretic was observed on the first day after vaccination n = 393 (24.3%). Factors associated with increased self-medication included premedication with analgesics/antipyretics (B: 0.545; 95% CI: 0.442; 0.651), administration of the mRNA-1273-vaccine compared to the BNT162b2-vaccine (B: 0.293; 95% CI: 0.188; 0.397), female gender (B: 0.159; 95% CI: 0.07; 0.249), prior experiences of vaccine reactions (B:0.117; 95% CI: 0.054; 0.18), expectations of vaccine reactions (B: 0.063; 95% CI: 0.003; 0.123), and the presence of common chronic conditions. A higher satisfaction with the vaccination process (B: -0.129; 95% CI: -0.222; -0.039) was associated with lower rates of self-medication.</p><p><strong>Conclusions: </strong>Factors influencing self-medication behavior after vaccination exist and could be assessed prior to vaccine administration. The observed association of previous experiences as well as expectations of vaccine reactions suggests that nocebo effects contribute to self-medication practices.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70372"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13067796/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147646199","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":"Oral Anticoagulant Use Among Older Adults in Long-Term Care Facilities: Trends Over Time and Impact of High-Risk Comorbidities.","authors":"S L Harrison, M C Inacio, T Air, C Lang, J K Sluggett, C Whitehead, G E Caughey","doi":"10.1002/pds.70356","DOIUrl":"10.1002/pds.70356","url":null,"abstract":"<p><strong>Purpose: </strong>To examine oral anticoagulant (OAC) use in older adults residing in long-term care facilities (LTCFs) since direct OACs (DOACs) were introduced, including trends over time and in people with high-risk comorbidities (prior gastrointestinal bleed and dementia).</p><p><strong>Methods: </strong>A repeated cross-sectional study using the Registry of Senior Australians National Historical Cohort was conducted and included individuals aged ≥ 65 years residing in LTCFs in Australia between 2013 and 2019. Yearly age- and sex-adjusted prevalence of OACs and 95% confidence intervals (CIs) were estimated using generalised estimating equation (GEE) Poisson models and adjusted prevalence ratios (aPRs) were calculated to estimate trends.</p><p><strong>Results: </strong>In 500 883 individuals, the prevalence of OAC use increased from 12.2% (95% CI 12.1-12.4) in 2013 to 16.5% (95% CI 16.4-16.7) in 2019 [aPR 1.05 (95% CI 1.05-1.05)]. This was driven by an increase in the use of DOACs, from 2.24% (95% CI 2.19-2.29) to 12.5% (95% CI 12.3-12.6) [aPR 1.25 (95% CI 1.25-1.26)]. Increases in OAC use were also observed in people with prior gastrointestinal bleed, from 12.9% (95% CI 11.8-13.9) to 17.1% (95% CI 16.2-17.9) [aPR 1.05 (95% CI 1.03-1.06)]. The use of OACs increased over the study period for people living with dementia from 9.93% to 12.8% [aPR 1.04 (95% CI 1.04-1.05)], and for people without dementia from 15.7% to 21.7% [aPR 1.06 (95% CI 1.06-1.06)].</p><p><strong>Conclusions: </strong>This population-based study showed increasing use of OACs among residents of LTCFs, including in higher-risk comorbidity groups, indicating growing confidence in the use of DOACs in these groups.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70356"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13036282/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147581471","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":"Surveillance of Maternal Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccines in the Vaccine Adverse Event Reporting System-United States, July 1, 2015-September 30, 2023.","authors":"Pedro L Moro, Brittney Romanson, Aynalem Getahun, Penelope Strid, Bicheng Zhang, Paige Marquez, Carol Ennulat, Hannah Brown, Martha Sharkey, Traci Hall, Pavita Jagdeo, Caitlin Stibbe, Jennifer Domville, Jenna Chambless, Gina Woody, Brooke Pate, Sharma Shashi, Rachel Purgatorio, Fatima Sheikh, Katherine Zielke, Erin Stroud","doi":"10.1002/pds.70355","DOIUrl":"10.1002/pds.70355","url":null,"abstract":"<p><strong>Objective: </strong>To assess the safety of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in pregnant women in the United States using data from the Vaccine Adverse Event Reporting System (VAERS).</p><p><strong>Design, setting: </strong>We searched VAERS for reports of Tdap in pregnant women vaccinated during July 2015 through September 2023. We reviewed reports and available medical records for pregnancy and non-pregnancy specific adverse events (AEs) in Tdap recipients. Reporting rates were estimated for reports of preterm birth, hypertensive disorders of pregnancy (HDP), and stillbirths and compared to published background rates for these conditions.</p><p><strong>Results: </strong>VAERS received a total of 654 reports after Tdap vaccine in pregnancy and 137 (20.9%) were serious; no maternal or infant deaths were reported. The most common pregnancy specific conditions reported were preterm birth (45, 6.9%), hypertensive disorders of pregnancy (40, 6.1%), and stillbirth (18, 2.8%). Two reports of verified Guillain-Barré Syndrome (GBS) were reported. The most common non-pregnancy specific conditions reported were pain (120, 18.3%), nausea (93, 14.2%), and fever (87, 13.3%). Reporting rates for preterm birth, HDP, and stillbirths were below background rates for these conditions.</p><p><strong>Conclusion: </strong>Most reports were non-serious and the most common AEs were similar to those observed in pre- and post-licensure studies. No new or unexpected AE was identified.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70355"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147531609","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}

{"title":"Medication, Vaccine, and Folic Acid Use Among Pregnant Women in Belgium: Insights from the BELpREG Cohort.","authors":"Laure Sillis, Sien Lenie, Emily Jacobs, Karel Allegaert, Annick Bogaerts, Maarten De Vos, Titia Hompes, Anne Smits, Kristel Van Calsteren, Jan Y Verbakel, Veerle Foulon, Michael Ceulemans","doi":"10.1002/pds.70369","DOIUrl":"10.1002/pds.70369","url":null,"abstract":"<p><strong>Background: </strong>Safety data for most medications in pregnancy remain limited, yet pharmacological treatment is often necessary. Evidence on real-world medication use in pregnancy including over-the-counter products and folic acid is scarce, especially in Belgium.</p><p><strong>Methods: </strong>We conducted a drug utilization study using self-reported data from BELpREG, a prospective, web-based pregnancy registry established in November 2022. Pregnant individuals aged ≥ 18 years receiving healthcare in Belgium can enrol voluntarily at any stage in pregnancy and complete online questionnaires at enrolment and every four weeks until delivery. All participants with follow-up beyond the first trimester were included, and trimester-specific cohorts were constructed based on completion of questionnaires after each trimester. Data were extracted in July 2025.</p><p><strong>Results: </strong>This study included 2096 participants, of whom 1767 were followed through trimester 2 and 1136 through trimester 3. Median gestational age at enrolment was 16 weeks. Prevalence estimates of medication use were 80.2% in the six months before conception, 85.8% in trimester 1, 92.0% in trimester 2, and 94.9% in trimester 3. The most common classes were analgesics, vaccines, antihistamines, antianemic preparations, and drugs for acid-related disorders. Paracetamol was most frequently used (35.4% in trimester 1), typically short term (median 3 days), followed by doxylamine-pyridoxine (26.7% in trimester 1). Folic acid supplementation was nearly universal, though only 59.9% met national guideline-concordant criteria. Maternal vaccine uptake was substantial but incomplete, with 66.5% receiving pertussis, 43.7% influenza, and 24.4% COVID-19 vaccination. Exposure to potentially inappropriate or teratogenic medications was rare.</p><p><strong>Conclusions: </strong>Medication use during pregnancy in Belgium was nearly universal, with high use of paracetamol and doxylamine-pyridoxine. Folic acid and vaccine uptake were substantial, but often not guideline-concordant.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70369"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147646201","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}

{"title":"A Cross-Sectional Survey of Evidence Needs for Medicinal Products in Europe With a Focus on Real-World Evidence.","authors":"Maria Melinder, Fabian Windfuhr, Tanja Dahlqvist, Carla Torre, Bruno Sepodes, Peter G M Mol, Diogo Almeida, Isabella Ekheden, Nils Feltelius, Kit Roes, Sieta T de Vries, Björn Wettermark","doi":"10.1002/pds.70358","DOIUrl":"10.1002/pds.70358","url":null,"abstract":"<p><strong>Purpose: </strong>To assess views among different stakeholders around evidence needs during assessment of clinical effects across the medicinal product life cycle, with a focus on real-world evidence (RWE) in regulatory and health technology assessor (HTA)/payer decision-making.</p><p><strong>Methods: </strong>A cross-sectional survey was distributed between November 2023-January 2024 to 1210 European regulators, HTAs, payers, and other stakeholders (i.e., industry, academia, healthcare professionals, and patient representatives). The survey included questions on their experience and views on evidence needs, which were analysed descriptively and with non-parametric testing.</p><p><strong>Results: </strong>191 respondents (110 regulators, 24 HTA/payers and 57 others) from 32 European countries completed the survey (response rate: 16%). Most respondents were between 41-60 years and 53% had > 10 years of work experience. Respondents were least confident in assessing evidence based on adjusted indirect comparisons and network meta-analyses. Randomization and clinically relevant endpoints were considered most relevant in studies, while country-specific data and patient preferences were considered least important. Respondents acknowledged that there are uncertainties on the clinical effect of medicinal products in the different stages of the medicinal product life cycle, but the views on the usefulness of RWE to address these uncertainties varied across stakeholder groups and life-cycle stages. RWE was considered most likely to be accepted as supplementary evidence for orphan diseases and when randomized controlled trials (RCTs) are infeasible.</p><p><strong>Conclusion: </strong>Our findings highlight opportunities and challenges in using RWE to reduce uncertainties in decision-making around medicinal products. This may contribute to a dialogue on how and when to augment evidence from RCTs with RWE.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70358"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13049559/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147618911","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":"Pharmacotherapeutic Monitoring and Drug-Related Problems in a Group of Patients From Colombia: Cross-Sectional Study, 2023-2024.","authors":"Luis Fernando Valladales-Restrepo, Ana Camila Delgado-Araujo, María Camila Oyuela-Gutiérrez, John Alexander López-Rincón, Andrés Gaviria-Mendoza, Manuel Enrique Machado-Duque, María Fernanda Hernández-Giraldo, Juan Pablo Albanes-Beltran, Jorge Enrique Machado-Alba","doi":"10.1002/pds.70366","DOIUrl":"10.1002/pds.70366","url":null,"abstract":"<p><strong>Purpose: </strong>A pharmacotherapeutic follow-up service is attended by pharmacists who systematically identify drug-related problems and work to resolve their associated negative outcomes. The aim was to describe the characteristics of a pharmacotherapeutic follow-up service and the factors associated with the presentation of drug-related problems in a group of patients affiliated to the Colombian Health System.</p><p><strong>Methods: </strong>This was a cross-sectional study of patients who attended a DADER method-based pharmacotherapeutic follow-up service. The drug-related problems and their associated negative outcomes as well as the interventions performed on the patients were identified. Descriptive analysis and binary logistic regression were performed considering the presence of drug-related problems as a dependent variable (p < 0.05).</p><p><strong>Results: </strong>A total of 18 563 patients were identified, with an average age of 64.8 ± 14.9 years, and 66.3% were women. The most common chronic diseases were hypertension (54.3%), diabetes mellitus (29.2%), and rheumatoid arthritis (25.9%). The average number of medications/patient was 5.0 ± 4.1. Drug-related problems were documented for 60.8% of the patients (1.6 drug-related problems/patient), mainly due to drug-drug interactions (25.4%). Negative outcomes associated with medication use were observed for 60.0% of the patients (42.0% predominantly related to safety). The most common intervention was patient education (50.9%), and the negative outcomes associated with Medication use were resolved for 31.1% of patients who had two or more consultations. Patients over 65 years of age (OR:1.20; 95% CI:1.06-1.36), those from Bogotá-Cundinamarca (OR:1.62; 95% CI:1.52-1.73), those treated with ≥ 10 drugs (OR:1.21; 95% CI:1.07-1.36) and those treated with anticoagulants (OR:1.91; 95% CI:1.70-2.14) were more likely to experience drug-related problems.</p><p><strong>Conclusions: </strong>Drug-related problems were frequently identified, with drug-drug interactions being the most prevalent problem. Drug-related problems were associated with increased age, an increased number of prescribed medications and the use of anticoagulants. Safety-related negative outcomes associated with medication use were common, education was the predominant intervention, and one-third of the negative outcomes associated with medication use were resolved.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70366"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147628294","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}

{"title":"Immunocompromised Status Definition in Observational Studies Using Electronic Health Records: A Scoping Review and a Proposal for a Phenotype Identification Algorithm.","authors":"Judit Riera-Arnau, Nicoletta Luxi, Fabio Riefolo, Martín Solorzano, Irene Pazos, Elena Ballarín, Lise Skovgaard Svingel, Lorenzo Chiusaroli, Elisa Martín-Merino, Elisa Barbieri, María Lopez-Lasanta, Sima Mohammadi, Denis Rotta, Alexandra Pacurariu, Catherine Cohet, Miriam Sturkenboom, Carlos E Durán","doi":"10.1002/pds.70362","DOIUrl":"10.1002/pds.70362","url":null,"abstract":"<p><p>Immunocompromised individuals experience an impaired immune function due to conditions that might be either congenital or acquired over the course of their lives. Epidemiological studies often rely on clinical definitions which, in some cases, benefit from being translated into machine-readable algorithms for application to electronic health records (EHRs) databases. The transient nature of certain immunocompromised states and the variability of phenotypes, definitions, coding practices, and data availability entangle this operation. To address these challenges, we conducted a scoping review of existing immunocompromised status definitions in MEDLINE, focusing on epidemiologic and pharmacoepidemiologic studies involving immunocompromised populations. Data extraction was guided by clinical experts, categorizing conditions and medications into seven categories: genetic/hereditary conditions, infectious diseases, malignancies and chemotherapy, organ and stem-cell transplantations, severe systemic conditions, immunosuppressive drugs, and autoimmune conditions associated with immunosuppressant use. Out of 137 citations, 56 studies were included. Most of the studies focused on a particular disease or therapeutic area. Frequently cited diagnoses included HIV/AIDS (17.9%) and organ transplantation (14.2%). Methotrexate, corticosteroids, TNF-alpha inhibitors, and calcineurin inhibitors were the most common drugs used to define immunocompromised status. Building on this review and expert opinion, we developed a phenotype algorithm that combines diagnostic, therapeutic, and procedural data in a modular way to identify immunocompromised populations in EHR data sources. The proposed phenotype algorithm can be applied across diverse data sources, settings and research questions. Future research should test its applicability across heterogeneous EHR data sources.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70362"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13031886/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147531598","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":"Curriculum in Pharmacoepidemiology Training Programs: A Cross-Sectional Study to Assess Educational Needs and Alignment With Core Competencies.","authors":"Amie Goodin, Deborah Layton, Ryan Chung, Vicki Osborne, Chioma Ejekam, Xiaojuan Li, Xuerong Wen, Kristian B Filion, Luciane Cruz Lopes, Daniela C Moga","doi":"10.1002/pds.70351","DOIUrl":"10.1002/pds.70351","url":null,"abstract":"<p><strong>Purpose: </strong>Pharmacoepidemiology is a key discipline for evidence-based decision-making, yet its educational programs have not been systematically assessed for alignment with international core competencies. Our objectives were to evaluate curricula alignment of pharmacoepidemiology training programs with ISPE-recommended core competency themes and identify key curriculum content development areas.</p><p><strong>Methods: </strong>The ISPE Core Competencies Workgroup and ISPE leadership developed a curriculum and needs assessment survey, incorporating feedback from global members. The survey was electronically distributed to leaders of pharmacoepidemiology training programs (e.g., department chairs and program directors) using the ISPE contact database, followed by snowball sampling to enhance representation. Institutional respondent characteristics were categorized by sector and geographic region. Competency mapping identified the most and least represented competency categories within curricula. Needs assessment responses were reported as proportions, and free-text responses were thematically analyzed, allowing for multiple themes per response.</p><p><strong>Results: </strong>Sixty-four institutions participated (73.4% academic programs, 18.8% industry/consulting, and 7.8% government/regulatory). Representation by global region was: 35.9% Europe, 29.7% North America, 23.4% Latin America, 7.8% Asia, 1.6% Africa, and 1.6% Gulf Region. Respondents prioritized developing standards in pharmacoepidemiology training curriculum in two areas-45.5% \"Epidemiology\" and 36.4% \"Statistics, Analysis, and Data Science\"-with few endorsements of other areas. The most represented competencies covered in curricula were \"Statistics\" (100%, 45/45) and \"Study Design\" (100%, 43/43). The least represented were \"Advanced Modeling\" (54%, 25/46) and \"Professional Practice\" (66%, 31/47). Key needs in pharmacoepidemiology curriculum centered around four themes: 33.3% (8/24) \"Methods (generally)\", 33.3% (8/24) \"Analytical Skills,\" 16.7% (4/24) \"Communication (writing, teaching),\" and 25.0% \"(6/24) Other (applications, new therapies).\" Content type that would best support curriculum development, as ranked by 42 respondents, was: \"Learning objectives with pre-packaged activities\" 45.2% (19/42), \"Recorded webinars/lectures\" 28.6% (12/42), \"Example syllabi\" 21.4% (9/42), and \"Reading lists\" 4.8% (2/42).</p><p><strong>Conclusions: </strong>This global assessment highlights critical gaps in pharmacoepidemiology training, particularly in advanced analytical methods and professional practice. ISPE has a unique opportunity to address these gaps by developing targeted educational activities and resources that enhance methodological rigor and practical skills.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70351"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13021568/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147521666","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 COVID-19 Disease Severity in Real-World Data: Implications for Medical Product Effectiveness Studies.","authors":"Mayura U Shinde, Katherine Shapiro, Laura Hou, Kevin Coughlin, Aaron M Madow, Fatma M Shebl, Patricia Bright, Gaia Pocobelli, James D Ralston, Vina F Graham, Margaret B Nolan, Ingrid A Binswanger, Natasha Pratt, Wei Hua, Noelle M Cocoros, Silvia Perez-Vilar","doi":"10.1002/pds.70363","DOIUrl":"https://doi.org/10.1002/pds.70363","url":null,"abstract":"<p><strong>Purpose: </strong>The U.S. Food and Drug Administration (FDA) defined disease severity criteria to assist clinical development of medical products for management of COVID-19. These definitions were translated to code-based algorithms for use in real-world data. We validated the algorithms' performance in ambulatory settings at three regional integrated healthcare delivery systems contributing data to FDA's Sentinel System.</p><p><strong>Methods: </strong>We identified cohorts of individuals ≥ 18 years that met the algorithms' criteria for mild, moderate, and severe COVID-19 at incident COVID-19 diagnosis or positive SARS-CoV-2 test, and separately, at incident COVID-19 treatment, from January 2022 through April 2023. We validated the algorithms via chart review of a random sample to calculate positive predictive values (PPVs) and 95% CIs.</p><p><strong>Results: </strong>The algorithms identified 33 071 patients at COVID-19 diagnosis or positive test; 26 985 mild (49 chart reviewed), 5180 moderate (55 reviewed), and 906 severe (56 reviewed). A total of 4512 patients were identified at COVID-19 treatment; 3474 mild (56 reviewed), 848 moderate (60 reviewed), and 190 severe (46 reviewed). The PPVs (1) at COVID-19 diagnosis or positive test were: mild 57% (95% CI: 43%-71%), moderate 58% (95% CI: 45%-71%), and severe 54% (95% CI: 41%-67%), and (2) at COVID-19 treatment: mild 57% (95% CI: 44%-70%), moderate 70% (95% CI: 58%-82%) and severe 72% (95% CI: 59%-85%).</p><p><strong>Conclusion: </strong>The algorithms had low-to-moderate performance in classifying COVID-19 severity in ambulatory settings, depending on assessment at diagnosis or treatment. Researchers should consider the performance of the algorithm when using real-world data to assess COVID-19 severity.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70363"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147691499","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}

{"title":"The Military Health System Data Repository: Leveraging Closed, Familial-Linked Electronic Health Record Data for a Large Generalizable US Population.","authors":"W Grant Day, Matthew W Reynolds, Luke Pittman, Jess Edison, Rachel Robbins, Glen Cook, Rich Zanetti, James A Cox, Karen Zeman, Christin DeStefano, Toni Rush, Wendy Funk, Veronika Pav, Wesley Campbell","doi":"10.1002/pds.70338","DOIUrl":"10.1002/pds.70338","url":null,"abstract":"<p><strong>Background: </strong>The Military Health System (MHS) Data Repository (MDR) is a large, longitudinal real-world data platform that has been used extensively in research, yet its overall structure, strengths, and limitations have not been comprehensively described for investigators outside the Department of Defense (DoD).</p><p><strong>Aims: </strong>To characterize the MDR as a fit-for-purpose real-world data source and evaluate its utility for retrospective and prospective clinical, epidemiologic, and regulatory-grade research.</p><p><strong>Materials and methods: </strong>We performed a descriptive review of the MHS clinical ecosystem and MDR architecture, including direct care and purchased care data streams, enrollment files, structured and unstructured electronic health record content, referral data, pharmacy capture, familial linkage, and integration with DoD registries and biospecimen repositories. We also assessed population characteristics, longitudinality, and key strengths and limitations relevant to research use.</p><p><strong>Results: </strong>The MDR captures data on more than 9.5 million beneficiaries and includes decades of longitudinal information from military treatment facilities and TRICARE-financed civilian care. The repository contains comprehensive claims, enrollment, pharmacy, laboratory, radiology, clinical note, and referral data, with strong mother-child and family linkage. Its integration with resources such as the Department of Defense Serum Repository enables biomarker and pre-diagnosis studies at scale. The population is broadly generalizable to the US population across age and sex, while offering unusual advantages in pregnancy, pediatric, oncology, pharmacoepidemiology, and biosurveillance research.</p><p><strong>Discussion: </strong>Key strengths include closed-system capture, long follow-up, exceptional pharmacy data, regulatory traceability, and linkage to registries and biospecimens. Limitations include incomplete visibility into some non-TRICARE-funded care and reduced clinical granularity for privately delivered care.</p><p><strong>Conclusion: </strong>The MDR is a uniquely powerful and collaborative real-world data platform for high-impact military and civilian health research.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 4","pages":"e70338"},"PeriodicalIF":2.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147481229","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}