{"entity": "journal", "iuid": "807bcf15e8fa40d18b0f88c5b1bc7918", "timestamp": "2026-09-23T21:55:00.034Z", "links": {"self": {"href": "https://publications-affiliated.scilifelab.se/journal/Pharmacoepidemiol%20Drug%20Saf.json"}, "display": {"href": "https://publications-affiliated.scilifelab.se/journal/Pharmacoepidemiol%20Drug%20Saf"}}, "title": "Pharmacoepidemiol Drug Saf", "issn": "1099-1557", "issn-l": null, "publications_count": 7, "publications": [{"entity": "publication", "iuid": "bba7632240c546a7a007346eb6498360", "links": {"self": {"href": "https://publications-affiliated.scilifelab.se/publication/bba7632240c546a7a007346eb6498360.json"}, "display": {"href": "https://publications-affiliated.scilifelab.se/publication/bba7632240c546a7a007346eb6498360"}}, "title": "Medications Used Among Nonhospitalized Pregnant Women With COVID-19: A Prospective Individual Patient Data Meta-Analysis in Europe and North America.", "authors": [{"family": "de Bruin", "given": "Odette", "initials": "O", "orcid": "0000-0001-6295-3411", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/911b45cf22ce454cbd479115c0e9a977.json"}}, {"family": "Maisonneuve", "given": "Emeline", "initials": "E", "orcid": "0000-0001-5765-4468", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/5bc34a21a3ac4d2697742e3e797f2c8c.json"}}, {"family": "Hurley", "given": "Eimir", "initials": "E", "orcid": "0000-0001-6776-1224", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/63d83f6bbc844b73ac52cf4a188a1b77.json"}}, {"family": "Nordeng", "given": "Hedvig M E", "initials": "HME", "orcid": "0000-0001-6361-2918", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/e149ec4deccc4c02a3d77948d4a3355d.json"}}, {"family": "B\u00e9rard", "given": "Anick", "initials": "A", "orcid": "0000-0001-7535-5517", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/945643632770419fb139cd993c07305d.json"}}, {"family": "Sheehy", "given": "Odile", "initials": "O", "orcid": "0000-0002-6784-2080", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/7dcc3a2109bd4d0fb3773ca84bb17eb2.json"}}, {"family": "Kaul", "given": "Padma", "initials": "P", "orcid": "0000-0003-2239-3944", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/0042e499f7b24cb794e2d7ee22286eab.json"}}, {"family": "Shinde", "given": "Mayura U", "initials": "MU"}, {"family": "Cosgrove", "given": "Austin", "initials": "A"}, {"family": "Lyons", "given": "Jennifer G", "initials": "JG"}, {"family": "Messenger-Jones", "given": "Elizabeth", "initials": "E"}, {"family": "Kempner", "given": "Maria E", "initials": "ME"}, {"family": "Toh", "given": "Sengwee", "initials": "S"}, {"family": "Hua", "given": "Wei", "initials": "W"}, {"family": "Hern\u00e1ndez-Mu\u00f1oz", "given": "Jos\u00e9 J", "initials": "JJ", "orcid": "0000-0002-2553-3159", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/617e214e65ab41b18b8b27c0e7ad2b2d.json"}}, {"family": "Sahin", "given": "Leyla", "initials": "L", "orcid": "0000-0002-7685-7524", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/b2ce6da32e354740a5a2ee9f9848195c.json"}}, {"family": "Cesta", "given": "Carolyn E", "initials": "CE", "orcid": "0000-0001-5759-9366", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/35e1b896082549c2b69ead371bf4e3a8.json"}}, {"family": "H\u00e4gg", "given": "David", "initials": "D", "orcid": "0000-0002-2610-5033", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/cc4f13f046ee49f39b92677eaaa41e79.json"}}, {"family": "Gini", "given": "Rosa", "initials": "R", "orcid": "0000-0002-6250-877X", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/10b66693cdc04e80ac5450f2e63a6d92.json"}}, {"family": "Paoletti", "given": "Olga", "initials": "O"}, {"family": "Poblador-Plou", "given": "Beatriz", "initials": "B"}, {"family": "Jordan", "given": "Sue", "initials": "S"}, {"family": "Thayer", "given": "Daniel", "initials": "D"}, {"family": "Rodr\u00edguez-Bernal", "given": "Clara L", "initials": "CL", "orcid": "0000-0003-2617-8635", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/812191eadd56405789ddb971577c4d6e.json"}}, {"family": "S\u00e1nchez-S\u00e1ez", "given": "Francisco", "initials": "F"}, {"family": "Lassalle", "given": "R\u00e9gis", "initials": "R"}, {"family": "Bernard", "given": "Marie-Agn\u00e8s", "initials": "MA"}, {"family": "Alsina", "given": "Ema", "initials": "E"}, {"family": "Ahmadizar", "given": "Fariba", "initials": "F"}, {"family": "Favre", "given": "Guillaume", "initials": "G", "orcid": "0000-0001-6181-3126", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/43764a2eb9544b559c88b0ab425bb9ad.json"}}, {"family": "Panchaud", "given": "Alice", "initials": "A", "orcid": "0000-0001-6086-2401", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/abd99a5f06aa401a86e0c14de367c914.json"}}, {"family": "Bloemenkamp", "given": "Kitty W M", "initials": "KWM", "orcid": "0000-0002-1377-4625", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/9d38c9f319f442be810979223a78883c.json"}}, {"family": "Plueschke", "given": "Kelly", "initials": "K"}, {"family": "de Vries", "given": "Corinne", "initials": "C"}, {"family": "Siiskonen", "given": "Satu J", "initials": "SJ", "orcid": "0000-0003-3095-9530", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/effb583f45be406190adc4db3d0ee036.json"}}, {"family": "Sturkenboom", "given": "Miriam C J M", "initials": "MCJM", "orcid": "0000-0003-1360-2388", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/4ac7233f5331454b9215810cbc940939.json"}}, {"family": "CONSIGN Collaboration Group", "given": "", "initials": ""}], "type": "journal article", "published": "2026-01-00", "journal": {"title": "Pharmacoepidemiol Drug Saf", "issn": "1099-1557", "volume": "35", "issue": "1", "pages": "e70303", "issn-l": null}, "abstract": "To estimate the prevalence of medication use in nonhospitalized pregnant women with COVID-19.\n\nA prospective two-stage individual patient meta-analysis across 10 data sources in Europe and North America studied medication use among nonhospitalized pregnant women with COVID-19 between January 2020 and December 2022. Comparisons were made between medication use within 30 days pre- and post-COVID-19 diagnosis in this cohort and two comparator groups: pregnant women without COVID-19 and nonpregnant women with COVID-19. Prevalence estimates were pooled using a random-effects model stratified by trimester.\n\n50 335 nonhospitalized pregnant women with COVID-19 were identified. The pooled prevalence of antibacterial use in the third trimester was higher post-COVID-19 diagnosis (6.8%, 95% confidence interval [CI] = 5.5-8.4, I2 = 94%) compared with the same women pre-COVID-19 (3.9%, 95% CI = 3.1-4.9, I2 = 89%). Overall, pregnant women with COVID-19 had higher medication use compared to pregnant women without COVID-19, although the CIs of the prevalence overlapped. Post-COVID-19, antithrombotic prevalence was 4.5% (95% CI = 1.1-16.5, I2 = 100%) among pregnant women with COVID-19 in the third trimester, compared to 2.1% (95% CI = 1.2-3.6, I2 = 99%) among those without COVID-19 in the third trimester. Compared to nonpregnant women with COVID-19, pregnant women with COVID-19 were less likely to be prescribed analgesics, antiprotozoals, corticosteroids, psychoanaleptics and psycholeptics, and more likely to be prescribed antithrombotics, cough and cold and nasal preparations, and drugs used in diabetes across all trimesters. High heterogeneity existed in nearly all analyses.\n\nThis international meta-analysis reveals low medication use and country-specific variations, enhancing insight into the management of COVID-19 in nonhospitalized pregnant women. Higher antithrombotic use post-COVID-19 suggests prophylactic treatment in this population, but variation between countries emphasizes the challenges of combining multinational data.", "doi": "10.1002/pds.70303", "pmid": "41449787", "labels": [], "xrefs": [{"db": "pmc", "key": "PMC12741507"}], "notes": [], "created": "2026-09-23T15:58:48.095Z", "modified": "2026-09-23T15:58:48.684Z"}, {"entity": "publication", "iuid": "491a452b3b0646278c44c993d28d3c25", "links": {"self": {"href": "https://publications-affiliated.scilifelab.se/publication/491a452b3b0646278c44c993d28d3c25.json"}, "display": {"href": "https://publications-affiliated.scilifelab.se/publication/491a452b3b0646278c44c993d28d3c25"}}, "title": "EpiCore-A Common Data Model for Pharmacoepidemiological Studies in Denmark, Norway, and Sweden.", "authors": [{"family": "Jensen", "given": "Peter Bj\u00f8dstrup", "initials": "PB", "orcid": "0000-0001-5435-9092", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/49e53e58a93c4cb49b089964ab105bd9.json"}}, {"family": "Andersen", "given": "Jacob H", "initials": "JH"}, {"family": "Ernst", "given": "Martin Thomsen", "initials": "MT"}, {"family": "Olesen", "given": "Morten", "initials": "M"}, {"family": "Karlstad", "given": "\u00d8ystein", "initials": "\u00d8", "orcid": "0000-0003-1204-787X", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/444d55a5814c4342a44da5f6488b6e23.json"}}, {"family": "Furu", "given": "Kari", "initials": "K", "orcid": "0000-0003-2245-0179", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/f00c9192b2a642869c13e93ca5526147.json"}}, {"family": "Eriksson", "given": "Julia", "initials": "J"}, {"family": "Gembert", "given": "Karin", "initials": "K"}, {"family": "Potteg\u00e5rd", "given": "Anton", "initials": "A", "orcid": "0000-0001-9314-5679", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/1daf4d9300f94bf6916f968437b52a80.json"}}], "type": "journal article", "published": "2025-11-00", "journal": {"title": "Pharmacoepidemiol Drug Saf", "issn": "1099-1557", "volume": "34", "issue": "11", "pages": "e70241", "issn-l": null}, "abstract": "The use of common data models (CDMs) is increasing; however, the complexity of many CDM frameworks constitutes a barrier for their use. For many local and collaborative use cases, simpler CDMs can suffice. Here, we propose the EpiCore CDM, a simple CDM framework for use in Scandinavian pharmacoepidemiological studies.\n\nThe EpiCore CDM was developed based on a set of guiding principles. It should (i) accommodate the most common elements of typical data sources in the field and region, (ii) be accessible to users without needing advanced technical expertise or database infrastructure, (iii) prioritize structural and syntactic harmonization of data and defer clinical concept mapping to the analytical phase, (iv) be usable in both collaborative and single site settings, and (v) include support for quality control procedures.\n\nThe EpiCore CDM comprises two mandatory administrative tables (person and observation), six optional event tables (diagnosis, procedure, encounter, drug, primcare, and cancer) and three optional lookup tables (drug_info, organisation_info, and prescriber_info). Each table, along with its columns and constraints is specified according to an EpiCore CDM specification template. This provides easy documentation and integrates with an R-package called EpiCoreAssistant, which provides quality control tools for testing the compliance of a CDM instance with the EpiCore specification. In the event that a project requires customization of the CDM, this is easily implemented in the template and testing. A step-by-step description is presented, demonstrating the steps involved in a typical CDM-based collaborative pharmacoepidemiological study using the EpiCore CDM.\n\nWe present the EpiCore CDM, a specification template and an R package that offers a simple framework for improved workflows, standardizations and collaboration, focused on Scandinavian pharmacoepidemiological studies and with relevance for a broad palette of register-based health care researchers.", "doi": "10.1002/pds.70241", "pmid": "41185087", "labels": [], "xrefs": [], "notes": [], "created": "2026-09-23T15:52:48.517Z", "modified": "2026-09-23T15:52:48.619Z"}, {"entity": "publication", "iuid": "c538a4e6d8f74c90adc85954ac81c754", "links": {"self": {"href": "https://publications-affiliated.scilifelab.se/publication/c538a4e6d8f74c90adc85954ac81c754.json"}, "display": {"href": "https://publications-affiliated.scilifelab.se/publication/c538a4e6d8f74c90adc85954ac81c754"}}, "title": "Lessons learned from a multi-data source research collaboration: The mirabegron post-authorization safety study program.", "authors": [{"family": "de Vogel", "given": "Stefan", "initials": "S", "orcid": "0000-0001-7318-2288", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/06a152302eaa49cea165e5d8d20c3f24.json"}}, {"family": "Seeger", "given": "John D", "initials": "JD", "orcid": "0000-0002-8020-3144", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/cf86384d5bfe47608aece36a99db17b4.json"}}, {"family": "Arana", "given": "Alejandro", "initials": "A", "orcid": "0000-0002-1593-3124", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/b47c73f9a3da40d2be3907923b50ee3a.json"}}, {"family": "Margulis", "given": "Andrea V", "initials": "AV", "orcid": "0000-0001-7388-6082", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/8927cb91ce964cc689eecc6239f3a3b9.json"}}, {"family": "McQuay", "given": "Lisa J", "initials": "LJ"}, {"family": "Perez-Gutthann", "given": "Susana", "initials": "S", "orcid": "0000-0001-5798-3691", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/a408fe1648804a229cda029254e232b7.json"}}, {"family": "Hallas", "given": "Jesper", "initials": "J", "orcid": "0000-0002-8097-8708", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/f8ecbf91c269413790b1c4116e997baf.json"}}, {"family": "Kristiansen", "given": "Nina Sahlertz", "initials": "NS"}, {"family": "Linder", "given": "Marie", "initials": "M", "orcid": "0000-0003-2619-2189", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/2caaaaa0836e48948cc20734a68c4e22.json"}}, {"family": "Odsbu", "given": "Ingvild", "initials": "I"}, {"family": "Suehs", "given": "Brandon", "initials": "B"}, {"family": "Xu", "given": "Yihua", "initials": "Y"}, {"family": "Uribe", "given": "Claudia", "initials": "C"}, {"family": "Appenteng", "given": "Kwame", "initials": "K"}, {"family": "Robinson", "given": "Noah Jamie", "initials": "NJ"}], "type": "journal article", "published": "2024-05-00", "journal": {"title": "Pharmacoepidemiol Drug Saf", "issn": "1099-1557", "volume": "33", "issue": "5", "pages": "e5799", "issn-l": null}, "abstract": "Many factors contribute to developing and conducting a successful multi-data source, non-interventional, post-authorization safety study (NI-PASS) for submission to multiple health authorities. Such studies are often large undertakings; evaluating and sharing lessons learned can provide useful insights to others considering similar studies.\n\nWe discuss challenges and key methodological and organizational factors that led to the delivery of a successful post-marketing requirement (PMR)/PASS program investigating the risk of cardiovascular and cancer events among users of mirabegron, an oral medication for the treatment of overactive bladder.\n\nWe provide context and share learnings, including sections on research program collaboration, scientific transparency, organizational approach, mitigation of uncertainty around potential delays, validity of study outcomes, selection of data sources and optimizing patient numbers, choice of comparator groups and enhancing precision of estimates of associations, potential confounding and generalizability of study findings, and interpretation of results.\n\nThis large PMR/PASS program was a long-term commitment from all parties and benefited from an effective coordinating center and extensive scientific interactions across research partners, scientific advisory board, study sponsor, and health authorities, and delivered useful learnings related to the design and organization of multi-data source NI-PASS.", "doi": "10.1002/pds.5799", "pmid": "38680102", "labels": [], "xrefs": [], "notes": [], "created": "2026-09-23T15:38:17.388Z", "modified": "2026-09-23T15:38:17.627Z"}, {"entity": "publication", "iuid": "f24fdfb1c5874337ad8bac7491b2173f", "links": {"self": {"href": "https://publications-affiliated.scilifelab.se/publication/f24fdfb1c5874337ad8bac7491b2173f.json"}, "display": {"href": "https://publications-affiliated.scilifelab.se/publication/f24fdfb1c5874337ad8bac7491b2173f"}}, "title": "Consistency between the National Patient Register and the Swedish Cancer Register.", "authors": [{"family": "Sakakibara", "given": "Sakura", "initials": "S", "orcid": "0009-0009-1695-6879", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/a49fc0aec3d2462a922ea52c8a0ca888.json"}}, {"family": "Pazzagli", "given": "Laura", "initials": "L", "orcid": "0000-0002-1908-6073", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/a1238a7c151343afb5daf301a63b63c2.json"}}, {"family": "Linder", "given": "Marie", "initials": "M", "orcid": "0000-0003-2619-2189", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/2caaaaa0836e48948cc20734a68c4e22.json"}}], "type": "journal article", "published": "2024-04-00", "journal": {"title": "Pharmacoepidemiol Drug Saf", "issn": "1099-1557", "volume": "33", "issue": "4", "pages": "e5780", "issn-l": null}, "abstract": "The Swedish National Patient Register (NPR) is widely used as a data source in epidemiological studies, but the consistency of all cancer diagnoses compared to the Swedish Cancer Register (SCR) remains unclear. Using NPR supplementary for detecting safety signals is beneficial due to shorter data extraction delays compared to using SCR alone. This study aims to evaluate the consistency of NPR for cancer diagnoses compared to SCR and its potential use in pharmacoepidemiology.\n\nPatients with a cancer diagnosis recorded in SCR during 2018-2020 were included. To measure the consistency of NPR diagnoses with SCR as the gold standard, positive predictive value (PPV), and sensitivity were calculated. As an empirical example showing differences in identification of cancer diagnoses in NPR and SCR, two nested case-control studies for the association between antidiabetic medications and pancreatic cancer were repeated using the two registers. Conditional logistic regression was performed and the 95% confidence intervals (CIs) for the odds ratios (ORs) were checked for overlaps.\n\nFor breast, male genital organs, and oral cancers consistency was high (PPV: 87.5%-97.4%, sensitivity: 82.2%-91.0%), while for female genital organs, thyroid, and ill-defined, secondary, and unspecified sites cancers it was low (PPV: 8.8%-90.0%, sensitivity: 19.9%-32.3%). All the CIs for the ORs from the nested case-control studies overlapped when pancreatic cancer was identified in NPR or SCR.\n\nConsistency of cancer diagnoses in NPR when compared to SCR depends on cancer type with higher consistency for some cancers and lower for others. Differences in diagnostic processes for different cancer types and coding of cancer in the two registers may explain part of the inconsistent results.", "doi": "10.1002/pds.5780", "pmid": "38511251", "labels": [], "xrefs": [], "notes": [], "created": "2026-09-23T13:00:49.051Z", "modified": "2026-09-23T13:00:49.191Z"}, {"entity": "publication", "iuid": "84132b483bd742ef925ba567ab364bc6", "links": {"self": {"href": "https://publications-affiliated.scilifelab.se/publication/84132b483bd742ef925ba567ab364bc6.json"}, "display": {"href": "https://publications-affiliated.scilifelab.se/publication/84132b483bd742ef925ba567ab364bc6"}}, "title": "The use of uncertain exposure-A method to define switching and add-on in pharmacoepidemiology.", "authors": [{"family": "Pazzagli", "given": "Laura", "initials": "L", "orcid": "0000-0002-1908-6073", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/a1238a7c151343afb5daf301a63b63c2.json"}}, {"family": "Linder", "given": "Marie", "initials": "M", "orcid": "0000-0003-2619-2189", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/2caaaaa0836e48948cc20734a68c4e22.json"}}, {"family": "Reutfors", "given": "Johan", "initials": "J", "orcid": "0000-0003-1372-4262", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/dbc162955acf4b2ba0b4dade363d4592.json"}}, {"family": "Brandt", "given": "Lena", "initials": "L"}], "type": "journal article", "published": "2022-01-00", "journal": {"title": "Pharmacoepidemiol Drug Saf", "issn": "1099-1557", "volume": "31", "issue": "1", "pages": "28-36", "issn-l": null}, "abstract": "When defining exposure to pharmacological treatments in pharmacoepidemiology, register data often do not provide information regarding if a pharmacological treatment is a switch or an add-on. This study aims to compare two methods defining switching and add-on therapies and their impact on exposure-outcome associations. Additionally, to guide bias reduction, it aims to describe how the methods relate to immortal time bias and selection bias.\n\nCohort study using Swedish population-based health registers to identify antidepressant (AD) prescriptions as exposures while hospitalizations for psychiatric reasons were used as an empirical outcome example. The first method for exposure definition used conditioning on future exposure (FE), the second used the concept of uncertain exposure (UE). To estimate associations between outcome and exposure categories \"Use of one AD,\" \"Use of two or more ADs\", and \"UE\" compared to \"Unexposed,\" hazard ratios (HRs) and 95% confidence intervals were estimated using Cox regression adjusted for age and sex.\n\nUsing the UE method, 7.2% of time periods were classified as \"UE\" with a notable proportion of psychiatric hospitalizations (7.7%) occurring during this time, while when using the FE method these hospitalizations were distributed over unexposed time and AD use time. The FE method resulted in slightly higher associations than the UE method. The highest HR was found during \"UE\": HR (95% CI) 5.54 (5.06-6.07).\n\nThis study suggests that to reduce the potential immortal time bias, selection bias, and exposure misclassification inherent to the FE method, the UE method could be used for identifying switching and add-on therapies. If not used as a main exposure definition, the UE method may be used to investigate the impact of UE time in a sensitivity analysis.", "doi": "10.1002/pds.5363", "pmid": "34558772", "labels": [], "xrefs": [], "notes": [], "created": "2026-09-23T13:32:42.604Z", "modified": "2026-09-23T13:32:42.634Z"}, {"entity": "publication", "iuid": "c5e3cb097b344cf083d320e7c629269f", "links": {"self": {"href": "https://publications-affiliated.scilifelab.se/publication/c5e3cb097b344cf083d320e7c629269f.json"}, "display": {"href": "https://publications-affiliated.scilifelab.se/publication/c5e3cb097b344cf083d320e7c629269f"}}, "title": "In utero opioid exposure and risk of infections in childhood: A multinational Nordic cohort study.", "authors": [{"family": "Mahic", "given": "Milada", "initials": "M", "orcid": "0000-0002-0203-9924", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/ed9a7d573adf449fac25f50576d002f4.json"}}, {"family": "Hernandez-Diaz", "given": "Sonia", "initials": "S", "orcid": "0000-0003-1458-7642", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/e25f86621d6d4f15b3ae5f4af596de6d.json"}}, {"family": "Wood", "given": "Mollie", "initials": "M"}, {"family": "Kieler", "given": "Helle", "initials": "H"}, {"family": "Odsbu", "given": "Ingvild", "initials": "I"}, {"family": "N\u00f8rgaard", "given": "Mette", "initials": "M"}, {"family": "\u00d6zt\u00fcrk", "given": "Buket", "initials": "B"}, {"family": "Bateman", "given": "Brian T", "initials": "BT"}, {"family": "Hjellvik", "given": "Vidar", "initials": "V"}, {"family": "Skurtveit", "given": "Svetlana", "initials": "S"}, {"family": "Handal", "given": "Marte", "initials": "M"}], "type": "journal article", "published": "2020-12-00", "journal": {"title": "Pharmacoepidemiol Drug Saf", "issn": "1099-1557", "volume": "29", "issue": "12", "pages": "1596-1604", "issn-l": null}, "abstract": "There is an increasing number of children with in utero exposure to opioids. Knowledge about opioid safety in pregnancy, particularly for outcomes later in childhood is scarce. It has been suggested that opioids can modulate immune system and increase the risk of infections. Our goal was to study the impact of in utero opioid exposure on the immune system and the risk of infections in childhood.\n\nThis population-based cohort study used nationwide registers from Denmark, Norway, and Sweden. Among pregnant women we identified users of opioids for two different indications, opioids used in opioid maintenance therapy (OMT) and opioids used for treatment of pain. We followed the exposed children and studied susceptibility for infections measured as number of antibiotic prescriptions expressed as Incidence rate ratios (IRRs) and diagnoses in specialist health care expressed as hazard ratios (HRs).\n\nAfter adjustment we did not observe increased risk for filling antibiotic prescriptions in children exposed to OMT opioids compared with OMT discontinuers (IRR, 1.08; 95% CI 0.81-1.44 in Norway and Sweden, and IRR, 0.74; 95% CI 0.63-0.88 in Denmark), or for diagnosis of infection in specialist health care (HR 0.83; 95% CI 0.55-1.26 in Norway and Sweden, and 0.82; 95% CI 0.62-1.10 in Denmark).\n\nIn this population-based cohort study, we did not observe increased risk of infections among children prenatally exposed to OMT opioids when compared to OMT discontinuers, nor long-term analgesic opioids exposed when compared to short-term analgesic opioids exposed.", "doi": "10.1002/pds.5088", "pmid": "32767610", "labels": [], "xrefs": [], "notes": [], "created": "2026-09-23T13:07:18.139Z", "modified": "2026-09-23T13:07:18.268Z"}, {"entity": "publication", "iuid": "eb86ffc075d6438fad7c08928e821b3a", "links": {"self": {"href": "https://publications-affiliated.scilifelab.se/publication/eb86ffc075d6438fad7c08928e821b3a.json"}, "display": {"href": "https://publications-affiliated.scilifelab.se/publication/eb86ffc075d6438fad7c08928e821b3a"}}, "title": "Anti-TNF treatment during pregnancy and birth outcomes: A population-based study from Denmark, Finland, and Sweden.", "authors": [{"family": "Br\u00f6ms", "given": "Gabriella", "initials": "G", "orcid": "0000-0002-2423-1968", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/ba30331e2aad4a8b8d7ba6a0578193b7.json"}}, {"family": "Kieler", "given": "Helle", "initials": "H", "orcid": "0000-0001-9338-7133", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/831da95a6b2f4a9b9e29aed574219101.json"}}, {"family": "Ekbom", "given": "Anders", "initials": "A", "orcid": "0000-0001-6674-5003", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/3e61ab107fe347aebb2c7bb29e3fb795.json"}}, {"family": "Gissler", "given": "Mika", "initials": "M", "orcid": "0000-0001-8254-7525", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/8d4fbc591a0547beaaf224856e96949f.json"}}, {"family": "Hellgren", "given": "Karin", "initials": "K", "orcid": "0000-0001-7149-0973", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/d7f3861a3f14424785315e5d4d3e330e.json"}}, {"family": "Lahesmaa-Korpinen", "given": "Anna-Maria", "initials": "AM", "orcid": "0000-0003-1062-2893", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/6530a707032341d09ae43c794c54e84a.json"}}, {"family": "Pedersen", "given": "Lars", "initials": "L", "orcid": "0000-0002-9341-3888", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/fa1b528444da46a89a923e3e3eb87280.json"}}, {"family": "Schmitt-Egenolf", "given": "Marcus", "initials": "M", "orcid": "0000-0002-3858-8474", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/8656f121cd504cddaf2cd658fbeed9d8.json"}}, {"family": "S\u00f8rensen", "given": "Henrik T", "initials": "HT", "orcid": "0000-0003-4299-7040", "researcher": {"href": "https://publications-affiliated.scilifelab.se/researcher/66671606c59445cb967124edb7827eda.json"}}, {"family": "Granath", "given": "Fredrik", "initials": "F"}], "type": "journal article", "published": "2020-03-00", "journal": {"title": "Pharmacoepidemiol Drug Saf", "issn": "1099-1557", "volume": "29", "issue": "3", "pages": "316-327", "issn-l": null}, "abstract": "To study the risk of preterm birth, caesarean section, and small for gestational age after anti-tumor necrosis factor agent treatment (anti-TNF) in pregnancy.\n\nPopulation-based study including women with inflammatory bowel disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, and their infants born 2006 to 2013 from the national health registers in Denmark, Finland, and Sweden. Women treated with anti-TNF were compared with women with nonbiologic systemic treatment. Adalimumab, etanercept, and infliximab were compared pairwise. Continuation of treatment in early pregnancy was compared with discontinuation. Odds ratios with 95% confidence intervals were calculated in logistic regression models adjusted for country and maternal characteristics.\n\nAmong 1 633 909 births, 1027 infants were to women treated with anti-TNF and 9399 to women with nonbiologic systemic treatment. Compared with non-biologic systemic treatment, women with anti-TNF treatment had a higher risk of preterm birth, odds ratio 1.61 (1.29-2.02) and caesarean section, 1.57 (1.35-1.82). The odds ratio for small for gestational age was 1.36 (0.96-1.92). In pairwise comparisons, infliximab was associated with a higher risk of severely small for gestational age for inflammatory joint and skin diseases but not for inflammatory bowel disease. Discontinuation of anti-TNF had opposite effects on preterm birth for inflammatory bowel disease and inflammatory joint and skin diseases.\n\nAnti-TNF agents were associated with increased risks of preterm birth, caesarean section, and small for gestational age. However, the diverse findings across disease groups may indicate an association related to the underlying disease activity, rather than to agent-specific effects.", "doi": "10.1002/pds.4930", "pmid": "32020767", "labels": [], "xrefs": [], "notes": [], "created": "2026-09-23T08:32:34.342Z", "modified": "2026-09-23T08:32:34.950Z"}], "created": "2026-09-23T08:32:34.885Z", "modified": "2026-09-23T08:32:34.885Z"}