{"entity": "researcher", "timestamp": "2026-09-23T22:14:25.730Z", "family": "Linder", "given": "Marie", "initials": "M", "orcid": "0000-0003-2619-2189", "affiliations": ["Centre for Pharmacoepidemiology, Department of Medicine Solna, Karolinska Institutet, Solna, Sweden."], "links": {"self": {"href": "https://publications-affiliated.scilifelab.se/researcher/2caaaaa0836e48948cc20734a68c4e22.json"}, "display": {"href": "https://publications-affiliated.scilifelab.se/researcher/2caaaaa0836e48948cc20734a68c4e22"}}, "publications": [{"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"}]}