@article{Maret-Ouda2017,

title = {Cohort profile: the Nordic Antireflux Surgery Cohort (NordASCo)},

author = {John Maret-Ouda and Karl Wahlin and Miia Artama and Nele Brusselaers and Martti Färkkilä and Elsebeth Lynge and Fredrik Mattsson and Eero Pukkala and Pål Romundstad and Laufey Tryggvadóttir and My von Euler-Chelpin and Jesper Lagergren},

doi = {10.1136/bmjopen-2017-016505},

issn = {2044-6055},

year  = {2017},

date = {2017-06-00},

journal = {BMJ Open},

volume = {7},

number = {6},

publisher = {BMJ},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Graner2017,

title = {Neuraminidase inhibitors during pregnancy and risk of adverse neonatal outcomes and congenital malformations: population based European register study},

author = {Sophie Graner and Tobias Svensson and Anna-Belle Beau and Christine Damase-Michel and Anders Engeland and Kari Furu and Anders Hviid and Siri Eldevik Håberg and Ditte Mølgaard-Nielsen and Björn Pasternak and Helle Kieler},

doi = {10.1136/bmj.j629},

issn = {1756-1833},

year  = {2017},

date = {2017-02-28},

journal = {BMJ},

publisher = {BMJ},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Karlstad2016,

title = {Use of drugs for ADHD among adults—a multinational study among 15.8 million adults in the Nordic countries},

author = {Øystein Karlstad and Helga Zoëga and Kari Furu and Shahram Bahmanyar and Jaana E Martikainen and Helle Kieler and Anton Pottegård},

doi = {10.1007/s00228-016-2125-y},

issn = {1432-1041},

year  = {2016},

date = {2016-12-00},

journal = {Eur J Clin Pharmacol},

volume = {72},

number = {12},

pages = {1507--1514},

publisher = {Springer Science and Business Media LLC},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Selmer2016,

title = {Individual‐based versus aggregate meta‐analysis in multi‐database studies of pregnancy outcomes: the Nordic example of selective serotonin reuptake inhibitors and venlafaxine in pregnancy},

author = {Randi Selmer and Bengt Haglund and Kari Furu and Morten Andersen and Mette Nørgaard and Helga Zoëga and Helle Kieler},

doi = {10.1002/pds.4033},

issn = {1099-1557},

year  = {2016},

date = {2016-10-00},

journal = {Pharmacoepidemiology and Drug},

volume = {25},

number = {10},

pages = {1160--1169},

publisher = {Wiley},

abstract = {AbstractPurposeCompare analyses of a pooled data set on the individual level with aggregate meta‐analysis in a multi‐database study.MethodsWe reanalysed data on 2.3 million births in a Nordic register based cohort study. We compared estimated odds ratios (OR) for the effect of selective serotonin reuptake inhibitors (SSRI) and venlafaxine use in pregnancy on any cardiovascular birth defect and the rare outcome right ventricular outflow tract obstructions (RVOTO). Common covariates included maternal age, calendar year, birth order, maternal diabetes, and co‐medication. Additional covariates were added in analyses with country‐optimized adjustment.ResultsCountry adjusted OR (95%CI) for any cardiovascular birth defect in the individual‐based pooled analysis was 1.27 (1.17–1.39), 1.17 (1.07–1.27) adjusted for common covariates and 1.15 (1.05–1.26) adjusted for all covariates. In fixed effects meta‐analyses pooled OR was 1.29 (1.19–1.41) based on crude country specific ORs, 1.19 (1.09–1.29) adjusted for common covariates, and 1.16 (1.06–1.27) for country‐optimized adjustment. In a random effects model the adjusted OR was 1.07 (0.87–1.32). For RVOTO, OR was 1.48 (1.15–1.89) adjusted for all covariates in the pooled data set, and 1.53 (1.19–1.96) after country‐optimized adjustment. Country‐specific adjusted analyses at the substance level were not possible for RVOTO.ConclusionResults of fixed effects meta‐analysis and individual‐based analyses of a pooled dataset were similar in this study on the association of SSRI/venlafaxine and cardiovascular birth defects. Country‐optimized adjustment attenuated the estimates more than adjustment for common covariates only. When data are sparse pooled data on the individual level are needed for adjusted analyses. Copyright © 2016 John Wiley & Sons, Ltd.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Zoega2015,

title = {Use of SSRI and SNRI Antidepressants during Pregnancy: A Population-Based Study from Denmark, Iceland, Norway and Sweden},

author = {Helga Zoega and Helle Kieler and Mette Nørgaard and Kari Furu and Unnur Valdimarsdottir and Lena Brandt and Bengt Haglund},

editor = {Igor Branchi},

doi = {10.1371/journal.pone.0144474},

issn = {1932-6203},

year  = {2015},

date = {2015-12-14},

journal = {PLoS ONE},

volume = {10},

number = {12},

publisher = {Public Library of Science (PLoS)},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Kieler2014,

title = {Use of antidepressants and association with elective termination of pregnancy: population based case–control study},

author = {H Kieler and H Malm and M Artama and A Engeland and K Furu and M Gissler and M Nørgaard and O Stephansson and U Valdimarsdottir and H Zoega and B Haglund},

doi = {10.1111/1471-0528.13164},

issn = {1471-0528},

year  = {2015},

date = {2015-11-00},

journal = {BJOG},

volume = {122},

number = {12},

pages = {1618--1624},

publisher = {Wiley},

abstract = {ObjectiveTo assess whether the use of selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, mirtazapine, venlafaxine or other antidepressants is associated with late elective termination of pregnancy.DesignCase–control study using data from national registers.SettingDenmark, Finland, and Norway during the period 1996–2007.PopulationA total of 14 902 women were included as cases and 148 929 women were included as controls.MethodsCases were women with elective termination of pregnancy at 12–23 weeks of gestation. Controls continued their pregnancy and were matched with cases on key factors.Main outcome measuresAssociation between antidepressant use during pregnancy and elective termination of pregnancy at 12–23 weeks of gestation for fetal anomalies, or for maternal ill health or socio‐economic disadvantage.ResultsAt least one prescription of antidepressants was filled by 3.7% of the cases and 2.2% of the controls. Use of any type of antidepressant was associated with elective termination of pregnancy for maternal ill health or socio‐economic disadvantage (odds ratio, OR 2.3; 95% confidence interval, 95% CI 2.0–2.5). Elective termination of pregnancy for fetal anomalies was associated with the use of mirtazapine (OR 2.2, 95% CI 1.1–4.5). There was no association between the use of any of the other antidepressants and elective termination of pregnancy for fetal anomalies.ConclusionThe use of any type of antidepressants was associated with elective termination of pregnancy at 12–23 weeks for maternal ill health or socio‐economic disadvantage, but not with terminations for fetal anomalies. Further studies need to confirm the findings concerning mirtazapine and termination of pregnancy for fetal anomalies.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Furu2015,

title = {Selective serotonin reuptake inhibitors and venlafaxine in early pregnancy and risk of birth defects: population based cohort study and sibling design},

author = {K. Furu and H. Kieler and B. Haglund and A. Engeland and R. Selmer and O. Stephansson and U. A. Valdimarsdottir and H. Zoega and M. Artama and M. Gissler and H. Malm and M. Norgaard},

doi = {10.1136/bmj.h1798},

issn = {1756-1833},

year  = {2015},

date = {2015-04-17},

journal = {BMJ},

volume = {350},

number = {apr17 3},

pages = {h1798--h1798},

publisher = {BMJ},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Andersen2014,

title = {Research on drug safety and effectiveness using pharmacoepidemiological databases},

author = {M. Andersen},

doi = {10.1111/joim.12235},

issn = {1365-2796},

year  = {2014},

date = {2014-06-00},

journal = {J Intern Med},

volume = {275},

number = {6},

pages = {548--550},

publisher = {Wiley},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Trifirò2014,

title = {Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how?},

author = {G. Trifirò and P. M. Coloma and P. R. Rijnbeek and S. Romio and B. Mosseveld and D. Weibel and J. Bonhoeffer and M. Schuemie and J. van der Lei and M. Sturkenboom},

doi = {10.1111/joim.12159},

issn = {1365-2796},

year  = {2014},

date = {2014-06-00},

journal = {J Intern Med},

volume = {275},

number = {6},

pages = {551--561},

publisher = {Wiley},

abstract = {AbstractA growing number of international initiatives (e.g. EU‐ADR, Sentinel, OMOP, PROTECT and VAESCO) are based on the combined use of multiple healthcare databases for the conduct of active surveillance studies in the area of drug and vaccine safety. The motivation behind combining multiple healthcare databases is the earlier detection and validation, and hence earlier management, of potential safety issues. Overall, the combination of multiple healthcare databases increases statistical sample size and heterogeneity of exposure for postmarketing drug and vaccine safety surveillance, despite posing several technical challenges. Healthcare databases generally differ by underlying healthcare systems, type of information collected, drug/vaccine and medical event coding systems and language. Therefore, harmonization of medical data extraction through homogeneous coding algorithms across highly different databases is necessary. Although no standard procedure is currently available to achieve this, several approaches have been developed in recent projects. Another main challenge involves choosing the work models for data management and analyses whilst respecting country‐specific regulations in terms of data privacy and anonymization. Dedicated software (e.g. Jerboa) has been produced to deal with privacy issues by sharing only anonymized and aggregated data using a common data model. Finally, storage and safe access to the data from different databases requires the development of a proper remote research environment. The aim of this review is to provide a summary of the potential, disadvantages, methodological issues and possible solutions concerning the conduct of postmarketing multidatabase drug and vaccine safety studies, as demonstrated by several international initiatives.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{vanStaa2014,

title = {Use of electronic healthcare records in large‐scale simple randomized trials at the point of care for the documentation of value‐based medicine},

author = {T.‐P. van Staa and O. Klungel and L. Smeeth},

doi = {10.1111/joim.12211},

issn = {1365-2796},

year  = {2014},

date = {2014-06-00},

journal = {J Intern Med},

volume = {275},

number = {6},

pages = {562--569},

publisher = {Wiley},

abstract = {AbstractA solid foundation of evidence of the effects of an intervention is a prerequisite of evidence‐based medicine. The best source of such evidence is considered to be randomized trials, which are able to avoid confounding. However, they may not always estimate effectiveness in clinical practice. Databases that collate anonymized electronic health records (EHRs) from different clinical centres have been widely used for many years in observational studies. Randomized point‐of‐care trials have been initiated recently to recruit and follow patients using the data from EHR databases. In this review, we describe how EHR databases can be used for conducting large‐scale simple trials and discuss the advantages and disadvantages of their use.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Stürmer2014,

title = {Propensity scores for confounder adjustment when assessing the effects of medical interventions using nonexperimental study designs},

author = {T. Stürmer and R. Wyss and R. J. Glynn and M. A. Brookhart},

doi = {10.1111/joim.12197},

issn = {1365-2796},

year  = {2014},

date = {2014-06-00},

journal = {J Intern Med},

volume = {275},

number = {6},

pages = {570--580},

publisher = {Wiley},

abstract = {AbstractTreatment effects, especially when comparing two or more therapeutic alternatives as in comparative effectiveness research, are likely to be heterogeneous across age, gender, co‐morbidities and co‐medications. Propensity scores (PSs), an alternative to multivariable outcome models to control for measured confounding, have specific advantages in the presence of heterogeneous treatment effects. Implementing PSs using matching or weighting allows us to estimate different overall treatment effects in differently defined populations. Heterogeneous treatment effects can also be due to unmeasured confounding concentrated in those treated contrary to prediction. Sensitivity analyses based on PSs can help to assess such unmeasured confounding. PSs should be considered a primary or secondary analytic strategy in nonexperimental medical research, including pharmacoepidemiology and nonexperimental comparative effectiveness research.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Hallas2014,

title = {Use of self‐controlled designs in pharmacoepidemiology},

author = {J. Hallas and A. Pottegård},

doi = {10.1111/joim.12186},

issn = {1365-2796},

year  = {2014},

date = {2014-06-00},

journal = {J Intern Med},

volume = {275},

number = {6},

pages = {581--589},

publisher = {Wiley},

abstract = {AbstractSelf‐controlled observational study designs, such as the case–crossover design and the self‐controlled case series, are reviewed, and their respective rationale, strengths and limitations are compared. Although no single design is generally superior to the others, they share the trait of being robust towards confounders that are stable over time. The self‐controlled designs can be particularly useful when using secondary healthcare data for pharmacoepidemiological research and might be useful in screening for adverse drug effects. The main limitations of self‐controlled designs are that they are amenable only to transient effects; some may be inefficient with long‐term exposure; and they may be sensitive towards trends in exposure.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Yasmina2014,

title = {Application of routine electronic health record databases for pharmacogenetic research},

author = {A. Yasmina and V. H. M. Deneer and A. H. Maitland‐van der Zee and T. P. van Staa and A. de Boer and O.H. Klungel},

doi = {10.1111/joim.12226},

issn = {1365-2796},

year  = {2014},

date = {2014-06-00},

journal = {J Intern Med},

volume = {275},

number = {6},

pages = {590--604},

publisher = {Wiley},

abstract = {AbstractInter‐individual variability in drug responses is a common problem in pharmacotherapy. Several factors (non‐genetic and genetic) influence drug responses in patients. When aiming to obtain an optimal benefit–risk ratio of medicines and with the emergence of genotyping technology, pharmacogenetic studies are important for providing recommendations on drug treatments. Advances in electronic healthcare information systems can contribute to increasing the quality and efficiency of such studies. This review describes the definition of pharmacogenetics, gene selection and study design for pharmacogenetic research. It also summarizes the potential of linking pharmacoepidemiology and pharmacogenetics (along with its strengths and limitations) and provides examples of pharmacogenetic studies utilizing electronic health record databases.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Andersen2014b,

title = {SYMPOSIUM (6th NorpEN meeting): Research on drug safety and effectiveness using pharmacoepidemiological databases},

author = {M. Andersen},

doi = {10.1111/joim.12235},

issn = {1365-2796},

year  = {2014},

date = {2014-06-00},

urldate = {2014-06-00},

journal = {J Intern Med},

volume = {275},

number = {6},

pages = {547},

publisher = {Wiley},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Kieler2014b,

title = {Nordic Databases to Evaluate Medications in Pregnancy},

author = {Helle Kieler},

doi = {10.2515/therapie/2014009},

issn = {0040-5957},

year  = {2014},

date = {2014-01-00},

journal = {Therapies},

volume = {69},

number = {1},

pages = {65--69},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Wettermark2013,

title = {The Nordic prescription databases as a resource for pharmacoepidemiological research—a literature review},

author = {B Wettermark and H Zoëga and K Furu and M Korhonen and J Hallas and M Nørgaard and AB Almarsdottir and M Andersen and K Andersson Sundell and U Bergman and A Helin‐Salmivaara and M Hoffmann and H Kieler and JE Martikainen and M Mortensen and M Petzold and H Wallach‐Kildemoes and C Wallin and HT Sørensen},

doi = {10.1002/pds.3457},

issn = {1099-1557},

year  = {2013},

date = {2013-07-00},

journal = {Pharmacoepidemiology and Drug},

volume = {22},

number = {7},

pages = {691--699},

publisher = {Wiley},

abstract = {ABSTRACTPurposeAll five Nordic countries have nationwide prescription databases covering all dispensed drugs, with potential for linkage to outcomes. The aim of this review is to present an overview of therapeutic areas studied and methods applied in pharmacoepidemiologic studies using data from these databases.MethodsThe study consists of a Medline‐based structured literature review of scientific papers published during 2005–2010 using data from the prescription databases in Denmark, Finland, Iceland, Norway, and Sweden, covering 25 million inhabitants. Relevant studies were analyzed in terms of pharmacological group, study population, outcomes examined, type of study (drug utilization vs. effect of drug therapy), country of origin, and extent of cross‐national collaboration.ResultsA total of 515 studies were identified. Of these, 262 were conducted in Denmark, 97 in Finland, 4 in Iceland, 87 in Norway, and 61 in Sweden. Four studies used data from more than one Nordic country. The most commonly studied drugs were those acting on the nervous system, followed by cardiovascular drugs and gastrointestinal/endocrine drugs. A total of 228 studies examined drug utilization and 263 focused on the effects and safety of drug therapy. Pregnant women were the most commonly studied population in safety studies, whereas prescribers' adherence to guidelines was the most frequent topic of drug utilization studies.ConclusionsThe Nordic prescription databases, with their possibility of record‐linkage, represent an outstanding resource for assessing the beneficial and adverse effects of drug use in large populations, under routine care conditions, and with the potential for long‐term follow‐up. Copyright © 2013 John Wiley & Sons, Ltd.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Stephansson2013,

title = {Selective Serotonin Reuptake Inhibitors During Pregnancy and Risk of Stillbirth and Infant Mortality},

author = {Olof Stephansson and Helle Kieler and Bengt Haglund and Miia Artama and Anders Engeland and Kari Furu and Mika Gissler and Mette Nørgaard and Rikke Beck Nielsen and Helga Zoega and Unnur Valdimarsdóttir},

doi = {10.1001/jama.2012.153812},

issn = {0098-7484},

year  = {2013},

date = {2013-01-02},

journal = {JAMA},

volume = {309},

number = {1},

publisher = {American Medical Association (AMA)},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Kieler2011,

title = {Selective serotonin reuptake inhibitors during pregnancy and risk of persistent pulmonary hypertension in the newborn: population based cohort study from the five Nordic countries},

author = {H. Kieler and M. Artama and A. Engeland and O. Ericsson and K. Furu and M. Gissler and R. B. Nielsen and M. Norgaard and O. Stephansson and U. Valdimarsdottir and H. Zoega and B. Haglund},

doi = {10.1136/bmj.d8012},

issn = {1468-5833},

year  = {2011},

date = {2011-01-12},

journal = {BMJ},

volume = {344},

number = {jan12 3},

pages = {d8012--d8012},

publisher = {BMJ},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Furu2010,

title = {The Nordic Countries as a Cohort for Pharmacoepidemiological Research},

author = {Kari Furu and Björn Wettermark and Morten Andersen and Jaana E. Martikainen and Anna Birna Almarsdottir and Henrik Toft Sørensen},

doi = {10.1111/j.1742-7843.2009.00494.x},

issn = {1742-7843},

year  = {2010},

date = {2010-02-00},

journal = {Basic Clin Pharma Tox},

volume = {106},

number = {2},

pages = {86--94},

publisher = {Wiley},

abstract = {Abstract:  The Nordic countries have a long tradition of registry‐based epidemiological research. Many population‐based health registries were established in the 1960s, with use of unique personal identifiers facilitating linkage between registries. In recent years, each country has established a national database to track prescription drugs dispensed to individuals in ambulatory care. The objectives were to present an overview of the prescription databases established in the Nordic countries, as well as to elaborate on their unique potential for record linkage and cross‐national comparison of drug utilization. Five Nordic countries collect drug exposure data based on drugs dispensed at pharmacies and have the potential to link these data to health outcomes. The databases together cover 25 million inhabitants (Denmark: 5.5 million; Finland: 5.3 million; Iceland: 0.3 million; Norway: 4.8 million; and Sweden: 9.2 million). In 2007, the registries encompassed 17 million prescription drug users (68% of the total population). We provide examples of how these databases have been used for descriptive drug utilization studies and analytical pharmacoepidemiological studies linking drug exposure to other health registries. Comparisons are facilitated by many similarities among the databases, including data source, content, coverage and methods used for drug utilization studies and record linkage. There are, however, some differences in coding systems and validity, as well as in some access and technical issues. To perform cross‐national pharmacoepidemiological studies, resources, networks and time are needed, as well as methods for pooling data. Interpretation of results needs to account for inter‐country heterogeneity and the possibility of spurious relationships. The Nordic countries have a unique potential for collaborative high‐quality cross‐national pharmacoepidemiological studies with large populations. This research may assist in resolving safety issues of international interest, thus minimizing the risk of either over‐reacting on possible signals or underestimating drug safety issues.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Bramness2009,

title = {Use of lithium in the adult populations of Denmark, Norway and Sweden},

author = {Jørgen G. Bramness and Gunilla Ringbäck Weitoft and Jesper Hallas},

doi = {10.1016/j.jad.2009.01.024},

issn = {0165-0327},

year  = {2009},

date = {2009-11-00},

journal = {Journal of Affective Disorders},

volume = {118},

number = {1-3},

pages = {224--228},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}