Mapping Outcomes and Registries Used in Current Danish Pharmacoepidemiological Research

References

• European Medicines Agency. Conditional marketing authorisation. European Medicines Agency; 2018. Available from: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation. Accessed June 13, 2021.
   Google Scholar
• Franklin JM, Schneeweiss S. When and how can real world data analyses substitute for randomized controlled trials? Clin Pharmacol Ther. 2017;102(6):924–933. doi:10.1002/cpt.857
   PubMed Web of Science ®Google Scholar
• Cave A, Kurz X, Arlett P. Real-world data for regulatory decision making: challenges and possible solutions for Europe. Clin Pharmacol Ther. 2019;106(1):36–39. doi:10.1002/cpt.1426
   PubMed Web of Science ®Google Scholar
• Eichler HG, Bloechl‐Daum B, Broich K, et al. Data rich, information poor: can we use electronic health records to create a learning healthcare system for pharmaceuticals? Clin Pharmacol Ther. 2019;105(4):912–922. doi:10.1002/cpt.1226
   PubMed Web of Science ®Google Scholar
• Goring S, Taylor A, Müller K, et al. Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: a systematic review. BMJ Open. 2019;9(2):e024895. doi:10.1136/bmjopen-2018-024895
   PubMed Web of Science ®Google Scholar
• Eichler HG, Pignatti F, Schwarzer‐Daum B, et al. Randomized Controlled Trials Versus Real World Evidence: neither Magic Nor Myth. Clin Pharmacol Ther. 2020;109(5):1212–1218. doi:10.1002/cpt.2083
   Web of Science ®Google Scholar
• Pedersen HKM. Helsevesenet i de nordiske land – er likhetene større enn ulikhetene? Tidsskrift for den Norske legeforening. 2000;120(1):14.
   Google Scholar
• Cohen JM, Cesta CE, Kjerpeseth L, et al. A common data model for harmonization in the Nordic Pregnancy Drug Safety Studies (NorPreSS). Nor J Epidemiol. 2021;29(1–2):1–2. doi:10.5324/nje.v29i1-2.4053
   Google Scholar
• Schmidt M, Schmidt SAJ, Adelborg K, et al. The Danish health care system and epidemiological research: from health care contacts to database records. Clin Epidemiol. 2019;11:563–591. doi:10.2147/CLEP.S179083
   PubMed Web of Science ®Google Scholar
• Schmidt M, Pedersen L, Sørensen HT. The Danish civil registration system as a tool in epidemiology. Eur J Epidemiol. 2014;29(8):541–549. doi:10.1007/s10654-014-9930-3
   PubMed Web of Science ®Google Scholar
• Jensen VM, Rasmussen AW. Danish education registers. Scand J Public Health. 2011;39((7_suppl)):91–94. doi:10.1177/1403494810394715
   Web of Science ®Google Scholar
• Lynge E, Sandegaard JL, Rebolj M. The Danish national patient register. Scand J Public Health. 2011;39((7_suppl)):30–33. doi:10.1177/1403494811401482
   Web of Science ®Google Scholar
• Schmidt M, Schmidt SAJ, Sandegaard JL, Ehrenstein V, Pedersen L, Sørensen HT. The Danish national patient registry: a review of content, data quality, and research potential. Clin Epidemiol. 2015;7:449–490. doi:10.2147/CLEP.S91125
   PubMed Web of Science ®Google Scholar
• Wallach Kildemoes H, Toft Sørensen H, Hallas J. The Danish national prescription registry. Scand J Public Health. 2011;39((7_suppl)):38–41. doi:10.1177/1403494810394717
   Web of Science ®Google Scholar
• Arboe B, Josefsson P, Jørgensen J, et al. Danish national lymphoma registry. Clin Epidemiol. 2016;8:577–581. doi:10.2147/CLEP.S99470
   PubMed Web of Science ®Google Scholar
• Green A. Danish clinical databases: an overview. Scand J Public Health. 2011;39((7_suppl)):68–71. doi:10.1177/1403494811402413
   Web of Science ®Google Scholar
• Danish Clinical Quality Program - National Clinical Registries (RKKP). Danish clinical quality program - national clinical registries. Available from: https://www.rkkp.dk/in-english/. Accessed May 31, 2021.
   Google Scholar
• Sørensen HT, Pedersen L, Jørgensen J, Ehrenstein V. Danish clinical quality databases – an important and untapped resource for clinical research. Clin Epidemiol. 2016;8:425–427. doi:10.2147/CLEP.S113265
   PubMed Web of Science ®Google Scholar
• Erlangsen A, Fedyszyn I. Danish nationwide registers for public health and health-related research. Scand J Public Health. 2015;43(4):333–339. doi:10.1177/1403494815575193
   PubMed Web of Science ®Google Scholar
• Thor Petersen C, Jensen KJ, Rosenzweig M, Ankarfeldt MZ, Kampen G, Petersen J. Outcomes measures in current Danish pharmacoepidemiological research: a protocol for a systematic mapping review [version 1; peer review: awaiting peer review]. F1000Res. 2021;10:368. doi:10.12688/f1000research.52727.1
   Google Scholar
• Petersen K, Vakkalanka S, Kuzniarz L. Guidelines for conducting systematic mapping studies in software engineering: an update. Inf Softw Technol. 2015;64:1–18. doi:10.1016/j.infsof.2015.03.007
   Web of Science ®Google Scholar
• Cooper ID. What is a “mapping study?”. J Med Libr Assoc. 2016;104(1):76–78. doi:10.3163/1536-5050.104.1.013
   PubMed Web of Science ®Google Scholar
• Grant MJ, Booth A. A typology of reviews: an analysis of 14 review types and associated methodologies. Health Info Libr J. 2009;26(2):91–108. doi:10.1111/j.1471-1842.2009.00848.x
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Medicinal product. European Medicines Agency. Available from: https://www.ema.europa.eu/en/glossary/medicinal-product. Accessed January 28, 2021.
   Google Scholar
• World Health Organization. Anatomical Therapeutic Chemical (ATC) classification. World Health Organization. Available from: https://www.who.int/tools/atc-ddd-toolkit/atc-classification. Accessed January 28, 2021.
   Google Scholar
• Egeberg A, Ottosen MB, Gniadecki R, et al. Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis. Br J Dermatol. 2018;178(2):509–519. doi:10.1111/bjd.16102
   PubMed Web of Science ®Google Scholar
• Hviid A, Hansen JV, Frisch M, Measles MM, Mumps R. Vaccination and autism: a nationwide cohort study. Ann Intern Med. 2019;170(8):513–520. doi:10.7326/M18-2101
   PubMed Web of Science ®Google Scholar
• Wium-Andersen IK, Osler M, Jørgensen MB, Rungby J, Wium-Andersen MK. Antidiabetic medication and risk of dementia in patients with type 2 diabetes: a nested case–control study. Eur J Endocrinol. 2019;181(5):499–507. doi:10.1530/EJE-19-0259
   Web of Science ®Google Scholar
• Pedersen SA, Gaist D, Schmidt SAJ, Hölmich LR, Friis S, Pottegård A. Hydrochlorothiazide use and risk of nonmelanoma skin cancer: a nationwide case-control study from Denmark. J Am Acad Dermatol. 2018;78(4):673–681.e9. doi:10.1016/j.jaad.2017.11.042
   PubMed Web of Science ®Google Scholar
• Ehrenstein V, Kristensen NR, Monz BU, Clinch B, Kenwright A, Sørensen HT. Oseltamivir in pregnancy and birth outcomes. BMC Infect Dis. 2018;18(1):519. doi:10.1186/s12879-018-3423-z
   PubMed Web of Science ®Google Scholar
• Sessa M, Mascolo A, Mortensen RN, et al. Relationship between heart failure, concurrent chronic obstructive pulmonary disease and beta-blocker use: a Danish nationwide cohort study. Eur J Heart Fail. 2018;20(3):548–556. doi:10.1002/ejhf.1045
   PubMed Web of Science ®Google Scholar
• Jennum P, Baandrup L, Tønnesen P, Ibsen R, Kjellberg J. Mortality and use of psychotropic medication in sleep apnoea patients: a population-wide register-based study. Sleep Med. 2018;43:19–24. doi:10.1016/j.sleep.2017.11.1142
   Web of Science ®Google Scholar
• Glintborg B, Ibsen R, Bilbo REQ, Lund Hetland M, Kjellberg J. Does a mandatory non-medical switch from originator to biosimilar etanercept lead to increase in healthcare use and costs? A Danish register-based study of patients with inflammatory arthritis. RMD Open. 2019;5(2):e001016. doi:10.1136/rmdopen-2019-001016
   Web of Science ®Google Scholar
• Christensen DH, Knudsen ST, Nicolaisen SK, et al. Can diabetic polyneuropathy and foot ulcers in patients with type 2 diabetes be accurately identified based on ICD-10 hospital diagnoses and drug prescriptions? Clin Epidemiol. 2019;11:311–321. doi:10.2147/CLEP.S197474
   PubMed Web of Science ®Google Scholar
• Albertsen N, Riahi S, Pedersen ML, Skovgaard N, Andersen S. The prevalence of atrial fibrillation in Greenland: a register-based cross-sectional study based on disease classifications and prescriptions of oral anticoagulants. Int J Circumpolar Health. 2022;81(1):2030522. doi:10.1080/22423982.2022.2030522
   Web of Science ®Google Scholar
• Strom BL. Chapter 1 - What is Pharmacoepidemiology? In: Strom BL, Kimmel SE, Hennessy S, editors. Textbook of Pharmacoepidemiology. 2nd ed. John Wiley & Sons; 2013:3–17.
   Google Scholar
• Waller P, Harrison-Woolrych M. Regulatory Aspects of Pharmacovigilance. In: An Introduction to Pharmacovigilance. 2nd ed. John Wiley & Sons Inc; 2017:75–94.
   Google Scholar
• Roach KE. Measurement of health outcomes: reliability, validity and responsiveness. J Prosthet Orthot. 2006;18(6):P8. doi:10.1097/00008526-200601001-00003
   Google Scholar
• European Medicines Agency. CPMP/UCH/291/95 - ICH topic E 8 - general considerations for clinical trials. 1998: 14.
   Google Scholar
• U.S. Food and Drug Administration. Center for drug evaluation and research and center for biologics evaluation and research. multiple endpoints in clinical trials, guidance for industry - DRAFT GUIDANCE. 2017: 54.
   Google Scholar
• Henderson M, Harvey S, Øverland S, Mykletun A, Hotopf M. Work and common psychiatric disorders. J R Soc Med. 2011;104(5):198–207. doi:10.1258/jrsm.2011.100231
   Web of Science ®Google Scholar
• Ibfelt EH, Jensen DV, Hetland ML. The Danish nationwide clinical register for patients with rheumatoid arthritis: DANBIO. CLEP. 2016;8:737–742. doi:10.2147/CLEP.S99490
   Web of Science ®Google Scholar
• Hetland ML. DANBIO–powerful research database and electronic patient record. Rheumatology. 2011;50(1):69–77. doi:10.1093/rheumatology/keq309
   Web of Science ®Google Scholar
• Danish Health Data Authority. List of approved clinical quality databases (in Danish: liste over godkendte kliniske kvalitetsdatabaser); 2021. Available from: https://sundhedsdatastyrelsen.dk/-/media/sds/filer/registre-og-services/de-kliniske-kvalitetsdatabaser/godkendte-kliniske-kvalitetsdatabaser.xlsx?la=da. Accessed May 10, 2021.
   Google Scholar
• Danish Clinical Quality Program - National Clinical Registries. RKKP documentation - the regions clinical quality program (in Danish: RKKP dokumentation - regionernes Kliniske Kvalitetsudviklingsprogram). Available from: https://www.rkkp-dokumentation.dk/Public/Default.aspx?msg=ChooseDB&error=WrongParm. Accessed August 1, 2021.
   Google Scholar
• Research Health Data Gateway. Application - single point of access to research health data. Available from: https://www.enindgangtilsundhedsdata.dk/en/Services/Ansoegningsportalen. Accessed June 12, 2021.
   Google Scholar
• Danish Health Data Authority. Research services; 2021. Available from: https://sundhedsdatastyrelsen.dk/da/english/health_data_and_registers/research_services. Accessed January 30, 2022.
   Google Scholar
• Danish Clinical Quality Program - National Clinical Registries. Guidelines for the transfer of personal data from the supported, nationwide clinical quality databases (research access) ver6.01 (in Danish: retningslinjer for videregivelse af personoplysninger fra de støttede, landsdækkende kliniske kvalitetsdatabaser (forskningsadgang)); 2020. Available from: https://www.rkkp.dk/siteassets/forskning/retningslinjer_forskning_version6_1.pdf. Accessed July 6, 2021.
   Google Scholar
• Vandenbroucke JP, Elm E, Von, Altman DG, et al. Strengthening the reporting of observational studies in epidemiology (STROBE): explanation and elaboration. PLoS Med. 2007;4(10):e297. doi:10.1371/journal.pmed.0040297
   PubMed Web of Science ®Google Scholar
• Benchimol EI, Smeeth L, Guttmann A, et al. The reporting of studies conducted using observational routinely-collected health data (RECORD) statement. PLoS Med. 2015;12(10):e1001885. doi:10.1371/journal.pmed.1001885
   PubMed Web of Science ®Google Scholar
• Arendt JFH, Hansen AT, Ladefoged SA, Sørensen HT, Pedersen L, Adelborg K. Existing data sources in clinical epidemiology: laboratory information system databases in Denmark. CLEP. 2020;12:469–475. doi:10.2147/CLEP.S245060
   Web of Science ®Google Scholar
• Danish Health Data Authority. The national hospital medication register (in Danish: sygehusmedicinregisteret (SMR)); 2021. Available from: https://sundhedsdatastyrelsen.dk/da/registre-og-services/om-de-nationale-sundhedsregistre/sygedomme-laegemidler-og-behandlinger/sygehusmedicinregisteret. Accessed August 31, 2021.
   Google Scholar
• Lif.dk. Increased consumption of medicines in 2020 (in Danish: Øget forbrug af medicin i 2020). Lif; 2021. Available from. https://www.lif.dk/oeget-forbrug-af-medicin-i-2020/. Accessed June 7, 2021.
   Google Scholar
• Rørth R, Fosbøl EL, Mogensen UM, et al. Evidence-based therapy and its association with workforce detachment after first hospitalization for heart failure. JACC. 2018;6(1):41–48. doi:10.1016/j.jchf.2017.09.019
   Google Scholar
• Jensen LS, Overgaard C, Garne JP, Bøggild H, Fonager K. The impact of prior psychiatric medical treatment on return to work after a diagnosis of breast cancer: a registry based study. Scand J Public Health. 2019;47(5):519–527. doi:10.1177/1403494817722291
   Web of Science ®Google Scholar
• Osler M, Wium‐Andersen MK, Wium‐Andersen IK, Gronemann FH, Jørgensen MB, Rozing MP. Incidence of suicidal behaviour and violent crime following antidepressant medication: a Danish cohort study. Acta Psychiatr Scand. 2019;140(6):522–531. doi:10.1111/acps.13097
   Web of Science ®Google Scholar
• Marquis P, Caron M, Emery MP, Scott JA, Arnould B, Acquadro C. The role of health-related quality of life data in the drug approval processes in the US and europe. Pharmaceut Med. 2011;25(3):147–160. doi:10.1007/BF03256856
   Google Scholar
• Angelis A, Lange A, Kanavos P. Using health technology assessment to assess the value of new medicines: results of a systematic review and expert consultation across eight European countries. Eur J Health Econ. 2018;19(1):123–152. doi:10.1007/s10198-017-0871-0
   PubMed Web of Science ®Google Scholar
• Danish Medicines Council. The Danish medicines council method guide for assessing of new new pharmaceuticals version 1.2; 2021. Available from: https://medicinraadet.dk/media/wq0dxny2/the_danish_medicines_council_methods_guide_for_assessing_new_pharmaceuticals_version_1-2_adlegacy.pdf. Accessed May 31, 2021.
   Google Scholar
• Sahl Andersen J, De Fine Olivarius N, Krasnik A. The Danish national health service register. Scand J Public Health. 2011;39((7_suppl)):34–37. doi:10.1177/1403494810394718
   Web of Science ®Google Scholar
• Statistics Denmark. Elderly documentation (in Danish: Ældredokumentation). Available from: https://www.dst.dk/da/Statistik/dokumentation/Times/aeldredokumentation. Accessed January 28, 2022.
   Google Scholar
• Danish Health Authority. Common access to health data shall strengthen research and development (in Danish: fælles indgang til sundhedsdata skal styrke forskning og udvikling); 2021. Available from: https://sum.dk/nyheder/2021/marts/faelles-indgang-til-sundhedsdata-skal-styrke-forskning-og-udvikling. Accessed June 12, 2021.
   Google Scholar
• Ribe AR, Vestergaard VCH, Fenger Grøn M, Pedersen HS, Lietzen LW, Brynningsen PK. Statins and risk of intracerebral haemorrhage in a stroke-free population: a nationwide Danish propensity score matched cohort study. EClinical Med. 2019;8:78–84. doi:10.1016/j.eclinm.2019.02.007
   Google Scholar
• Broe A, Pottegård A, Hallas J, Ahern TP, Lamont RF, Damkier P. Phthalate exposure from drugs during pregnancy and possible risk of preterm birth and small for gestational age. Eur J Obstet Gynecol Reprod Biol. 2019;240:293–299. doi:10.1016/j.ejogrb.2019.07.023
   PubMed Web of Science ®Google Scholar
• Weeke PE, Kellemann JS, Jespersen CB, et al. Long-term proarrhythmic pharmacotherapy among patients with congenital long QT syndrome and risk of arrhythmia and mortality. Eur Heart J. 2019;40(37):3110–3117. doi:10.1093/eurheartj/ehz228
   Web of Science ®Google Scholar
• Elkjær LS, Bech BH, Sun Y, Laursen TM, Christensen J. Association between prenatal valproate exposure and performance on standardized language and mathematics tests in school-aged children. JAMA Neurol. 2018;75(6):663. doi:10.1001/jamaneurol.2017.5035
   PubMed Web of Science ®Google Scholar
• Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009;339(1):b2700–b2700. doi:10.1136/bmj.b2700
   PubMed Web of Science ®Google Scholar