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Swedish title Registerbaserad forskning - Läkemedelsepidemiologi: läkemedelsanvändning och säkerhet
English title Register-based research - Pharmacoepidemiology: drug use and safety
Course number 3063
Credits 3.0
Responsible KI department Institutionen för medicin, Solna
Specific entry requirements All applicants must have basic and documented skills in using statistical software (SAS, Stata, or R) for data management and analysis, and have - at a minimum - basic level knowledge in epidemiology and biostatistics.
Grading Passed /Not passed
Established by The Board of Doctoral Education
Established 2018-02-02
Purpose of the course The purpose of the course is to gain knowledge and hands on experience in conducting Nordic register-based research using health data and socioeconomic data with a special focus on pharmacoepidemiological methodology and data sources.
Intended learning outcomes At the end of the course the student should be able to:
- Demonstrate knowledge of basic concepts in pharmacoepidemiology and its relevance for public health
- Demonstrate knowledge of sources of health and socioeconomic register data in the Nordic countries
- Demonstrate knowledge of legal issues and sharing of data within and across Nordic countries
- Independently plan and produce a study protocol to perform a pharmacoepidemiologic study including description of data sources
- Independently analyze register data using statistical software

Contents of the course The course will cover Nordic register-based research with a special focus on pharmacoepidemiology. In pharmacoepidemiological studies, a broad range of data sources are available for use, such as nationwide health registers (e.g. hospital contacts, births, deaths, and cancer), medical quality registers, medical records, biological data (biobanks), and socioeconomic data. The course will cover the available data sources in the Nordic countries, and the legal issues and issues related to data access and data sharing across countries. Special emphasis will be on the nationwide prescription registers and other registers used for pharmacoepidemiologic research. The participants will be introduced to epidemiologic study design and sources of errors in pharmacoepidemiologic studies and methods to correct such errors. Through group work the participants will independently develop a study protocol for a register-based study. The participants will become familiar with Nordic register data and challenges when performing register studies. They will strengthen their analytic skills through computer labs by working on simulated Nordic register data.
Teaching and learning activities Lectures, group work, and computer labs (individual and group work).
Compulsory elements It is compulsory to participate in the individual work and group work. Any absence will have to be compensated by extra individual assignments outside the course periods and provided by the course organizers.
Examination Oral and written presentation of group work. Each student will be assessed individually. It has to be shown that all the intended learning outcomes are reached.
Literature and other teaching material Recommended literature:
Selected parts from one optional textbook in pharmacoepidemiology:
1. Strom BL, Kimmel SE, Hennessy S. Pharmacoepidemiology. 5th edition, Wiley, 2012 (e-book available at KI library).
2. Strom BL, Kimmel SE, Hennessy S. Textbook of Pharmacoepidemiology. 2nd edition, Wiley, 2013 (e-book available at KI library).
3. Hartzema AG, Tilson HH, Chan KA. Pharmacoepidemiology and Therapeutic Risk Management. 1st edition, Harvey Whitney Books Company, 2008
Selected parts from one optional textbook in epidemiology:
1. Rothman KJ. Epidemiology: an introduction. 2nd edition. Oxford University Press, 2012
2. Weiss NS. Clinical Epidemiology: The study of the outcome of illness. 3rd edition, Oxford University Press, 2006

Current scientific articles as suggested by course leaders and lecturers as appropriate.
Course responsible Helle Kieler
Institutionen för medicin, Solna

0736334492
Helle.Kieler@ki.se

Contact person Ingvild Odsbu
Institutionen för medicin, Solna


ingvild.odsbu@ki.se