Course catalogue doctoral education - VT24

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Title Register-based research - Pharmacoepidemiology: drug use and safety
Course number 3063
Programme 0-Inte del av forskarutbildningsprogram
Language English
Credits 3.0
Date 2018-11-26 -- 2019-03-08
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.
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.
Number of students 8 - 20
Selection of students Applicants will be prioritized as follows: 1) PhD-students within pharmacoepidemiology or related area 2) Postdocs with focus on pharmacoepidemiology 3) Others that have passed the postdoctoral level and have ongoing research activity in pharmacoepidemiology Selection will be based on: 1) The relevance of the course syllabus for the applicant's project according to written motivation 2) Date for registration as a doctoral student (priority given to earlier registration date)
More information VENUE: Eugeniahemmet T3, Karolinska University Hospital Solna FORMAT: The format will be a two-week course divided into two separate parts of five full working days each (in total 10 full working days/3 HEC, equivalent to 3 ECTS). All students must complete both parts of the course. Part 1 will be held during the autumn term 2018 (week 48), and Part 2 will be held during the spring term 2019 (week 10). During Part 1 of the course the students will work in groups and develop a study protocol for a pharmacoepidemiological study. The final examination assignment of Part 1 will be a written study protocol and an oral presentation of the protocol by each study group in a final plenary session. During Part 2 of the course the students will strengthen their analytic skills through computer labs. Students will get hands-on experience performing basic epidemiologic analyses in a simulated Nordic register data set under the supervision of the faculty. The exercises will be cross-platform exercises, i.e. it will be possible for the participants to use different statistical software (Stata, SAS, or R). Group assignments will be given during each computer lab session. The final examination assignment of Part 2 will be oral presentation of the group assignments, including the results of analyses, in a final plenary session. Two distinguished international researchers and lecturers will be part of the teaching faculty during Part 2 of the course. Professor Sonia Hernandez-Diaz from the Harvard T.H. Chan School of Public Health, USA is an expert in drug safety studies in pregnancy, and Professor K. Arnold Chan, Director of the National Taiwan University Health Data Research Center, Taiwan has comprehensive experience in pharmacoepidemiology from both academia and the private sector, and as advisor for regulatory authorities.
REIMBURSEMENT OF TRAVEL AND ACCOMODATION EXPENSES: Participants living outside commuting distance from Stockholm can apply for a maximum of 6000 SEK per course occasion to cover travel expenses, and a maximum of 1200 SEK/night (max 5 nights per course occasion) to cover accommodation expenses. The participants must follow the travel regulations of their respective institutions. 10 seats are reserved for PhD students. 12 seats are reserved for students from other Nordic countries than Sweden.
WHEN APPLYING APPLICANTS SHOULD: 1) State their current position and level of training (e.g., doctoral student and date of registration, post doc) and current institution 2) List their previous courses in epidemiology/biostatistics and the institution where they were completed 3) Describe previous experience with studies in pharmacoepidemiology or another epidemiologic field (if any) 4) Motivate their interest in this course with respect to their current and future research plans and how they expect to benefit from the course
Additional course leader Professor Morten Andersen, University of Copenhagen, Denmark
Latest course evaluation Not available
Course responsible Helle Kieler
Institutionen för medicin, Solna

Helle.Kieler@ki.se
Contact person Ingvild Odsbu
Institutionen för medicin, Solna

ingvild.odsbu@ki.se