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Swedish title Nyckelbegrepp och principer för design och kritisk tolkning av registerbaserade studier
English title Key Concepts and Principles for Design and Critical Interpretation of Register-based Studies
Course number 5401
Credits 4.5
Responsible KI department Institutet för miljömedicin
Specific entry requirements
Grading Passed /Not passed
Established by The Committee for Doctoral Education
Established 2021-05-24
Purpose of the course Swedish registers constitute a unique resource for research, and thus contribute to better public health and welfare. Individual-level data, so-called microdata, includes vital events, health aspects, and demographic and socioeconomic indicators for the entire population over decades. These features make these data an indispensable and powerful resource for answering a multitude of research questions in a time- and cost-effective manner. However, when using these properties for research purposes, ethical and legal considerations must be encompassed to the full.

The purpose of this course is to provide participants with knowledge on how registers can and should be used for research purposes. This course will cover central concepts and principles for design and critical interpretation of register-based studies, taking ethical aspects and legal principles into consideration, and will be divided into three aligned modules.
Intended learning outcomes After successfully completing this course the student is expected to be able to:
Module 1:
- describe theoretical models for causation and discuss the principles of causal mechanisms,
- recognise and formulate well-defined research questions and explain how these are related to the choice of study design,
- explain and contrast central concepts in epidemiological and sociological life-course research,
- explain strengths and weaknesses in common methods and study designs used in register-based research,
- apply knowledge, skills and scientific approach when critically reviewing register-based studies as well as when designing studies in this field.

Module 2:
- reason about how to identify register data to answer the research question under study,
- reflect upon different quality aspects, comparability and discrepancies between data sources,
- identify and explain possible sources and structures of bias,
- evaluate how different sources of bias may influence the findings arising in studies and steps to prevent these,
- apply the knowledge attained to identify and reason about potential biases in own research.

Module 3:
- discuss legal principles and laws that apply to research on personal data,
- reason about legal systems that protect individual privacy with respect to how personal data are used and distributed to others,
- reason about ethical principles that apply, with specific focus on personal privacy, informed consent and the concept of benefit/harm,
- give adequate consideration of ethical aspects and legal principles when handling personal data in relation to own and others´ research projects.
Contents of the course The course focus on methodological, practical, ethical and legal aspects of utilising register data for research purposes.

Module 1: Central concepts, designs and methods in epidemiological and sociological life-course research. The module focuses on formulation of research questions, central concepts and general principles for study designs and methods commonly used when utilising register data. Designs and methods will be presented in the context of several case studies.

Module 2: Identification of data and analysis of bias in registers. The module focuses on major steps in identifying relevant data, and comparability and discrepancies between data sources. We will cover how to identify and prevent different sources of bias, and aspects that should be kept in mind to gain a deeper understanding of when and how bias can occur, as well as the magnitude and possible direction of bias. Issues related to data quality, such as different variable definitions, data collection methods, reporting procedures, completeness and coverage, and how these aspects can vary, for instance over time and between geographic regions, will be highlighted.

Module 3: Ethical and legal aspects of using personal information in register-based research. The research community is entrusted with their professional responsibility when utilising register data for research purposes. As register data is not primarily collected for research, it is critical to protect and guarantee individual privacy with respect to how personal data are used and distributed to others. This module will be integrated in the above modules and address legal aspects and laws that apply to register-based research, and ethical principles that should be emphasised in this context.
Teaching and learning activities The course will be divided into three aligned modules. The emphasis is on analysis, synthesis and the ability to make critical and independent interpretations, so-called higher order thinking skills. Different strategies, such as interactive lectures and various forms of group assignments will be used. All activities are designed to stimulate active learning, and communication between peers and teachers. Diverse perspectives and a broad, cross-border approach for various problem areas will be promoted, and cross-fertilisation between different disciplines will be stimulated. The collaborative-learning nature of assignments is also highlighted and peer learning emphasised.
Compulsory elements The individual (summative) examination.
Examination Learning outcomes, teaching and learning activities, and assessment methods will be constructed so that they harmonise, so-called constructive alignment. Assessment and learning are seen as linked and not separate processes. The examination tasks contain formative and summative features. Different methods for feedback on assignments are used, both so-called peer assessment and teacher-to-student assessment. The individual, summative examination consists of an individual task to be performed as a take-home examination.
Literature and other teaching material Suggested reading:
Rothman KJ. Epidemiology: An Introduction. 2nd ed. Oxford, UK: Oxford University Press; 2012.
Scientific papers and other material will be distributed before and during the course.
Course responsible Anita Berglund
Institutet för miljömedicin


Anita.Berglund@ki.se

Contact person Johanna Bergman
Institutet för miljömedicin


johanna.bergman@ki.se

Nobels väg 13

17177
Stockholm