Planning and analysis of interventional studies

Course content

This seminar aims at deepening and extending the methodological understanding students acquired from basic quantitative methods courses, emphasizing the development of problem-solving competence in practical scenarios. Basic study design and statistical analysis of clinical trials, including sample size planning and statistical testing, will be reviewed using examples from clinical studies in psychology and medicine. Specifically, students will learn how to deal with the problem of multiple testing, to adjust for baseline covariates, to analyse subgroups, to cope with missing data, to handle clustered data (e.g., group therapy), to analyse binary data, count data, or event times, to compare natural (i.e., not randomized groups), to test for equivalence instead of difference, and to do interim analyses. In addition, students can choose 2 to 3 special topics to study.

By completing the course, students will be able to plan and analyse of standard study designs in real world-settings, including basic pre-processing of data, import and export of different files, performing data analysis, and standardized reporting. Most of the analyses will be done with SPSS, but the participants will also need to acquire some basic R skills. To facilitate students’ active engagement, this seminar will take place in the form of flipped classroom. Participants will need to elaborate the materials on their own before the class. Guided by the predefined learning goals and study questions of the session’s topic, they listen a short audio presentation, read a summary of the topic and the respective literature. In class, they will collaborate in pairs to work out the problems in an assignment, applying the knowledge they learned before the class. The instructor will give guidance as well as individualized instructions and feedback. Assignments can be handed in for feedback and improvements. At the end of the semester, participants need to complete a final assignment and submit it with together with all the assignments they completed during the seminar. The grading will be based on the final submission.

Learning outcome

On successful completion of the module, students will have achieved a high level of academic and methodological competency in relation to the specific design, planning, development, and/or application-related content and focus in the individual methodology courses. They will be able to demonstrate this by a) developing a data acquisition tool and/or b) conducting an academic and methodologically based study of a defined psychological subject, problem, target field or concept.

By the end of the class, students will be able to:

  • define and describe which psychological subject, problem, target field or concept they seek to a) uncover/study with the data acquisition tool and/or b) study by using the given analysis method(s)
  • describe the work process that leads to a) the development of a data acquisition tool and/or b) the analytical implementation of the study
  • explain and argue for the methodological and analytical choices taken during the process
  • reflect on and discuss methods critically (strengths and weaknesses) in relation to the methodological and/or analytical choices taken in connection with the work, and in relation to how these choices influence each other (the dynamics of the work process)
  • submit/present in writing or orally the result of the practical work in the form of a) a data acquisition tool and/or b) a test result.
Not relevant
7,5 ECTS
Type of assessment
Written examination, 90 minutes
Written assignment at Peter Bangs Vej

Due to the COVID19 situation the University is closed for physical attendance.
The summerexam 2020 is temporarily changed to:
An online take-home exam of 1 h 30 minutes, run via Digital exam.
Written exam aids are permitted. The exam is still individual, and it is not allowed to communicate with others about the assignment.
Written aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assessment

Se 'Learning objectives'

  • Category
  • Hours
  • Class Instruction
  • 30
  • English
  • 30