Planning and analysis of interventional studies

Course content

Course description: Using examples from clinical studies in psychology and medicine, we review the basic study design in clinical trials, including statistical tests and sample size planning. Step by step we learn how to extend the methodology to adjust for baseline performance, to analyze subgroups, to do interim analyses, to test for equivalence instead of difference, to deal with missing data, to deal with multiple outcome variables, to analyze binary data, count data, and event times, to deal with clustered data (e.g. group therapy), and to compare natural (i.e., not randomized groups). In the end, students will be able to plan and analyze of standard study designs in real world-settings, including basic preprocessing of data, import and export of different files, and standardized reporting. Most of the analyses will be done with SPSS, but the participants will also need to acquire some basic R skills.. 

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.
ECTS
7,5 ECTS
Type of assessment
Written examination, 90 minutes
Written assignment at Peter Bangs Vej
Aid
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