NNEK20007U Trial Methodology

Volume 2022/2023
Education

MSc Programme in Human Nutrition
 

Content

The course will focus on the design and planning of randomized trials in nutrition and health research. Through lectures, exercises and journal clubs, the course will cover various practical and academic aspects of the planning and conduct of a randomized controlled trial (RCT).

Learning Outcome

After completion of the course the students should be able to:

Knowledge

  • Defining intervention and outcomes
  • Define and explain the key characteristics of the RCT
  • Define and explain bias, confounding, effect modification and chance in relation to the RCT
  • Explain the strength and limitations of the simple RCT, as well as factorial, cluster and cross-over RCT
  • Explain the principles of sample size estimation and power
  • Explain the problem with multiple comparisons and ways to reduce it
  • Describe the formal requirements and approvals needed for a trial, data protection and publication agreements

 

Skills

  • Calculate the sample size needed for a randomized trial
  • Generate a random sequence based on variable block size

 

Competences

  • Design a trial for a given research question
  • Argue for the the quality of the methodology and the reporting of a randomized trial
  • Develop a plan for trial management appraising the challenges from early planning to study implementation and publication

Relevant course material will be uploaded on Absalon.

Academic qualifications equivalent to a BSc degree is required,
Basic understanding of epidemiological concepts, such as source and study population, validity, causal inference, chance and power, type 1 and type 2 errors, bias, confounding and effect modification are expected.
Lectures, individual and group-based exercises, and journal clubs.
  • Category
  • Hours
  • Lectures
  • 10
  • Preparation
  • 60
  • Exercises
  • 40
  • Project work
  • 95
  • Exam
  • 1
  • Total
  • 206
Written
Collective
Peer feedback (Students give each other feedback)

We provide written feedback on draft reports, and oral feedback on the final report is provided by peer students and lecturers.

Credit
7,5 ECTS
Type of assessment
Oral examination, 20 minutes
Type of assessment details
Description: Questions to the project report and curriculum. The exam is without preparation time.
Exam registration requirements

Approved project report.

Aid
Only certain aids allowed

Project report with notes.

Marking scale
7-point grading scale
Censorship form
No external censorship
Internal grading. More assessors.
Re-exam

Same as the ordinary exam.

Criteria for exam assesment

Please see "Learning Outcome"