Trial Methodology

Course 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).

Education

MSc Programme in Human Nutrition
 

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

Lectures, individual and group-based exercises, and journal clubs.

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.

Written
Collective
Peer feedback (Students give each other feedback)

We provide a thorough feed-back on all the written assignments mostly in plenum, but also for at least one of the assignments some individual feedback in writing on language as well as content.

ECTS
7,5 ECTS
Type of assessment
Written assignment, 27 hours
Description: The exam consists of a written take home assignment. The students have 27 hours to do the assignment and are allowed to use all course literature, notes, and internet.
Aid
All aids allowed
Marking scale
7-point grading scale
Censorship form
No external censorship
Internal grading. One assessor.
Criteria for exam assessment

Please see "Learning Outcome"

Single subject courses (day)

  • Category
  • Hours
  • Lectures
  • 10
  • Preparation
  • 95
  • Exercises
  • 74
  • Exam
  • 27
  • English
  • 206