NNEK20007U Trial Methodology
MSc Programme in Human Nutrition
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).
After completion of the course the students should be able to:
- 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
- Calculate the sample size needed for a randomized trial
- Generate a random sequence based on variable block size
- 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.
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.
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.
- 7,5 ECTS
- Type of assessment
- Written assignment, 27 hoursDescription: 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.
- All aids allowed
- Marking scale
- 7-point grading scale
- Censorship form
- No external censorship
Internal grading. One assessor.
Same as the ordinary exam.
Criteria for exam assesment
Please see "Learning Outcome"