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

ECTS
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.
Aid
Only certain aids allowed

Project report with notes.

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

Please see "Learning Outcome"

Single subject courses (day)

  • Category
  • Hours
  • Lectures
  • 10
  • Preparation
  • 60
  • Exercises
  • 40
  • Project work
  • 95
  • Exam
  • 1
  • English
  • 206

Kursusinformation

Language
English
Course number
NNEK20007U
ECTS
7,5 ECTS
Programme level
Full Degree Master
Duration

1 block

Placement
Block 2
Schedulegroup
C
Capacity
No restrictions.
The number of seats may be reduced in the late registration period
Studyboard
Study Board of Food, Human Nutrition and Sports
Contracting department
  • Department of Nutrition, Exercise and Sports
Contracting faculty
  • Faculty of Science
Course Coordinators
  • Henrik Friis   (3-6d6b7745736a7d7833707a336970)
  • Benedikte Grenov   (3-676c7745736a7d7833707a336970)
Saved on the 28-02-2022

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