15. Protocol violations Flashcards
1
Q
What are protocol violations?
A
Subjects do not or only partly receive their allocated intervention
2
Q
What can cause protocol violations?
A
- Poor tolerance
- Poor adherence
- Use of other interventions
- Investigator error
(can appear systematically or at random)
3
Q
What are the effects of protocol violations?
A
Only measuring the remaining group introduces bias > over or underestimation of the outcomes
