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
Interventional Research
flashcards
Decks in class (18)
# Cards
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1. Classes of intervention studies18
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2. Rationale of and prerequisites for experimental intervention research0
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3. Historical development of intervention trials4
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4. Core elements of the ‘classic’ intervention study design0
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5. Intervention strategies0
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6. Alternative intervention study designs2
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7. Random allocation9
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8. Study population0
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9. Design/choice of the intervention0
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10. Outcome measurement0
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11. Pros and cons of a run-in period (qualification period).1
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12. Role of placebo intervention within the context of a randomized trial.0
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13. Pragmatic vs. explanatory designs0
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14. Mixed methods designs4
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15. Protocol violations3
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16. Statistical analysis of intervention trial results0
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17. Sample size and power calculation0
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21. Ethical and legislative aspects of intervention trials0
