In- and exclusion criteria

Question 1

In- and exclusion criteria

Answer 1

to determine if a patient is eligible for your RCT

• dependent on:
• rq and generalizability
• safety issues
• practical issues

Question 2

rq and generalizability

Answer 2

• you need your population
• if effectiveness: less strict inclusion

efficacy:
- many in and exclusion criteria
- still comparable to population you want to offer intervention in the future?
effectivness:
- few in- and exclusion criteria
- Effets might be lower
- more comparable to population you want to offer intervention to in the future

Question 3

always consider!

Answer 3

1. safety (e.g. suicidal ideation); e.g. when including participants with MDD –> exclude people with severe suicidal ideation, what do we do with them? make sure they are safe (suicide protocol, e.g. responsibility is with patient center, contact GP…)
2. severity level of the disorder (not too high, not too low)
3. comorbid disorders (which ones?)
4. capabilities (e.g., language)
5. other treatments (e.g., medications; current, just finished)

Question 4

practical issues

Answer 4

• you need to define and measure your in- and exclusion criteria