Inclusion and Exclusion Criteria Flashcards
- To understand what are eligibility criteria - To understand the reason for eligibility criteria - To critically appraise eligibility criteria
What must research experiments test?
They must test an alternate hypothesis.
How do you ensure that experiments are valid?
By making sure they measure a condition and reflect reality, that they are reliable and that they are replicable.
What are eligibility criteria?
Criteria which outline who can or cannot participate in a clinical study. They outline to common features which define a cohort.
Why are eligibility criteria used?
To ensure the participants are a safe group to include in the study and that they are a homogenous population for research integrity.
What are some typical exclusion criteria?
- Abnormalities on blood tests or vital signs outside of a pre-defined range.
- Major systemic illness.
- Major psychiatric illness.
- Use of prohibited medications.
What is screening?
A process potential participants undergo prior to study initiation to determine their eligibility for the study.
What criteria do participants need to meet?
Participants must meet all inclusion criteria and not meet any exclusion criteria.
What are eligibility criteria based on?
The research question being address by the trial, the trial protocol and the type of trial being conducted.
What is typically involved in the screening process?
A full medical history, safety assessments, physical and/or neurological assessments, blood tests, ECG, imaging, psychological assessments.
Why may there be further testing for neurological trials?
To ensure the participants have the key features of the target disease and that individuals with confounding characteristics are excluded.
What could happen if a participant’s disease is too mild or severe?
If the disease is too mild there may be no response shown to the intervention. If the disease is too severe it may dilute the results of those who did respond.
What could happen if there are too many inappropriate participants?
If there are too many inappropriate participants who do not respond to the intervention, the results of responsive subjects may be diluted. This means more subjects may be required to disprove the null hypothesis and increasing the risk of type II errors.
What happens if there is over-screening?
There may be a failure to recruit participants, appropriate participants may not be accepted, there is a greater time and financial burden and subjects may be more likely to drop-out.
What happens if there is under-screening?
It may allow the inclusion of inappropriate or confounding participants, there may be safety concerns and there may be noise in the dataset.
Why is it important to have good eligibility criteria?
Good criteria give a precise definition of the study population and allow the study to be valid and reliable. This increases the likelihood a response is due to the intervention and not a confounding factor or chance.
