General Methodological Concepts of Research Flashcards
What is the most useful and appropriate study design?
It Depends…on the question and the perspective
Quantitative
Numbers used to represent data
Qualitative
Words used to represent data
Two types of Quantitative Studies
- Interventional
2. Observational
Interventional
Forced allocation to study groups
- Already picked the groups and subjects are forced into one of them.
Observational
No forced allocation to study groups
- Patients preselect which group they will go in
What is study design selection based on?
- Perspective of research question
- Ability/desire of researcher to force group allocation (randomization)
- Ethics and methodology
- Efficiency & practicality (time/resource commitment)
- Costs
- Validity of acquired information (internal validity)
- Applicability of acquired to non-study patients (Generalizability)
Null Hypothesis
- Research prospective that states that there will be no difference between the groups being compared
What are the 3 various statistical-perspectives that can be taken by the researcher?
- Superiority
- Noninferiority
- Equivalency
Alternative Hypothesis
- Research perspective that states the will be a true difference between the groups being compared
Type 1 Error
Rejecting of the null when you shouldn’t have
Type 2 Error
Not rejecting the null when you should have
Population
- All individuals that make up a common group. A sample can be obtained from it
Sample
A subset or part of the full, complete population
What is the study population selection based on?
- Research Hypothesis/Question
- Population of interest
- Groups of individuals most useful and applicable to answer the research question
- Inclusion & Exclusion selection criteria (interventional)
- Case & Control group OR Exposed + Nonexposed group selection criteria (observational)
- Ethics
Equipoise
- Genuine confidence that an intervention may be worthwhile (risk vs. benefit) in order to use in humans
- Believe that the data is valuable and any risks clearly don’t outweigh the benefits.
What are the four key principles of bioethics.
- Autonomy
- Justice
- Benevolence
- Nonmaleficence
Autonomy
Patient gets the right to decide whether to participate or not.
They must be fully educated at a level that they understand
Beneficence
- To benefit, or do good for, the patient (not society)
Justice
- Equal + fair treatment regardless of patient characteristics
Nonmaleficence
- Do no harm.
- Researchers must not
- Withhold information
- Provide false information
- Exhibit professional incompetence
What is the Belmont Report?
The Guiding principles that researchers should be aware of.
What are the 3 guiding principles of the Belmont Report?
- Respect for persons - research should be voluntary
- Beneficence - risk justified by potential benefits
- Justice - risks and benefits equally distributed
What is Consent?
- Agreement to participate, based on being completely informed.
Age 18 to give consent
Must be mentally capable
What is assent?
- Agreement to participate, based on being completely informed, given by those not able to give legal consent.
Age: Children and adolescent, under 18
Must be mentally-capable
What does IRB stand for?
Institutional Review Board
What is the role of the IRB?
- makes the decision on whether research should occur before it starts
What is the sole purpose of the IRB?
- To protect the health and well being of study participants
List the levels of IRB Review
- Full board
- Expedited
- Exempt
Full Board
- used for ALL interventional trials with more than minimal risk to patients
Expedited
Minimal risk and/or no patient identifiers
Exempt
- No patient identifiers
- low/no risk
- de-identified
What is the main different between the 3 levels of review?
- Number of members & time for committee review
- Level of detail to Documentation needed for review
Who decides the level of review?
The IRB
Who keeps up with reviewing the study after it has started?
- Data Safety & Monitoring Board (DSMB)
