Other Study Designs

Question 1

Factorial Design

Answer 1

Answer two or more research questions in one cohort of subjects

Question 2

Factorial Design Pros

Answer 2

More efficient

Save time and resources

Question 3

Factorial Design Cons

Answer 3

Potential interactions between treatment effects

Question 4

Medical Tests

Answer 4

Risk factor screening
Disease diagnosis
Estimate prognosis

Question 5

Medical tests descriptive or observational

Answer 5

Causality is usually irrelevant
Objective: association between a test and a particular outcome
Criteria for clinical usefulness

Question 6

Considerations

Answer 6

Performance of the “gold standard”
Generalizability (disease spectrum and variability)
Blinding
Cost vs Charges

Question 7

Health Related Quality of Life

Answer 7

Refers to total well being including physical health and functioning, psychological health and functioning, social functioning and pt perceptions of general well being

Question 8

Cost-effective threshold

Answer 8

Value judgement with no current consensus

Question 9

Quasi-experimental design

Answer 9

Pre-post intervention
Treatment is not random
Answers: What is the effect of X on Y?
Cannot make definitive causal inferences

Question 10

Define Utility

Answer 10

Evaluate the impact of a new poly, practice guideline, therapeutic agent

Question 11

Define autonomy

Answer 11

Respect each participant as a person capable of making an informed decision regarding participation in the research study
Uncoherced and fully informed

Question 12

Ethical Principles per Belmont Report

Answer 12

Autonomy
Beneficence
Justice

Question 13

Define Deneficence

Answer 13

Maximize benefits for the individual participant and/or society while minimizing risk of harm to the individual
Individual takes risk and population takes benefits

Question 14

Define Justice

Answer 14

Equitable selection of participants

Equality in distribution of benefits and burdens among the population groups likely to benefit from the research

Question 15

Institutional Review Board

Answer 15

Oversight committee to ensure that human research is ethical and justified
All research reviewed here first
Exemption of waiver is determined by IRB

Question 16

Informed Consent

Answer 16

Disclosure
Understanding
Voluntary
Competence
Consent

Question 17

Children Consent

Answer 17

Pt’s Assent

Parental/Guardian Consent

Question 18

Special populations include

Answer 18

Childre, cognitively impaired, terminally ill, prisoners