Class #15 General Methodological Concepts of Research Flashcards
What kind of studies have the highest research evidence
Meta-analyses studies
What kind of studies have the second highest strength of evidence
Systematic Reviews
Study design selection is based on
Perspective of research question (hypothesis)
Ability/desire to force group allocation (randomization)
Ethics of methodology
efficiency & Practicality (time/resource commitment)
Costs
Validity of acquired information (internal & External)
What is internal validity
are the methods and study design valid
What is external validity
how do the findings compare to the general public
What is a null hypothesis
a research perspective which states there will be no (true) difference between the groups being compared
What is an alternative Hypothesis (H1)
A research perspective which states there will be a (true) difference between the groups being compared
Name 3 statistical perspectives that can be taken by the researcher
Superiority
Non-inferiority
Equivalency
Type I Error (alpha error)
False positive
Type II Error (Beta error)
False negative
What are observational studies
considered to be “natural”
researchers “observe” subject elements occurring naturally or selected by individual (naturally or freely)
most observational study designs are not able to prove causation
What are most observational study designs not bale to prove
Causation
In observational studies there is no what?
no researcher-forced group allocation
What are interventional study designs
Considered “experimental”
investigator-selects interventions (exposure)
There is researcher-forced group allocation
in interventional studies there is what
researcher-forced group allocation
Name 5 types of Interventional Studies in order from least to most evidence `
Pre-clinical, phase 1, Phase 2, Phase 3, Phase 4
The 5 types of interventional studies have what in common
they each have a researcher-forced group allocation
they are analytical studies
Name 5 types of observational studies from least to most evidence
Cases (reports/Series), Ecological, Cross-sectional, Case-Control, Cohort
What are the 3 types of observational studies that are analytical studies
Cross-sectional, Case-control, and Cohort
What is a study population
The final group of individual selected for a study
What is a population
All individuals making up a common group; form which a sample (smaller set) can be obtained, if desired
what is a sample
A subset or portion of the full, complete population (“representatives”)
what is generally used to draw a sample for a study
Randomization processes
When is using a sample needed
When studying the complete population is not feasible
what is the most common type of bias
Selection bias
What are study population selections based on
Research hypothesis/question
inclusion & Exclusion selection criteria (interventional studies) & Case and Control group or exposed and non exposed group selection criteria
- Desired vs. Logical vs. plausible selection criteria
- These impact generalizability
-external validity
Ethics
Study population selection has an effect on what factor
External Validity
What is Equipoise
genuine confidence that an intervention may be worthwhile (risk vs. benefit) in order to use it in humans
what are the 4 principles of bioethics
Autonomy, Beneficence, Justice, Nonmaleficence
What is meant by Autonomy in bioethics
it is one of the 4 key principles
- self-rule/self-determination, participants must…….
- have full & complete understanding of the risks and benefits
- must be able to decide for ones-self, without outside influences
What is meant by Beneficence in bioethics
One of the 4 basic principles
To benefit, or do good for, the patient (not society)
What is meant by justice in bioethics
One of the 4 basic principles
equal & Fair treatment regardless of patient characteristics
What is meant by nonmaleficence in bioethics
Do not harm, researchers must not……
- withhold information - provide false information - Exhibit professional incompetence
Belmont Report
1978
Issued by national commission for protection of human subjects of biomedical and behavioral research
what are the 3 guiding principles of the Belmont Report
Respect for persons
- research should be voluntary, subjects autonomous
Beneficence
-Research risks are justified by potential benefits
Justice
- Risks and benefits of the research are equally distributed
what is consent
Agreement to participate, based on being fully and completely informed (given by mentally-capable individuals of legal consenting age)
What is the IRB
Institutional Review Board
Determines if a study is ethical (proper/safe)
role is to protect human subjects form undue risk
When must all human subject studies be reviewed and by who
Prior to the study by the Institutional Review Board (IRB)
Who regulates the IRB
Federal statues (laws and regulations)
Who developed the federal statutes that the IRB must follow
The Department of Health and Human Services (DHHS)
What are the Federal statutes normally called
CFR (common federal rules)
The CFR apply to what
All studies funded by federal government; standards also usually apply to studies reviewed by an IRB
What agency enforces that administers and enforces the regulations of the CFR (common Federal Rules)
Office of Human Research Protections (OHRP)
What are the 3 levels of IRB review
Full Board
Expedited
Exempt
When is Full board review used
used for all interventional trials with more than minimal/no risk to patients
when is expedited review used
Minimal risk and/ no patient identifiers
When is exempt review used
No patient identifiers, low/no risk, deidentified dataset analysis, environmental studies, use of existing data/specimens (de-identified)
What is the Data Safety and monitoring board (DSMB)
Semi-independent committee not involved with the conduct of the study but charged with reviewing study data as study progresses, to assess for undue risk or benefit
The Data Safety and monitoring board (DSMB) has _______ determined review periods (interim analyses)
Pre-determined
If either overly-positive or overly-negative findings are evident then the DSMB can do what
Stop the study early
What are two methodologies of human studies
outcomes and internal validity
What is internal validity
Assessments (measurements)
- scientifically-rigorous and standardized
- objective better than subjective assessments
- Valid, accurate and reproducible
