Midterm Flashcards
A protocol outline includes what 6 things?
RQ, background & significance, study design, study population, measurements and statistics
A RQ is the __ of the study that must be __ and meet ___
objective of the study; focused; FINER criteria
Background & significance section of the protocol should include (6):
- rationale
- what is already known
- why is the RQ/study important
- what answers the study will provide
- cites previous research (uncertainties that still remain)
- how this study will address uncertainties from prior research
2 types of study design:
- observational
2. experimental
What are the types of observational studies?
cross sectional; case-control; cohort
What are the types of experimental studies?
randomized controlled trial (RCT)
The study population is defined by:
inclusion/exclusion criteria
Measurements section of protocol includes (4):
- what variables will be measured
- predictor variable(s)
- outcome variable(s)
- confounding variables
A predictor variable typically occurs __. It could have been ___. It is the ___ variable.
first; causal; independent
intervention
An outcome variable is the __ of the study, aka the ___; it is the ___ variable; ___ per research question
goal of the study; endpoint; dependent; one endpoint per RQ
ex= MI, death, stroke, decrease in BP
What are confounding variables?
anything that can influence/effect the outcome; needs to be controlled;
What is the difference between internal and external validity?
Internal validity= are the results accurate?
External validity= can the results be applied to the general population?
What are the two types of errors in research?
- random error: due to chance
2. systematic error: due to bias
Random error is due to __. It is distorted in what direction?
chance; equally likely to distort study in either direction
Systematic error is due to __. It is distorted in what direction?
Bias; distorts study in one direction
What are the three ways to reduce random error in research?
improve study design, increase sample size, increase precision
- sample size has no effect on systematic error
- *precision= consistency (hitting same spot on dart board)
What are the two ways to reduce systematic error?
improve study design, and increase accuracy
**accuracy= hitting bulls eye
What are the three characteristics of a good researcher?
skeptical, creative, tenacious
To determine if a RQ is feasible, look at (4):
number of subjects; technical expertise; cost in time and money; scope
Good clinical research __, __ and __ previous findings or provides __
confirms, refutes, extends; new findings
To confirm that a RQ is novel (3):
literature review, consulting experts, search funded research (ex= NIH)
An ethical RQ is the key to __. Don’t want study to (2):
IRB approval; pose unacceptable risk or invade privacy
A good RQ is relevant to (3):
scientific knowledge; clinical and healthy policy guidelines; future research
Advantages (2) and disadvantages (2) to multiple RQs:
adv: efficiency, back up plan
disadv: increases complexity, drawing statistical inferences