General Methodological Concepts of Research Flashcards
What is the most used study design and method? (general)
Quantitative
What is a main difference between interventional and observational quantitative studies?
interventional is forced allocation to study groups while observational is not forced- it is based on nature.
what study design is considered experimental, clinical study, human study?
Interventional
What is an observational study design?
Researches observe the subject that are naturally selected to those groups- NO forced allocation to groups
Does an observational study or interventional study “prove” causation?
Interventional
What is the foundational basis of the research evidence pyramid?
In vitro research and animal research
What is the most useful and appropriate study design?
It depends on the research being done, and what they are asking
What is a research question?
It is the purpose or statement for the experiment, it helps frame the study intent and can direct how a researcher forms the study
What are a few things that study design and method selection are based on?
Perspective of the research question Ethics of methodology selected Efficiency and practicality Costs Internal validity External Validity
Differentiate between a population and sample?
Population is all of the individuals who make up a common group, while a sample is a smaller portion of the population. Ex: Population is 130 COB students but research is done on 20% of them only.`
What is generalizability?
The ability to apply the results of the study to everyone who fits the criteria. External Validity
Describe a null hypothesis.
There will be no difference between the two groups being studied. It is the most conservative option and what is trying to be disproved. Reject or fail to reject the null.
What are the three statistical perspectives taken by a researcher in regards to null hypothesis?
Superiority
Noninferiority
Equivalency
What is a type one error?
False positive- pregnant male
Rejecting null and claiming there is a difference when there truly wasn’t
What is a type two error?
False negative- pregnant woman told she is not
failing to reject null when there is a difference
What is the difference between prospective and retrospective studies?
the difference is whether or not the outcome is known at the start
Define prospective study?
Groups are followed into the future to asses outcomes
Used by ALL interventional studies
What is a retrospective study?
outcomes have already occurred, the goal is to assess the past history to associate an exposure, faster than prospective, majority but not all of observational studies.
What are ambidirectional studies?
Combination of retro and prospective studies
Uses a retrospective design to look at difference in occurrences but adds future data.
What are probability samples?
Everyone in the population has an equal probability of inclusion
What is Simple Random Sampling?
Assign random numbers to participants and draw to put them into groups. Completely random, flip of the coin chance
Stratified Simple Random Sampling?
Stratify sampling frame by characteristics such as gender or age and then use simple random sampling
What is Multi-Stage Random Sampling?
Uses simple random sampling at multiple stages.
Region-City-House/Clinic/Hospital- Individual/occurrence
What is Non-Probability Sampling Scheme?
Quasi-Systematic or Convenience- NOT completely random or fully probabilistic
Ex: all whose last name is A-M or M-Z, all who attend clinics on MWF, Referred by peers
What is a concern with Non Probability Sampling Scheme?
There is some type of order to the randomness which could introduce selection bias
What is a primary outcome?
Key outcome of the study answers the main research question
What is a secondary research question?
Accidental findings, still important but not the main question. Such as finding out side effects of the main study drug
Patient presents with a persistent cough, low O2 saturation, when questioned they inform you they are a 3 pack a day smoker. Smoking is what kind of causal factor in development of lung cancer?
Component
While attending a conference a speaker states that for every two minutes of sitting a person does it takes one minute off of their life. He presents data that showed 50% increase mortality among the 12 people studied. Which part of hills criteria is iffy?
Consistency or plausibility
What is one way to achieve high external validity?
selecting a large sample
A researcher was testing drug X. They note that people who take it have a rash after four weeks, one year into the study they notice acute lung infections due to low WBC’s. What kind of study is this?
Tutors say Ambidirectional- I thought Prospective
70 high school freshman, 63 sophomores, 34 juniors and 83 seniors are randomly chosen for a study. What kind of sampling is this?
Stratified random sampling
What is the most important type of outcome?
Patient oriented (other choice was disease oriented)
What is a downside to combined outcomes?
They don’t tell you specifics- did the majority of people suffer a major bleed or did they die?
What is internal validity?
Methods used inside the study is it reproducible, is it clinically applicable and usable?
What is Equipoise?
Confidence that an intervention is worth while the benefits out weight the harm
What are the four key principles of bioethics?
- Autonomy: participants must decide themselves no outside influence
- Beneficence: benefit the individual (not society)
- Justice: fair and equal treatment of every patient
- Nonmaleficence: do no harm, dont withold info, provide false info, or be incompetent
What is the Belmont Report?
Ethical Conduct of research standards. Issued by national commission for protection of human subjects of biomedical behavioral research. It has 3 principles
What are the three principles of the Belmont Report?
Respect for persons
Beneficence
Justice
What is consent vs assent?
Consent is agreement to participate- fully informed and of legal age to consent
Assent is agreement to participate based on fully informed- consent is given by capable adults typically in case of kids
What does the IRB do?
They review studies before they start to determine if they are fit to begin. They protect the interests of the participants.
What is CFR?
Common Federal Rules- rules developed by the department of health and human services (DHHS) for the IRB to implement
Who enforces the CFR’s?
OHRP Office of human research protection
What are the three differences between the levels of review by the IRB?
Number of members who review
Time it takes
Level of documentation needed to be reviewed
What type of study uses a full board IRB review?
ALL interventional studies with more than minimal risk to patients. Collect a lot of information, drug trials
What kind of study uses an expedited level of review?
Minimal moderate risk to patient with or without patient identifiers.
What kind of study uses exempt level of review?
Low no risk no patient identifiers, data without ID, environmental studies, using existing data or specimens
What is the DSMB?
Data Safety and Monitoring Board. 3rd party who are not involved with conduct of study but review the data as it progresses to determine if they can continue. Can stop if overly positive or negative results
What are buzz words for interventional studies?
Randomized or phase #
