Quiz #2 Flashcards
Define controlled clinical trial
A study testing a specific drug or other treatment involving 2 or more groups of patients with the same disease. One group receives treatment and the other receives an alternate treatment, a placebo treatment or no treatment. The groups are followed up to compare the differences in outcomes
Define Randomized Control trial
A controlled clinical trial where patients are randomly allocated to treatment and comparison groups
Define hypothesis
an idea/explanation tested through study and experimentation
Define Independent variable
The variable that is intentionally changed to observe its effect on the dependent variable
What is the difference between sample and population?
Sample: a representative unit of the population for study
Population: a set of individuals sharing specified properties
What is the difference between convenience sampling and probability sampling?
Convenience: the subjects selected for inclusion in the sample are easiest to access (like volunteer)
Probability: the subjects selected for inclusion in the study are done at random
Define cofounder
Unknown or unmeasured variables that may affect the relationship between exposure and outcome
Has a relationship with BOTH the exposure and the outcome
What is the difference between patient-level and cluster randomization?
They are both units of randomization
Patient-level: each subject is individually allocated to intervention or control
Cluster: subjects are allocated as part of a group (example: all patients of pharmacy A are intervention, all patients of pharmacy B are control)
What is the simple method of randomization?
Subject assignment without any consideration of previous assignments or affiliations
What is the stratified method of randomization?
Subjects grouped based on an important characteristic, then randomly sampled from that group into intervention or control
(example: female vs male, middle age vs elderly)
What is the block randomization method?
Enroll and randomize subjects within multiple smaller ‘blocks’ that eventually add up to the desired sample size
Done to make an even amount of people in one group and ensures blinding
What is the serial/factorial method of randomization?
Subjects are randomized into one group and then randomized into a second group
EX: randomized to intervention or control, then further randomize intervention group into different doses
What is quasi-randomization?
RED FLAG: not a true form of research where patients are not randomly allocated to a group and so confounding variables would be a problem
What is clinical Equipoise?
The point where there is no current clinical preference between treatments; equally likely that treatment A or treatment B will turn out to be superior
Ethics would not approve a trial unless this was proven by the experimenter
What is the difference between single, double and triple blinding?
Single = subject OR investigator Double = subject AND investigator Triple = subject AND investigator AND data analyst
What is an open label study?
No one is blinded
What is involved in a cross-over study design?
Subjects serve as their own control and each subject receives all treatments sequentially
Define Washout Period
Drug-free interval between treatments designed to eliminated carry-over effects from one treatment to the next during a cross-over study