RESEARCH DESIGN and ETHICS Flashcards
a true experimental design in which subjects are randomly assigned to at least two comparison groups
randomized controlled trial
list the three essential characteristics of an experiment
- independent variable must be manipulated by researcher
- a control group must be incorporated into the design
- subjects must be randomly assigned to groups
experimental trials that examine the effect of interventions on patient or community populations; either therapeutic or preventative
clinical trials
pre-clinical research
in vitro
animal research
design drug delivery or surgical methods
if successful seek approval to begin human trials
phase 1
purpose is determining safety
small number of subjects
data on dosage, timing, side effects
phase II
demonstrate effectiveness
small samples several years
should be better than current protocol to continue
phase 3
compares new therapy to standard treatment or procedure
- randomized, controlled, blinded trial
large scale, many subjects
- if successful, seek FDA approval
phase 4
- patients followed after FDA approval
-evaluate effects in other populations - if problems are found, drug may be taken off market
aka one way design
one independent variable with any number of levels
- may have one or more dependent variables
-compares 2 or more groups randomly assigned
single factor experiment independent groups
factorial designs incorporates two or more independent variables; looks for main effects and the interaction effect of variables a and b together
multi factor designs for independent groups
example of a multi factor design for independent groups
analyzed by 2 or 3 way anova
one group, repeated measurements “within subjects” design
- each subject is its own control
- controls for individual differences because most factors remain constant throughout trials
repeated measures design
one independent variable (with levels), one group
- each subject is exposed to every level of the independent variable
-crossover design
one way repeated measure design
this is an example of:
each subject has eyesight measured with contacts and glasses and without any aid
one way repeated measures design
groups are selected on the basis of whether or not they have the disorder under study; PURPOSE IS TO DETERMINE WHY CASES HAVE THE DISEASE AND CONTROLS DO NOT
case-control study
two groups are chosen, one which has been exposed to a clinical intervention or agent, by chance or choice; ESTABLISH RELATIONSHIP BETWEEN EXPOSURE AND RISK OF DEVELOPING A PARTICULAR DISEASE
cohort study
description of new, interesting, and unique clinical cases as a means of sharing special information to professional colleagues
case studies
DESCRIPTIVE RESEARCH DESIGNS
description of developmental change and sequencing of behaviors over time
developmental studies
observation of different age or developmental groups at one point in time
cross-sectional study
called “Self reports” meaning that the researcher does not directly observe the behaviors but only records the respondents report of them
interviews and questionnaires
can be used under any classification of research, but they are most commonly used as methods for collecting descriptive data
surveys
these are the objectives that delineate what the researcher is trying to find out
formulation of guiding questions
detailed outline listing each item of information needed to answer guiding questions
questionnaire outline
find out if there is a similar questionnaire out there that can be used with modification; doesn’t necessarily have to be in the same field.
review of existing surveys
