Lecture 8 (summary lecture) Flashcards
(69 cards)
What are the 6 components of a scientific research question?
1) Population
2) Intervention
3) Comparator
-ex: placebo, treatment, usual care
4) Outcomes
-ex: clinical, economic, humanistic
5) Timing
6) Setting
What is the gold standard for experimental research design if you want to show cause and effect?
Randomized control trials (RCT)
Give 2 examples of types of observational studies that illustrate associations between specific variables
Cohort or cross-sectional studies
Give 2 examples of research design
Observational vs experimental
Research oversight: IRB and monitoring board should be _______________ from investigators
independent
Differentiate between the roles of the IRB and Data and Safety Monitoring Board
1) IRB = Ethics + Study protocol review
2) Data and Safety Monitoring Board = Reviews trends of unblinded or study arm of trials
Define informed consent
Ongoing dialogue intended to provide sufficient information so that the individual can make his/her own decision about research participation
Informed consent:
Persons with diminished ____________ require special safeguards to prevent their exploitation in research
autonomy
Pediatric patients can _________ to treatment, but cannot consent to treatment
assent
True or false: Research design must confer internal and external validity
True
Define internal validity
Reflects the extent to which the clinical outcome of interest (dependent variable) in a study is caused by the treatment (independent variable)
1) ____________ variable = clinical outcome
2) ____________ variable = treatment
1) Dependent
2) Independent
Define external validity
The extent to which the results of a study can be generalized to other settings
Randomized controlled trials (RCTs)
Because of randomization, all observed as well as unobserved baseline characteristics are distributed evenly among the experimental and control groups, which thereby alleviates the systematic differences among participants in influencing study results.
What does this imply?
randomization increases internal validity of RCTs.
True or false: Since RCTs are conducted in tightly controlled clinical settings, the results may not be generalizable to routine (real-world) settings.
True
Observational studies:
Define cohort studies
two groups, the exposed and the unexposed, are followed (prospectively or retrospectively) over a period of time until the development of outcome of interest
Observational studies:
Define case-control studies and give an example
Comparison of exposure status among individuals with the disease or outcome of interest (cases) and those without the disease or outcome (controls)
-Example: Patients with squamous cell carcinoma; Who smoked?
Observational studies:
What has the highest level of observational evidence?
Cohort studies
Observational studies:
1) What are two types of cohort studies?
2) Give an example of cohort studies
1) Prospective or retrospective
2) Example: Smokers vs. non-smokers; Who develops squamous cell carcinoma?
Observational studies: Define cross-sectional and give an example
Prevalence studies; exposure and outcome of interest are measured at the same point in time
-Example: How many people were infected with COVID-19 and died during 2020?
Observational studies: Define case series and give some well-known examples
1) Collection of case reports
2) Credited with the discovery of AIDS and identification of the relationship between thalidomide and birth defects
Observational studies: Define case report. What is unique about this?
1) Single patient with novel predicament
2) Lowest level of observational evidence
What observational study has the lowest level of observational evidence?
Case report studies
What studies maximize validity and minimize bias?
RCTs