Brainscape's Knowledge GenomeTM


Top Flashcards (Certified)
All Flashcards

Clinical Research Design > Exam 1 > Flashcards

Exam 1 Flashcards

(59 cards)

Start Studying
1
Q

What is clinical research?

A

Structured process of investigating facts & theories & exploring connections with the purpose of improving individual & public health

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What are the steps of the research process?

A
  1. Identify research question
  2. Design the study
  3. Implement the study
  4. Analyze data
  5. Disseminate Findings
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Describe descriptive research

A
  • Qualitative
  • Describe populations
  • developmental research, normative research, descriptive surveys, case reports, historical research, qualitative research
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Describe Exploratory research

A
  • Observational
  • Find relationships
  • Ex.) cohort, case-control, correlational and predictive research, methodological research
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Describe explanatory research

A
  • Experimental
  • Cause & effect
  • Ex.) RCT, pragmatic case trials, quasi-experiments, single-subject designs
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Where do research questions come from?

A
  • Clinical experience
  • Clinical theory
  • Professional literature
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What is the abbreviation to keep in mind when framing the clinical research question?

A
  • PICO
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What does PICO stand for?

A
  • Population or problem
  • Intervention
  • Comparison or control
  • Outcomes
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What is a null hypothesis?

A

No difference

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What is the difference between directional and nondirectional hypotheses?

A
  • Directional: show a certain direction (ie increase or decrease)
  • Nondirectional: Can only show there is a difference but not which way it is going
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What is the difference between simple or complex hypothesis?

A

Simple: relationship between single dependent and single independent
Complex: multiple variables

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What is a case study?

A

Describes an individual with a disease

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What is a case series?

A

Describes a group of individuals with a disease

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

What is an ecological (population) study?

A
  • Correlational study at a population level
  • Compare average disease and exposure in several populations
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What is a cross-sectional/observational study?

A

Describe exposure and/or disease in a population

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What is a case-control study?

A

Compare exposure histories in people with disease (cases) and people without diseases (controls)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

What is a cohort study?

A

Compare rates of disease in people with different exposure histories or follow a population forward (prospective) or backward (retrospective) in time

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

What is an experimental study?

A

Examine outcome after an intervention

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

What is a randomized control trial (RCT)?

A

Examine outcomes in participants assigned to intervention or control group

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

What are covariates?

A

Two variables that vary together, can be very difficult or even impossible to separate the direct effects of each on the outcome of interest

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

What is the independent variable?

A

Predictor, explanatory variable, induces or explain the change of interest

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

What is dependent variables?

A

Outcome variables

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

What is primary literature and give some examples?

A
  • Original research and/or new scientific discoveries
  • Immediate results of research activities
  • Often includes analysis of data collected in the fields or lab

EX: Original research, dissertations, technical reports, conference proceeding

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

What is secondary literature and give some examples?

Study These Flashcards
A
  • Summarize and synthesizes primary literature
  • Usually broader and less current than primary literature

EX: Literature review articles, books

25
What is tertiary literature?
- Summarizes or condenses version of materials - Usually with reference to primary or secondary sources - Good place to look up facts or get general overview EX: Textbooks, dictionaries, encyclopedia, handbooks
26
What is the order of the evidence hierarchy?
- Systematic Reviews - RCT - Cohort Studies - Case control studies - Case series, case reports - Editorials, expert opinions
27
What is minimal detectable change?
Indicates the amount of change required to exceed measurement variability - Derived using stable sample at 2 time points
28
What is minimal clinically important difference?
Indicates the amount of change required to produce clinically meaningful change - Best estimated in a changing sample over time
29
What design classification does the ones listed below fall under and describe each: Between- subject design Within- Subject Factorial
- Experimental design Between: assigned to independent groups Within: subjects act as their own controls Factorial: way of describing an experimental design that is based on the number of factors
30
What is quasi-experimental design?
Does not include either random assignment or a control group
31
Describe the pretest- posttest control group design?
- Two or more independent groups - One independent variable - One or more dependent variables - Random assignment - Also known as parallel group stuides - Scientific standard for investigating cause & effect relationships
32
Describe the factorial designs for independent groups
- Incorporates 2 or more independent variables - Subject randomly assigned to various combinations of the levels of variables - Larger samples are needed
33
How are factorial designs described?
- According to the number of independent variables - By the number of levels within each factor
34
How are factorial designs analyzed?
- main effect of each independent variables - Interaction effects - 2 or 3 way analyses of variance are commonly used
35
What is the gold standard for experimental research?
RCT
36
Describe the difference between Therapeutic trials Diagnostic trials Preventive Trials
Therapeutic trials: effect of an intervention Diagnostic trials: accuracy of diagnostic procedures Preventive Trials: eval of whether a procedure or agent reduces risk of developing a disease or disorder
37
Why is the pretest- posttest control group design strong in internal validity?
- Randomization controls for potential biases - Threats not controlled for are attrition and differential social threats
38
What is the threat to external validity in pretest-posttest control group design?
Potential interaction of treatment & testing
39
Describe Posttest- Only control group design
- Similar to pretest-posttest control group design - Except no pretest is administered to either group
40
What are multiple Factor Experimental Designs used for?
- To determine the effects of the interaction between multiple factors - Two factor, 3x2 factorial design
41
What is a repeated measure designs?
- Also called within-subject design - Subjects used as their own control
42
What is the effects of repeated measures?
- Practice effects - Carryover effects - Order effects
43
Describe a crossover design
- Participants are randomized to a treatment sequence - Used to control for order effects - Should only be used when condition is stable - Considerations for washout period
44
What does Sequential Clinical Trials allow, compare and when is it stopped?
- Allows: for continuous analysis of data - Compares: Success of intervention for successive pairs of subjects - Stopped: as soon as evidence is strong enough to detect a difference
45
Sequential Clinical Trials are an alternative approach for?
RCT
46
All RCT are what kind of research?
Experimental
47
What is evidence based reserach?
Dissemination and application Multiple perspectives Research evidence, clinical expertise, pt values, clinical circumstances
48
What is translational reserach?
Application of basic scientific findings to clinically relevant issues , while generating scientific questions based on clinical dilemmas “Bench to bedside”
49
What is the process of developing a research question?
1. Identify the problem 2. Identify the rationale 3. Identify the type of research
50
Describe each type of clinical trial: Therapeutic trials: Diagnostic trials: Preventive trials:
Therapeutic trials: effect of an intervention Diagnostic trials: Accuracy of diagnostic procedures Preventive trials: Evaluation of whether a procedure or agent reduces risk of developing a disease or disorder
51
Describe Random Assignment
Process of assigning subjects to groups, participants have an equal chance of being assigned to any group Minimizes bias by creating groups that are similar at the start of the trial Random assignment is different than random selection Randomization minimizes the bias that would occur if participants were able to choose the intervention or control group that they preferred
52
What is concealed allocation?
Ensures group assignment is done without knowledge of those involved in the experimental process Minimizes bias in group formation Ex: sealed envelopes, external services separate from the research institution
53
Describe control groups
nactive controls: Placebo, sham, attention control groups Wait list controls Active controls
54
What does blinding do?
Minimizes observation bias by ensuring those involved in the study are unaware of a subject’s group assignment (participants, care givers, outcome assessors) Also referred to as masking “Double blind” means both participants and researchers are unaware of group assignment
55
Describe open-label trials
No blinding of researchers or participants due to logistic or ethical reasons Potential Biases: Detection bias, performance bias
56
Describe phase 1-4 clinical trial
Phase 1 - is the treatment safe? Phase 2 - does the treatment work? Phase 3: How does this treatment compare with standard care Phase 4: What else do we need to know
57
What is a superiority trial?
Newer intervention better than usal care
58
What is a non-inferiority trial?
Newer intervention is not worse than usual care
59
What is equivalence trials?
Bioequivalance of treatment effect

Clinical Research Design (1 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions