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Clinical Research Design > Exam 1 > Flashcards

Exam 1 Flashcards

1
Q

What is clinical research?

A

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

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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
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3
Q

Describe descriptive research

A
  • Qualitative
  • Describe populations
  • developmental research, normative research, descriptive surveys, case reports, historical research, qualitative research
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4
Q

Describe Exploratory research

A
  • Observational
  • Find relationships
  • Ex.) cohort, case-control, correlational and predictive research, methodological research
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5
Q

Describe explanatory research

A
  • Experimental
  • Cause & effect
  • Ex.) RCT, pragmatic case trials, quasi-experiments, single-subject designs
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6
Q

Where do research questions come from?

A
  • Clinical experience
  • Clinical theory
  • Professional literature
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7
Q

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

A
  • PICO
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8
Q

What does PICO stand for?

A
  • Population or problem
  • Intervention
  • Comparison or control
  • Outcomes
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9
Q

What is a null hypothesis?

A

No difference

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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
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11
Q

What is the difference between simple or complex hypothesis?

A

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

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12
Q

What is a case study?

A

Describes an individual with a disease

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13
Q

What is a case series?

A

Describes a group of individuals with a disease

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14
Q

What is an ecological (population) study?

A
  • Correlational study at a population level
  • Compare average disease and exposure in several populations
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15
Q

What is a cross-sectional/observational study?

A

Describe exposure and/or disease in a population

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16
Q

What is a case-control study?

A

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

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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

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18
Q

What is an experimental study?

A

Examine outcome after an intervention

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19
Q

What is a randomized control trial (RCT)?

A

Examine outcomes in participants assigned to intervention or control group

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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

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21
Q

What is the independent variable?

A

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

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22
Q

What is dependent variables?

A

Outcome variables

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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

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24
Q

What is secondary literature and give some examples?

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

EX: Literature review articles, books

25
Q

What is tertiary literature?

A
  • 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
Q

What is the order of the evidence hierarchy?

A
  • Systematic Reviews
  • RCT
  • Cohort Studies
  • Case control studies
  • Case series, case reports
  • Editorials, expert opinions
27
Q

What is minimal detectable change?

A

Indicates the amount of change required to exceed measurement variability

  • Derived using stable sample at 2 time points
28
Q

What is minimal clinically important difference?

A

Indicates the amount of change required to produce clinically meaningful change

  • Best estimated in a changing sample over time
29
Q

What design classification does the ones listed below fall under and describe each:
Between- subject design
Within- Subject
Factorial

A
  • 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
Q

What is quasi-experimental design?

A

Does not include either random assignment or a control group

31
Q

Describe the pretest- posttest control group design?

A
  • 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
Q

Describe the factorial designs for independent groups

A
  • Incorporates 2 or more independent variables
  • Subject randomly assigned to various combinations of the levels of variables
  • Larger samples are needed
33
Q

How are factorial designs described?

A
  • According to the number of independent variables
  • By the number of levels within each factor
34
Q

How are factorial designs analyzed?

A
  • main effect of each independent variables
  • Interaction effects
  • 2 or 3 way analyses of variance are commonly used
35
Q

What is the gold standard for experimental research?

A

RCT

36
Q

Describe the difference between
Therapeutic trials
Diagnostic trials
Preventive Trials

A

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
Q

Why is the pretest- posttest control group design strong in internal validity?

A
  • Randomization controls for potential biases
  • Threats not controlled for are attrition and differential social threats
38
Q

What is the threat to external validity in pretest-posttest control group design?

A

Potential interaction of treatment & testing

39
Q

Describe Posttest- Only control group design

A
  • Similar to pretest-posttest control group design
  • Except no pretest is administered to either group
40
Q

What are multiple Factor Experimental Designs used for?

A
  • To determine the effects of the interaction between multiple factors
  • Two factor, 3x2 factorial design
41
Q

What is a repeated measure designs?

A
  • Also called within-subject design
  • Subjects used as their own control
42
Q

What is the effects of repeated measures?

A
  • Practice effects
  • Carryover effects
  • Order effects
43
Q

Describe a crossover design

A
  • 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
Q

What does Sequential Clinical Trials allow, compare and when is it stopped?

A
  • 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
Q

Sequential Clinical Trials are an alternative approach for?

A

RCT

46
Q

All RCT are what kind of research?

A

Experimental

47
Q

What is evidence based reserach?

A

Dissemination and application
Multiple perspectives
Research evidence, clinical expertise, pt values, clinical circumstances

48
Q

What is translational reserach?

A

Application of basic scientific findings to clinically relevant issues , while generating scientific questions based on clinical dilemmas
“Bench to bedside”

49
Q

What is the process of developing a research question?

A
  1. Identify the problem
  2. Identify the rationale
  3. Identify the type of research
50
Q

Describe each type of clinical trial:
Therapeutic trials:
Diagnostic trials:
Preventive trials:

A

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
Q

Describe Random Assignment

A

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
Q

What is concealed allocation?

A

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
Q

Describe control groups

A

nactive controls: Placebo, sham, attention control groups
Wait list controls
Active controls

54
Q

What does blinding do?

A

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
Q

Describe open-label trials

A

No blinding of researchers or participants due to logistic or ethical reasons
Potential Biases: Detection bias, performance bias

56
Q

Describe phase 1-4 clinical trial

A

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
Q

What is a superiority trial?

A

Newer intervention better than usal care

58
Q

What is a non-inferiority trial?

A

Newer intervention is not worse than usual care

59
Q

What is equivalence trials?

A

Bioequivalance of treatment effect

Clinical Research Design (1 decks)

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