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Pod Med > Introduction to Clinical Research Design Lectures 1/2 > Flashcards

Introduction to Clinical Research Design Lectures 1/2 Flashcards

1
Q

What is a thoughtful integration of the best available evidence, coupled with clinical experience?

A

evidence-based practice

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2
Q

Kerlinger’s definiton of research?

A

scientific research is systematic, controlled empirical and critical investigation of natural phenomena guided by theory and hypothesis about presumed relationships is among such phenomena

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3
Q

A case study is defined as?

A

not research, but a scholarly activity

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4
Q

What are the 6 levels of evidence (starting with the lowest)?

A
  1. expert opinions
  2. cross-sectional studies + case studies
  3. uncontrolled longitudinal studies
  4. controlled longitudinal studies
  5. randomized
  6. meta-analysis
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5
Q

Where do you have the most bias? least bias?

A

most bias: at the bottom of the chart (generate hypothesis)

least bias: establish causality

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6
Q

Describe the 3 aspects of biomedical research?

A

I1. hypothesis-driven

  1. experimentally-executed
  2. leads to further interactions of hypothesis and hypothesis testing
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7
Q

What is a proposed explanation for a phenomenon?

A

a hypothesis

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8
Q

For a hypothesis to be put forward as a scientific hypothesis, what is required?

A

the scientific method requires that one can test is

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9
Q

What are research ethics? (2 things)

A
  1. conforming to accepted standards of social behavior or professional behavior
  2. adhering to ethical and moral principles
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10
Q

What is an example of research misconduct as discussed in class and it’s consequence?

A

falsification of data… no longer eligible for residency that is federally funded

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11
Q

What are the 4 research ethics guidelines to follow?

A
  1. Honesty
  2. Accuracy
  3. Objectivity
  4. Efficiency
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12
Q

What are the 3 types of observational studies?

A
  1. Cohort (includes prospective and retrospective)
  2. Case-Control
  3. Cross-Sectional
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13
Q

What is a from of longitudinal study used in medicine?

A

cohort study

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14
Q

EBP allows health care providers to address health care questions with what approach?

A

evaluative and qualitative

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15
Q

What type of study consists of an analysis of risk factors and follows a group of people who do not have the disease?

A

cohort study

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16
Q

EBP allows the practitioner to assess current and past research, clinical guidelines, and other information resources in order to identify what?

A

relevant literature while differentiating between high and low quality findings

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17
Q

Honesty, accuracy, objectivity, and efficiency are considered what things?

A

research ethic guidelines

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18
Q

What study uses correlations to determine the absolute risk of subject contradiction?

A

cohort studies

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19
Q

What are the 5 reasons research is done?

A
  1. evidence based medicine
  2. advance practice of medicine
  3. legal obligation to test new products
  4. intellectual curiosity
  5. academic credence
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20
Q

DHHS regulations defines research how?

A

systematic investigation, including research development, test, evaluation, designed to develop or contribute to generalizable knowledge

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21
Q

What is an activity that involves a prospective plan that incorporates data collection and data analysis to answer a question?

A

systematic investigation

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22
Q

Surveys/questionnaires are examples of what?

A

systematic investigation

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23
Q

What are 7 things that are considered systematic investigations?

A
  1. surveys/questionnaires
  2. interviews/focus groups
  3. analyses of existing data or biological specimens
  4. epidemiological studies
  5. evaluations of social or educational programs
  6. cognitive and perceptual experiments
  7. medical chart review studies
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24
Q

How do cross-sectional studies differ from case-control studies?

A

cross-sectionaL: aim to provide data on the entire population

case-control: studies only individuals with a specific characteristic

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25
Q

Investigations designed to develop or contribute to generalizable knowledge are those designed to do what 3 things?

A
  1. draw general conclusions
  2. inform policiy
  3. generalize findings beyond a single individual or an internal program
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26
Q

Interviews and focus groups are examples of what?

A

systematic investigation

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27
Q

T/F: Research results do not have to be published or presented to qualify the experiment or data gathering as research.

A

True

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28
Q

What makes an experiment or data collection, “research”?

A

need to have an intent to contribute to “generalizable” scholarly knowledge

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29
Q

T/F. Participants in research studies do not deserve protection if the study is not published.

A

False. THEY DO!

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30
Q

Data collected from a defined time involve what type of study?

A

cross-sectional studies

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31
Q

What studies are used to assess the prevalence of acute or chronic conditions?

A

cross-sectional studies

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32
Q

What is a benefit to case-control studies?

A

relatively inexpensive and can be carried out by a small team or individual researchers

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33
Q

Example of the case-control study we learned in class

A

study between tobacco smoking and lung cancer by Sir Richard Doll

34
Q

People argued that Sir Richard Doll’s case study did not show causation, but these people were later proved wrong. Why?

A

results from cohort studies confirmed a causal link

35
Q

What type of study forms a class of research methods that involve observation of all of a population at a defined time?

A

cross-sectional study

36
Q

What type of study answers questions about the causes of disease or the reults of medical intervention?

A

cross-sectional study

37
Q

What studies may involve questions about the past, but often rely on data originally collected for other purposes?

A

cross-sectional study

38
Q

What type of studies are not suitable for rare diseases?

A

cross-sectional

39
Q

What study is a form of a clinical trial?

A

randomized controlled trial

40
Q

What is used in testing the safety and efficacy or effectiveness of healthcare services or technologies?

A

randomized control studies

41
Q

When are study subjects randomly allocated to receive or another treatment?

A

after assessment of eligibility and recruitment

before the intervention study begins

42
Q

Cost of a cross-sectional study?

A

moderately expensive

43
Q

What is a study in which both the investigator or the participant are blind to the nature of the treatment the participant is receiving?

A

double blind

44
Q

What study produces objective results?

A

double blind

45
Q

What study involves experiments who know the makeup of the test/control groups, but not the subject.

A

single-blind

46
Q

What is a study when neither experimenter or subjects are blind to the treatments?

A

non-blind

47
Q

What 3 things reduce bias?

A

randomization
blinding
prospective study

48
Q

In clinical practice, what is generally considered the gold standard for research design?

A

randomized control trial

49
Q

What study is largely about life history of segments of population?

A

cohort

50
Q

In your own words, what is a cohort study?

A

a type of study that takes a look at a group of people who do not have a disease, and then try to calculate their risk based on risk factors

longitudinal
do not have a disease
try to find risk factor by looking at history of population segment

51
Q

What are the 2 subdivisions of cohort studies?

A

prospective and retrospective

52
Q

What type of study has a design in epidemiology?

A

case-control

53
Q

What is a case-control study in your own words?

A

comparing healthy people to subjects with the condition to identify factors that may contribute to a medical condition.

54
Q

What study involves measurements on a sample or a series of samples f rom the same population at several times before and after a manipulated event?

A

nonrandomized trial

55
Q

What is considered a type of quasi-experiment?

A

nonrandomized

56
Q

What is the phase for exploratory, first-in-human trials conducted in accordance with the FDA?

A

Phase 0

57
Q

What phase involves microdosing?

A

phase 0

58
Q

What phase is the first state of testing in human subjects?

A

Phase 1

59
Q

What phase occurs once the safety of the study drug has been confirmed?

A

Phase 2

60
Q

How many volunteers are utilized in a Phase 1 study?

A

20-100

61
Q

When does the development process of a drug usually fail? What stage?

A

Phase 2 (does not work as planned or has toxic effects)

62
Q

How many volunteers are in a Phase 2 study?

A

20-300

63
Q

What phase involves trials designed to asses the safety, tolerability, pharmocokinetics, and pharmacodynamics of a drug?

A

Phase 1

64
Q

What is an example of a Clinical trial of Phase 2 that failed (learned about it in class)

A

Jesse Gelsinger: ornithine transcarbamylase deficiency; principal investigator has financial ties to the study and eligibility was not respected

65
Q

What are a few reasons the University of Pennsylvania study was unethical?

A

failure to disclose in the informed-consent documentation that monkeys died when given this treatment; failure to report other side effects etc

66
Q

What study phase involves randomized controlled multicenter trials?

A

Phase 3

67
Q

How many people are used in a Phase III phase study?

A

300-3,000

68
Q

What Phase is also know as “post-marketing surveillance trial”?

A

Phase 4

69
Q

What trial involves the safety surveillance and ongoing technical support of a drug after it receives permission to be sold?

A

Phase 4

70
Q

What trial aims at being the definitive assessment of how effective the drug is, in comparison with the current, “gold standard” treatment.

A

Phase 3

71
Q

What Phase involves the comparative effectiveness research and community-based research?

A

Phase 5

72
Q

What type of study is this:

20 subjects with PF were matched for age and sex to 20 controls.

A

Case-Control

73
Q

What is the key to success of case-control studies?

A

matched with a control

74
Q

What Phase is used to signify the integration of a new clinical treatment into widespread public health practice?

A

Phase 5

75
Q

What study is this: This study examined bone fractures in a cross section of 9th and 10th grade girls at an urban high school. As a whole, 80% of the groups…

A

cross sectional

76
Q

Can statistical manipulations be used to rescue an intrinsically flawed study?

A

NO

77
Q

T/F. The best research usually comes from university-affiliated or independent, non profit research institutes (including government based organizations).

A

True

78
Q

Does it matter who funded the research?

A

YES!

79
Q

T/F. Journals will not tend to publish single studies unless the discuss how they intend to relate or be used in other studies or why they disagree with others.

A

T

80
Q

T/F. Observations without controls leaves you wandering the the dark?

A

T

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