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Pod Med Exam 2 > Intro to Clinical Research Design > Flashcards

Intro to Clinical Research Design Flashcards

1
Q

What is evidence based practice (EBP)?

A

integration of evidence with clinical experience

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2
Q

What are the benefits to EBP?

A
  • allows HCP to address healthcare questions with evaluative and qualitative approach
  • to differentiate between high-quality and low-quality findings
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3
Q

Why research?

A

1) evidence based medicine
2) advance practice
3) legal obligation to test new products
4) intellectual curiosity
5) academic credence

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4
Q

According to DHHS regulation, what is research?

A

systemic investigation that will develop or contribute to generalizable knowledge

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5
Q

What is systemic investigation?

A

involves a plan that has data collection (quantitative or qualitative) and data analysis to answer a question

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6
Q

What is generalizable knowledge?

A

It allows you to:

1) draw general conclusions
2) inform policies
3) findings beyond a single individual or an internal program

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7
Q

Do research results have to be published or presented in order for it be considered as research?

A

No, but if you don’t publish it, it never happened

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8
Q

What is the definition of scientific research?

A

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

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9
Q

According to the federal definition, are case studies consider as research?

A

no, but it is a scholarly activity

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10
Q

What are the levels of evidence in order of least bias (1) to most bias (6)?

A

1) meta-analysis/ systematic review (least bias)
2) randomized controlled studies
3) controlled longitudinal studies
4) uncontrolled longitudinal studies
5) cross-sectional studies and case studies
6) expert opinions (most bias)

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11
Q

What is intellectual driving force?

A

biomed research is hypothesis driven, experimentally-executed and leads to further iterations of hypothesis and hypothesis testing

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12
Q

What is a hypothesis?

A
  • proposed explanation for a phenomenon

- in order for it to be a scientific hypothesis, the scientific method must be used to test it

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13
Q

What is research ethics?

A
  • conforming to accepted standards of social or professional behavior
  • adhering to ethical and moral principles
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14
Q

What is research misconduct?

A

falsifying or manipulating data in published or non-published research

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15
Q

What are the four guidelines to follow for research ethics?

A
  • honesty
  • accuracy
  • objectivity (avoid bias)
  • efficiency
    Bottom line: don’t falsify and don’t add to the data
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16
Q

What are the different types of observational study designs?

A
  • cohort (prospective and retrospective)
  • case-control
  • cross-sectional
17
Q

What is a cohort study?

A
  • follows a group of people who do not have the disease and uses correlations to determine the absolute risk of subject contraction
  • Basically about the life histories of segments of populations
  • can be prospective or retrospective
18
Q

What is a case-control study?

A
  • study design in epidemiology
  • compares subjects who have the condition (case) with subjects who do not (control) but otherwise similar
  • relatively inexpensive
19
Q

What’s an example of case-control study that had major impact?

A

demonstration of the link between tobacco smoking and lung cancer by Sir Richard Doll and others

20
Q

What is a cross-sectional study?

A

observes a population or a representative subset at a defined time

21
Q

How is cross-sectional study different from case-control study?

A

cross-sectional studies provide data on the entire population under study
case-control studies typically include only individuals with special characteristics

22
Q

What are treatment studies?

A

pertains to randomized and non-randomized clinical trials

23
Q

What are the three different types of randomized controlled trial?

A

1) double-blind
2) single-blind
3) non-blind

24
Q

What is a double-blind study?

A

both the investigator and the participant are blind to the nature of the treatment given (thought to produce objective results)

25
Q

What is a single-blind study?

A

the experimenters knew and not the subjects

26
Q

What is a non-blind study?

A

both experimenter and subjects know about the treatments

27
Q

What are the benefits to randomized controlled studies?

A

All of these reduce bias:

  • randomization
  • blinding
  • prospective study
28
Q

What is non-randomized trial (quasi-experiment)?

A
  • interrupted time series design
  • series of samples from the same population are obtained several times before and after a manipulated event or naturally occurring event
29
Q

Which study design is probably the most expensive?

A

randomized controlled trial

30
Q

What is phase 0 of a clinical trial?

A

exploratory, first-in-human trials (1-2 person)

31
Q

What is phase 1 of a clinical trial?

A
  • first stage of testing in human subjects
  • small group, 20-100, healthy volunteers
  • assesses the safety, tolerability, pharmacokinetics and pharmacodynamics of a drug
32
Q

What is phase 2 of a clinical trial?

A
  • assesses how well the drug works
  • larger group, 20-300
  • this is the phase where a new drug fails
33
Q

What is phase 3 of a clinical trial?

A
  • randomized controlled multicenter trials on larger patient groups (300-3000)
  • definitive assessment of the effectiveness of the drug, as compared to the ‘gold standard’
34
Q

What is phase 4 of a clinical trial?

A

aka post-marketing surveillance trial

  • safety surveillance (pharmacovigilance)
  • ongoing technical support
  • permission to be sold (if anything changes)
35
Q

What is phase 5 of a clinical trial?

A
  • comparative effectiveness research and community-based research
  • integration into public health
36
Q

What is the role of statistics in research?

A
  • should consider before study begins

- can’t use to rescue a flawed study

37
Q

What are some statistical issues?

A

need to consider:

  • dropouts/exceptions
  • randomization
  • intermediate endpoint
38
Q

How should one approach literature?

A

Questions to ask when considering literature:

  • is the researcher at a reputable institution?
  • who funded the study?
  • what is being reported (unusual lab reading or real health outcome)?
  • how does it compare to previous research?
  • was it controlled?

Pod Med Exam 2 (12 decks)

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