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MED 106- RESEARCH METHODS AND ESSENTIAL MEDICAL STATISTICS > 37. INTERVENTIONAL STUDIES > Flashcards

37. INTERVENTIONAL STUDIES Flashcards

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USMLE® Step 1 flashcards
1
Q
  1. Which studies are conducted in the present time period?
A
  • Cross Sectional Studies
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2
Q
  1. Which studies are aimed at analysing future results?
A
  • Prospective Cohort Studies
  • Randomised Controlled Trials
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3
Q
  1. Which studies look at the past?
A
  • Retrospective Cohort Studies
  • Case Control Studies
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4
Q
  1. What is an Analytical Study?
A
  • this is when you compare groups
  • the researcher does have some kind of influence
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5
Q
  1. What is a Descriptive Study?
A
  • this is when you describe what you see in nature
  • the researcher has no influence

EXAMPLES:
- Case Reports
- Case Series studies

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6
Q
  1. What are Experimental (intervention) Studies?
A
  • the researcher in this study completely controls the
    exposure

THEY CONTROL THE FOLLOWING ASPECTS OF THE EXPOSURE:
- type
- amount
- duration
- randomisation

RANDOMISATION:
- how the exposure will be distributed to the population

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7
Q
  1. What is the most vigorous type of study design?
A
  • Experimental (Intervention) Studies

THIS IS BECAUSE OF:
- Random Assignment
- Concealment
- Blinding

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8
Q
  1. What effect does Random Assignment have?
A
  • it reduces the Confounding Bias
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9
Q
  1. What effect does Concealment have?
A
  • it reduces Selection Bias
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10
Q
  1. What does Blinding reduce?
A
  • it reduces the Biased Measurement
  • this means that it reduces information bias
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11
Q
  1. When looking at an Experimental (Intervention0 Study, what can be said about the conclusions made about the Exposure-Outcome association?
A
  • these conclusions are accurate
  • this is because of the Prospective Design of the study
  • it is because of the High Internal Validity of the trials
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12
Q
  1. What are the disadvantages of Trials?
A
  • they are not always possible
  • they are not always appropriate
  • they are not always ethical
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13
Q
  1. What is necessary to compare groups in an Experimental (Intervention) Study?
A
  • there needs to be Randomised Control Trials
  • there needs to be Non-Randomised Control Trials
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14
Q
  1. What are the four different types of Trials we have in Experimental (Intervention) Studies?
A
  1. Prophylactic Trials
  2. Treatment Trials
  3. RCT Trials
  4. Community (Cluster) Trials
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15
Q
  1. Define: Prophylactic Trials.
A
  • these trials evaluate the efficiency of the intervention
  • this intervention is designed to prevent disease

EXAMPLES OF INTERVENTIONS:
- vaccines
- vitamin supplements
- patient education

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16
Q
  1. Define: Treatment Trials.
A
  • these trials evaluate the efficacy of curative drugs
  • they evaluate the efficacy of interventions
  • they evaluate the efficacy of drugs that are designed to
    manage signs and symptoms of a disease
17
Q
  1. Define: RCT Trials.
A
  • these are trials that use individuals
  • these are tightly controlled trials
  • they are narrowly focused
  • they use highly selected groups
  • they can be a short or long trial
18
Q
  1. Define: Community (Cluster) Trials.
A
  • they are trials that look at cities, regions, schools or
    hospitals
  • they are less rigid
  • they are aimed at a group of individuals
  • they are long trials
  • they are used for prevention
19
Q
  1. Define: Clinical Trail Phases.
A
  • they are designed to answer a specific research
    question
20
Q
  1. How many phases are there to Clinical Trials?
A
  • there are 4 phases
21
Q
  1. What is Phase I of Clinical Trials?
A
  • the researchers test a new drug or treatment
  • they test it on a small group of people for the first time
  • they do this to evaluate its safety
  • they want to determine a safe dosage
  • they want to see the side effect
  • there is no control group in this Phase
22
Q
  1. What is Phase II of Clinical Trials?
A

NB:
- we only move onto this phase if Phase I has passed all
the safety requirements

  • the drug is given to a larger group of people
  • this aims to see if the drug is effective
  • this is a form of outcome assessment
  • this phase aims to further evaluate the safety of the
    drug
  • there is no control group included
23
Q
  1. What is Phase III of Clinical Trials?
A
  • the drug is given to a large group of people
  • this aims to confirm its effectiveness
  • it monitors the side effects

THESE RESULTS ARE THEN COMPARED TO:
- commonly used treatments or placebos
- this allows us to collect information on how we can use
the drug safely

24
Q
  1. What is Phase IV of Clinical Trials?
A
  • these are the studies that are done after the drug has
    been marketed
  • they allow us to gather information about the drug’s
    effects in various populations
  • it lets us track any side effects of the drug’s long term
    use

MED 106- RESEARCH METHODS AND ESSENTIAL MEDICAL STATISTICS (43 decks)

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