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Drug Literature > Quiz 2 > Flashcards

Quiz 2 Flashcards

1
Q

What is systematic review?

A

Analysis of lit to address a specific question using rigorous procedures – including defined inclusion and exclusion criteria and literature search procedure – to identify and summarize existing studies and synthesize an answer

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2
Q

What is a problem with systematic review?

A

Heterogenity

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3
Q

What is meta analysis?

A
  1. A systematic review which uses statistical methods to combine data from multiple studies of the same topic
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4
Q

How does meta analysis differ from systematic review?

A

M: A quantitative and more objective type of systematic review.

Goes beyond critique to conduct secondary statistical analysis on outcomes of studies

Results are combined to produce overall statistic

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5
Q

What is a problem with meta anaylsis?

A

Heterogenity

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6
Q

What is a clinical practice guideline?

A

Statements that include recommendations intended to optimize patient care

Assess the benefits and harms of alternative care options

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7
Q

What is CPGs based on?

A
  1. Systematic assessment of the best available research and practice experience.
  2. Large committees weigh all available evidence and expert opinions to estimate the benefits and harms of diagnostic procedures and treatments
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8
Q

What is CPGs used for?

A

Tell how evidence was evaluated

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9
Q

What is a population?

A

the set of all subjects or measurements

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10
Q

What is a sample?

A

The group from which you will collect data

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11
Q

What is a parallel design?

A

Each subject is randomized to either the experimental or the control group and receive the intervention assigned for the duration of the study

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12
Q

What is crossover design?

A
  1. Each subject receives all interventions in a specified sequence.
  2. There is a washout period between treatments.
  3. Balanced
  4. Requires fewer subjects because each serves as her/his own control.
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13
Q

How are subjects selected in crossover design?

A

Randomization of sequence helps to account for temporal trends

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14
Q

Identify the comparison between parallel and crossover designs?

A

P: Groups assigned different treatments, shorter duration, sample size-large, no carryover effect, acute cases
C: Each patient receives both treatments, longer, smaller, carryover effect, not in acute but chronic and stable cases

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15
Q

What are the advantages of crossover?

A
  1. Small sample size
  2. Balances cofounders
  3. Can examine participant by intervention interaction
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16
Q

What are the disadvantages of crossover?

A
  1. Potential carry over
  2. Longer follow up
  3. More loss follow up with longer trials and exposure to multiple interventions
  4. Parallel takes less time but larger sample size
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17
Q

What scenarios would cross overs be the most advantageous?

A
  1. Chronic, stable diseases with no permanent cure
  2. Interventions with quickly reversible effect
  3. Drugs with short half-life
  4. Endpoints with large intrasubject variation
  5. Short interventions are necessary
18
Q

What is factorial design?

A
  1. An experiment that manipulates >1 independent variable (factors) at one time
  2. Uses the same study population test >1 intervention
  3. Measures every combination of variables and levels
19
Q

How are each factors measured in factorial design?

A

A number of different settings called levels

20
Q

How are factorial designs subjects selected?

A

Randomly assigned to a treatment combination from a pool of all possible combinations of factor levels

21
Q

What is an example of factorial design?

A

RCT which contains 2 levels: “on” active treatment condition and “off” control treatment condition

22
Q

What are the advantages of factorial design?

A
  1. Investigation of results of interactions between factors
  2. Interactions aren’t detected by one factor but many
  3. Allows effects of a factor to be estimated at a number of levels of other factors yielding conclusions that are valid over a range of experimental condition
23
Q

Distinguish the differences among factorial, parallel, and crossovers regarding rondomizizatinon and outcomes?

A
24
Q

What is non-equivalent control group?

A
  1. Compares groups where subjects are not randomly assigned to groups
  2. Researcher has no control over the intervention
  3. Used when a natural and common phenomenon affects a population
25
Q

What are the advantages of non-equivalent control group?

A
  1. Lower temporal bias than cross-sectional design
  2. Can be done when randomization is impractical or unethical
26
Q

What are the disadvantages of non-equivalent control groups?

A
  1. Potential maturation bias and history bias
  2. Possible regression to the mean
  3. Selection bias
27
Q

What is time series methods?

A
  1. Add more observations to pre-post test so that trends over time can be observed
  2. Decrease probability of maturation bias
  3. Multiple observations are made, before and after intervention
  4. Track trends
28
Q

What is time series method useful for

A
  1. Examining trends in an outcome over time
  2. The possibility of an immediate treatment effect
  3. The sustainability of a treatment effect over time
29
Q

What is double dummy design?

A
  1. Use for blinding in trials investigating active interventions that can not be made indistinguishable
30
Q

How is double dummy design laid out?

A

Uses 2 placebos, one for each intervention

31
Q

How are subjects selected in double dummy?

A

Randomized to receive one active treatment and one placebo not knowing which

For comparison of 2 treatments, A and B each subject takes 2 sets of treatment, either active A and placebo B or placebo A and active B.

32
Q

What is adaptive design?

A
  1. Uses accumulating data from trial to modify aspects of the trial
  2. Trial arm may be dropped
33
Q

What can be changed in adaptive design?

A
  1. Sample size can be recalculated
  2. Dose
  3. End point
  4. Randomization ratio
34
Q

What is the reason adaptive design is stopped?

A

Efficacy, futility, ssafety

35
Q

What is stratified random sampling?

A
  1. Population to be sampled is 1st divided into groups based on characteristics believed to be importnat
  2. Probabilities may be different between the groups
  3. Assures that the different characteristics on which strata are based are sufficiently represented in the sample
  4. Resulting data must be analyzed using statistics that account for stratification
36
Q

What is cluster random sampling?

A
  1. Researchers divide the population to sampled into smaller groups or clusters
  2. Researchers then randomly select clusters to be in the sample.
  3. Unit randomized is not individual subjects but clusters of subjects
37
Q

What is cluster random sampling useful for?

A
  1. When the target of an intervention is a system rather than an individual patient
  2. Better able to test if a new standard of care, recommendation, or systems wide policy is affecting outcomes
38
Q

What is block random sampling?

A
  1. Individuals are arbitrarily divided into blocks (subsets) with even numbers of subjects and then randomly assigned from those blocks to the different treatment groups.
  2. Blocks have no significance other than an assignment group.
  3. Guarantees equal numbers in the two treatment groups.
39
Q

What is non-inferiority design?

A
  1. Not the same as equivalence
  2. Design produces a statistical measure that shows that the tested intervention is clinically not significantly inferior to a standard treatment or active control (a real drug not placebo).
  3. Specifies a statistical tolerance (boundary) that is deemed not clinically significant
40
Q

Why do we use non-inferiority?

A
  1. New product similar efficacy but expect to have other advantages such as safety or cost.
  2. Establishing superiority difficult
  3. Testing vs placebo unethical

Drug Literature (9 decks)

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