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Winter P2 > Exam 1 - DI 726 > Flashcards

Exam 1 - DI 726 Flashcards

1
Q

What studies provide what level of evidence?

A 
Systematic reviews of RCTs (Highest)
RCTs
Observational Cohort
Case Control
Physiologic Studies
Case Reports/Case Series (Lowest)
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2
Q

Case Control

A

Retrospective, where comparison groups are designated by outcome.

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3
Q

Randomized Control Trial

A

Study Design where comparison groups are randomly assigned by investigator

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4
Q

Case Report/ Case Series

A

No comparison group, just a showcase of a individual(s) in their disease state

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5
Q

Retrospective observational Cohort Studies

A

Study design where comparison groups are not designated by outcome, and data is analyzed after event takes place.

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6
Q

When would cohort studies be the best study to use?

A
  • In investigations with multiple endpoints (e.g. risk of death from various causes)
  • When estimating incidence in exposed populations
  • In investigation of exposure to rare environmental factors
  • Investigation of cofactors that vary over time
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7
Q

When would case-control studies be best used?

A
  • Investigation of rare diseases

- Investigation of exposure to multiple agents

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8
Q

IMRAD

A 
introduction
Methods
Results
and
Discussion
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9
Q

Validity

A

Meaning of Measurement

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10
Q

Reliability

A

Measurement consistency/Precision

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11
Q

Internal validity vs external validity

A

Internal Validity - does study use good methods/prove hypothesis
External Validity - Is study applicable/does it represent target population/ Replicable

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12
Q

Reliability vs Clinical Importance

A

Reliability - Statistically significant (precision); result not due to chance (p-value/CI); consistent to other studies
Clinical - Significant (relevance); outcome important to patients; treatment effect meaningful

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13
Q

Control with Cross Over Studies

A

Use self control by exposing experimental subjects and controls to periods of exposure and control.

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14
Q

Historical Control

A

Study uses results from previous study to compare to subjects from current study.

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15
Q

Placebo Control Trial

A
  • Gold Standard in controls
    FDA requires 2 positive Placebo control trials for new drug approval.
    Controls for factors other than intervention over time
  • Treatment Standards
  • Seasonality
  • Disease Waxing/Waning
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16
Q

Hawthorne Effect

A

Placebo Effect
- Patient expectations produce positive effect, most commonly seen in symptoms/disease w/ stronger psychological component (Pain, depression, Nausea)

17
Q

Ethics of PCTs

A
  • Unethical to use placebo in place of standard care

- Must have informed consent and patient must not be harmed

18
Q

What are the three analytical designs used in active control?

A

Superiority Trials
Equivalency Trials
Non-Inferiority Trials

19
Q

Superiority Trials

A
  • Shows efficacy is better than standard

- Have strong evidence for effectiveness

20
Q

Equivalency Trials

A
  • Can establish generic equivalency
  • Do not establish effectiveness by itself
  • Assumes standard is effective
21
Q

Non-Inferiority Trials

A
  • Establish not inferior to standard therapy
  • Does not establish efficacy by itself
  • assumes standard is effective
22
Q

What is association?

A

The statistical measure of dependence/relationship between two events, characteristics or variables.

  • measured in samples
  • use statistical tests and modeling to make inferences about population
23
Q

What is causal inference?

A

Possible explanations for observed data/association
Inferring causal relationship based upon body of research and knowledge.
- no set rules, guides for weighing evidence in support of causation.

24
Q

What systems for determining Causal relationship exist?

A
  • Koch’s Postulates

- Bradford Hill’s criteria for Causation

25
Q

What is the only required Bradford Hills Criterion for causality?

A

Temporality of exposure occurring before disease.

26
Q

What are the components of causal inference and how are they tested?

A
  1. True/Causal Effect
  2. Chance (Statistical Tests)
  3. Confounding
    (Study Design/Statistics/Subjective Assessment)
  4. Effect Modification
  5. Bias (study design/Subjective assement)
27
Q

What is Risk?

A

A term for measures of probability of a given outcome (incidence)
- Risk Measures quantify probability of a given outcome in a group of people

28
Q

What are measures of association?

A

Measures of association compare risks between groups of people.

29
Q

In case series studies:

  1. What are we studing?
  2. How do we measure?
  3. Advantages
  4. Disadvantages
A
  1. Study of “case” patients only
  2. Describe exposures or outcomes
  3. Convenience sample, or hypothesis generation
  4. Cannot measure association
30
Q

What are odds ratios?

A

A ratio calculated on odds, not probabilities or rates

  • the are a proxy measure for risk
  • A measure of association that can contribute to causal inference

Winter P2 (6 decks)

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