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FRCA Final > Statistics & Landmark Trials > Flashcards

Statistics & Landmark Trials Flashcards

1
Q

Define Absolute Risk

A

The number of events in a group, divided by the number of people in that group.

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2
Q

What is the absolute risk control (ARC)

A

Absolute risk in the control group (i.e. number of events in control arm divided by total numbers in control arm)

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3
Q

What is the absolute risk treatment (ART)

A

Absolute risk in the treatment group (i.e. number of events in treatment arm divided by total numbers in treatment arm)

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4
Q

Absolute risk reduction

A

ARC - ART

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5
Q

Number needed to treat

A

1 / Absolute risk reduction

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6
Q

Relative Risk

A

ART / ARC

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7
Q

Relative Risk Reduction

A

(ARC - ART) / ARC or 1 - RR

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8
Q

Sensitivity

A

TP / (TP + FN)

Ability for a test to descriminate if a person has a condition

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9
Q

Specificity

A

TN / (TN + FP)

Ability for a test to discrimiate if a person doesn’t have a condition

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10
Q

Positive Predictive Value

A

TP / (TP + FP)

Describes the performance of a test. I.e. the likelihood that a positive result is accurate.

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11
Q

Negative Predictive Value

A

TN / (TN + FN)

Describes the performance of a test. I.e. the likelihood that a negative result is accurate.

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12
Q

What is Prevalence?

A

The proportion of a population found to have a condition. e.g. 1 in 10,000.

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13
Q

What is Incidence?

A

A measure of the probability of occurrence of a given medical condition in a population within a specified period of time. E.g. 1 in 10,000 per year. It can be thought of as the rate as which a disease proliferates in the population.

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14
Q

Odds Ratio

A

Odds of the event : non-event

OR = 1 is no difference

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15
Q

What are the main problems associated with meta-analysis?

A
  • Publication bias
  • Language bias
  • Replication bias
  • Requires some homogeneity between studies
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16
Q

What is type 1 error

A
  • A.K.A. Alpha error.
  • Incorrect rejection of the null hypothesis
  • I.e. finds a difference where non-exists
17
Q

What is a type 2 error?

A
  • Incorrect acceptance of the null hypothesis
  • i.e. saying there is no difference when there really is
18
Q

What are observational studies?

A
  • The investigator does not assign exposures
  • There can however be comparison groups
  • With comparison groups => Analytical Study
    • Cohort study
    • Case-control study
    • Cross sectional study
  • Without comparison groups => Descriptive Study
    • Case report
    • Case series
19
Q

What is the heirarchy of medical evidence?

A
  • 1a) Systematic review of RCTs
  • 1b) Individual well designed RCT
  • 1c) All or none study
  • 2a) Systematic review of Cohort studies
  • 2b) Individual cohort study
  • 3a) Systematic review of case-control studies
  • 3b) Individual case-control study
  • 4) Case-series
  • 5) Expert opinion, bench research, first principles
20
Q

What is the grading of recommendation for scientific literature?

A
  • A - Consistent level 1 studies
  • B - Consistent level 2 or 3 studies, or extrapolations from level 1
  • C - Level 4 studies, or extrapolations from level 2 or 3
  • D - Level 5 evidence, or troubling/inconsistent studies at any level
21
Q

Describe the process required for drug approval

A
  • Pre-clinical studies
  • Phase 0
    • First in human
    • Micro dosing
    • Preliminary data on pharmacokinetics
  • Phase 1
    • Healhty volunteers
    • Dose-ranging
  • Phase 2
    • Larger groups
    • Efficacy testing
  • Phase 3 => at least 2 required to market
    • RCTs to assess efficacy
  • Phase 4
    • Post marketing surveillance
22
Q

What was the OPTIMISE (2014) trial investigating?

A

In high-risk patients undergoing gastrointestinal surgery, does a cardiac output-guided haemodynamic therapy algorithm compared to clinician-guided standard therapy reduce death and major morbidity within 30 days?

23
Q

What was the intervention protocol in OPTIMISE?

A
  • Colloid and dopexamine administration from induction of anaesthesia to 6 hours after end of surgery guided by LiDCO monitor.
  • 250ml bolus colloid over 5 minutes – positive response if rise in stroke volume of at least 10% sustained for 20 minutes.
24
Q

What was the outcome from OPTIMISE?

A

There was a reduction in 30 day composite adverse major outcomes, but not statistically significant (p = 0.07). No difference in other end points

25
Q

What factors affect the positive predictive value?

A

Sensitivity, Specificity and Prevalence.

26
Q

What is the Positive likelihood ratio?

A

Sensitivity / False Positive Rate

27
Q

What is the negative likelihood ratio?

A

False negative rate / Specificity

FRCA Final (21 decks)

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