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STATISTICS - STEP 2 > FA > Flashcards

FA Flashcards

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1
Q

Clinical trial - definition

A

Experimental study involving humans. Compares therapeutic benefits of 2 or more treatments, or the treatment and placebo

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2
Q

Double blinded study

A

Neither patient nor doctor knows whether the patient is in the treatment or control group

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3
Q

Triple blind refers to

A

The additional blinding of the researchers analyzing data

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4
Q

Clinical trial study quality improves when study is

A
  1. Randomized
  2. Controlled
  3. Double blinded
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5
Q

Clinical trial phase 1 sample

A

Small number of healthy volunteers or patients with disease of interest

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6
Q

Clinical trial phase 1 purpose

A

Assesses

  1. safety (is it safe?)
  2. toxicity
  3. pharmacokinetics
  4. Pharmacodynamics
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7
Q

Clinical trial phase 2 sample

A

Small number of patients with disease of interest

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8
Q

Clinical trial phase 2 purpose

A

Assess treatment

  1. efficacy (does it work?)
  2. optimal dosing
  3. adverse effects
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9
Q

Clinical trial phase 3 sample

A

Large number of patients randomly assigned either to the treatment under investigation or the best available treatment (or placedo)

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10
Q

Clinical trial phase 3 purpose

A

Compares the new treatment to the current standard of care (is it as good or better?)

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11
Q

Clinical trial phase 4 sample

A

Postmarketing surveillance trial of patients after approval

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12
Q

Clinical trial phase 4 purpose

A

Detects rare or long term adverse effects. Can result in a drug withdrawn from market (can it stay?)

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13
Q

Types of studies

A
  1. Cross-sectional study
  2. Case-control study
  3. Cohort study
  4. Twin concordance
  5. Adoption study
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14
Q

Adoption study design

A

Compares sibling raised by biological vs adoptive parents

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15
Q

Adoption study measures

A

Heritability and influence of environmental factors

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16
Q

Twin concordance study measures

A

Heritability and influence of environmental factors (nature vs nurture)

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17
Q

Twin concordance study design

A

Compares frequency with which both monozygotes twins or both dizygotic twins develop same disease

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18
Q

Cross-sectional study type

A

Observational

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19
Q

Cross-sectional study design

A

Collects data from a group of people to assess frequency of disease and related factors at a particular point in time (disease PREVALENCE)

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20
Q

Cross-sectional study/ask

A

What is happening?

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21
Q

Case control study type

A

Observational and retrospective

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22
Q

Cross-sectional study measures

Study These Flashcards
A
  1. Disease prevalence

2. Can show risk factor association with disease (but does not establish causality)

23
Q

Case control study/asks

Study These Flashcards
A

What happened

24
Q

Case control study design

Study These Flashcards
A
  1. Compares a group of people with disease to a group without disease
  2. Look for prior exposure or risk factors
25
Case control study measure
Odds ration (OR)
26
Case control study example (copd-smoking)
Patients with copd had higher odds of a history of smoking than those without copd
27
Cohort study type
Observational and prospective or retrospective
28
Cohort study design
1. Compares a group with a given exposure of risk factor to a group without such exposure 2. Looks to see if exposure increases the likehood of disease 3. Can be prospective (who will develop the disease) or retrospective (historical) (who developed the disease)
29
Cohort study measure
Relative risk
30
Cohort study/ask
Who developed the disease Or Who will develop the disease (exposed vs not
31
Cohort study example (copd/smoker)
Smokers had a higher risk of developing copd than nonsmokers
32
Clinical treatment trials - type of study (why)
cohort study --> some members with a specific illness are given one treatment and other members are given another treatment or placebo
33
Fixed properties of a test
1. Sensitivity | 2. Specificity
34
Sensitivity - definition (and equation)
Proportion of all people with disease who test positive or, The probability that a test detects disease when disease is present TP/(TP+FN)=1-FN rate
35
High sensitivity test used for screening in disease with ..... prevalence
LOW
36
Specificity - definition (and equation)
Proportion of people without disease who test negative or, The probability that a test indicates non disease when disease is absent TN/(TN+FP)=1-FP rate
37
100 sensitivity vs specificity - rule in vs rule out
sensitivity - rule out (low FN rate) | specificity - rule in (low FP rate)
38
Positive predictive value - definition (and equation)
1. Proportion positive test that are true postive 2. Probability that person actually has the disease given a positive test result TP/(TP+FP)
39
PPV varies directly with
Prevalence or pretest probability | High pretest --> high PPV
40
Negative predictive value - definition (and equation)
1. Proportion of negative test results that are true negative 2. Probability that person actually is disease free given negative test result TN/TN+FN
41
NPV varies inversely with
1. Prevalence 2. Pretest probability High pretest probability --> low NPV
42
fixed properties of a test and properties that vary
fixed: specificity, sensitivity vary: PPV, NPV (depending on disease prevalence)
43
association between PPV, NPV, sensitivity, specificity
high sensitivity --> high NPV | high specificity --> high PPV
44
Likelihood ratio?
likelihood that a given test result would be expected in a patient with the target disorder compared to the likelihood that the same result would be excepted in a patient without the target disorder
45
positive likelihood ratios indicate
LR+ = sens / (1 - spec) = TP/FP --> probability of an individual with the condition having a positive test / probability of an individual without the condition having a positive test
46
negative likelihood ratios indicate
LR- = (1-sensit) / specif) FN/TN--> probability of an individual with the condition having a negative test / probability of an individual without the condition having a negative test
47
Number of LR in very useful diagnostic tests
LR+ grearer than 10 | LR- lower than 0.1
48
how to estimate posttest odd
multiple LR with pretest odds
49
Prevalence
Number of existing cases/number of people at risk | At a point in time
50
Incidence rate
(Number of new cases in a specified time of period)/(population at risk during same time)
51
Prevalence directly reversible
1. Incidence | 2. Average disease dutation
52
Incidence and prevalence in common cold. Bigger?
Very similar because duration is short
53
Positive and negative predictive value vary depending on
Disease prevalence
54
town population is 7.500. In 2011, 200 residents diagnosed with RA. in 2012, 100 more residents are discovered by RA. incidence, prevalence?
``` incidence = 100/7300 prevelance = 300/7500 ```

STATISTICS - STEP 2 (6 decks)

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