Block 3 Flashcards

1
Q

Key word: Max dose

  • Look for the max tolerable dose
  • Other treatments have failed
  • Normal organ function
  • Test drugs on a small sample
A

Phase 1

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2
Q

Describe phase 1

A

Key word: Max dose

  • Look for the max tolerable dose
  • Other treatments have failed
  • Normal organ function
  • Test drugs on a small sample
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3
Q

No therapeutic effects

A

Phase 0

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4
Q

Describe Phase 0

A

no therapeutic effects

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5
Q

Key words: FDA approval

  • Done on large studies
A

Phase 3

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6
Q

Describe Phase 3

A

Key words: FDA approval

  • Done on large studies
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7
Q

Key words: S-W-I-M (Safety-Work-Improvement- Market)

  • Long term effects and safety concerns
A

Phase 4

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8
Q

Describe phase 4 trial

A

Key words: S-W-I-M (Safety-Work-Improvement- Market)

  • Long term effects and safety concerns
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9
Q

Describe the features of permutated block randomization

A

2 groups & used for small studies; it’s good for maintaining balance

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10
Q

Describe the features of stratified block randomization

A

Involves 4 strata (ex. male 65 +/- & female 65 +/-)

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11
Q

Involves 4 strata (ex. male 65 +/- & female 65 +/-

A

Stratified block randomization

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12
Q

Describe open label blinding

A

no blinding in the study

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13
Q

no blinding in the study

A

Describe open label blinding

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14
Q

Describe triple blinding

A

The participants, researchers, and data analysts are all blinded

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15
Q

The participants, researchers, and data analysts are all blinded

A

Triple blinding

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16
Q

Describe double blind

A

Researchers and participants are both blind

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17
Q

Researchers and participants are both blind

A

Double blind

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18
Q

Describe what a metanalysis is?

A

Quantitatively combine and analyze the results from multiple studies on a specific topic, in order to draw more reliable and generalizable conclusions.

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19
Q

Describe the steps of performing a metanalysis

A

1) Define your research Q
2) Literature review
3) Select studies
4) Extract data
5) Analyze data
6) Report results

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20
Q

1) Define your research Q
2) Literature review
3) Select studies
4) Extract data
5) Analyze data
6) Report results

A

steps of performing a metanalysis

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21
Q

Quantitatively combine and analyze the results from multiple studies on a specific topic, in order to draw more reliable and generalizable conclusions.

A

Describe what a metanalysis is?

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22
Q

Describe inclusion factors

A

study design
population characteristics
treatment types
outcome measures

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23
Q

study design
population characteristics
treatment types
outcome measures

Are examples of what

A

Inclusion factors

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24
Q

Describe the steps of analyzing the data

A

1) Inverse variance weighing
2) unweighing inverse variance (via applying the random variance effects composition variable)

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25
Q

How do we unweigh inverse variance

A

random effects variance composition is determined by how much the effects of a study vary in terms of their size

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26
Q

random effects variance composition is determined by how much the effects of a study vary in terms of their size

A

REVC (Random effects variance composition)

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27
Q

Describe case control studies

A

Measure the ASSOCIATION between exposure to a factor & development of a disease (usually exposed group has more risk)

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28
Q

Measure the ASSOCIATION between exposure to a factor & development of a disease (usually exposed group has more risk)

Only use ODDS RATIO (can’t use relative risk)

A

Case-Control study

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29
Q

Describe a cohort study

A

observational study that follows a group of individuals with similar characteristics over a period of time to observe and analyze how certain factors or exposures influence the development of specific outcomes or diseases.

Use odds ratio OR relative risk

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30
Q

observational study that follows a group of individuals with similar characteristics over a period of time to observe and analyze how certain factors or exposures influence the development of specific outcomes or diseases.

Use odds ratio OR relative risk

A

Cohort study

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31
Q

Describe the features of Expressed attributable risk (EAR)

A

Key word: preventing disease

the additional risk or probability of developing a condition that can be directly attributed to a particular cause.

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32
Q

Key word: preventing disease

the additional risk or probability of developing a condition that can be directly attributed to a particular cause.

A

Exposed attributable risk (EAR)

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33
Q

Ratio of risks equation (incidence rates)

A

Disease risk in exposed / disease risk in unexposed

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34
Q

Disease risk in exposed / disease risk in unexposed

A

Ratio of risks

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35
Q

Difference in risk equation

A

(disease risk in exposed)-(disease risk in unexposed)

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36
Q

Relative risk (causation) equation

A

risk in exposed (incidence) / risk in non exposed (incidence)

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37
Q

risk in exposed (incidence) / risk in non exposed (incidence)

A

Relative risk (causation) equation

38
Q

When do you use relative risk?

A

In a cohort study

39
Q

When do you use odds ratio

A

a cohort or case control

40
Q

Incidence exposed equation

A

a/(a+b)

41
Q

a/(a+b)

A

Incidence exposed

42
Q

Incidence in unexposed

A

c/(c+d)

43
Q

c/(c+d)

A

Incidence in unexposed

44
Q

Equation for exposed attributable risk (EAR)

A

(incidence in exposed in pop (abs)) - (incidence in pop without risk factor)

45
Q

Absolute EAR equation

A

(incidence in exposed)-(incidence in unexposed)

46
Q

(incidence in exposed)-(incidence in unexposed)

A

Absolute EAR(abs)

47
Q

Relative EAR equation

A

EAR(absolute)/ incidence exposed

48
Q

Describe the Population attributable risk (PAR)

A

Disease that’s attributed to exposure

49
Q

Population attributable risk (PAR) equation

A

(Incidence in exposed)-(incidence in unexposed)

50
Q

Describe the mean

A

It’s continuous and discrete nominal

It’s heavily influenced by outliers!!!

51
Q

It’s continuous and discrete nominal

sum of all entries’ / total # of entries

It’s heavily influenced by outliers!!!

A

Mean

52
Q

Describe the median

A

It’s not logically ordered (nominal)

Middle number

not effected much by outliers

53
Q

It’s not logically ordered (nominal)

Middle number

not effected much by outliers

A

Median

54
Q

Describe the quartiles

A

lower = 25%
2nd 50%
upper = 75%

55
Q

What is the IQR equation?

A

Q3-Q1

It’s not influenced by outliers

56
Q

Data sets with small spreads then to have values close to the _______ & _________

A

close to the mean & has small variances (standard deviations)

57
Q

The _______ the variances & standard deviations the more the __________ indicative of the whole data set

A

smaller

mean

58
Q

Describe standard deviation

A

The average distance of observations from mean & variance

59
Q

The average distance of observations from mean & variance

A

Standard deviation

60
Q

Small standard deviation means the data is

A

close to the mean

61
Q

Probability of complimentary equation

A

1- (the probability of the event occurring)

62
Q

Describe conditional probability

A

The probability of an event happens given that another event has happened

63
Q

The probability of an event happens given that another event has happened

A

conditional probability

64
Q

Describe the addition rule

A

for mutually exclusive events (precluding i.e roll a 3 then a 6)

The probability of A or B

P= A+B

65
Q

Describe the multiplication rule

A

For independent events (flip heads and roll a 3)

probability of A & B

P= A*B

66
Q

Positive skew

A

Right

mode<median<mean

67
Q

Negative skew

A

Left

mean<median<mode

68
Q

Describe a sampling error

A

Biased selection and randomized variation

69
Q

Biased selection and randomized variation

A

Sampling error

70
Q

Describe a standard error

A

construct confidence intervals

71
Q

construct confidence intervals

A

Describe a standard error

72
Q

Standard deviation measures

A

vairation

73
Q

Describe a standard deviation error

A

Is precise (not good!)

74
Q

Is precise (not good!)

A

Describe a standard deviation error

75
Q

Describe a small standard deviation error

A

the estimate is precise (the sample size is large but there’s less variance)

76
Q

the estimate is precise (the sample size is large but there’s less variance)

A

small standard deviation error

77
Q

A small standard deviation has

A

small error and small confidence interval

78
Q

Standard error of mean (SEM) equation

A
79
Q

Standard error of proportions equation

A
80
Q

Small studies on variable data give

A

wider confidence intervals

81
Q

Confidence interval of the mean equation

A
82
Q
A

Confidence interval of the mean equation

83
Q
A

Standard error of proportions equation

84
Q
A

Standard error of mean (SEM) equation

85
Q

Confidence intervals (properties)

A
86
Q
A

CI properties

87
Q

List the parameters needed for calculation sample size

A
  • the minimum level of confidence we need in order to confidently say that there is a meaningful difference between two groups or variables being compared.
  • Acceptable error
  • The magnitude of the effect under investigation
    – the amount of disease in a population
  • the relative sizes of the groups being compared
88
Q
  • the minimum level of confidence we need in order to confidently say that there is a meaningful difference between two groups or variables being compared.
  • Acceptable error
  • The magnitude of the effect under investigation
    – the amount of disease in a population
  • the relative sizes of the groups being compared
A

the parameters needed for calculation sample size

89
Q

Factors affecting sample size

A
  • acceptable level of significance (p-value)
  • power of the study (1-B)
  • expected effect size
  • underlying event rate in population (prevalence rate)
  • standard deviation in population
90
Q
  • acceptable level of significance (p-value)
  • power of the study (1-B)
  • expected effect size
  • underlying event rate in population (prevalence rate)
  • standard deviation in population
A

Factors affecting sampling size