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
How do we unweigh inverse variance
random effects variance composition is determined by how much the effects of a study vary in terms of their size
26
random effects variance composition is determined by how much the effects of a study vary in terms of their size
REVC (Random effects variance composition)
27
Describe case control studies
Measure the ASSOCIATION between exposure to a factor & development of a disease (usually exposed group has more risk)
28
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)
Case-Control study
29
Describe a cohort study
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
30
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
Cohort study
31
Describe the features of Expressed attributable risk (EAR)
Key word: preventing disease the additional risk or probability of developing a condition that can be directly attributed to a particular cause.
32
Key word: preventing disease the additional risk or probability of developing a condition that can be directly attributed to a particular cause.
Exposed attributable risk (EAR)
33
Ratio of risks equation (incidence rates)
Disease risk in exposed / disease risk in unexposed
34
Disease risk in exposed / disease risk in unexposed
Ratio of risks
35
Difference in risk equation
(disease risk in exposed)-(disease risk in unexposed)
36
Relative risk (causation) equation
risk in exposed (incidence) / risk in non exposed (incidence)
37
risk in exposed (incidence) / risk in non exposed (incidence)
Relative risk (causation) equation
38
When do you use relative risk?
In a cohort study
39
When do you use odds ratio
a cohort or case control
40
Incidence exposed equation
a/(a+b)
41
a/(a+b)
Incidence exposed
42
Incidence in unexposed
c/(c+d)
43
c/(c+d)
Incidence in unexposed
44
Equation for exposed attributable risk (EAR)
(incidence in exposed in pop (abs)) - (incidence in pop without risk factor)
45
Absolute EAR equation
(incidence in exposed)-(incidence in unexposed)
46
(incidence in exposed)-(incidence in unexposed)
Absolute EAR(abs)
47
Relative EAR equation
EAR(absolute)/ incidence exposed
48
Describe the Population attributable risk (PAR)
Disease that's attributed to exposure
49
Population attributable risk (PAR) equation
(Incidence in exposed)-(incidence in unexposed)
50
Describe the mean
It's continuous and discrete nominal It's heavily influenced by outliers!!!
51
It's continuous and discrete nominal sum of all entries' / total # of entries It's heavily influenced by outliers!!!
Mean
52
Describe the median
It's not logically ordered (nominal) Middle number not effected much by outliers
53
It's not logically ordered (nominal) Middle number not effected much by outliers
Median
54
Describe the quartiles
lower = 25% 2nd 50% upper = 75%
55
What is the IQR equation?
Q3-Q1 It's not influenced by outliers
56
Data sets with small spreads then to have values close to the _______ & _________
close to the mean & has small variances (standard deviations)
57
The _______ the variances & standard deviations the more the __________ indicative of the whole data set
smaller mean
58
Describe standard deviation
The average distance of observations from mean & variance
59
The average distance of observations from mean & variance
Standard deviation
60
Small standard deviation means the data is
close to the mean
61
Probability of complimentary equation
1- (the probability of the event occurring)
62
Describe conditional probability
The probability of an event happens given that another event has happened
63
The probability of an event happens given that another event has happened
conditional probability
64
Describe the addition rule
for mutually exclusive events (precluding i.e roll a 3 then a 6) The probability of A or B P= A+B
65
Describe the multiplication rule
For independent events (flip heads and roll a 3) probability of A & B P= A*B
66
Positive skew
Right mode
67
Negative skew
Left mean
68
Describe a sampling error
Biased selection and randomized variation
69
Biased selection and randomized variation
Sampling error
70
Describe a standard error
construct confidence intervals
71
construct confidence intervals
Describe a standard error
72
Standard deviation measures
vairation
73
Describe a standard deviation error
Is precise (not good!)
74
Is precise (not good!)
Describe a standard deviation error
75
Describe a small standard deviation error
the estimate is precise (the sample size is large but there's less variance)
76
the estimate is precise (the sample size is large but there's less variance)
small standard deviation error
77
A small standard deviation has
small error and small confidence interval
78
Standard error of mean (SEM) equation
79
Standard error of proportions equation
80
Small studies on variable data give
wider confidence intervals
81
Confidence interval of the mean equation
82
Confidence interval of the mean equation
83
Standard error of proportions equation
84
Standard error of mean (SEM) equation
85
Confidence intervals (properties)
86
CI properties
87
List the parameters needed for calculation sample size
- 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
- 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
the parameters needed for calculation sample size
89
Factors affecting sample size
- 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
- 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
Factors affecting sampling size