Biostatistics Flashcards

1
Q

Steps or Path to publication

A
  • BEGIN With a RESEARCH QUESTION
  • DESIGN the STUDY
  • ENROLL the SUBJECTS
  • COLLECT the DATA
  • ANALYZE the DATA
  • PUBLISH
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2
Q

BEGIN With a RESEARCH QUESTION

A

Write a null hypothesis

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3
Q

DESIGN the STUDY

A

RCT

Case-Control

etc.

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4
Q

ENROLL the SUBJECTS

A

Assign treatment groups or identify subjects belonginging to a cohort or other group

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5
Q

COLLECT the DATA

A

Prospective

Retrospective

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6
Q

ANALYZE the DATA

A

Enter into statistical database

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7
Q

Continuous data has a logical order with values that continuously increase (or decrease) by the same amount. The two types of continuous data are?

A

interval data and ratio data

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8
Q

interval data has no meaningful zero

A

Celsius temperature scale is an example of interval data because it has no meaningful zero (0°C does not mean no temperature; it is the freezing point of water).

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9
Q

ratio data has a meaningful zero

(zero equals none)

A

Heart rate is an example of ratio data; a HR of 0 BPM is cardiac arrest (zero equals none; the heart is not beating).

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10
Q

RATIO DATA

Equal difference between values, with a true, meaningful zero

(0 = NONE)

A

Examples: age, height, weight, time, blood pressure

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11
Q

NTERVAL DATA

Equal difference between values, but with out a meaningful zero

(O does not = NONE)

A

Examples: Celsius and Fahrenheit temperature scales

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12
Q

DISCRETE (CATEGORICAL) DATA

A

Data fits into a limited number of categories

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13
Q

NOMINAL DATA

Categories are in an arbitrary order

Order of categories does not matter

A

Examples; gender, ethnicity

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14
Q

ORDINAL DATA

Categories are ranked in a logical order, but the difference between categories is not equal

Order o f categories matters

A

Examples: NYHA Functional Class l-IV;

0-10 pain scale

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15
Q

The mean is preferred for

A

continuous data that is normally distributed

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16
Q

The median is preferred for

A

ordinal data or continuous data that is skewed

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17
Q

The mode is preferred for

A

nominal data

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18
Q

Standard deviation (SP):

A

indicates how spread out the data is, and to what degree the data is dispersed away from the mean

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19
Q

Characteristics of a Gaussian Distribution

A

68% of the values fall within 1 SD of the mean and 95% of the values fall within 2 SDs of the mean.

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20
Q

An independent variable

A

is changed (manipulated) by the researcher

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21
Q

dependent variable

A

The dependent variables can be affected by the independent variables

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22
Q

Null hypothesis

A

What the researcher is trying to reject

The null hypothesis states that there is no significant difference between two treatment groups.

Example: Xarelto is equal to orange tic tacs in the prevention of blod clots.

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23
Q

When investigators design a study, they select a maximum permissible error margin, called?

A

alpha (a).

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24
Q

The p-value is compared to alpha. If alpha is set at 0.05 and the p-value is less than 0.05, the null hypothesis is?

A

rejected, and the result is statistically significant.

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25
Q

A confidence interval (Cl) provides the same information about significance as the p-value, plus the precision of the result.

A

CI = 1 - a

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26
Q

Type-I Errors

A

False positives

Results stated significance when in fact there was no significance and null hypothesis should have been accepted.

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27
Q

Type II errors

A

False Negative

The null hypothesis was accepted when it should have been rejected

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28
Q

Study power

A

The ability to avoid a Type II error (False Negative)

Power = 1-beta

beta is usually set to 0.1 or 0.2 (10% or 20%)

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29
Q

Risk

A

Total people in the group with an Unfavorabel Event [UE] (all the things that went bad) / Total number of people in the group [TIG] (How many people could have had a bad event)

UE / TIG

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30
Q

Relative risk

A

Risk in the Treatment Group (TG) / Risk in the Control Group (CG)

TG / CG

31
Q

Absolute risk reduction is more useful because it includes the reduction in risk and the incidence rate of the outcome.

A

take the risk of the control group and subtract the risk from the treatment group.

32
Q

Risk

A

500 people in a treatment group

43 had an event occur

Risk is 43/500 = (0.086 or 8.6%)

500 people in the control group

136 had an event

Risk is 136/500 = (0.272 or 27%)

33
Q

Relative Risk

A

Risk in treatment group / risk in control group

Risk is TG - 43/500 = (0.086 or 8.6%)

Risk is CG - 136/500 = (0.272 or 27%)

RR 0.86/.272 = .31 or 31%

34
Q

Relative Risk Ratio

A

Easy way is 1-RR. [1-0.31 = 0.69]

Calcualtions way

R of CG - R of TG / R of CG

(.272 - 0.86)/.272

Risk in treatment group / risk in control group 0.86/.272 = .31 or 31%

35
Q

Odd ratio formula

A
36
Q

In a survival analysis (e.g. analysis of death or disease progression), instead of using “risk,” a hazard rate is used.

A
37
Q
  1. RR = 1 (or 100%) implies
  2. RR > 1 (or 100%) implies
  3. RR < 1 (or 100%) implies
A
  1. no difference in risk of the outcome between the groups.
  2. greater risk of the outcome in the treatment group.
  3. lower risk (reduced risk) of the outcome in the treatment group.
38
Q

OR or HR = 1:

A

the event rate is the same in the treatment and control arms. There is no advantage to the treatment.

39
Q

OR or HR >1:

A

the event rate in the treatment group is higher than the event rate in the control group; for example, a HR of 2 for an outcome of death indicates that there are twice as many deaths in the treatment group.

40
Q

OR or HR <1:

A

the event rate in the treatment group is low^ than the event rate in the control group; for example, a HR of 0.5 for an outcome of death indicates that there are half as many deaths in the treatment group.

41
Q

normally distributed,

A

parametric methods are appropriate

42
Q

T-Tests

A

method used when the endpoint has continuous data and the data is normally distributed

43
Q

A student t-test is used when

A

the study has two independent samples: the treatment and the control groups

44
Q

Analysis of variance (ANOVA), or the F-test, is used

A

to test for statistical significance when using continuous data with 3 or more samples, or groups.

45
Q

animal or ordinal data, a chi-square test is used

A

to determine statistical significance between treatment groups.

For example, if a study assesses the difference in mortality (nominal data) between two groups, or pain scores based on a pain scale (ordinal data), a chi-square test could be used.

46
Q

PARAMETRIC TESTS

(Data has a normal distribution)

A

One-sample t-test

Dependent/paired t-test (if one group has before and after measures)

Two groups (e.g. treatment and control groups)

Independent/unpaired student t-test

Three or more groups

ANOVA (or F-test)

47
Q

Sensitivity

A

The tru positive

How likely you actualy have a positive test

Tested positive / total that have the condition

48
Q

Specificity

A

The true negative

How likely your negative test result is actualy negative

Tested negative / total that do not have the condition

49
Q

Senstivity and apecificity formula

A
50
Q

Senstivity and specificity formula (different look)

A
51
Q

Forrest plots

A
  • The boxes show the effect estimate
  • Diamonds represent pooled results
  • Horizontal lines through the boxes illustrate the length of the confidence interval
  • The vertical solid line is the line of no effect
52
Q

Recall for ratio data, the result is not statistically significant if the confidence interval ?

A

crosses one, so the vertical line

53
Q

Crosses 1 no significance

Crosses 0 no significance

A

Ratio data

Confidence interval

54
Q

■ Case-control studies:

A

retrospective comparisons of cases (patients with a disease) and controls (patients without a disease).

55
Q

■ Cohort studies:

A

retrospective or prospective comparisons of patients with an exposure to those without an exposure.

56
Q

■ Randomized controlled trials:

A

prospective comparison of patients who were randomly assigned to groups.

57
Q

■ Meta-analyses:

A

analyzes the results of multiple studies.

58
Q

Types of medical studies

A
  1. Systemic reviews and Meta analysis
  2. RCT
  3. Cohort Studies
  4. Case-Control
  5. Case series and Case Reports
  6. Expert opinions
59
Q

CASE-CONTROL STUDY

A

Compares patients w ith a disease (cases) to those with out the disease

retrospectively

60
Q

COHORT STUDY

A

Compares outcomes of a group of patients exposed and not exposed to a treatment; the researcher follows both groups prospectively.

Can be influenced by confounders, which are other factors that affect the outcome

61
Q

CASE REPORT AND CASE SERIES

A

Describes an adverse reaction or a unique condition that appears in a single patient (case report) or a few patients (case series).

62
Q

META-ANALYSIS

A

Combines results from multiple studies in order to develop a conclusion that has greater statistical power than is possible from the Individual smaller studies.

63
Q

SYSTEMATIC REVIEW ARTICLE

A

Summary of the clinical literature that focuses on a specific topic or question

64
Q

The ECHO model (Economic, Clinical and Humanistic Outcomes) provides a broad evaluative framework to:

A

assess the outcomes associated with diseases and treatments.

65
Q

Economic outcomes:

A

include direct, indirect and intangible costs of the drug compared to a medical intervention.

66
Q

Clinical outcomes:

A

include medical events that occur as a result of the treatment or intervention.

67
Q

■ Humanistic Outcomes:

A

include consequences of the disease or treatment as reported by the patient or caregiver (e.g., patient satisfaction, quality of life).

68
Q

Cost-minimization analysis (CMA)

A

is used when two or more interventions have demonstrated equivalence in outcomes, and the costs of each intervention are being compared.

69
Q

Cost-minimization analysis CMA is considered the easiest analysis to perform, but:

A

use of this method is limited given its ability to compare only alternatives with demonstrated equivalent outcomes.

70
Q

Cost-benefit analysis (CBA)

A

is a systematic process for calculating and comparing benefits and costs of an intervention in terms of monetary units (dollars).

71
Q

Cost-effectiveness analysis (CEA)

A

is used to compare the clinical effects of two or more interventions to the respective costs

72
Q

Cost-effectiveness analysis (CEA): The main advantage of this method is:

A

that the outcomes are easier to quantify when compared to other analyses, and clinicians are familiar with these types of outcomes since they are similar to outcomes seen in clinical trials and practice

73
Q

Cost-utility analysis (CUA)

A

is a specialized form of CEA that includes a quality-of-life component of morbidity assessments, using common health indices such as quality-adjusted life years (QALYs) and disability-adjusted life years (DALYs)