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The Cycle
y of Research
Definitions of Terms
Study
y Design
g
Measurement Scales
The description
p
of any
y medical or health research study
y
should provide answers to the following:
Cycle of Research
It can be
b ttoo expensive
i and/or
d/ titimetime-consuming
i tto collect
ll t
data for the population
St d off th
Study
the population
l ti may b
be impossible
i
ibl
Cycle of Research
i average weight
i.e.
i ht off 1,000
1 000 b
boys sampled
l d ffrom th
the
U.S.
Random Sampling
Selection Bias
Garbage in
Garbage out
10
11
F large
For
l
populations,
l ti
th
the diff
difference b
between
t
these is negligible
12
Gender
Clinic
Age groups
13
14
Cycle of Research
15
Study Design
16
Cycle of Research
17
Calculation
Th ttwelve
The
l males
l were weighed,
i h d resulting
lti
in weights in pounds of :
{129,134,136,140,141,142,144,155,158,162,
165,191}
The statistics how obtained were the
average
g and standard deviation of the
weights.
18
Cycle of Research
19
Estimation
20
Cycle of Research
21
Inference
B comparison
By
i
with
ith national
ti
lh
health
lth d
data
t
from the CDC, we conclude that young
athletic
thl ti males
l h
have llower average weights
i ht
than young males overall, and thus their
b i glycogen
brain
l
results
lt may nott b
be
generalizable to young males overall.
PubH 6414 Lesson 1
22
Population
Sample
study cycle
Parameter
Statistic
Status
Household
income
<$5000
Educatio
n>high
school
Not
Employe
married
d
or
separated
Had
had
Pap
mammograp
smear hy
Yes
27%
68%
68%
80%
48%
35%
No
73%
32%
32%
20%
52%
65%
Question 1:
___ corresponds
p
to the
procedure highlighted in
this picture?
1.
2.
3.
Population
Sample
Parameter
Statistic
Question 2:
2.
3.
4.
Question 3:
Forty-eight
y g percent
p
had their most
recent Pap smear is ___?
1.
2
2.
3.
Parameter
Statistic used to
Statistic,
estimate
parameter
Statistic, also the
parameter
t
Question 4:
select
l the
h picture
i
corresponding
di to the
h
following
g statement.
2.
4.
3.
30
Case Series
A case series is observational
Subjects are observed and the outcomes or
characteristics of the observation are described
31
Case--Series Example
Case
32
Cross--Sectional Design
Cross
33
Non--response bias
Non
34
Case--Control Design
Case
D t
Determine
i pastt exposure to
t suspected
t d risk
i k ffactor(s)
t ( ) for
f
the disease or condition from
Cases
C
Cases
already
l d h
have th
the di
disease
Controls
Controls individuals from a similar population who do not have
the disease
35
http://www.cancer.gov/cancertopics/factsheet/brain
htt
http://www.cancer.gov/cancertopics/factsheet/brain//
/
t i /f t h t/b i -tumors
t
tumorscell--phones
cell
PubH 6414 Lesson 1
36
Case--Control Design
Case
37
Cohort Design
smokers
k
and
d nonnon-smokers
k
overweight and normal weight
38
Ri k ffactor
Risk
t exposure is
i d
determined
t
i d iin th
the
present and information about the outcome is
collected
co
ected at a future
utu e ttime
e
39
40
Cohort Design
Long follow
follow--up time required can result in loss to
follow--up (or drop out) of some subjects in the study
follow
41
Experimental Studies
New drug
New surgical procedure
Ed cation / counseling
Education
co nseling program
Exercise program
42
Experimental Studies
43
44
45
In a RCCT Subjects
j
are randomlyy assigned
g
to the
intervention group or the control group
These trials p
provide the strongest
g
evidence for a
cause--effect relationship between the intervention and
cause
the outcome.
Drawbacks of randomized controlled clinical trials
Time-consuming
TimeExpensive
46
MRFIT: Multiple
p Risk Factor Intervention Trial
12,866 men with RF for CHD randomly assigned to
47
Blinded studies
Single
Singleg -blind
Double--blind
Double
Triple--blind
Triple
48
Random Assignment
Observational studies use random sampling but
controlled clinical trials use random assignment
In a randomized clinical trial, subjects are
selected based on inclusion and exclusion
criteria
49
Recall bias
Compliance bias
50
51
Problem 1
PubH 6450
52
1.
2.
3
3.
Twenty-five male
Twentyvolunteers
Male who ages
g 18
to 24 years
All males
PubH 6450
53
2. The interested p
population
p
is ____?
1.
2.
3
3.
Twenty-five male
Twentyvolunteers
Male who ages
g 18
to 24 years
All males
PubH 6450
54
2
2.
3.
4.
The age of
volunteers
The time to fall
asleep
Th doses
The
d
off
melatonin
The doses of a
placebo
PubH 6450
55
1.
2.
3
3.
4.
Cross-sectional
CrossCase--control
Case
Cohort
Clinical trial
PubH 6450
56
Problem 2
PubH 6450
57
Population
S
Sample
l
Selected to
treatment or
placebo groups by
someone
PubH 6450
58
2.
3.
4.
Retrospective and
observational
Retrospective and
experimental
Prospective and
experimental
Prospective and
observational
PubH 6450
59
1.
2.
3
3.
4.
Cross-sectional
CrossCase--control
Case
Cohort
Clinical trial
PubH 6450
60
Problem 3
PubH 6450
61
3.
Vitamins A and E
Whether patients
get breast cancer
Whether patients
h
have
neoplasms
l
or
pathology of
gastrointestinal
t i t ti l or
reproductive
systems
t
PubH 6450
62
2.
3.
4.
Retrospective and
observational
Retrospective and
experimental
Prospective and
observational
Prospective and
experimental
PubH 6450
63
1.
2.
3
3.
4.
Cross-sectional
CrossCase--control
Case
Cohort
Clinical trial
PubH 6450
64
Measurement Scales
The two broad categories of data are Categorical
and Numerical
Categorical data
Numerical data
66
Ordinal
O di l two
t
or more categories
t
i that
th t have
h
a
natural order
67
Contingency Tables
Data for two categorical characteristics are often
displayed
p y in contingency
g
y tables. The cell counts are
the number of subjects with each combination of
the characteristics.
Smoker
Ex--smoker
Ex
15
10
Non--smoker
Non
75
68
Numerical Scales
69
Numerical
Ordinal Nominal
scale
Continuous Discrete
not ordered
any value
integers
on the scale
PubH 6414 Lesson 1
70
Question
Q
i 1:
1
Is this variable qualitative or quantitative?
Infant birth weight (grams)
1.
2.
Q lit ti
Qualitative
Quantitative
Q estion 2:
Question
Is this variable categorical or continuous?
Household income
(below
(b l normal,
l normal,
l above
b
normal)
l)
1.
2
2.
Categorical
Continuous
Question
Q
ti n 3:
3
Is this variable qualitative or quantitative?
Number of children in the family
1.
2.
3.
4.
Qualitative
Quantitative (Discrete)
Quantitative ((Continuous))
None of these.
Question 4:
Is this variable quantitative?
Social Security number
1
1.
2.
True
False
Question 5:
Rate your instructors teaching ability.
1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent
Categorical
Continuous
Either
Neither
Question 6
Rate your instructors teaching ability.
1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent
Nominal
Ordinal
Binary
None of these.
Question 7
OUTCOME WHEN TOSSING A
COIN.
Heads or tails
Nominal
Ordinal
Binary
None of these.
Question 8
Number of heads when tossing a
coin 30 times.
I this
Is
hi variable
i bl Bi
Binary??
1
1.
2.
No
Yes
Question 8
Number of heads when tossing a
coin 30 times.
Wh iis this
What
hi variable?
i bl ?
1
1.
2.
3.
4.
Quantitative (Discrete)
Quantitative (Continuous)
Nominal
Categorical
g
Binary
y
80
F Categorical
For
C t
i lD
Data
t
Statistics: proportion, percent, rates, relative
risk,
i k odds
dd ratio
i
Tables and graphs: bar charts, pie charts,
contingency
ti
ttables
bl
81
Readings:
http://www.biostat.umn.edu/~susant/FALL09PH6414LAB.html
http://www.biostat.umn.edu/~
susant/FALL09PH6414LAB.html
Start
St t Homework
H
k 1:
1 Problems
P bl
1 and
d2
New vocabulary: look up any unfamiliar terms in
the Pocket Dictionary of Statistics or the text
glossary
PubH 6414 Lesson 1
82