Solutions to Problems

1. A study is run to estimate the mean total cholesterol level in children 2-6 years of age. A
sample of 9 participants is selected and their total cholesterol levels are measured as
follows.

185 225 240 196 175 180 194 147 223

Generate a 95% confidence interval for the true mean total cholesterol levels in adults
with a history of hypertension.

X X
2

185 34,225
225 50,625
240 57,600
196 38,416
175 30,625
180 32,400
194 37,636
147 21,609
223 49,729
1,765 352,865

196.1
9
1,765
n
X
X
8
/9 (1,765) 352,865
1 n
)/n ( X
s
2 2 2

29.0 841.1
8
6728.89
8
346,136.1 352,865

n
s
t X , df = n 1 = 9 1 = 8

For 95% confidence, t = 2.306
n
s
t X
9
29.0
) 306 . 2 ( 196.1

196.1 + 22.29

(173.8, 218.4)




2. A clinical trial is planned to compare an experimental medication designed to lower
blood pressure to a placebo. Before starting the trial, a pilot study is conducted involving
10 participants. The objective of the study is to assess how systolic blood pressure
changes over time untreated. Systolic blood pressures are measured at baseline and again
4 weeks later. Compute a 95% confidence interval for the difference in blood pressures
over 4 weeks.

Baseline 120 145 130 160 152 143 126 121 115 135
4 Weeks 122 142 135 158 155 140 130 120 124 130


Baseline 4 Weeks Difference = 4 Weeks-Baseline Difference
2

120 122 2 4
145 142 -3 9
130 135 5 25
160 158 -2 4
152 155 3 9
143 140 -3 9
126 130 4 16
121 120 -1 1
115 124 9 81
135 130 -5 25
9 183

9 . 0
10
9
n
e Differenc
X
d

9
/10 (9) 183
1 n
/n ces) (Differe es Differenc
s
2 2 2

4 . 4 19.43
n
s
t X
d
d
, df = n 1 = 10 1 = 9

For 95% confidence, t = 2.262
n
s
t X
d
d

10
4.4
) 262 . 2 ( 9 . 0

0.9+3.1

(-2.2, 4.0)




3. The main trial is conducted and involves a total of 200 patients. Patients are enrolled and
randomized to receive either the experimental medication or the placebo. The data
shown below are data collected at the end of the study after 6 weeks on the assigned
treatment.

Experimental
(n=100)
Placebo (n=100)
Mean (Std Dev) Systolic Blood Pressure 120.2 (15.4) 131.4 (18.9)
% Hypertensive 14% 22%
% With Side Effects 6% 8%

a. Generate a 95% confidence interval for the difference in mean systolic blood pressures
between groups.
2 1
2 1
n
1
n
1
ZSp ) X - X (
Check s
1
2
/s
2
2
= 15.4
2
/18.9
2
=0.66
2 n n
1)s (n 1)s (n
Sp
2 1
2
2 2
2
1 1



2 100 100
1)18.9 - (100 1)15.4 (100
Sp
2 2



19 . 297 Sp =17.2
100
1
100
1
) 1.960(17.2 131.4) - (120.2 .
-11.2 + 4.77
(-16.0, -6.4)
b. Generate a 95% confidence interval for the difference in proportions of patients with
hypertension between groups.

2
2 2
1
1 1
2 1
n
) p (1 p
n
) p - (1 p
Z ) p - p (


Sample size is adequate with at least 5 successes and failures in each group.



100
) 22 . 0 1 ( 22 . 0
100
) 14 . 0 1 ( 14 . 0
96 . 1 ) 22 . 0 14 . 0 (

-0.08 + 1.96 (0.054)

-0.08 + 0.106

(-0.19, 0.03)

c. Generate a point estimate for the relative risk of side effects in patients assigned to the
experimental group as compared to placebo. Generate a 95% confidence interval for the
relative risk.

R R

=p
1
/ p
2
= 0.06/0.08 = 0.75

2
2 2 2
1
1 1 1
n
)/x x - (n
n
)/x x - (n
Z R) R

Ln(
Sample size is adequate with at least 5 successes and failures in each group.
100
92/8
100
94/6
1.96 Ln(0.75)
-0.29+ 1.96 (0.521)
-0.29+1.02
(-1.31, 0.73)
The 95% confidence interval for Ln(RR) is (-1.31, 0.73). To generate the confidence
interval for the relative risk, we take the antilog (exp) of the lower and upper limits:
(exp(-1.31), exp(0.73))
(0.27, 2.08)

4. The following data are collected as part of a study of coffee consumption among
undergraduate students. The following reflect cups per day consumed:

3 4 6 8 2 1 0 2

X X
2



3 9
4 16
6 36
8 64
2 4
1 1
0 0
2 4
26 134

a. Compute the sample mean
3 . 3
8
26
n
X
X
b. Compute the sample standard deviation

7
/8 (26) 134
1 n
)/n ( X
s
2 2 2

7 . 2 7.07
7
5 . 84 134

c. Construct a 95% confidence interval for the mean number of cups of coffee consumed
among all undergraduates.
n
s
t X , df = n 1 = 8 1 = 7

For 95% confidence, t = 2.365
n
s
t X
8
2.7
) 365 . 2 ( 3.3

3.3+ 2.26

(1.0, 5.6)


5. A clinical trial is conducted comparing a new pain medication for arthritis. Participants
are randomly assigned to receive the new medication or a placebo. The outcome is pain
relief within 30 minutes. The data are shown below.

Pain Relief No Pain Relief
New Medication 44 76
Placebo 21 99

p
1
= 44/120 = 0.367, p
2
= 21/120 = 0.175



a. Estimate the risk difference in pain relief between treatments

D R

= p
1
- p
2
= 0.367 0.175 = 0.192

b. Estimate the relative risk in pain relief between treatments

R R

=p
1
/ p
2
= 0.367/0.175 = 2.097

c. Estimate the odds ratio in pain relief between treatments

R O

=
212 . 0
580 . 0
825 . 0 / 175 . 0
633 . 0 / 367 . 0
) p /(1 p
) p /(1 p
2 2
1 1

= 2.74

d. Construct a 95% confidence interval for the odds ratio
) x (n
1
x
1
) x (n
1
x
1
Z R) O

Ln(
2 2 2 1 1 1

Sample size is adequate with at least 5 successes and failures in each group.

99
1
21
1
76
1
44
1
1.96 Ln(2.74)
1.01 + 1.96 (0.306)
1.01 + 0.60
(0.41, 1.61)
The 95% confidence interval for Ln(OR) is (0.41, 1.61). To generate the confidence
interval for the odds ratio, we take the antilog (exp) of the lower and upper limits:
(exp(0.41), exp(1.61))
(1.51, 5.00)


6. The following data are collected in a clinical trial evaluating a new compound designed
to improve wound healing in trauma patients. The new compound is compared against a
placebo. After treatment for 5 days with the new compound or placebo the extent of
wound healing is measured and the data are shown below.

Wound Healing: % Reduction in Size of Wound


Treatment None 1-25% 26-50% 51-75% 76-100%
New Compound (n=125) 4 11 37 32 41
Placebo (n=125) 12 24 45 34 10

Suppose that clinicians feel that if the percent reduction in the size of the wound is
greater than 50% then the treatment is a success.

a. Generate a 95% confidence interval for the percent success in patients receiving the new
compound.
p = 73/125 = 0.584
n
) p - (1 p
Z p
Sample size is adequate with at least 5 successes and failures in the sample.

125
0.584) - 0.584(1
960 . 1 0.584
0.584 + 0.086

(0.498, 0.670)

b. Generate a 95% confidence interval for the difference in the percent success between the
new compound and placebo

p
1
= 73/125 = 0.584, p
2
= 44/125 = 0.352

2
2 2
1
1 1
2 1
n
) p (1 p
n
) p - (1 p
Z ) p - p (


Sample size is adequate with at least 5 successes and failures in each group.

125
) 352 . 0 1 ( 352 . 0
125
) 584 . 0 1 ( 584 . 0
96 . 1 ) 352 . 0 584 . 0 (

0.232 + 1.96 (0.061)

0.232+ 0.120

(0.112, 0.352)

c. Generate a 95% confidence interval for the relative risk of treatment success between
treatments



R R

=p
1
/ p
2
= 0.584/0.352 = 1.66

2
2 2 2
1
1 1 1
n
)/x x - (n
n
)/x x - (n
Z R) R

Ln(
Sample size is adequate with at least 5 successes and failures in each group.
125
81/44
125
52/73
1.96 Ln(1.66)
0.507 + 1.96 (0.143)
0.507 + 0.28
(0.227, 0.787)
The 95% confidence interval for Ln(RR) is (0.227, 0.787). To generate the confidence
interval for the relative risk, we take the antilog (exp) of the lower and upper limits:
(exp(0.227), exp(0.787))
(1.25, 2.20)
d. Generate a 95% confidence interval for the odds ratio of treatment success between
treatments.

R O

=
543 . 0
404 . 1
648 . 0 / 352 . 0
416 . 0 / 584 . 0
) p /(1 p
) p /(1 p
2 2
1 1

= 2.59

) x (n
1
x
1
) x (n
1
x
1
Z R) O

Ln(
2 2 2 1 1 1

Sample size is adequate with at least 5 successes and failures in each group.

81
1
44
1
52
1
73
1
1.96 Ln(2.59)
0.952+ 1.96 (0.261)
0.952+ 0.51
(0.44, 1.46)


The 95% confidence interval for Ln(OR) is (0.44, 1.46). To generate the confidence
interval for the odds ratio, we take the antilog (exp) of the lower and upper limits:
(exp(0.44), exp(1.46))
(1.55, 4.31)

7. A clinical trial is conducted to compare an experimental medication to placebo to reduce
the symptoms of asthma. Two hundred participants are enrolled in the study and
randomized to receive either the experimental medication or placebo. The primary
outcome is self-reported reduction of symptoms. Among 100 participants who receive
the experimental medication, 38 report a reduction of symptoms as compared to 21
participants of 100 assigned to placebo.

a. Generate a 95% confidence interval for the difference in proportions of participants
reporting a reduction of symptoms between the experimental and placebo groups.

p
1
= 38/100 = 0.38, p
2
= 21/100 = 0.21

2
2 2
1
1 1
2 1
n
) p (1 p
n
) p - (1 p
Z ) p - p (


Sample size is adequate with at least 5 successes and failures in each group
.
100
) 21 . 0 1 ( 21 . 0
100
) 38 . 0 1 ( 38 . 0
96 . 1 ) 21 . 0 38 . 0 (

0.17 + 1.96 (0.063)

0.17 + 0.12

(0.05, 0.29)

b. Estimate the relative risk for reduction in symptoms between groups

R R

=p
1
/ p
2
= 0.38/0.21 = 1.81

c. Estimate the odds ratio for reduction in symptoms between groups

R O

=
27 . 0
61 . 0
79 . 0 / 21 . 0
62 . 0 / 38 . 0
) p /(1 p
) p /(1 p
2 2
1 1

= 2.26.



d. Generate a 95% confidence interval for the relative risk

2
2 2 2
1
1 1 1
n
)/x x - (n
n
)/x x - (n
Z R) R

Ln(
Sample size is adequate with at least 5 successes and failures in each group.

100
79/21
100
62/38
1.96 Ln(1.81)
0.59 + 1.96 (0.232)
0.59 + 0.455
(0.135, 1.045)
The 95% confidence interval for Ln(RR) is (0.135, 1.045). To generate the confidence
interval for the relative risk, we take the antilog (exp) of the lower and upper limits:
(exp(0.135), exp(1.045))
(1.14, 2.84)

8. The following table displays descriptive statistics on the participants involved in the
study described in Problem 7.

Characteristic Experimental Medication
(n=100)
Placebo
(n=100)
Mean (SD) Age, years 47.2 (4.3) 46.1 (5.1)
% Males 46% 58%
Mean (SD) Educational Level, years 13.1 (2.9) 14.2 (3.1)
Mean (SD) Annual Income, $000s $36.560 ($1,054) $37.470 ($998)
Mean Body Mass Index 24.7 (2.7) 25.1 (2.4)

a. Generate a 95% confidence interval for the mean age among participants assigned to the
placebo.
n
s
Z X
100
5.1
) 960 . 1 ( 46.1



46.1 + 0.999

(45.1, 47.1)

b. Generate a 95% confidence interval for the difference in mean ages in participants
assigned to the experimental versus the placebo groups.
2 1
2 1
n
1
n
1
ZSp ) X - X (
Check s
1
2
/s
2
2
= 4.3
2
/5.1
2
=0.71
2 n n
1)s (n 1)s (n
Sp
2 1
2
2 2
2
1 1



72 . 4 25 . 22
2 100 100
1)5.1 - (100 1)4.3 (100
Sp
2 2




100
1
100
1
) 1.960(4.72 46.1) - (47.2 .
1.1 + 1.31
(-0.21, 2.41)
c. Generate a 95% confidence interval for the difference in mean body mass index in
participants assigned to the experimental versus the placebo groups.

2 1
2 1
n
1
n
1
ZSp ) X - X (
Check s
1
2
/s
2
2
= 2.7
2
/2.4
2
=1.26
2 n n
1)s (n 1)s (n
Sp
2 1
2
2 2
2
1 1



55 . 2 52 . 6
2 100 100
1)2.4 - (100 1)2.7 (100
Sp
2 2




100
1
100
1
) 1.960(2.55 25.1) - (24.7 .


-0.4 + 0.71
(-1.11, 0.31)


9. A crossover trial is conducted to compare an experimental medication for migraine
headaches to a currently available medication. A total of 50 patients are enrolled in the
study and each patient receives both treatments. The outcome is the time, in minutes,
until the headache pain resolves. Following each treatment, patients record the time it
takes until pain is resolved. Treatments are assigned in random order (i.e., some patients
receive the currently available medication first and then the experimental medication and
others receive the experimental medication first and then the currently available
medication). The mean difference in times between the experimental and currently
available medication is -9.4 minutes, with a standard deviation of 2.8 minutes. Construct
a 95% confidence interval for the mean difference in times between the experimental and
currently available medication.

n
s
Z X
d
d


50
2.8
) 960 . 1 ( 9.4 -

-9.4 + 0.78

(-10.2, -8.6)


10. Suppose in the study described in Problem 9, each participantis also asked if the assigned
medication causes any stomach upset. Among the 50 participants, 12 report stomach
upset with the experimental medication. Construct a 90% confidence interval for the
proportion of participants who might experience stomach upset with the experimental
medication.

p = 12/50 = 0.24
n
) p - (1 p
Z p
Sample size is adequate with at least 5 successes and failures in the sample.

50
0.24) - 0.24(1
645 . 1 0.24
0.24 + 0.099



(0.14, 0.34)


11. A 95% confidence interval for the mean diastolic blood pressure in women is 62 to 110.
What is the margin of error? What is the standard error?

CI has form: 86 + 24

Margin of error is 24 (1.96*Standard Error = 24), thus Standard Error = 12.24.


12. The following data are collected from 10 randomly selected patients undergoing physical
therapy following knee surgery. The data represent the percent gain in range of motion
after 3 weeks of therapy. Generate a 95% confidence interval for the mean percent gain
in range of motion.

24% 32% 50% 62% 21% 45% 80% 24% 30% 10%


10
378
X
= 37.8


3 . 21 29 . 455
9
4 . 288 , 14 18,386
1 10
/10 (378) 18,386
1 n
/n X) ( X
s
2 2 2

n
s
t X , df = n 1 = 10 1 = 9

For 95% confidence, t = 2.262
n
s
t X
10
21.3
) 262 . 2 ( 37.8

37.8 + 15.24

(22.6, 53.0)


13. The following data are collected in a randomized trial to test the efficacy of a new drug
for migraine headaches. The following are characteristics of study participants overall
and then organized by the treatment to which they are assigned.

New Drug Placebo All


(n=100) (n=100) (n=200)
Mean (SD) Age, years 32.8 (4.7) 31.9 (5.1) 32.0 (4.9)
% Male 54% 48% 51%
% High School Graduate 76% 80% 78%
Severity of Migraine Headaches
% Mild 22% 20% 21%
% Moderate 38% 42% 39%
% Severe 40% 38% 39%
Median (Q1-Q3) Number of Days
Missed Work in Past Year Due to
Migraine

5 (3-12)

6 (2-18)

6 (3-17)
Min-Max Number of Days Missed Work
in Past Year Due to Migraine
0-35 0-48 0-48

a. Generate a 95% confidence interval for the difference in mean ages between groups.

2 1
2 1
n
1
n
1
ZSp ) X - X (
Check s
1
2
/s
2
2
= 4.7
2
/5.1
2
=0.85
2 n n
1)s (n 1)s (n
Sp
2 1
2
2 2
2
1 1



90 . 4 05 . 24
2 100 100
1)5.1 - (100 1)4.7 (100
Sp
2 2




100
1
100
1
) 1.960(4.90 31.9) - (32.8 .
0.9 + 1.36
(-0.46, 2.26)

b. Generate a 95% confidence interval for the difference in proportions of males
between groups.

2
2 2
1
1 1
2 1
n
) p (1 p
n
) p - (1 p
Z ) p - p (


Sample size is adequate with at least 5 successes and failures in each group.



100
) 48 . 0 1 ( 48 . 0
100
) 54 . 0 1 ( 54 . 0
96 . 1 ) 48 . 0 54 . 0 (

0.06 + 1.96 (0.071)

0.06 + 0.14

(-0.08, 0.20)

c. Generate a 95% confidence interval for the difference in proportions of patients with
severe migraine headaches between groups.

2
2 2
1
1 1
2 1
n
) p (1 p
n
) p - (1 p
Z ) p - p (


Sample size is adequate with at least 5 successes and failures in each group.

100
) 38 . 0 1 ( 38 . 0
100
) 40 . 0 1 ( 40 . 0
96 . 1 ) 38 . 0 40 . 0 (

0.02 + 1.96 (0.069)

0.02 + 0.13

(-0.11, 0.15)


14. A clinical trial is run to assess the efficacy of a new pacemaker device in patients with
atrial fibrillation (AF). Two hundred participants are randomized to receive the new
pacemaker or a currently available pacemaker. There are two primary outcomes of
interest the number of days in a three month period with an atrial fibrillation event and
hospitalization for atrial fibrillation over the three month follow-up period. Data on
baseline characteristics and the outcomes are shown below.

Baseline Characteristics New Pacemaker
(n=100)
Available Pacemaker
(n=100)
Mean (SD) Age, years 67.3 (5.9) 66.9 (5.6)
% Male 48% 52%

Outcomes
Mean (SD) Number of days with AF
event
8.4 (3.2) 14.9 (3.9)
% Hospitalized for AF 4% 9%



a. Compute a 95% confidence interval for the difference in mean number of days with
an AF event between participants receiving the new pacemaker as compared to the
availablepacemaker.

2 1
2 1
n
1
n
1
ZSp ) X - X (
Check s
1
2
/s
2
2
= 3.2
2
/3.9
2
= 0.67
2 n n
1)s (n 1)s (n
Sp
2 1
2
2 2
2
1 1



56 . 3 73 . 12
2 100 100
1)3.9 - (100 1)3.2 (100
Sp
2 2




100
1
100
1
) 1.960(3.56 14.9) - (8.4 .
-6.5 + 0.99
(-7.49, -5.51)

b. Compute a 95% confidence interval for the mean number of days with an AF event
among participants receiving the new pacemaker.

n
s
Z X
100
3.2
) 960 . 1 ( 8.4

8.4 + 0.63

(7.77, 9.03)


15. A pilot study is run to investigate the feasibility of recruiting pregnant women into a
study of risk factors for preterm delivery. Women are invited to participate at their first
clinical visit for prenatal care. The following represent the gestational ages in weeks of
women who consented to participate in the study. Compute a 95% confidence interval
for the mean gestational age of women enrolling in the study.

11 14 21 22 9 10 13 18




8
118
X
= 14.8


0 . 5 07 . 25
7
1740.5 - 1916
1 8
/8 (118) 1916
1 n
/n X) ( X
s
2 2 2

n
s
t X , df = n 1 = 8 1 = 7

For 95% confidence, t = 2.365
n
s
t X
8
5.0
) 365 . 2 ( 14.8

14.8 + 4.18

(10.6, 19.0)


16. A clinical trial is run comparing a new drug for high cholesterol to a placebo. A total of
40 participants are randomized (with equal assignment to treatments) to receive either the
new drug or placebo. Their total serum cholesterol levels are measured after eight weeks
on the assigned treatment. Participants receiving the new drug reported a mean total
serum cholesterol level of 209.5 (std dev = 21.6) and participants receiving the placebo
reported a mean total serum cholesterol level of 228.1 (std dev = 19.7).

a. Construct a 95% confidence interval for the difference in mean total serum
cholesterol levels between participants receiving the new drug versus placebo.


2 1
2 1
n
1
n
1
tSp ) X - X (

df = n
1
+ n
2
-2 = 20 + 20 -2 = 38

Check s
1
2
/s
2
2
=21.6
2
/19.7
2
= 1.20
2 n n
1)s (n 1)s (n
Sp
2 1
2
2 2
2
1 1





7 . 20 33 . 427
2 20 20
1)19.7 - (20 1)21.6 (20
Sp
2 2




20
1
20
1
) 2.024(20.7 228.1) - (209.5 .
-18.6 + 13.25
(-31.85, -5.35)

b. Is the new drug effective? Justify briefly.

Yes. The 95% confidence interval for the difference in means does not include the
null value (0) and thus there is a statistically significant difference in mean total
serum cholesterol levels between participants receiving the new drug versus placebo.