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Lisa M. Sullivan, PhD

Chapter 7 Solutions to Problems

1.

The following data was 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.

Treatment

New Compound (n=125)

Placebo (n=125)

0-25%

15

36

26-50%

51-75%

37

32

45

34

76-100%

41

10

Is there a difference in the extent of wound healing by treatment? (Hint: Are treatment

and the percent wound healing independent?) Run the appropriate test at a 5% level of

significance.

Step 1.

H0: Treatment and percent wound healing are independent

H1: H0 is false.

=0.05

Step 2.

(O - E) 2

E

2

The condition for appropriate use of the above test statistic is that each expected

frequency is at least 5. In Step 4 we will compute the expected frequencies and we

will ensure that the condition is met.

Step 3.

df=(2-1)(4-1)=3 and the decision rule is Reject H0 if 2 > 7.81.

Step 4.

We now compute the expected frequencies using the formula,

Expected Frequency = (Row Total * Column Total)/N.

The top number in each cell of the table is the observed frequency and the bottom

number is the expected frequency, shown in parentheses.

Treatment

New Compound

Placebo

0-25%

15

(25.5)

36

26-50%

51-75%

37

32

(41)

(33)

45

34

Total

76-100%

41

(25.5)

10

125

125

1

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

(25.5)

51

Total

(41)

82

(33)

66

(25.5)

51

250

(15 25.5) 2 (37 41) 2 (32 33) 2 (41 25.5) 2

2

25.5

41

33

25.5

2

2

2

(36 25.5)

(45 41)

(34 33)

(10 25.5) 2

25.5

41

33

25.5

2 = 4.32 + 0.39 + 0.03 + 9.42 + 4.32 + 0.39 + 0.03 + 9.42 = 28.32

Step 5.

2.

Conclusion.

Reject H0 because 28.32 > 7.81. We have statistically significant evidence at

=0.05 to show that H0 is false; treatment and percent wound healing are not

independent. The p-value is p < 0.005.

Use the data in Problem 1 and pool the data across the treatments into one sample of size

n=250. Use the pooled data to test whether the distribution of the percent wound healing is

approximately normal. Specifically, use the following distribution: 30%, 40%, 20% and 10%

and =0.05 to run the appropriate test.

Treatment

Number of Patients

0-25%

51

26-50%

51-75%

82

66

Step 1.

H0: p1=0.3, p2=0.4, p3=0.2, p4=0.1

H1: H0 is false.

=0.05

Step 2.

2

76-100%

51

Total

250

(O - E) 2

E

We must assess whether the sample size is adequate. Specifically, we need to check

min(np0, np1, , n pk) > 5. The sample size here is n=250 and the proportions

specified in the null hypothesis are 0.3, 0.4, 0.2 and 0.1. Thus, min( 250(0.3),

250(0.4), 250(0.2), 250(0.1))=min(75, 100, 50, 25)=25. The sample size is more

than adequate so the formula can be used..

Step 3.

df=k-1=4-1=3, Reject H0 if 2 > 7.81.

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Step 4.

Treatment

Number of Patients

Expected

0-25%

51

75

26-50%

51-75%

82

66

100

50

76-100%

51

25

Total

250

250

(51 75) 2 (82 100) 2 (66 50) 2 (51 25) 2

2

75

100

50

25

2

= 7.68 + 3.24 + 5.12 + 27.04 = 43.08.

Step 5.

3.

Conclusion.

Reject H0 because 43.08 > 7.81. We have statistically significant evidence at

=0.05 to show that H0 is false. The p-value is p < 0.005.

The following table displays descriptive statistics on the participants involved in the

study described in Problem 1.

Characteristic

Mean Age, years

% Males

Mean Educational Level, years

Mean Annual Income, $000s

Mean Body Mass Index

New Compound

47.2

44%

13.1

$36,560

24.7

Placebo

46.1

59%

14.2

$37,470

25.1

p-value

0.7564

0.0215

0.6898

0.3546

0.0851

briefly. (Hint: No calculations, just interpret above.)

There is a statistically significant difference in the proportions of males (p=0.0215) and a

marginally significant difference in mean body mass index (p=0.0851). None of the other

characteristics are significantly different between groups using a 5% level of significance.

4.

educating their parents on proper nutrition and exercise. A sample of 40 families with a child

between the ages of 10-15 who has been diagnosed with high cholesterol agree to participate in

the study. All parents are provided educational information on nutrition and exercise. After

following the prescribed program, their childs total cholesterol level is measured. The childrens

mean cholesterol level is 175 with a standard deviation of 19.5. Is there significant evidence of a

reduction in total cholesterol in the children? Run the appropriate test at the 5% level of

significance and assume that the null value for total cholesterol is 191.

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Step 1.

H0: =

191

H1: <

191

=0.05

Step 2.

X 0

Z

s/ n .

Step 3.

Step 4.

Z

Step 5.

5.

X 0

s/ n

175 - 191

19.5/ 40 = -5.19

Conclusion.

Reject H0 because -5.19 < -1.645. We have statistically significant evidence at

=0.05 to show that the mean total cholesterol level is lower than 191. The p-value

is p<0.0001.

The following data were collected in an experiment designed to investigate the impact of

different positions of the mother during ultrasound on fetal heart rate. Fetal heart rate is

measured by ultrasound in beats per minute. The study includes 20 women who are assigned

to one position and have the fetal heart rate measured in that position. Each woman is

between 28-32 weeks gestation. The data are shown below.

Back

140

144

146

141

139

Mean = 142.0

Side

141

143

145

144

136

Mean = 141.8

Sitting

144

145

147

148

144

Mean = 145.6

Standing

147

145

148

149

145

Mean =146.8

Is there a significant difference in mean fetal heart rates by position? Run the test

at a 5% level of significance.

Step 1.

H0: =

2=

3=

4

H1: Means are not all equal

=0.05

Step 2.

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Step 3.

df1=k-1=4-1=3 and df2=N-k=20-4=16. Reject H0 if F > 3.24.

Step 4.

Back

n1=5

Side

n2=5

X 1= 142.0

X 2= 141.8

Sitting

n3=5

X 3= 145.6

Standing

n4=5

X 4= 146.8

2

SSB = n j (X j - X )

We can now compute

.

2

2

SSB = 5(142.0-144.1) + 5(141.8-144.1) + 5(145.6 144.1)2 + 5(146.8 -144.1)2

SSB = 96.2

2

( - )

Next, SSE = X X j .

Back

(X 142.0)

140

-2

144

2

146

4

141

-1

139

-3

(X 142.0)2

4

4

16

1

9

34.0

Side

141

143

145

144

136

(X 141.8)

-0.8

1.2

3.2

2.2

-5.8

(X 141.8)2

0.64

1.44

10.24

4.84

33.64

50.8

(X 145.6)

-1.6

-0.6

1.4

2.4

-1.6

(X 145.6)2

2.56

0.36

1.96

5.76

2.56

13.2

Sitting

144

145

147

148

144

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Thus, (X- X 3)2 = 13.2.

Standing

147

145

148

149

145

(X 146.8)2

0.04

3.24

1.44

4.84

3.24

12.8

(X 146.8)

0.2

-1.8

1.2

2.2

-1.8

2

SSE = ( X - X j) = 110.8.

We can now construct the ANOVA table.

Source of

Variation

Sums of Squares

SS

Degrees

of

freedom

df

Mean Squares

MS

Between

Treatments

96.2

32.1

4.7

Error or

Residual

110.8

16

6.9

Total

207.0

19

Step 5.

6.

Conclusion.

We reject H0 because 4.7 > 3.24. We have statistically significant evidence at

=0.05 to show that there is a difference in mean fetal heart rate by position.

A clinical trial is conducted comparing a new pain reliever for arthritis to a placebo.

Participants are randomly assigned to receive the new treatment or a placebo and the outcome is

pain relief within 30 minutes. The data are shown below.

New Medication

Placebo

Pain Relief

44

21

No Pain Relief

76

99

Is there a significant difference in the proportions of patients reporting pain relief? Run

the test at a 5% level of significance.

Step 1.

2012 Jones & Bartlett Learning, LLC

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

H0: p1 = p2 (equivalent to RD = 0, RR=1 or OR=1)

H1: p1 p2 (equivalent to RD 0, RR 1 or OR 1)

=0.05

Step 2.

p1 - p 2

Z

1

1

p(1 - p)

n 1 n2

Step 3.

Step 4.

We first compute the overall proportion of successes:

x1 x 2

44 21

p1 - p 2

0.367 0.175

Z

1

1

1

1

0.27(1 0.27)

p(1 - p)

120 120

n1 n 2

Step 5.

=3.35.

Conclusion.

Reject H0 because 3.35 > 1.960. We have statistically significant evidence at

=0.05 to show that there is a difference in the proportions of patients reporting

pain relief. The p-value is p<0.001.

7.

blood pressure to a placebo. Before starting the trial, a pilot study is conducted involving 7

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. Is

there a statistically significant difference in blood pressures over time? Run the test at a 5% level

of significance.

Baseline

4 Weeks

120

122

145

142

130

135

160

158

152

155

143

140

126

130

Difference

Difference2

-2

4

3

9

-5

25

2

4

-3

9

3

9

-4

16

Differences = -6

Differences2 = 76

7

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Xd

sd

76 (6) 2 /7

3.44

6

Step 1.

H0: d=

0

H1: d

0

=0.05

Step 2.

X d

t d

sd / n .

Step 3.

Step 4.

Step 5.

8.

6

0.86

7

Xd d

sd / n

0.86

3.44 / 7 = -0.66.

Conclusion.

Do not reject H0 because -2.447 < -0.66 < 2.447. We do not have statistically

significant evidence at =0.05 to show that there is a difference in blood pressure

over 4 weeks.

The main trial in Problem 7 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.

Mean (SD) Systolic Blood Pressure

% Hypertensive

% With Side Effects

Experimental (n=100)

120.2 (15.4)

14%

6%

Placebo (n=100)

131.4 (18.9)

22%

8%

a. Test if there is a significant difference in mean systolic blood pressures between groups

using =0.05.

Step 1.

H0: =

2

H1:

2

=0.05

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Step 2.

X1 - X 2

Z

1

1

Sp

n1 n 2

.

Step 3.

Step 4.

Sp

100 100 2

=17.23

120.2 - 131.4

17.23

Step 5.

1

1

Conclusion.

Reject H0 because -4.60 < -1.960. We have statistically significant evidence at

=0.05 to show that the mean blood pressures are not equal. The p-value is

p<0.0001.

groups using =0.05.

Step 1.

H0: p1 = p2 (equivalent to RD = 0, RR=1 or OR=1)

H1: p1 p2 (equivalent to RD 0, RR 1 or OR 1)

=0.05

Step 2.

p1 - p 2

Z

1

1

p(1 - p)

n 1 n2

Step 3.

Step 4.

We first compute the overall proportion of successes:

2012 Jones & Bartlett Learning, LLC

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

x1 x 2

14 22

p1 - p 2

0.14 0.22

Z

1

1

1

1

0.18(1 0.18)

p(1 - p)

100 100

n1 n 2

Step 5.

9.

= -1.47.

Conclusion.

Do not reject H0 because -1.960 < -1.47 < 1.960. We do not have statistically

significant evidence at =0.05 to show that there is a difference in the proportions

of patients with hypertension.

Suppose in the trial described in Problem 8 that patients were recruited from 3 different

clinical sites. Use the following data to test if there is a difference in the proportions of

hypertensive patients across clinical sites.

Hypertensive

Not Hypertensive

Site 1

10

68

Site 2

14

56

Step 1.

H0: Site and hypertensive status are independent

H1: H0 is false.

=0.05

Step 2.

2

Site 3

12

40

(O - E) 2

E

The condition for appropriate use of the above test statistic is that each expected

frequency is at least 5. In Step 4 we will compute the expected frequencies and we

will ensure that the condition is met.

Step 3.

df=(2-1)(3-1)=2 and the decision rule is Reject H0 if 2 > 5.99.

Step 4.

We now compute the expected frequencies using the formula,

Expected Frequency = (Row Total * Column Total)/N.

10

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

The top number in each cell of the table is the observed frequency and the bottom

number is the expected frequency, shown in parentheses.

Hypertensive

Not Hypertensive

Total

Site 1

10

(14.0)

68

(64.0)

78

Site 2

14

(12.6)

56

(57.4)

70

Site 3

12

(9.4)

40

(42.6)

52

Total

36

164

200

(10 14.0) 2 (14 12.6) 2 (12 9.4) 2

2

14.0

12.6

9.4

2

2

(68 64.0)

(56 57.4)

(40 42.6) 2

64.0

57.4

42.6

2 = 1.14 + 0.15 + 0.72 + 0.25 + 0.03 + 0.16 = 2.46.

Step 5.

10.

Conclusion.

Do not reject H0 because 2.46 < 5.99. We do not have statistically significant

evidence at =0.05 to show that H0 is false or that site and hypertensive status are

not independent.

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. Test

if there is a significant difference in the proportions of participants reporting a reduction of

symptoms between the experimental and placebo groups. Use =0.05.

Step 1.

H0: p1 = p2 (equivalent to RD = 0, RR=1 or OR=1)

H1: p1 p2 (equivalent to RD 0, RR 1 or OR 1)

=0.05

Step 2.

p1 - p 2

Z

1

1

p(1 - p)

n 1 n2

11

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Step 3.

Step 4.

We first compute the overall proportion of successes:

x1 x 2

38 21

p1 - p 2

0.38 0.21

Z

1

1

1

1

0.295(1 0.295)

p(1 - p)

100

100

n

n

2

1

Step 5.

11.

= 2.64.

Conclusion.

Reject H0 because 2.64 > 1.960. We have statistically significant evidence at

=0.05 to show that there is a difference in the proportions of patients reporting a

reduction in symptoms. The p-value is p<0.010.

Suppose more detail is actually recorded in the primary outcome in the clinical trial

described in Problem 10. The data are recorded as follows.

Treatment

Experimental

Placebo

Much

Worse

10

12

Worse

Change in Symptoms

No change

Better

17

25

35

42

28

12

Much

Better

10

9

Is there a difference in change in symptoms by treatment group? Run the appropriate test

at a 5% level of significance.

Step 1.

H0: Treatment and change in symptoms are independent

H1: H0 is false.

=0.05

Step 2.

2

(O - E) 2

E

12

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

The condition for appropriate use of the above test statistic is that each expected

frequency is at least 5. In Step 4 we will compute the expected frequencies and we

will ensure that the condition is met.

Step 3.

df=(2-1)(5-1)=4 and the decision rule is Reject H0 if 2 > 9.49.

Step 4.

We now compute the expected frequencies using the formula,

Expected Frequency = (Row Total * Column Total)/N.

The top number in each cell of the table is the observed frequency and the bottom

number is the expected frequency, shown in parentheses.

Treatment

Experimental

Placebo

Total

Much

Worse

10

(11)

12

(11)

22

Change in Symptoms

Worse

No

Better

change

17

35

28

(21)

(38.5)

(20)

25

42

12

(21)

(38.5)

(20)

42

77

40

Much

Better

10

(9.5)

9

(9.5)

19

Total

100

100

200

(10 11) 2 (17 21) 2 (35 38.5) 2 (28 20) 2 (10 9.5) 2

2

11

21

38.5

20

9.5

2

2

2

2

(12 11)

(25 21)

(42 38.5)

(12 20)

(9 9.5) 2

11

21

38.5

20

9.5

2 = 0.09 + 0.76 + 0.32 + 3.20 + 0.03 + 0.09 + 0.76 + 0.32 + 0.03 = 8.8.

Step 5.

12.

Conclusion.

Do not reject H0 because 8.8 < 9.49. We do not have statistically significant

evidence at =0.05 to show that H0 is false or that treatment and change in

symptoms are not independent.

asthma symptom severity measured on a scale of 0-100 with higher scores indicating more

severe symptoms. In the participants who receive the experimental medication the mean

symptom score is 74 with a standard deviation of 5.6 and in the placebo group the mean

symptom score is 85 with a standard deviation of 6.0. Is there a significant difference in mean

symptom scores between groups? Run the appropriate test at a 5% level of significance.

Step 1.

2012 Jones & Bartlett Learning, LLC

13

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

H0: =

2

H1:

2

=0.05

Step 2.

X1 - X 2

Z

1

1

Sp

n1 n 2

.

Step 3.

Step 4.

Sp

100 100 2

=5.8

74 - 85

Z

5.8

Step 5.

13.

1

1

Conclusion.

Reject H0 because -13.41 < -1.960. We have statistically significant evidence at

=0.05 to show that the mean symptom scores are not equal. The p-value is

p<0.0001.

adults in a study of cardiovascular risk factors report exercising a mean of 38 minutes per day

with a standard deviation of 19 minutes. Based on the sample data, is the physical activity

significantly less than recommended? Run the appropriate test at a 5% level of significance.

Step 1.

H0: =

60

H1: <

60

=0.05

Step 2.

X 0

Z

s/ n .

14

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Step 3.

Step 4.

Z

Step 5.

14.

X 0

s/ n

38 - 60

19/ 50 = -8.19.

Conclusion.

Reject H0 because -8.19 < -1.645. We have statistically significant evidence at

=0.05 to show that the mean number of minutes of exercise is less than 60. The pvalue is p<0.0001.

Suppose a hypertension trial is mounted and 18 participants are randomly assigned to one

of the comparison treatments. Each participant takes the assigned medication and their systolic

blood pressure (SBP) is recorded after 6 months on the assigned treatment. The data are as

follows.

Standard Treatment

124

111

133

125

128

115

Placebo

134

143

148

142

150

160

New Treatment

114

117

121

124

122

128

Is there a difference in mean SBP among treatments? Run the appropriate test at

=0.05.

Step 1.

H0: =

2=

3

H1: Means are not all equal

=0.05

Step 2.

Step 3.

df1=k-1=3-1=2 and df2=N-k=18-3=15. Reject H0 if F > 3.68.

Step 4.

Standard

n1=6

X 1= 122.7

Placebo

n2=6

X 2= 146.2

New Treatment

n3=6

X 3= 121.0

15

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

If we pool all N=18 observations, the overall mean is X = 130.0.

SSB = n j (X j - X )

.

SSB = 6(122.7-130.0)2 + 6(146.2-130.0)2 + 6(121.0-130.0)2

SSB = 2380.4.

2

( - )

Next, SSE = X X j .

Standard Treatment

124

111

133

125

128

115

(X 122.7)

1.3

-11.7

10.3

2.3

5.3

-7.7

(X 122.7)2

1.69

136.89

106.09

5.29

28.09

59.29

337.34

(X 146.2)

-12.2

-3.2

1.8

-4.2

3.8

13.8

(X 146.2)2

148.84

10.24

3.24

17.64

14.44

190.44

384.84

(X 121.0)

-7

-4

0

3

1

7

(X 121.0)2

49

16

0

9

1

49

124

Placebo

134

143

148

142

150

160

Thus, (X- X 2)2 = 384.84.

New Treatment

114

117

121

124

122

128

Thus, (X- X 3)2 = 124.0

2

SSE = ( X - X j) = 846.18.

We can now construct the ANOVA table.

2012 Jones & Bartlett Learning, LLC

16

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Source of

Variation

Sums of Squares

SS

Degrees

of

freedom

df

Mean Squares

MS

Between

Treatments

2380.4

1190.2

21.1

Error or

Residual

846.2

15

56.4

Total

3226.6

17

Step 5.

15.

Conclusion.

We reject H0 because 21.1 > 3.68. We have statistically significant evidence at

=0.05 to show that there is a difference in mean systolic blood pressure among

treatments.

A study is conducted to compare mean cholesterol levels for individuals following a low

carbohydrate diet for at least 6 months to individuals following a conventional (low-fat, low

calorie) diet for at least 6 months. The data are summarized below:

Diet Program

Low Carbohydrate

Conventional

Sample Size

50

75

Mean Cholesterol

225.4

203.8

24.5

21.6

Test if there is a significant difference in mean cholesterol levels between the diet

programs using a 5% level of significance.

Step 1.

H0: =

2

H1:

2

=0.05

Step 2.

X1 - X 2

Z

1

1

Sp

n1 n 2

.

Step 3.

Step 4.

17

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Sp

50 75 2

= 22.8.

Z

225.4 - 203.8

22.8

Step 5.

16.

1

1

50 75 = 5.19.

Conclusion.

Reject H0 because 5.19 > 1.960. We have statistically significant evidence at

=0.05 to show that the mean cholesterol levels are not equal. The p-value is

p<0.0001.

Another outcome variable in the study described in Problem 15 was hypercholesterolemia, defined as total cholesterol over 220. Among the individuals who follow

the low carbohydrate diet, 56% are hypercholesterolemic and among the individuals who

follow the conventional diet, 40% are hypercholesterolemic. Test if there is a significant

difference in the proportions using a 5% level of significance.

Step 1.

H0: p1 = p2 (equivalent to RD = 0, RR=1 or OR=1)

H1: p1 p2 (equivalent to RD 0, RR 1 or OR 1)

=0.05

Step 2.

p1 - p 2

Z

1

1

p(1 - p)

n 1 n2

Step 3.

Step 4.

We first compute the overall proportion of successes:

x1=0.56(50) = 28 and x2=0.40(75) = 30.

x 1 x 2 28 30

n 1 n 2 50 75 = 0.46.

18

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

We now substitute to compute the test statistic.

p1 - p 2

0.56 0.40

Z

1

1

1

1

0.46(1 0.46)

p(1 - p)

50 75

n1 n 2

Step 5.

= 1.76.

Conclusion.

Do not reject H0 because -1.960 < 1.76 < 1.960. We do not have statistically

significant evidence at =0.05 to show that there is a difference in the proportions

of patients with hypercholesterolemia between treatments.

The following table compares background characteristics of the participants

involved in the study described in Problem 15. Are there any statistically

significant differences in patient characteristics between the different diet

programs? Justify briefly.

Low carbohydrate

(n=50)

52.1

42

15.3

$39,540

Men (%)

Mean educational level (years)

Mean family income

Conventional

(n=75)

53.4

34

12.9

$47,980

p-value

0.7564

0.0145

0.0237

0.0576

There is a statistically significant difference in the proportions of men in each diet group

(p=0.0145) and in the mean educational levels between diet groups (p=0.0237). There is

also a marginally statistically significant difference in mean family income (p=0.0576.

17.

18.

MISSING

Suppose the results of the analysis in Problems 15 to Problem 17 are reported and

criticized because the participants were not randomized to different diets and that there may be

other factors associated with changes in cholesterol. A third study is run to estimate the effect of

the low carbohydrate diet on cholesterol levels. In the third study, participants cholesterol levels

are measured before starting the program and then again after 6 months on the program. The

data are shown below.

Before Program

After 6 Months

210

215

230

240

190

190

215

200

260

280

200

210

Is there a significant increase in cholesterol after 6 months on the low carbohydrate diet?

Run the appropriate test at a 5% level of significance.

19

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Difference

Difference2

5

25

10

100

0

0

-15

225

Xd

30

5.0

6

20

400

10

100

Differences = 30

Differences2 = 850

850 (30) 2 /6

sd

11.8

5

Step 1.

H0: d=

0

H1: d>

0

=0.05

Step 2.

X d

t d

sd / n .

Step 3.

Step 4.

Step 5.

19.

Xd d

sd / n

5 .0

11.8 / 6 = 1.04.

Conclusion.

Do not reject H0 because 1.04 < 2.015. We do not have statistically significant

evidence at =0.05 to show that there is a difference in cholesterol after 6 months

on the diet.

terms of their effects on weight reduction. A total of 80 participants are involved and are

randomly assigned to the comparison groups (in equal numbers). The outcome of interest is

weight reduction, measured in pounds. The following data are observed after 3 months on

treatment.

Mean (SD)

Weight Reduction

A

6.4 (4.1)

B

8.9 (4.0)

C

2.2 (3.9)

Placebo

2.5 (4.3)

Is there a significant difference in mean weight reduction among the 4 treatments? Use a

5% level of significance. Hint: SST=1,889.

20

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Step 1.

H0: =

2=

3=

4

H1: Means are not all equal

=0.05

Step 2.

Step 3.

df1=k-1=4-1=3 and df2=N-k=80-4=76. Reject H0 if F > 2.73.

Step 4.

To organize our computations we will complete the ANOVA table. In order to

compute the sums of squares we must first compute the sample means for each

group and the overall mean.

A

B

C

Placebo

n1=20

n2=20

n3=20

n4=20

X 1= 6.4

X 2= 8.9

X 3= 2.2

X 4= 2.5

If we pool all N=80 observations, the overall mean is X = 5.0.

SSB = n j (X j - X )

.

SSB = 20(6.4 5.0)2 + 20(8.9-5.0)2 + 20(2.2-5.0)2 + 20(2.5-5.0)2

SSB = 39.2 + 304.2 + 156.8 + 125.0 = 625.2

Source of

Variation

Sums of Squares

SS

Degrees

of

freedom

df

Mean Squares

MS

Between

Treatments

625.2

208.4

12.53

Error or

Residual

1263.8

76

16.63

Total

1889.0

79

Step 5.

20.

Conclusion.

Reject H0 because 12.53 > 2.73. We have statistically significant evidence at

=0.05 to show that there is a difference in mean weight reduction among the four

treatments.

The mean lifetime for cardiac stents is 8.9 years. A medical device company has

implemented some improvements in the manufacturing process and hypothesizes that the

2012 Jones & Bartlett Learning, LLC

21

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

lifetime is now longer. A study of 40 new devices reveals a mean lifetime of 9.7 years with a

standard deviation of 3.4 years. Is there statistical evidence of a prolonged lifetime of the stents?

Run the test at a 5% level of significance.

Step 1.

H0: =

8.9

H1: >

8.9

=0.05

Step 2.

X 0

Z

s/ n .

Step 3.

Step 4.

Z

Step 5.

21.

X 0

s/ n

9.7 - 8.9

3.4/ 40 = 1.49

Conclusion.

Do not reject H0 because 1.49 < 1.645. We do not have statistically significant

evidence at =0.05 to show that the lifetime is longer than 8.9 years.

A study is conducted in 100 children to assess risk factors for obesity. Children are

enrolled and undergo a complete physical examination. At the examination, height and

weight of the child, their mother and father are measured and converted to body mass

index scores (weight(kg)/height(m)2). Data on self-reported health behaviors are

captured by interview and merged with the physical examination data. The primary

outcome variable is childs obesity for analysis, children are classified as normal weight

(BMI<25) or overweight/obese (BMI>25). Data on key study variables are summarized

below.

Characteristics

Mean (SD) Age, years

% Male

Mothers BMI

Normal (BMI<25)

Overweight (BMI 25-29.9)

Obese (BMI>30)

Fathers BMI

Normal (BMI<25)

Normal Weight

Overweight/Obese

Total

(n=62)

13.4 (2.6)

45%

(n=38)

11.1 (2.9)

51%

(n=100)

12.5 (2.7)

47%

40 (65%)

15 (24%)

7 (11%)

16 (41%)

14 (38%)

8 (21%)

56 (56%)

29 (29%)

15 (15%)

34 (55%)

16 (41%)

50 (50%)

22

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Overweight (BMI 25-29.9)

Obese (BMI>30)

Mean (SD) Systolic Blood

20 (32%)

8 (13%)

123 (15)

14 (38%)

8 (21%)

139 (12)

34 (34%)

16 (16%)

129 (14)

Pressure

Mean (SD) Total Cholesterol

186 (25)

211 (28)

196 (26)

overweight/obese children? Run the test at a 5% level of significance.

Step 1.

H0: =

2

H1:

2

=0.05

Step 2.

X1 - X 2

Z

1

1

Sp

n1 n 2

.

Step 3.

Step 4.

Sp

62 38 2

= 2.7.

13.4 - 11.1

2.7

Step 5.

22.

1

1

62 38 = 4.13.

Conclusion.

Reject H0 because 4.13 > 1.960. We have statistically significant evidence at

=0.05 to show that the mean ages are not equal. The p-value is p<0.0001.

Use the data shown in Problem 21 and test if there is an association between mothers

BMI and the childs obesity status (i.e., normal versus overweight/obese)? Run the test at

a 5% level of significance.

23

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Step 1.

H0: Mothers BMI and childs obesity status are independent

H1: H0 is false.

=0.05

Step 2.

2

(O - E) 2

E

The condition for appropriate use of the above test statistic is that each expected

frequency is at least 5. In Step 4 we will compute the expected frequencies and we

will ensure that the condition is met.

Step 3.

df=(3-1)(2-1)=2 and the decision rule is Reject H0 if 2 > 5.99.

Step 4.

We now compute the expected frequencies using the formula,

Expected Frequency = (Row Total * Column Total)/N.

The top number in each cell of the table is the observed frequency and the bottom

number is the expected frequency, shown in parentheses.

Mother:

Normal

Overweight

Obese

Total

Child:

Normal

40

(34.7)

15

(18.0)

7

(9.3)

62

Child:

Overwt/Obese

16

(21.3)

14

(11.0)

8

(5.7)

38

Total

56

29

15

100

(40 34.7) 2 (16 21.3) 2 (15 18.0) 2 (14 11.0) 2 (7 9.3) 2 (8 5.7) 2

2

34.7

21.3

18.0

11.0

9 .3

5 .7

2

= 0.81 +1.32 + 0.5 + 0.82 + 0.57 + 0.93 = 4.95.

Step 5.

Conclusion.

Do not reject H0 because 4.95 < 5.99. We do not have statistically significant

evidence at =0.05 to show that H0 is false or that mothers BMI and childs

obesity status are not independent.

24

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

23.

Use the data shown in Problem 21 and test if there is a significant difference in the

proportions normal versus overweight/obese children who are male. Run the test at a 5%

level of significance.

Step 1.

H0: p1 = p2 (equivalent to RD = 0, RR=1 or OR=1)

H1: p1 p2 (equivalent to RD 0, RR 1 or OR 1)

=0.05

Step 2.

p1 - p 2

Z

1

1

p(1 - p)

n 1 n2

Step 3.

Step 4.

p

The overall proportion is given as:

x1 x 2

n 1 n 2 = 0.47.

p1 - p 2

0.45 0.51

Z

1

1

1

1

0.47(1 0.47)

p(1 - p)

62 38

n1 n 2

Step 5.

24.

= -0.58.

Conclusion.

Do not reject H0 because -1.96 < -0.58 < 1.96. We do not have statistically

significant evidence at =0.05 to show that there is a difference in the proportions

of normal versus overweight/obese children who are male.

A study is run to compare body mass index (BMI) in participants assigned to different

diet programs and the data are analyzed in Excel. Use the Excel results to answer the questions

below.

a.

ANOVA

Source of Variation

SS

df

MS

P-value

F crit

25

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Between Groups

Within Groups

Total

40.791667

35.166666

75.958327

3

20

23

13.597

1.758

7.734

0.0012733

3.10

H0: =

2=

3=

4

H1: Means are not all equal

=0.05

Reject H0 because 7.734 > 3.10 (p=0.0013). We have significant evidence,

=0.05, that the means are not all equal

25.

A clinical trial is conducted to test the efficacy of a new drug for hypertension. The new

drug is compared to a standard drug and to a placebo in a study involving n=120

participants. The primary outcome is systolic blood pressure measured after 4 weeks on

the assigned drug. The table below shows characteristics of study participants measured

at baseline (prior to randomization).

Baseline Characteristic

Mean (SD) Age

N (%) Male

Mean (SD) BMI

Mean (SD) SBP

N (%) Diabetic

N (%) Current Smokers

Placebo (n=40)

75.2 (4.4)

12 (30.0%)

26.1 (4.9)

142.1 (19.2)

13 ( 32.5%)

4 (10.0%)

75.6 (4.8)

13 (32.5%)

25.1 (3.0)

150.4 (19.8)

11 (27.5%)

2 (5.0%)

74.7 (5.6)

9 (22.5%)

26.9 (4.1)

144.5 (19.7)

8 (20.0%)

1 (2.5%)

Test if the mean SBP at baseline is significantly higher in participants assigned to the

Standard Drug as compared to those assigned to the New Drug. Use a 5% level of

significance.

Step 1.

H0: S=

N

H1: S

N

=0.05

Step 2.

X1 - X 2

Z

1

1

Sp

n1 n 2

.

26

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Step 3.

Step 4.

Sp

40 40 2

= 19.75.

150.4 - 144.5

19.75

Step 5.

26.

1

1

40 40 = 1.34

Conclusion.

Do not reject H0 because 1.34 < 1.645. We do not have statistically significant

evidence at =0.05 to show that the mean SBP at baseline is significantly higher

in participants assigned to the Standard Drug as compared to those assigned to the

New Drug.

Use the data shown in Problem 25 and test if there is a significant difference in the

proportions of men assigned to each of the 3 treatments. (HINT: Are gender and

treatment independent?) Use a 5% level of significance.

Step 1.

H0: Gender and treatment group are independent

H1: H0 is false.

=0.05

Step 2.

2

(O - E) 2

E

frequency is at least 5. In Step 4 we will compute the expected frequencies and we

will ensure that the condition is met.

Step 3.

df=(2-1)(3-1)=2 and the decision rule is Reject H0 if 2 > 5.99.

Step 4.

We now compute the expected frequencies using the formula,

Expected Frequency = (Row Total * Column Total)/N.

2012 Jones & Bartlett Learning, LLC

27

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

The top number in each cell of the table is the observed frequency and the bottom

number is the expected frequency, shown in parentheses.

Male

Female

Total

Placebo

12

(11.3)

28

(28.7)

40

Standard

13

(11.3)

27

(28.7)

40

New

9

(11.3)

31

(28.7)

40

Total

34

86

120

(12 11.3) 2 (13 11.3) 2 (9 11.3) 2 (28 28.7) 2 (27 28.7) 2 (31 28.7) 2

2

11.3

11.3

11.3

28.7

28.7

28.7

2 = 0.04 +0.26 + 0.47 + 0.02 + 0.10 + 0.18 = 1.07.

Step 5.

27.

Conclusion.

Do not reject H0 because 1.07 < 5.99. We do not have statistically significant

evidence at =0.05 to show that H0 is false or that gender and treatment group are

not independent.

Use the data shown in Problem 25 and test if a there is a significant difference in the

proportion of diabetic participants in the Placebo as compared to the Standard Drug groups. Use

a 5% level of significance.

Step 1.

H0: pP = pS (equivalent to RD = 0, RR=1 or OR=1)

H1: pP pS (equivalent to RD 0, RR 1 or OR 1)

=0.05

Step 2.

p1 - p 2

Z

1

1

p(1 - p)

n 1 n2

Step 3.

Step 4.

p

The overall proportion is given as:

2012 Jones & Bartlett Learning, LLC

x 1 x 2 13 11

n1 n 2

80 = 0.3.

28

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

We now substitute to compute the test statistic.

p1 - p 2

0.325 0.275

Z

1

1

1

1

0.3(1 0.3)

p(1 - p)

40 40

n1 n 2

Step 5.

28.

= 0.49.

Conclusion.

Do not reject H0 because -1.96 < 0.49 < 1.96. We do not have statistically

significant evidence at =0.05 to show that there is a difference in the proportions

of diabetic participants in the Placebo as compared to the Standard Drug groups.

Use the data shown in Problem 25 and test if there is a significant difference in mean age

among the 3 groups. (HINT: SStotal=2893.) Use a 5% level of significance.

Step 1.

H0: =

2=

3

H1: Means are not all equal

=0.05

Step 2.

Step 3.

df1=k-1=3-1=2 and df2=N-k=120-3=117. Reject H0 if F > 3.09.

Step 4.

To organize our computations we will complete the ANOVA table

The overall mean is X = (75.2+75.6+74.7)/3 = 75.2.

2

SSB = n j (X j - X )

We can now compute

.

2

2

SSB = 40(75.2 75.2) + 40(75.6-75.2) + 40(74.7-75.2)2

SSB = 0 + 6.4 + 10.0 = 16.4

Source of

Variation

Sums of Squares

SS

Degrees

of

freedom

df

Mean Squares

MS

Between

Treatments

16.4

8.2

0.33

Error or

Residual

2876.6

117

24.6

29

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Total

Step 5.

29.

2893

119

Conclusion.

Do not reject H0 because 0.33 < 3.09. We do not have statistically significant

evidence at =0.05 to show that there is a difference in mean age among the 3

groups.

Some scientists believe that alcoholism is linked to social isolation. One measure of

social isolation is marital status. A study of 280 adults is conducted and each participant

is classified as not alcoholic, diagnosed alcoholic or undiagnosed alcoholic, and

categorized by marital status. Is there significant evidence of an association? Run the

appropriate test at a 5% level of significance.

Married

Not Married

Diagnosed

Alcoholic

21

59

Undiagnosed

Alcoholic

37

63

Step 1.

H0: Marital status and alcoholism are independent

H1: H0 is false.

=0.05

Step 2.

2

Not Alcoholic

58

42

(O - E) 2

E

frequency is at least 5. In Step 4 we will compute the expected frequencies and we

will ensure that the condition is met.

Step 3.

df=(2-1)(3-1)=2 and the decision rule is Reject H0 if 2 > 5.99.

Step 4.

We now compute the expected frequencies using the formula,

Expected Frequency = (Row Total * Column Total)/N.

The top number in each cell of the table is the observed frequency and the bottom

number is the expected frequency, shown in parentheses.

Diagnosed

Alcoholic

2012 Jones & Bartlett Learning, LLC

Undiagnosed

Alcoholic

Not Alcoholic

Total

30

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Married

Not Married

Total

21

(33.1)

59

(46.9)

80

37

(41.4)

63

(58.6)

100

58

(41.4)

42

(58.6)

100

116

164

280

(21 33.1) 2 (37 41.4) 2 (58 41.4) 2 (59 46.9) 2 (63 58.6) 2 (42 58.6) 2

2

33.1

41.4

41.4

46.9

58.6

58.6

2 = 4.42 +0.47 + 6.66 +3.12 +0.33 +4.70 =19.7.

Step 5.

30.

Conclusion.

Reject H0 because 19.7>5.99. We have statistically significant evidence at =0.05

to show that H0 is false or that marital status and alcoholism are not independent.

The p-value is p<0.005.

antioxidant vitamins and cancer risk. The table below shows data for plasma vitamin-A

concentration in stomach-cancer patients and in controls (participants similar to the cancer

patients but free of disease). Is there a significant difference in the mean concentration of plasma

antioxidant vitamins between patients with stomach cancer and controls? Run the appropriate

test at a 5% level of significance.

N

20

50

Controls

Mean

2.41

2.78

Std Dev

0.15

0.19

Step 1.

H0: =

2

H1:

2

=0.05

Step 2.

X1 - X 2

t

1

1

Sp

n1 n 2

, df = n1 + n2 -2 = 20 = 50 2 = 68

Step 3.

Step 4.

31

Essentials of Biostatistics for Public Health, 2nd Edition

Lisa M. Sullivan, PhD

Sp

20 50 2

= 0.18.

2.41 - 2.78

0.18

Step 5.

1

1

20 50 = -7.77.

Conclusion.

Reject H0 because -7.77 < -1.960. We have statistically significant evidence at

=0.05 to show that there a significant difference in the mean concentration of

plasma antioxidant vitamins between patients with stomach cancer and controls.

The p-value is p<0.01.

32

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