Statistic in Health Care Management Week 4

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Chapter 7

Hypothesis Testing Procedures

Learning Objectives

• Define null and research hypothesis, test

statistic, level of significance and decision rule

• Distinguish between Type I and Type II errors

and discuss the implications of each

• Explain the difference between one- and two-

sided tests of hypothesis

Learning Objectives

• Estimate and interpret p-values

• Explain the relationship between confidence interval

estimates and p-values in drawing inferences

• Perform analysis of variance by hand

• Appropriately interpret the results of analysis of

variance tests

• Distinguish between one and two factor analysis of

variance tests

Learning Objectives

• Perform chi-square tests by hand

• Appropriately interpret the results of chi-square tests

• Identify the appropriate hypothesis testing procedures

based on type of outcome variable and number of

samples

Hypothesis Testing

• Research hypothesis is generated about

unknown population parameter

• Sample data are analyzed and determined to

support or refute the research hypothesis

Hypothesis Testing Procedures

Step 1

Null hypothesis (H0):

No difference, no change

Research hypothesis (H1):

What investigator

believes to be true

Hypothesis Testing Procedures

Step 2

Collect sample data and determine whether sample

data support research hypothesis or not.

For example, in test for m, evaluate . X

Hypothesis Testing Procedures

Step 3

• Set up decision rule to decide when to believe null

versus research hypothesis

• Depends on level of significance, a = P(Reject H0|H0 is true)

Hypothesis Testing Procedures

Steps 4 and 5

• Summarize sample information in test statistic (e.g.,

Z value)

• Draw conclusion by comparing test statistic to

decision rule. Provide final assessment as to whether

H1 is likely true given the observed data.

P-values

• P-values represent the exact significance of the data

• Estimate p-values when rejecting H0 to summarize significance of the data (can approximate with statistical tables, can get exact value with statistical computing package)

• P-value is the smallest a where we still reject H0

Hypothesis Testing Procedures

1. Set up null and research hypotheses, select a

2. Select test statistic

2. Set up decision rule

3. Compute test statistic

4. Draw conclusion & summarize significance

Errors in Hypothesis Tests

Hypothesis Testing for m

• Continuous outcome

• 1 Sample

H0: m=m0

H1: m>m0, m<m0, m≠m0

Test Statistic

n>30 (Find critical

value in Table 1C,

n<30 Table 2, df=n-1)

ns/

μ-X Z

0 =

ns/

μ-X t

0 =

Example 7.2.

Hypothesis Testing for m

The National Center for Health Statistics (NCHS)

reports the mean total cholesterol for adults is 203. Is

the mean total cholesterol in Framingham Heart

Study participants significantly different?

In 3310 participants the mean is 200.3 with a standard

deviation of 36.8.

Example 7.2.

Hypothesis Testing for m

1. H0: m=203

H1: m≠203 a=0.05

2. Test statistic

3. Decision rule

Reject H0 if z > 1.96 or if z < -1.96

ns/

μ-X Z

0 =

Example 7.2.

Hypothesis Testing for m

4. Compute test statistic

5. Conclusion. Reject H0 because -4.22 <-1.96. We have

statistically significant evidence at a=0.05 to show that

the mean total cholesterol is different in the Framingham

Heart Study participants.

22.4 3310/8.36

2033.200

ns/

μ-X Z 0 =

 ==

Example 7.2.

Hypothesis Testing for m

Significance of the findings. Z = -4.22.

Table 1C. Critical Values for Two-Sided Tests

a Z

0.20 1.282

0.10 1.645

0.05 1.960

0.010 2.576

0.001 3.291

0.0001 3.819 p<0.0001.

New Scenario

• Outcome is dichotomous (p=population proportion)

– Result of surgery (success, failure)

– Cancer remission (yes/no)

• One study sample

• Data

– On each participant, measure outcome (yes/no)

– n, x=# positive responses,

n

x p̂ =

Hypothesis Testing for p

• Dichotomous outcome

• 1 Sample

H0: p=p0 H1: p>p0, p<p0, p≠p0

Test Statistic

(Find critical value in Table 1C)

5)]pn(1,min[np 00



n

)p-(1p

p-p̂ Z

00

0 =

Example 7.4.

Hypothesis Testing for p

The NCHS reports that the prevalence of cigarette smoking among adults in 2002 is 21.1%. Is the prevalence of smoking lower among participants in the Framingham Heart Study?

In 3536 participants, 482 reported smoking.

Example 7.2.

Hypothesis Testing for p

1. H0: p=0.211

H1: p<0.211 a=0.05

2. Test statistic

3. Decision rule

Reject H0 if z < -1.645

n

)p-(1p

p-p̂ Z

00

0 =

Example 7.2.

Hypothesis Testing for p

4. Compute test statistic

5. Conclusion. Reject H0 because -10.93 < -1.645. We have

statistically significant evidence at a=0.05 to show that the

prevalence of smoking is lower among the Framingham Heart

Study participants. (p<0.0001)

93.10

3536

)211.01(211.0

211.0136.0

n

)p-(1p

p-p̂ Z

00

0 = 

 ==

Hypothesis Testing for Categorical and

Ordinal Outcomes*

• Categorical or ordinal outcome

• 1 Sample

H0: p1=p10, p2=p20,…,pk=pk0 H1: H0 is false

Test Statistic

(Find critical value in Table 3,

df=k-1)

* c2 goodness-of-fit test

= E

E)-(O χ

2 2

Chi-Square Tests

c2 tests are based on the agreement between

expected (under H0) and observed (sample)

frequencies.

Test statistic

E

)E - (O Σ = χ

2 2

Chi-Square Distribution

If H0 is true c 2 will be close to 0, if H0 is false, c

2 will

be large

Reject H0 if c 2 > Critical Value from Table 3

Example 7.6.

c2 goodness-of-fit test

A university survey reveals that 60% of students get

no regular exercise, 25% exercise sporadically and

15% exercise regularly. The university institutes a

health promotion campaign and re-evaluates exercise

one year later.

None Sporadic Regular

Number of students 255 125 90

Example 7.6.

c2 goodness-of-fit test

1. H0: p1=0.60, p2=0.25,p3=0.15

H1: H0 is false a=0.05

2. Test statistic

3. Decision rule df=k-1=3-1=2

Reject H0 if c 2 > 5.99

= E

E)-(O χ

2 2

Example 7.6.

c2 goodness-of-fit test

4. Compute test statistic

None Sporadic Regular Total

No. students (O) 255 125 90 470

Expected (E) 282 117.5 70.5 470

(O-E)2/E 2.59 0.48 5.39

c2 = 8.46

= E

E)-(O χ

2 2

Example 7.6.

c2 goodness-of-fit test

5. Conclusion. Reject H0 because 8.46 > 5.99. We have

statistically significant evidence at a=0.05 to show that

the distribution of exercise is not 60%, 25%, 15%.

Using Table 3, the p-value is p<0.005.

New Scenario

• Outcome is continuous

– SBP, Weight, cholesterol

• Two independent study samples

• Data

– On each participant, identify group and measure

outcome

– )s(ors,X,n),s(ors,X,n 2

2

2221

2

111

Two Independent Samples

RCT: Set of Subjects Who Meet

Study Eligibility Criteria

Randomize

Treatment 1 Treatment 2

Mean Trt 1 Mean Trt 2

Two Independent Samples

Cohort Study - Set of Subjects Who

Meet Study Inclusion Criteria

Group 1 Group 2

Mean Group 1 Mean Group 2

Hypothesis Testing for (m1m2)

• Continuous outcome

• 2 Independent Sample

H0: m1=m2 (m1m2 = 0)

H1: m1>m2, m1<m2, m1≠m2

Hypothesis Testing for (m1m2)

• Continuous outcome

• 2 Independent Sample

H0: m1=m2

H1: m1>m2, m1<m2, m1≠m2

Test Statistic

n1>30 and (Find critical value

n2> 30 in Table 1C,

n1<30 or Table 2,

df=n1+n2-2)

n2<30

21

21

n

1

n

1 Sp

X - X Z

=

21

21

n

1

n

1 Sp

X - X t

=

Pooled Estimate of Common Standard

Deviation, Sp

• Previous formulas assume equal variances

(s1 2=s2

2)

• If 0.5 < s1 2/s2

2 < 2, assumption is reasonable

2nn

1)s(n1)s(n Sp

21

2

22

2

11



 =

Example 7.9.

Hypothesis Testing for (m1m2)

A clinical trial is run to assess the effectiveness of a new drug in lowering cholesterol. Patients are randomized to receive the new drug or placebo and total cholesterol is measured after 6 weeks on the assigned treatment.

Is there evidence of a statistically significant reduction in cholesterol for patients on the new drug?

Example 7.9.

Hypothesis Testing for (m1m2)

Sample SizeMean Std Dev

New Drug 15 195.9 28.7

Placebo 15 227.4 30.3

Example 7.2.

Hypothesis Testing for (m1m2)

1. H0: m1=m2

H1: m1<m2 a=0.05

2. Test statistic

3. Decision rule, df=n1+n2-2 = 28

Reject H0 if t < -1.701

21

21

n

1

n

1 Sp

X - X t

=

Assess Equality of Variances

• Ratio of sample variances: 28.72/30.32 = 0.90

2nn

1)s(n1)s(n Sp

21

2

22

2

11



 =

5.2989.870 21515

1)30.3(151)28.7(15 Sp

22

== 

 =

Example 7.2.

Hypothesis Testing for (m1m2)

4. Compute test statistic

5. Conclusion. Reject H0 because -2.92 <

-1.701. We have statistically significant evidence at a=0.05 to show that the mean cholesterol level is lower in patients on treatment as compared to placebo. (p<0.005)

92.2

15

1

15

1 5.29

4.2279.195

n

1

n

1 Sp

X - X t

21

21 =

 =

=

New Scenario

• Outcome is continuous

– SBP, Weight, cholesterol

• Two matched study samples

• Data

– On each participant, measure outcome under each

experimental condition

– Compute differences (D=X1-X2)

– dd s,Xn,

Two Dependent/Matched Samples

Subject ID Measure 1 Measure 2

1 55 70

2 42 60

.

.

Measures taken serially in time or under different

experimental conditions

Crossover Trial

Treatment Treatment

Eligible R

Participants

Placebo Placebo

Each participant measured on Treatment and placebo

Hypothesis Testing for md

• Continuous outcome

• 2 Matched/Paired Sample

H0: md=0

H1: md>0, md<0, md≠0

Test Statistic

n>30 (Find critical value

in Table 1C,

n<30 Table 2, df=n-1)

ns

μ - X Z

d

dd =

ns

μ - X t

d

dd =

Example 7.10.

Hypothesis Testing for md

Is there a statistically significant difference in mean systolic blood pressures (SBPs) measured at exams 6 and 7 (approximately 4 years apart) in the Framingham Offspring Study?

Among n=15 randomly selected participants, the mean difference was -5.3 units and the standard deviation was 12.8 units. Differences were computed by subtracting the exam 6 value from the exam 7 value.

Example 7.10.

Hypothesis Testing for md

1. H0: md=0

H1: md≠0 a=0.05

2. Test statistic

3. Decision rule, df=n-1=14

Reject H0 if t > 2.145 or if z < -2.145

ns

μ - X t

d

dd =

Example 7.2.

Hypothesis Testing for md

4. Compute test statistic

5. Conclusion. Do not reject H0 because -2.145 < -1.60 <

2.145. We do not have statistically significant evidence

at a=0.05 to show that there is a difference in systolic

blood pressures over time.

60.1 15/8.12

03.5

ns

μ - X t

d

dd = 

==

New Scenario

• Outcome is dichotomous

– Result of surgery (success, failure)

– Cancer remission (yes/no)

• Two independent study samples

• Data

– On each participant, identify group and measure

outcome (yes/no)

– 2211

p̂,n,p̂,n

Hypothesis Testing for (p1-p2)

• Dichotomous outcome

• 2 Independent Sample

H0: p1=p2

H1: p1>p2, p1<p2, p1≠p2

Test Statistic

(Find critical value

in Table 1C)

5)]p̂(1n,p̂n),p̂(1n,p̂min[n 22221111



  

   

 

=

21

21

n

1

n

1 )p̂-(1p̂

p̂-p̂ Z

Example 7.12.

Hypothesis Testing for (p1-p2)

Is the prevalence of CVD different in smokers as compared to

nonsmokers in the Framingham Offspring Study?

Free of CVD

History of CVD

Total

Nonsmoker 2757 298 3055

Current smoker 663 81 744

Total 3420 379 3799

Example 7.2.

Hypothesis Testing for (p1-p2)

1. H0: p1=p2

H1: p1≠p2 a=0.05

2. Test statistic

3. Decision rule

Reject H0 if Z < -1.96 or if Z > 1.96

  

   

 

=

21

21

n

1

n

1 )p̂-(1p̂

p̂-p̂ Z

Example 7.2.

Hypothesis Testing for (p1-p2)

4. Compute test statistic

0.0975 3055

298 p̂ 0.1089,

744

81 p̂

21 ====

  

   

 

=

21

21

n

1

n

1 )p̂-(1p̂

p̂-p̂ Z

0.0988 3055744

29881 p̂ =

 =

927.0

3055

1

744

1 0.0988)-0.0988(1

0.0975-0.1089 Z =

 

  

 

=

Example 7.2.

Hypothesis Testing for (p1-p2)

5. Conclusion. Do not reject H0 because -1.96 < 0.927 <

1.96. We do not have statistically significant evidence at

a=0.05 to show that there is a difference in prevalent

CVD between smokers and nonsmokers.

Hypothesis Testing for More than 2 Means*

• Continuous outcome

• k Independent Samples, k > 2

H0: m1=m2=m3 … =mk H1: Means are not all equal

Test Statistic

(Find critical value in Table 4) *Analysis of Variance

k)/(N)XΣΣ(X

1)/(k)XX(Σn F

2

j

2

jj



 =

Test Statistic - F Statistic

• Comparison of two estimates of variability in data

• Between treatment variation, is based on the assumption

that H0 is true (i.e., population means are equal)

• Within treatment, Residual or Error variation, is

independent of H0 (i.e., we do not assume that the

population means are equal and we treat each sample

separately)

F Statistic

k)/(N)XΣΣ(X

1)/(k)XX(Σn F

2

j

2

jj



 =

Difference BETWEEN each group mean and overall mean

Difference between each observation and its group mean (WITHIN group variation - ERROR)

F Statistic

F = MSB/MSE

MS = Mean Square

What values of F that indicate H0 is likely

true?

Decision Rule

Reject H0 if F > Critical Value of F with

df1=k-1 and df2=N-k

from Table 4

k= # comparison groups

N=Total sample size

ANOVA Table

Source of Sums of Mean

Variation Squares df Squares F

Between

Treatments k-1 SSB/k-1 MSB/MSE

Error N-k SSE/N-k

Total N-1

)X - X( n Σ = SSB j 2

j

)X - X( Σ Σ = SSE j 2

)X -X( Σ Σ = SST 2

Example 7.14.

ANOVA

Is there a significant difference in mean weight loss

among 4 different diet programs? (Data are pounds lost over 8 weeks)

Low-Cal Low-Fat Low-Carb Control

8 2 3 2

9 4 5 2

6 3 4 -1

7 5 2 0

3 1 3 3

Example 7.14.

ANOVA

1. H0: m1=m2=m3=m4

H1: Means are not all equal a=0.05

2. Test statistic

k)/(N)XΣΣ(X

1)/(k)XX(Σn F

2

j

2

jj



 =

Example 7.14.

ANOVA

3. Decision rule

df1=k-1=4-1=3

df2=N-k=20-4=16

Reject H0 if F > 3.24

Example 7.14.

ANOVA

Summary Statistics on Weight Loss by

Treatment

Low-Cal Low-Fat Low-Carb Control

N 5 5 5 5

Mean 6.6 3.0 3.4 1.2

Overall Mean = 3.6

Example 7.14.

ANOVA

)X - X( n Σ = SSB j 2

j

=5(6.6-3.6)2+5(3.0-3.6)2+5(3.4-3.6)2+5(1.2-3.6)2

= 75.8

Example 7.14.

ANOVA

Low-Cal (X-6.6) (X-6.6)2

8 1.4 2.0

9 2.4 5.8

6 -0.6 0.4

7 0.4 0.2

3 -3.6 13.0

Total 0 21.4

)X - X( Σ Σ = SSE j 2

Example 7.14.

ANOVA

Low-Fat (X-3.0) (X-3.0)2

2 -1.0 1.0

4 1.0 1.0

3 0 0

5 2.0 4.0

1 -2.0 4.0

Total 0 10.0

)X - X( Σ Σ = SSE j 2

Example 7.14.

ANOVA

Low-Carb (X-3.4) (X-3.4)2

3 -0.4 0.2

5 1.6 2.6

4 0.6 0.4

2 -1.4 2.0

3 -0.4 0.2

Total 0 5.4

)X - X( Σ Σ = SSE j 2

Example 7.14.

ANOVA

Control (X-1.2) (X-1.2)2

2 0.8 0.6

2 0.8 0.6

-1 -2.2 4.8

0 -1.2 1.4

3 1.8 3.2

Total 0 10.6

)X - X( Σ Σ = SSE j 2

Example 7.14.

ANOVA

)X - X( Σ Σ = SSE j 2

=21.4 + 10.0 + 5.4 + 10.6 = 47.4

Example 7.14.

ANOVA

Source of Sums of Mean

Variation Squares df Squares F

Between 75.8 3 25.3 8.43

Treatments

Error 47.4 16 3.0

Total 123.2 19

Example 7.14.

ANOVA

4. Compute test statistic

F=8.43

5. Conclusion. Reject H0 because 8.43 > 3.24. We have

statistically significant evidence at a=0.05 to show that

there is a difference in mean weight loss among 4

different diet programs.

Two Factor ANOVA

• Compare means of a continuous outcome across two

grouping variables or factors

– Overall test – is there a difference in cell means

– Factor A – marginal means

– Factor B – marginal means

– Interaction – difference in means across levels of

Factor B for each level of Factor A?

Interaction

Cell Means Factor B

1 2 3

Factor A 1 45 58 70

2 65 55 38

35

40

45

50

55

60

65

70

75

1 2 3

A1

A2

No Interaction

Cell Means Factor B

1 2 3

Factor A 1 45 58 70

2 38 55 65

35

40

45

50

55

60

65

70

75

1 2 3

A1

A2

EXAMPLE 7.16

Two Factor ANOVA

• Clinical trial to compare time to pain relief of three

competing drugs for joint pain. Investigators

hypothesize that there may be a differential effect in

men versus women.

• Design – N=30 participants (15 men and 15 women)

are assigned to 3 treatments (A, B, C)

EXAMPLE 7.16

Two Factor ANOVA

• Mean times to pain relief by treatment and gender

• Is there a difference in mean times to pain relief?

Are differences due to treatment? Gender? Or both?

Men Women

A 14.8 21.4

B 17.4 23.2

C 25.4 32.4

EXAMPLE 7.16

Two Factor ANOVA Table Source Sums of Mean

Of Variation Squares df Squares F p-value

Model 967.0 5 193.4 20.7 0.0001

Treatment 651.5 2 325.7 34.8 0.0001

Gender 313.6 1 313.6 33.5 0.0001

Treatment*Gender 1.9 2 0.9 0.1 0.9054

Error 224.4 24 9.4

Total 1191.4 29

Hypothesis Testing for Categorical or Ordinal

Outcomes*

• Categorical or ordinal outcome

• 2 or More Samples

H0: The distribution of the outcome is

independent of the groups

H1: H0 is false

Test Statistic

(Find critical value in Table 3

* c2 test of independence df=(r-1)(c-1))

= E

E)-(O χ

2 2

Chi-Square Test of Independence

Outcome is categorical or ordinal (2+ levels) and there are two or more independent comparison groups (e.g., treatments).

H0: Treatment and Outcome are Independent (distributions of

outcome are the same across

treatments)

Example 7.17.

c2 Test of Independence

Is there a relationship between students’ living

arrangement and exercise status?

Exercise Status

None Sporadic Regular Total

Dormitory 32 30 28 90

On-campus Apt 74 64 42 180

Off-campus Apt 110 25 15 150

At Home 39 6 5 50

Total 255 125 90 470

Example 7.17.

c2 Test of Independence

1. H0: Living arrangement and exercise status are

independent

H1: H0 is false a=0.05

2. Test statistic

3. Decision rule df=(r-1)(c-1)=3(2)=6

Reject H0 if c 2 > 12.59

= E

E)-(O χ

2 2

Example 7.17.

c2 Test of Independence

4. Compute test statistic

O = Observed frequency

E = Expected frequency

E = (row total)*(column total)/N

= E

E)-(O χ

2 2

Example 7.17.

c2 Test of Independence

4. Compute test statistic

Table entries are Observed (Expected) frequencies

Exercise Status

None Sporadic Regular Total

Dormitory 32 30 28 90

(90*255/470=48.8) (23.9) (17.2)

On-campus Apt 74 64 42 180

(97.7) (47.9) (34.5)

Off-campus Apt 110 25 15 150

(81.4) (39.9) (28.7)

At Home 39 6 5 50

(27.1) (13.3) (9.6)

Total 255 125 90 470

Example 7.17.

c2 Test of Independence

4. Compute test statistic

5.60χ

9.6

9.6)(5 ...

17.2

17.2)(28

23.9

23.9)(30

48.8

48.8)(32 χ

2

2222 2

=

 

 

 

 =

Example 7.17.

c2 Test of Independence

5. Conclusion. Reject H0 because 60.5 > 12.59. We have

statistically significant evidence at a=0.05 to show that

living arrangement and exercise status are not

independent. (P<0.005)