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Tutorial 7 Sample Size Calculation Dr. Shaik Shaffi: Dr. Rufaidah Dabbagh Dr. Nurah Al Amro

This document provides examples and explanations for calculating sample sizes needed for various study designs: 1. It discusses calculating the sample size needed for a descriptive study to estimate a single mean or proportion within a specified level of precision. 2. It demonstrates calculating the sample size needed to detect a difference between two treatment groups' outcomes, such as a 10 mmHg difference in blood pressure, with a given power and significance level. 3. Finally, it works through calculating the sample size required to detect an odds ratio of 3 between exposure and outcome groups in a case-control study, and the number of patients needed in each arm of a clinical trial to reject the null hypothesis that two cancer therapies have the same risk ratio

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76 views

Tutorial 7 Sample Size Calculation Dr. Shaik Shaffi: Dr. Rufaidah Dabbagh Dr. Nurah Al Amro

This document provides examples and explanations for calculating sample sizes needed for various study designs: 1. It discusses calculating the sample size needed for a descriptive study to estimate a single mean or proportion within a specified level of precision. 2. It demonstrates calculating the sample size needed to detect a difference between two treatment groups' outcomes, such as a 10 mmHg difference in blood pressure, with a given power and significance level. 3. Finally, it works through calculating the sample size required to detect an odds ratio of 3 between exposure and outcome groups in a case-control study, and the number of patients needed in each arm of a clinical trial to reject the null hypothesis that two cancer therapies have the same risk ratio

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TUTORIAL 7

SAMPLE SIZE
CALCULATION

DR. SHAIK SHAFFI


Dr. Rufaidah Dabbagh Dr. Nurah Al
Amro
Q1) Sample size estimation for a
descriptive study (single mean):
 We want to estimate the mean systolic blood
pressure of Saudi females.
 The standard deviation is around 20 mmHg
 We wish to estimate the true mean to within 10
mmHg with 95% confidence.

 What is the required sample size ?


Solution 1 (using formula)
 Sample size n = Z2(1-α) σ2 /d2
 s=20 d=10 (1- α) =0.95
 Z(1-α) =1.96 for 95% confidence level

 n = (1.96)2 x(20)2 /(10)2 = 15.37

 Since we cannot take 0.37 of a person, we round up


to 16 women as our sample size.
Solution 1 (using table)
 Referring to table 1:

 Look at the row for the sd = 20


 Look at the column for d= 10
 The sample size will be the number that intersects
those two.
Q2) Sample size estimation for a
descriptive study (single
proportion):
 We wish to estimate the proportion of Saudi males
who smoke.

 What sample size do we require to achieve a 95%


confidence interval of width ± 5% ( that is to be
within 5% of the true value) ? In a study some
years ago that found approximately 30% were
smokers.
Solution 2 (using formula)
 Using the formula for sample size for a single
proportion:
 Sample size n = Z2(1-α) p(1-p)/d2
 p=0.3 d=.05
 (1-α)=0.95 Z(1-α)= 1.96 for 95% confidence level

 Then n = (1.96)2(0.3)(0.7)/(0.05)2 = 322.7


≈ 323
Solution 2 (using Tables)
 Referring to table 2 (estimating a population
proportion):

 Go to the row for the d= 0.05


 Go to the column for p= 30%
 The sample size should be the number that intersects
those two.
Solution 2 (using Epi Info)
Press the “S” key for sample size
Choose population survey by pressing
“P”
Fill in the information as given in the
problem, then press “F4”

From the stem of the question:


Expected frequency of outcome is 30%,
worst acceptable result within a 5% of true value is 30% + 5% = 35%
Solution 2 continued
Q(3) Calculate Sample Size
 A new antihypertensive drug is to be tested against
current treatment practice in people with systolic blood
pressure > 160 mmHg and/or diastolic blood pressure
>95 mmHg.
 It is felt that if the new drug can achieve blood pressure
levels that are on the average 10 mmHg lower than
those achieved using current treatment then it would be
accepted by the medical community.
 The investigators would like at least 90% power and
have chosen α = 0.01 (two-sided) as the current therapy
is quite acceptable and they want to be sure that the
new therapy is superior before switching over. Blood
pressure measurements have a standard deviation of 20
mmHg.
Solution 3 (using formula)
 Sample size n =2 σ2 (Z(1-α)+ Z(1-β)2
d2
 Where:
 d=10 σ=20 α=0.01 Z(1-α) = 2.58
β=(1-power)= 1-0.9= 0.10 Z(1-β) = 1.28

 Plug into formula:


 n = 2 x202 (2.58+1.28)2 /(10)2 = 119.2≈ 120
Solution 3 (using tables)
 Referring to table 3:

 Look at row for sd = 20


 Look at column for d= 10
 The sample size should be the number that intersects
the two
Question 4
 A standard regimen has an efficacy of 80% and a
new regimen has been claimed to be 90% effective.

 What is the sample size required to test whether the


new treatment is really effective at 5% level with
90% power ?
Solution 4 (using formula)
 Sample size calculation for proportion:
n = (Z(1-α)+Z(1-β))2 [p1(1-p1)+ p2(1-p2)]
(p1-p2)2
 p1=80% p2=90% α=0.05 (1-α)=0.95
 Z(1-α)= 1.96 for 95% confidence level
 (Power=1-β)=0.90 Z(1-β)= 1.282 for 90% power
 n= (1.96+1.282)2((0.8x0.2)+(0.9x0.1)) / (0.8-0.9)2=
263 patients for each treatment
 Total sample size: 263x2= 526
Solution 4 (using tables)
 Referring to table 4:

 Look at row for P1 = 90%


 Look at column for P2= 80%
 The sample size should be the number that intersects
those two lines
Question 5
 To find whether contaminated food had caused
diarrhea in an area, a study is planned in that area
where 30% individuals ate contaminated food but
had no diarrhea.
 We want to detect an odds ratio of 3 in individuals
who ate contaminated food and had diarrhea as
compared to controls.
 How large sample ion each group is required to
have an 80% chance of getting this odds ratio at the
5% level .
Solution 5 using Epi info

Choose “unmatched cohort and cross


sectional study”
Solution 5 cont.
Solution 5 cont.
Question 6
 Two competing therapies for a particular cancer are
to be evaluated by the cohort study strategy in a
multi center clinical trial.
 Patients are randomized to either treatment A or B
and are followed for recurrence of disease for 5
years following treatment.
 How many patients should be studied in each of
two arms of the trial in order to be 90% of rejecting
Ho: RR=1 in favor of the alternative Ha: RR±1,if
the test is to be performed at the α=0.05 level and if
it is assumed that p2=0.35 and RR=1.5.
Solution 6

 Choose unmatched case control study


Solution 6 cont.
Solution 6 cont.
Thank you

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