Problem (1)

In an experiment to compare the efficacy of two anti-emetic drugs, you administer a

standard anaesthetic to 171 patients having day-case tonsillectomy. 87 patients are given
standard dose oral ondansetron pre-operatively, and 84 are given oral droperidol. The
incidence of post-operative nausea and vomiting (PONV) in the post-operative period is
recorded.

Study design
The patients were randomly allocated to one of the two treatments. Comment on how the
patients should be randomised.

Results
Look at Table I: ‘Observed numbers of patients.’ What is the overall incidence of PONV
in this study?

Calculate a 95% confidence interval for the overall incidence of PONV.

Do the same for the O and D groups separately.

How can we calculate the confidence interval for the difference in the incidence of nausea
between the two groups?

Look at Table II: ‘Expected frequencies’. How many patients in the Droperidol group
were expected to experience nausea?

How are the numbers in Table II, ‘Expected frequencies’, calculated?

Look at Table III. What is the P  value for this study?

What do you conclude from this study?

Table I: Observed number of patients

Droperidol Ondansetron total

No PONV 53 76 129
PONV 34 8 42
total 87 84 171
 

Table II: Expected frequencies

Droperidol Ondansetron
No PONV 65.632 63.368
PONV 21.368 20.632
 

Table III:  Statistical calculation

Chisq.test: P = 7.162E-06
Problem (2)

In a study to evaluate the effectiveness of epinephrine in reducing the vascular uptake of

local anaesthetic, you administer a standard nerve block to 50 patients. 25 patients (group
B) are given l-bupivacaine, and 25 (group BE) are given l-bupivacaine with epinephrine,
in standard doses. Venous blood samples are taken at 30 and 60 minutes after block, and
plasma bupivacaine is measured.

Results

Examine the results in Table I.

Using the methods in Altman chapter 4, calculate a 95% c.i. for the plasma concentration
at 30 minutes in both groups. 
Calculate a 95% c.i. for the difference in concentration between these two groups.

Do the same for the concentrations at 60 minutes.

Table II and III show the results of a t-test on the concentrations of bupivacaine at 30
minutes and at 60 minutes. 
Are these paired or unpaired data?
Should we use the two-tailed test or the one-tailed test?

How do you interpret these results? How useful is it to know the p values and the
confidence intervals?

Table I

Plasma concentration of l-Bupivacaine, mcg/ml – descriptive statistics

Group B Group BE
30Min 60Min 30Min 60Min
Mean 3.734 2.335 2.653 1.605
Standard Error 0.159 0.155 0.102 0.117
Median 3.847 2.403 2.535 1.665
Standard Deviation 0.794 0.776 0.508 0.583
Sample Variance 0.630 0.603 0.258 0.340
Kurtosis -0.633 -0.364 -0.023 -0.770
Skewness -0.238 -0.159 0.681 -0.056
Range 2.831 2.922 1.958 2.070
Minimum 2.169 0.820 1.740 0.554
Maximum 5.001 3.742 3.698 2.623
Sum 93.340 58.379 66.326 40.123
Count 25 25 25 25
 

Table II

t-Test: Two-Sample Assuming Equal Variances

Plasma conc. at 30 minutes
B BE
Mean 3.7335905 2.65305088
Variance 0.6300051 0.25828748
Observations 25 25
Pooled Variance 0.4441463
Hypothesized Mean Difference 0
df 48
t Stat 5.7323498
P(T<=t) one-tail 3.205E-07
t Critical one-tail 1.6772242
P(T<=t) two-tail 6.41E-07
t Critical two-tail 2.0106348
 

Table III

t-Test: Two-Sample Assuming Equal Variances

… at 60 minutes
B BE
Mean 2.3351722 1.60492236
Variance 0.6027137 0.34001324
Observations 25 25
Pooled Variance 0.4713635
Hypothesized Mean Difference 0
df 48
t Stat 3.7605253
P(T<=t) one-tail 0.0002303
t Critical one-tail 1.6772242
P(T<=t) two-tail 0.0004606
t Critical two-tail 2.0106348