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2. [13 marks] In an early clinical trial of a new drug, researchers advertised for patients...

2. [13 marks] In an early clinical trial of a new drug, researchers advertised for patients with a certain difficult-to-treat condition. Applicants with other medical complications, or extreme age (either young or old) were excluded. Those participating in the trial were randomly divided into three treatment groups. One group received a placebo, another received 20 milligrams (mg) of the drug per day, and the third group received a daily dose of 40 mg. All doses (including placebo) were identical in packaging and appearance, and neither the patients nor the clinicians knew who was in which treatment group. After a month, patients were clinically assessed and the researchers classified them according to Treatment and Change in Condition. The data are summarised below:

                                                                            Change in condition

      Treatment                        Improved                       No Change                            Worse

        Placebo                              35                                      70                                        95

            20mg                              62                                       76                                        62

            20mg                              88                                        80                                        32

(a) Identify the predictor and response variables in these data, and justify your choice. [2]

(b) Test the hypothesis that the different doses have no effect on patient outcomes. If you conclude that they do have an effect, describe it. Use a 1% significance level.

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Answer #1

(a)

Since researcher want to see the effect of different treatments so the predictor variable is Treatment.

The response variable is "Change in condition"

(b)

Here we need to use chi square test of independence.

Hypotheses are:

H0: The different doses have no effect on patient outcomes.

Ha: The different doses have effect on patient outcomes.

Following table shows the row total and column total:

Improved No change Worse Total
Placebo 35 70 95 200
20 mg 62 76 62 200
40 mg 88 80 32 200
Total 185 226 189 600

Expected frequencies will be calculated as follows:

ith row total ith row total Eij 20 grand total

Following table shows the expected frequencies:

Improved No change Worse Total
Placebo 61.667 75.333 63 200
20 mg 61.667 75.333 63 200
40 mg 61.667 75.333 63 200
Total 185.001 225.999 189 600

Following table shows the calculations for chi square test statistics:

O E (O-E)^2/E
35 61.667 11.53175749
62 61.667 0.00179819
88 61.667 11.24469958
70 75.333 0.377535595
76 75.333 0.005905632
80 75.333 0.289128124
95 63 16.25396825
62 63 0.015873016
32 63 15.25396825
Total 54.97463413

Following is the test statistics:

(O _ E)_)-54.97

Degree of freedom: df =( number of rows -1)*(number of columns-1) = (3-1)*(3-1)=4

The p-value is: 0.0000

Conclusion: Since p-value is less than 0.01 so we reject the null hypothesis. That is we cannot conclude that the different doses have no effect on patient outcomes.

Excel function used for p-value: "=CHIDIST(54.97, 4)"

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