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[answered] A clinical trial is conducted to evaluate the efficacy of a


2. A clinical trial is conducted to evaluate the efficacy of a new drug for prevention of hypertension in patients with pre-hypertension (defined as systolic blood pressure between 120?139 mmHg or diastolic blood pressure between 80?89 mmHg). A total of 20 patients are randomized to receive the new drug or a currently available drug for treatment of high blood pressure. Participants are followed for up to 12 months, and time to progression to hypertension is measured. The experiences of participants in each arm of the trial are shown below.


2. A clinical trial is conducted to evaluate the efficacy of a new drug for prevention of hypertension in patients with pre-hypertension (defined as systolic blood pressure between 120?139 mmHg or diastolic

 

blood pressure between 80?89 mmHg). A total of 20 patients are randomized to receive the new drug or

 

a currently available drug for treatment of high blood pressure. Participants are followed for up to 12

 

months, and time to progression to hypertension is measured. The experiences of participants in each

 

arm of the trial are shown below. New Drug Currently Available Drug Hypertension Free of Hypertension Hypertension Free of Hypertension 7 8 6 8 8 8 7 9 10 8 9 11 9 10 11 11 11 12 12

 

12 Estimate the survival (time to progression to hypertension) functions for each treatment

 

group using the Kaplan-Meier approach. New Drug

 

Complete the table below. Time,

 

Months Number at

 

Risk

 

Nt 0 10 Number of

 

Events (Hypertension)

 

Dt Number

 

Censored

 

Ct Survival Probability

 

St+1 = St*((Nt-Dt)/Nt) Number of

 

Events (Hypertension)

 

Dt Number

 

Censored

 

Ct Survival Probability

 

St+1 = St*((Nt-Dt)/Nt) 7

 

8

 

9

 

10

 

11

 

12 Currently Available Drug

 

Complete the table below. Time,

 

Weeks Number at

 

Risk

 

Nt 0 10 6

 

7

 

8

 

9

 

10

 

11

 

12 To answer the question as to whether or not there is a difference in time to progression, a

 

Chi square statistic is computed. The critical value for rejection of the null hypothesis is 3.84. The computed Chi square is 0.335.

 

Based on comparing the computed Chi square and the critical Chi square, which of the

 

following is (are) true?

 

A. There is not statistically significant evidence to show that the time to progression is

 

different between groups.

 

B. There is statistically significant evidence to show that the time to progression is different between groups.

 

C. The time to progression is essentially the same for each group.

 

D. a and c.

 

The hazard ratio risk of progression to hypertension is 0.658. Based on this computation,

 

which of the following is (are) true?

 

A. The risk of progression to hypertension is reduced by 34.2% in patients assigned

 

to the new drug as compared to the currently available drug.

 

B. The risk of progression to hypertension is 1.52 times higher in patient?s current

 

drug as compared to the new drug.

 

C. The risk of progression to hypertension is 5.12 times higher in patient?s current

 

drug as compared to the new drug

 

D. a and b

 


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