A clinical trial is conducted to evaluate the efficacy of a new drug for prevention of hypertension in patients with…

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	Number of Events (Hypertension) Dt	Number Censored Ct	Survival Probability St+1 = St*((Nt-Dt)/Nt)
0	10
7
8
9
10
11
12

 

Currently Available Drug

Complete the table below.

 

Time, Weeks	Number at Risk Nt	Number of Events (Hypertension) Dt	Number Censored Ct	Survival Probability St+1 = St*((Nt-Dt)/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