Which of the following statements best describe efficacy?
• It is an estimate of the benefit of treatment under ideal conditions It is an
• estimate of the reduction of disease in treated groups
QUESTION 2
A study is conducted for a pharmaceutical agent that has shown promise for reducing heart disease
among women. In order to more fully test the agent, an additional study is done restricting the
participants to be r&omized to those who have a history of hypertension. Which of the following
advantages cannot be claimed by the researchers?
The generalizability of the study is increased
QUESTION 3
What is the main advantage of the r&omization of the 168 study participants to one of the two dr
treatment groups?
Reduces the potential for selection bias in allocation of treatment group
QUESTION 4
After entry into the study, patients were first classified into three groups, those who had a previous
AMI, those with a first AMI who were at high risk for other cardiovascular diseases such as congestive
heart failure, & those with a first AMI who were at low risk for other cardiovascular diseases. Which
term best describes the study design?
R&omized clinical trial with stratified r&omization
QUESTION 5
After assignment to treatment group, 77% of those in the placebo group were men, while 80% of
those in the drug X group were men. Which statement is most likely to be true?
• R&omization was successful since the investigators did not alter the selection of participants
in either group in order to ensure equal percentages of men
,QUESTION 6
A preliminary analysis was conducted after 6 months & found that 87% of participants in the
placebo group & 85% of those in the drug X group had taken more than 90% of their prescribed
dosages.
Which statement best describes this finding?
, The characteristics of patients who failed to comply with the treatment dosages should be assessed as they may differ from those who c
QUESTION 7
Which of the following statements best describes the reason for conducting the study as a double-
blind trial?
Double blinding ensures that potential biases regarding selection, follow-up, & analysis can be reduced
QUESTION 8
A multicenter double-blind r&omized study was carried out to compare the effect of drug X with that
of a placebo in patients surviving acute myocardial infarction (AMI). Treatment with the drug started 7
days after infarction in 1,884 patients, 52% of all persons who were evaluated for entry into the study.
945 participants were r&omized to treatment with drug X while 939 were assigned to the placebo
group. Patients were then followed for 12 months for reinfarction. There were 152 deaths in the
placebo group & 98 in the group receiving drug X.
The researchers conclude that treatment with drug X reduces mortality in patients who have had an
AMI. The researchers are:
Correct because the rate of death is decreased in the drug X group
QUESTION 9
The following data come from a study of approaches to smoking cessation. Smokers who want to quit
were r&omized to one of four groups: control group C who received no intervention assistance,
quitting guide group Q who received brochures about how to quit smoking, quitting guide & support
group QS who received quitting brochures as well as social support brochures listing benefits of
smoking cessation, & telephone support group T who received the brochures & a monthly phone call
from a counselor. Participants received mailed surveys at 8, 16, & 24 months after r&omization. The
results after 2 years are in the table below. Which group had the least success in terms of quitting
smoking?
Group QS