Question 1

In contrast to observational studies, intervention studies are employed to:

Accepted Answer

A)   generate knowledge about the etiology and natural history of disease.
B)   formulate strategies for prevention.
C)   test the efficacy of prevention measures.
D)   All are correct. C

Question 2

Clinical trials enroll individual subjects and enable randomization of subjects to receive or not receive the intervention.

Accepted Answer

A) True 
 B)False  True

Question 3

Phase III clinical trials for a cancer drug involve:

Accepted Answer

A)   initial testing in humans.
B)   testing with different tumor types.
C)   checking the new therapy against available therapies.
D)   None of these is correct. C

Question 4

The physical examination records of the incoming freshman class of 1935 at the University of Minnesota are examined in 1980 to see whether their recorded height and weight at the time of admission to the university are related to their chance of developing coronary heart disease by 1981. Which of the following study designs most appropriately characterizes this situation?

Accepted Answer

A)   Cross-sectional study
B)   Case-control study
C)   Prospective cohort study
D)   Historical prospective cohort study
E)   Clinical trial

Question 5

In community intervention studies, it is important for the investigator to evaluate whether a program has achieved its intended results before assuming the benefits of the intervention.

Accepted Answer

A) True 
 B)False

Question 6

The purpose of the washout period is to control the carryover effect.

Accepted Answer

A) True 
 B)False

Question 7

Match the following terms with their definitions.
Arm

Accepted Answer

A)   A study plan on which all clinical trials are based
B)   Any of the treatment groups in a randomized trial
C)   The process of learning the key facts about a clinical trial before deciding whether or not to participate
D)   A modification of the effect of the drug when administered with another drug
E)   None of the above

Question 8

Which of the following types of health issues is likely to be addressed in community trials?

Accepted Answer

A)   Smoking cessation
B)   HIV/AIDS
C)   Healthy eating
D)   All are correct.

Question 9

To assess clinical end points, investigators:

Accepted Answer

A)   compare rates of disease.
B)   compare rates of death.
C)   compare rates of recovery.
D)   All are correct.

Question 10

A therapeutic trial involves the study of the effectiveness of a substance or program to prevent disease.

Accepted Answer

A) True 
 B)False

Question 11

Match the following terms with their definitions.
Efficacy

Accepted Answer

A)   A study plan on which all clinical trials are based
B)   Any of the treatment groups in a randomized trial
C)   The process of learning the key facts about a clinical trial before deciding whether or not to participate
D)   A modification of the effect of the drug when administered with another drug
E)   None of the above

Question 12

External validity is not connected with the selection of sample subjects.

Accepted Answer

A) True 
 B)False

Question 13

The purpose of a double-blind design in clinical trials is to reduce error that results from:

Accepted Answer

A)   the way in which the outcome is assessed.
B)   subjects' knowledge of their assignment to study conditions.
C)   nonrandom assignment to study conditions.
D)   the way in which the outcome is assessed and subjects' knowledge of their assignment to study conditions.
E)   All are correct.

Question 14

A major advantage of community trials is that they are able to:

Accepted Answer

A)   control delivery of the intervention to many study units.
B)   estimate directly the realistic impact of behavior change.
C)   randomize subjects precisely to the study conditions.
D)   All are correct.

Question 15

Randomized controlled trials at the community level are typically used in special situations where there is a simple intervention.

Accepted Answer

A) True 
 B)False

Question 16

Match the following terms with their definitions.
Protocol

Accepted Answer

A)   A study plan on which all clinical trials are based
B)   Any of the treatment groups in a randomized trial
C)   The process of learning the key facts about a clinical trial before deciding whether or not to participate
D)   A modification of the effect of the drug when administered with another drug
E)   None of the above

Question 17

Treatment crossover refers to any change of treatment for a patient in a clinical trial that involves a switch of study treatments.

Accepted Answer

A) True 
 B)False

Question 18

Controlled clinical trials enable researchers to:

Accepted Answer

A)   test new drugs, new therapies, and new medical devices.
B)   exercise control over who will receive an exposure.
C)   identify definitive relationships between causes and effects.
D)   All are correct.

Question 19

Intervention designs involve only controlled clinical trials.

Accepted Answer

A) True 
 B)False

Question 20

Which of the four stages of evaluation requires the collection of baseline information before the program starts?

Accepted Answer

A)   Process evaluation
B)   Impact evaluation
C)   Outcome evaluation
D)   None of these is correct.

Exam 8: Experimental Study Designs

In contrast to observational studies, intervention studies are employed to:

Clinical trials enroll individual subjects and enable randomization of subjects to receive or not receive the intervention.

Phase III clinical trials for a cancer drug involve:

In community intervention studies, it is important for the investigator to evaluate whether a program has achieved its intended results before assuming the benefits of the intervention.

The purpose of the washout period is to control the carryover effect.

Match the following terms with their definitions. Arm

Which of the following types of health issues is likely to be addressed in community trials?

To assess clinical end points, investigators:

A therapeutic trial involves the study of the effectiveness of a substance or program to prevent disease.

Match the following terms with their definitions. Efficacy

External validity is not connected with the selection of sample subjects.

The purpose of a double-blind design in clinical trials is to reduce error that results from:

A major advantage of community trials is that they are able to:

Randomized controlled trials at the community level are typically used in special situations where there is a simple intervention.

Match the following terms with their definitions. Protocol

Treatment crossover refers to any change of treatment for a patient in a clinical trial that involves a switch of study treatments.

Controlled clinical trials enable researchers to:

Intervention designs involve only controlled clinical trials.

Which of the four stages of evaluation requires the collection of baseline information before the program starts?