Gordis Epidemiology 6th Edition

Celentano Test Bank

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Chapter 10: Assessing Preventive and Therapeutic Measures: Randomized
Trials
Celentano: Gordis Epidemiology, 6th Edition

Test Bank

MULTIPLE CHOICE

1. Participants in a clinical trial might report different symptoms when they know they are part of
the intervention group instead of the control group. To avoid that, researchers use the following:

a. Confounding
b. Randomization
c. Concealment of random allocation
d. Masking
e. Effect modifiers

ANS: D

Masking is used to prevent participants from knowing whether they are receiving an intervention
(most times a drug) or a control (placebo).

2. In a clinical trial, researchers might influence the selection of participants into a group
(intervention or control), hence introducing bias into the study. What can be done to prevent
from this threat to the validity of the study?

a. Confounding
b. Randomization
c. Concealment of random allocation
d. Masking
e. Effect modifiers

ANS: B

The main purpose of randomization is to prevent the potential bias on the part of the
investigators from assigning participants into the groups of the trial.

3. In a clinical trial, sometimes patients agree to receive an intervention but later decide to stop
taking the medication. Moreover, some patients who were assigned to placebo decide to stop
taking the placebo pill and buy the drug on their own (even when they do not know that they are
taking a placebo pill). When this happens, researchers typically do the analysis according to the
original assignment of the treatment regardless of the actual treatment received. What is the
name of this procedure to analyze the data?

a. Randomization

Copyright © 2020 by Elsevier, Inc. All rights reserved.

Test Bank 10-2

b. Intention-to-treat analysis
c. Concealment of random allocation
d. Analysis as treated
e. Mediation analysis

ANS: B

Regardless of the actual treatment that patients receive, researchers typically analyze the data
respecting the original assignment of patients to the study arms. For example, a patient is
assigned to receive treatment A (taking a pill daily), but he decides to stop taking such pill.
When the analysis is done, this patient will be categorized into the treatment A group. This
analysis is called intention-to-treat.

4. Two similar drugs (drug A and drug B) to alleviate back pain were released simultaneously.
An investigator decides to test which of the drugs works better. He decides to conduct a trial in
which randomly, half of the participants receive drug A for a month while the other half received
drug B. After 2 weeks without any medication, participants switch the drug they were receiving
(those who received A start taking B, and those who received B start taking A). What type of
study design was illustrated in this example?

a. Cross-sectional study
b. Factorial randomized clinical trial
c. Crossover randomized clinical trial
d. Crossover cohort study
e. Phase II clinical trial

ANS: C

In a crossover clinical trial, participants receive one drug and later switch to another one. The
effect of these drugs is compared within the same population.

Copyright © 2020 by Elsevier, Inc. All rights reserved.