Questionnaire Text Analysis PDN 10-21-22

Text Analysis Study Questionnaire
OMB Control No.: 0910-XXX
Expiration Date: XX/XX/20XX
Paperwork Reduction Act Statement: According to the Paperwork Reduction Act of 1995, an
agency may not conduct or sponsor and a person is not required to respond to a collection
of information unless it displays a valid OMB control number. The valid OMB control number
for this information collection is 0910-XXXX, and the expiration date is XX/XX/20XX. The
time required to complete this information collection is estimated to average 20 minutes per
response, including the time for reviewing instructions and completing and reviewing the
collection of information. Send comments regarding this burden estimate or any other
aspects of this collection of information, including suggestions for reducing burden, to
PRAStaff@fda.hhs.gov. This survey is being conducted on behalf of the U.S. Food and Drug
Administration.
[PROGRAMMERS: Please add a task bar to show respondents where they are in the survey.]
[PROGRAMMERS: The test link had a mobile view displayed on the right-hand side of the
web page. Please disable that view for all computer respondents.]
This survey will take about 20 minutes to complete. If possible, we ask you to complete the
study in one sitting (without taking any breaks) to avoid distractions.
You will be shown several prescription drug names and asked questions about each one.
Please answer the questions to the best of your ability.
[NEXT SCREEN]
Next to each drug name you will see an audio icon. Please be sure to click in the center of
each audio icon so you can hear how each drug name is pronounced.
[PROGRAMMER: Randomize to 1 of 10 blocks of drug names. Within that, randomize the
order of the 12 names. Show question module for 1 drug name at a time]
A drug called [DRUG 1] [INSERT AUDIO ICON] has recently been developed to treat
[MEDICAL INDICATION].
1. Please tell us what comes to mind when you see and hear [DRUG NAME]. Please
provide as much detail as you can.
As you answer, please consider the following features of the drug:
• General impressions
• The drug’s benefits and how well it would work
• The drug’s risks and side effects
• How it compares to other drugs
• Any other information about the drug

[PROGRAMMER: PLEASE ENSURE THIS NEXT QUESTION APPEARS ON A SEPARATE PAGE]
2. Please write a story or narrative about [drug name]. Please use as much detail as
you can.

[PROGRAMMER: Repeat question module for all 12 drug names.]
[PROGRAMMER: After all modules have been completed, ask Q3-Q7]
Thank you for answering those questions about each of the drug names you saw. Now, we
just have a few more questions about the full list of names. [PROGRAMMER—DO NOT
INCLUDE THIS INSTRUCTION ON EVERY PAGE, JUST BEFORE THE FIRST INSTANCE OF
THIS QUESTION]
Please consider the drug name shown, then answer the questions about it:
[
A drug called [DRUG 1] [INSERT AUDIO ICON] has recently been developed to treat
[MEDICAL INDICATION].
[PROVIDER VERSION; RANDOMIZE ORDER]
Q3-7. How much do you agree or disagree with each of the following statements?:

Strongly
disagree

Disagree

Neither
agree nor
disagree

Agree

Strongly
agree

The
proposed
name
overstates
the efficacy
of the drug.
The
proposed
name
minimizes
the risks
associated
with the
drug.
The
proposed
name
broadens the
indication of
the drug.
The
proposed
name implies
the drug is
superior to
other drugs
for this
condition.
The
proposed
name implies
unique
effectiveness
or
composition.

[CONSUMER VERSION; RANDOMIZE ORDER]
Q3-7. How much do you agree or disagree with each of the following statements?:
Strongly
Disagree
Neither
Agree
Strongly
disagree
agree nor
agree
disagree
The
proposed
name
overstates
the

effectiveness
of the drug.
The
proposed
name
minimizes
the risks
associated
with the
drug.
The
proposed
name implies
the drug can
be used for
more than
just the
medical
indication for
which it is
typically
prescribed.
The
proposed
name implies
the drug is
better than
other drugs
for this
condition.
The
proposed
name implies
the drug is
unique in
how well it
works or its
ingredients.
[REPEAT FOR ALL DRUG NAMES]
Debriefing screen
This concludes the survey. Our goal was to gather people’s reactions to information about
prescription drug names. As you may have recognized, to get your true reaction to this
information, some of the drug names we used in the study were not for real drugs.
[CONSUMERS ONLY]
Please see your healthcare professional for questions about your health and your medical
conditions.
Thank you very much for your time.