Phase 2: Number of Completes

Terms and Phrases Study Phase 2 Survey-Consumer-Last Update (6.30.2020)

List of Terms and Phrases for Consumers
1. Convenient
17. Restores; rebuilds
2. Straightforward/simple/easy to use
18. Many/most/some/few; majority
3. Prevent; vs. help prevent; vs.
19. Prescription drug promotion versus
reduce the incidence
prescription drug advertising
4. Proven to help; proven effective
20. reaction; serious reaction; severe
5. Natural
life-threatening reaction
6. Targeted; acts locally, targeted
21. Endpoint
mechanism of action
22. Pure; purity
7. Powerful; potent
8. #1 prescribed
9. New (as in new product)
10. Novel/unique; first and only; works
differently
11. FDA-approved
12. Off-label
13. Reverses
14. Individual results may vary
15. Significant (as in statistically
significant)
16. Manageable safety profile;
established safety profile; wellstudied safety profile; well-tolerated

1

Screener

Hello, we are recruiting people for a research study sponsored by the Food and Drug Administration.
The purpose of the study is to find out how people understand words and phrases that are commonly
used in prescription drug advertising.
RTI International, an independent, nonprofit research institute, will be conducting the survey with
consumers nationwide. The survey will take approximately 20 minutes. If you participate, you will
receive a $20 check in appreciation for your time. To see if you are eligible, please complete the brief
survey linked below.
1. How old were you on your last birthday?
_____

Over Age 18  CONTINUE
Under Age 18 TERMINATE

2. Are you a medical or health professional?
Yes

 TERMINATE

No

 CONTINUE
3. Have you ever worked for…?

Department of Health and
Human Services

 TERMINATE

U.S. Food and Drug
Administration

 TERMINATE

Market research firm

 TERMINATE

Pharmaceutical company

 TERMINATE

Itracks

 TERMINATE

RTI International

 TERMINATE

None of the above

 CONTINUE

[IF NOT ELIGIBLE:
Thank and Terminate]
We’re sorry, but you are not eligible for this study. There are many possible reasons people
are not eligible for this study. These reasons were decided earlier by the researchers.
However, thank you for your interest in this study and for taking the time to answer our
questions today.

2

[IF ELIGIBLE]
Introduction and Purpose
You have been invited to take part in a research study. The purpose of the study is to find
out how people understand words and phrases that are commonly used in prescription drug
advertising. RTI International, a nonprofit research organization in North Carolina, is
conducting this study sponsored by the US Food and Drug Administration (FDA).
Procedures
You are one of about 1,000 people from around the United States being asked to participate
in this phase of the study. If you agree to participate, you will take part in a web-based
survey. The survey should take about 20 minutes. All aspects of the study may not be
revealed until the end.
Benefits
There is no direct benefit to you for participating. Your responses are very important
because they will help researchers find out how people understand information included in
prescription drug advertising.
Risks
There are no known risks to participating in this study. Although the questions we ask are
not related to your personal health, there is always a chance that you may feel
uncomfortable with some of the questions. You do not have to answer any question that you
don’t want to answer. Although we have taken steps to ensure your confidentiality, there is
still a small risk that your privacy could be broken.
Confidentiality
The privacy and confidentiality of your information is of the highest importance, and we are
committed to maintaining a secure environment in which you can participate. All
information you share in this study will be kept confidential to the extent provided by law.
The study team will not reveal your name or any of your responses, and your personal
information (name, address, phone number) will not be linked to any of your responses.
The information you share with us will be combined into a summary report so that details of
individual surveys cannot be linked to a specific participant. You will not be recontacted
about this research study in the future.
Reimbursement
After the interview has been completed, you will receive a check by mail for $20 within 4-6
weeks in appreciation for your time.
Right to Refuse or Withdraw
Your participation in this study is completely voluntary, and you can withdraw from the
study for any reason at any time without penalty.
Persons to Contact
If you have questions about the study, you can call the project director, Dr. Bridget Kelly, at
1-800-334-8571, ext. 22098. She can be reached between 9:00 AM and 5:00 PM Eastern

3

Time Monday to Friday. If you have questions about your rights as a participant, you can
call RTI’s Office of Research Protection toll-free at 1-866-214-2043.
[CONSENT1.] If you have read the previous screens and agree to participate, please click the
Yes button. If not, click the No button.
1. Yes, I agree to participate. [Continue to 1st survey screen]
2. No, I do not agree to participate. [Go on to next question]
[IF CONSENT1=NO OR SKIP]
[CONSENT2.] Are you sure you don't want to participate? Your opinions are important to us.
Please select the Yes button if you’d like to proceed to the survey. Select the No button to
exit.
1. Yes, I agree to participate. [Continue to 1st survey screen]
2. No, I do not agree to participate. [Exit]

4

This survey focuses on words and phrases that are commonly used in prescription drug
advertising. Each question includes one or more example statements featuring the word or
phrase we are asking about. This survey will take about 20 minutes to complete. We ask
you to complete the study in one sitting (without taking any breaks) in order to avoid
distractions.
Please answer the questions to the best of your ability.

“Taking one dose a day of drug A is convenient.”
Q1. What do you think about drug A when you read that it is “convenient”? PLEASE CHECK ALL THAT
APPLY.
It requires fewer doses than other drugs.
I can take it at a time that works best for me.
It fits into my lifestyle.
I don’t have to stop what I’m doing to take medication multiple times per day.
It does not require as many trips to the doctor or pharmacy.
[Additional answer options to be developed based on Phase 1 interviews]
Other (please specify):__________________
Q2. When you read the statement in the column to the left, what comes to mind
about the following drugs? PLEASE CHECK ALL THAT APPLY.
The
drug
will not
be
difficult
to take.

The pill
is small
and not
difficult
to
swallow.

The dose
does not
involve
measurement.

The dose
does not
involve
cutting
pills in
half.

[Additional
answer
options to
be
developed
based on
Phase 1
interviews.]

Other
(please
specify):

Drug B is
“straightforward
to use”.
Drug C is “simple
to use”.
Drug D is “easy to
use.”

5

Q3. How safe do you think each of the following drugs is compared to other drugs for the same
condition? CHECK THE BOX IN THE COLUMN THAT COMES CLOSEST TO YOUR BELIEFS.
1
Much
less
safe

2
A little
bit less
safe

3
Equally
as safe

4
A little
bit more
safe

5
Much
safer

Drug A is “convenient.”
Drug B is “straightforward to use”.
Drug C is “simple to use”.
Drug D is “easy to use.”

Q4. How effective do you think each of the following drugs is compared to other drugs for the same
condition? CHECK THE BOX IN THE COLUMN THAT COMES CLOSEST TO YOUR BELIEFS.
1
Much less
effective

2
A little
bit less
effective

3
Equally
as
effective

4
A little
bit more
effective

5
Much
more
effective

Drug A is “convenient”.
Drug B is “straightforward to
use”.
Drug C is “simple to use”.
Drug D is “easy to use.”

Q5. When you read the statement in the column to the left, what comes to mind about the following
drugs? PLEASE CHECK THE BOX IN THE COLUMN THAT COMES CLOSEST TO YOUR BELIEFS.
The drug
will
eliminate
severe
asthma
attacks.

The drug
will make
severe
asthma
attacks
less likely.

[Alternate
wording: The
drug will
reduce the
likelihood of a
severe asthma
attack.]

[Additional
answer
options to be
developed
based on
Phase 1
interviews.]

Other
(please
specify):

Drug E is shown
to “prevent”
severe asthma
attacks.
Drug F is shown
to “help
prevent”
severe asthma
attacks.
6

Drug G is
shown to
“reduce the
incidence” of
severe asthma
attacks.
Drug H is
“proven to
help” reduce
the risk of
severe asthma
attacks.
Drug I is
“proven
effective” at
reducing the
risk of severe
asthma attacks.

“Drug J is a prescription medication that’s made from a natural ingredient: omega-3 fish oil.”
Q6. What do you think about drug J when you read that it is made from a “natural” ingredient?
PLEASE CHECK ALL THAT APPLY.
It is made only from ingredients occurring in nature.
It does not include any synthetic ingredients.
It is environmentally friendly.
It is less effective.
It is more expensive.
[Additional answer options to be developed based on Phase 1 interviews]
Other (please specify):__________________
“Drug K addresses migraines by “targeting” and blocking calcitonin gene related peptide (CGRP)
receptors.”
Q7. When you read the statement above, what comes to mind about drug K? PLEASE CHOOSE THE
ANSWER THAT COMES CLOSEST TO YOUR BELIEFS.
It works at the site of the headache but may also travel to other parts of the body.
It affects only the CGRP receptors and not other cells in the body.
[Additional answer options to be developed based on Phase 1 interviews]
Other (please specify):__________________
Q8. When you read the statement in the column to the left, what comes to mind about the following
drugs? CHECK THE BOX IN THE COLUMN THAT COMES CLOSEST TO YOUR BELIEFS.
It works only
at the site of
the headache
and does not
travel to

It works at the
site of the
headache but
may also travel

[Additional
answer options
to be developed
based on Phase
1 interviews.]

Other (please
specify):

7

other parts of
the body.

to other parts of
the body.

Drug L “acts
locally” to help
address migraines.
Drug M has a
“targeted
mechanism of
action” to help
address migraines.

Q9. When you read the statement in the column to the left, what comes to mind about the following
drugs? CHECK THE BOX IN THE COLUMN THAT COMES CLOSEST TO YOUR BELIEFS.
It is
strong
.

It
work
s
bette
r
than
other
drugs
.

It has
longlasting
benefits
.

It
works
quickly
.

It has
many
side
effects
.

It could
be
addictive.

[Addition
al answer
options
to be
develope
d based
on Phase
1
interview
s.]

Other
(please
specify)
:

Drug N is a
“powerful
” singletablet
regimen
with a high
barrier to
resistance.
”
Drug O is a
“potent”
singletablet
regimen
with a high
barrier to
resistance.
”

8

Q10. How safe do you think each of the following drugs is compared to other drugs for the same
condition? CHECK THE BOX IN THE COLUMN THAT COMES CLOSEST TO YOUR BELIEFS.
1
Much
less
safe

2
A little
bit less
safe

3
Equally
as safe

4
A little
bit more
safe

5
Much
safer

Drug E is shown to “prevent”…
Drug F is shown to “help prevent”…
Drug G show to “reduce the
incidence” of…
Drug H is “proven to help”…
Drug I is “proven effective…”
Drug J is made from a “natural”
ingredient.
Drug K works by “targeting”…
Drug L “acts locally…”
Drug M has a “targeted mechanism
of action.”
Drug N is “powerful…”
Drug O is “potent.”

Q11. How effective do you think each of the following drugs is compared to other drugs for the
same condition? CHECK THE BOX IN THE COLUMN THAT COMES CLOSEST TO YOUR BELIEFS.
1
Much less
effective

2
A little
bit less
effective

3
Equally
as
effective

4
A little
bit more
effective

5
Much
more
effective

Drug E is shown to “prevent”…
Drug F is shown to “help
prevent”…
Drug G is shown to “reduce the
incidence” of…
Drug H is “proven to help”…
Drug I is “proven effective.”
Drug J is made from a “natural”
ingredient.
Drug K works by “targeting”…
Drug L “acts locally.”

9

Drug M has a “targeted
mechanism of action.”
Drug N is “powerful.”
Drug O is “potent.”

“Drug P is the #1 prescribed weight loss brand.”
Q12. How would knowing that a drug is the “#1 prescribed” brand affect your intention to ask your
doctor about it? PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR BELIEFS. Would it
make you:
1
A lot less likely
to ask about it

2
A little less
likely to ask
about it

3
Neither more
nor less likely
to ask about it

4
A little more
likely to ask
about it

5
A lot more
likely to ask
about it

Q13. How would knowing that a drug is the “#1 prescribed” brand affect other people’s intentions
to ask their doctors about it? PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR
BELIEFS. Would it make them:
1
A lot less likely
to ask about it

2
A little less
likely to ask
about it

3
Neither more
nor less likely
to ask about it

4
A little more
likely to ask
about it

5
A lot more
likely to ask
about it

Q14. What do you think about drug L when you read that it is the #1 prescribed” brand? PLEASE
CHECK ALL THAT APPLY.
It is the most popular brand (most commonly prescribed).
It is favored by doctors.
It is a higher quality drug.
It is more readily accessible.
It is less expensive than other brands.
It is more expensive than other brands.
It is more likely to be covered by insurance than other brands.
It is less likely to be covered by insurance than other brands.
[Additional answer options to be developed based on Phase 1 interviews]
Other (please specify):__________________
Q15. What do you think of the drugs below when you read each of the statements in the left-hand
column? PLEASE CHECK ALL THAT APPLY:
It uses a
different
mechanism
of action

It may be
expensive

It has
not
been
studied
for
very
long

It is
first
in its
class

It is
possible
there are
side
effects
that have
not yet
been
identified

It is
likely
to be
cutting
edge

Other
(please
specify):

10

Drug Q is
“new.”
Drug R
“works
differently.”
Drug S is the
“first and
only” drug
to…
Drug T uses a
“novel
mechanism
of action.”

“Drug U is a prescription drug available for the treatment of plaque psoriasis. Drug U is FDA approved.”
Q16. What do you think about drug U when you read that it has been “FDA approved”? PLEASE
CHECK ALL THAT APPLY.
It must not have any serious side effects.
The drug has been evaluated for safety and effectiveness.
The drug offers benefits that are greater than the risks.
[Additional answer options to be developed based on Phase 1 interviews.]
Other (please specify):__________________
“Drug V is used off-label.”
Q17. What do you think when you read that a prescription drug is used “off-label”? PLEASE CHECK
ALL THAT APPLY.
It does NOT have FDA approval for this use.
It is used for an unapproved medical condition, age group, dose, etc.
It is used illegally.
It is not approved to be prescribed to patients.
[Additional answer options to be developed based on Phase 1 interviews.]
Other (please specify):__________________
“Drug W reverses bone loss.”
Q18. What does “reverses” mean in the statement above? PLEASE CHOOSE THE ANSWER THAT
COMES CLOSEST TO YOUR BELIEFS.
It will improve bone density.
It will return bone density to normal.
It will stop bone density loss.
It will slow bone density loss.
It will have no effect on bone density.
[Additional answer options to be developed based on Phase 1 interviews.]
Other (please specify):_________________
“Cure means no virus found in the blood 3 months after treatment ends. Individual results may vary.”

11

Q19. What do you think of when you read, “Individual results may vary”? PLEASE CHOOSE THE
ANSWER THAT COMES CLOSEST TO YOUR BELIEFS.
The benefits will generally be the same for everyone.
The benefits will differ depending on the person.
It will work for few people.
It does not work.
[Additional answer options to be developed based on Phase 1 interviews.]
Other (please specify):__________________
Statement 1 (control – no term assessed): “Compared with placebo, people taking drug X saw a slight
decrease in respiratory symptoms. It is not certain if drug X was responsible for this decrease.” [NOTE
for team: This is a fictitious example]
Now please read this statement:
Statement 2: “Compared with placebo, people taking drug X saw a slight decrease in respiratory
symptoms. This change was not statistically significant.”
Q20. Compared to the initial statement, has this statement changed your opinion about drug X’s
effectiveness?
Yes
No
Q21. What do you think about drug X when you read that the difference between it and a placebo
was not “statistically significant”? PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR
BELIEFS.
There was no difference.
There was no detectable difference.
There may have been a difference, but it was not large enough to meet a specific statistical
threshold.
[Alternate answer options to be developed based on Phase 1 interviews.]
Other (please specify):
Q22. When you read the statement in the column to the left, what comes to mind about the
following drugs? PLEASE CHECK THE BOX IN THE COLUMN THAT COMES CLOSEST TO YOUR
BELIEFS.
The risks
are well
understood.

The drug
has only
minimal
risks.

There are
specific
options for
addressing
the risks or
side
effects.

[Alternate
answer
options to
be
developed
based on
Phase 1
interviews.]

Other
(please
specify):

Drug Y offers a
“manageable safety
profile.”
12

Drug Z offers an
“established safety
profile.”
Drug AA offers a
“well-studied safety
profile.”
Drug BB is “well
tolerated.”

Statement 1: “Drug Y offers a manageable safety profile.”
Statement 2: “Drug Z offers an established safety profile.”
Statement 3: “Drug AA offers a well-studied safety profile.”
Statement 4: “Drug BB is well-tolerated.”
Q23. Do these four statements mean the same thing or do some of them mean something different
to you?
They all mean the same thing.
They mean something different. Please specify the difference: ______________________
Q24. When you read the statement in the column to the left, what comes to mind about the
following drugs? PLEASE CHECK THE BOX IN THE COLUMN THAT COMES CLOSEST TO YOUR
BELIEFS.
It
improves
the
condition
of vaginal
tissue only
slightly

It will
return
vaginal
tissue to its
original
condition.

It will
relieve
symptoms.

[Additional
answer
options to be
developed
based on
Phase 1
interviews]

Other
(please
specify):

Drug CC “restores”
vaginal tissue.
Drug DD “rebuilds”
vaginal tissue.

Q21.

Do these statements mean the same thing to you or do they mean different things?
They mean the same thing.
They mean different things. Please specify the difference: _____________________

13

Q25. How safe do you think each of the following drugs is compared to other drugs for the same
condition? PLEASE CHECK THE BOX IN THE COLUMN THAT COMES CLOSEST TO YOUR BELIEFS.
1
Much
less
safe

2
A little
bit less
safe

3
Equally
as safe

4
A little
bit
more
safe

5
Much
safer

Drug P is the “#1 prescribed” brand.
Drug Q is “new.”
Drug R “works differently.”
Drug S is the “first and only” drug
to…
Drug T uses a “novel mechanism of
action.”
Drug U is “FDA approved.”
Drug V is used “off label.”
Drug W “reverses”…
“Individual results may vary.”
The difference between drug X and a
placebo was not “statistically
significant.”.
Drug CC “restores”…
Drug DD “rebuilds”…

Q26. How effective do you think each of the following drugs is compared to other drugs for the
same condition? PLEASE CHECK THE BOX IN THE COLUMN THAT COMES CLOSEST TO YOUR
BELIEFS.
1
Much
less
effective

2
A little
bit less
effective

3
Equally
as
effective

4
A little
bit more
effective

5
Much
more
effective

Drug P is the “#1 prescribed”
brand.
Drug Q is “new.”
Drug R “works differently.”
Drug S is the “first and only”…
Drug T uses a “novel mechanism
of action.”
Drug U is “FDA approved.”
Drug V is used “off label.”

14

Drug W “reverses”…
“Individual results may vary.”
The difference between drug Y and
a placebo was not “statistically
significant.”
Drug CC “restores”…
Drug DD “rebuilds”…

“For [many/a few/some/the majority/most] drug EE cuts the number of monthly migraine days in
half…or more....with some people being migraine free.”
Q27.

How many people out of 100 do you think of when you see each of the following?
__________________________(enter a number from 0–100)

Many

__________________________(enter a number from 0–100)

A few

__________________________(enter a number from 0–100)

Some
The majority
Most

__________________________(enter a number from 0–100)
__________________________(enter a number from 0–100)

Statement 1: “Pharmaceutical companies engage in prescription drug promotion to market their
products.”

Statement 2: “Pharmaceutical companies engage in prescription drug advertising to market their
products.”
Q28.

Do these statements mean the same thing to you or do they mean different things?
They mean the same thing to me.
They mean different things to me. Please specify the difference: ______________________

“Pharmaceutical companies engage in prescription drug promotion to market their products.”
“Pharmaceutical companies develop prescription drug advertising to market their products.”
Q29. Which of the following do you think about when you read “prescription drug promotion” and
“prescription drug advertising”? PLEASE CHECK ALL THAT APPLY.
Prescription drug
promotion

Prescription drug
advertising

Pharmaceutical representatives’
visits to doctors’ offices to
discuss prescription drugs

□

□

Drug information provided to
doctors at medical conferences

□

□

15

Print or web materials developed
specifically for healthcare
providers about a prescription
drug

□

□

Television or radio ads about the
drug directed at consumers

□

□

Print ads in magazines or
journals directed at consumers

□

□

Websites, web or social media
ads about the drug directed at
consumers

□

□

[Additional answer options to be
developed based on Phase 1
interviews]

□

□

Other (please
specify):__________________

□

□

[Note to team: Term 28 includes, “reactions;” “serious reactions;” “severe, life-threatening
reactions,”]
Statement 1: Drug FF can cause reactions.
Statement 2: Drug GG can cause serious reactions.
Statement 3: Drug HH can cause severe, life-threatening reactions.

Q30. How safe do you think each of the following drugs is compared to other drugs for the same
condition?

Drug FF can cause reactions
Drug GG can cause serious reactions
Drug HH can cause severe, life-threatening
reactions

1
Much
less
safe

2
A little
bit less
safe

3
Equally
as safe

4
A little
bit
more
safe

5
Much
safer

Q31. How effective do you think each of the following drugs is compared to other drugs for the

same condition?

Drug FF can cause reactions
Drug GG can cause serious
reactions
Drug HH can cause lifethreatening reactions

1
Much less
effective

2
A little bit
less
effective

3
Equally as
effective

4
A little bit
more
effective

5
Much more
effective

16

Drug II’s effectiveness was based on clinical trial endpoints.

Q32. Within this context, what does “endpoint” mean to you?
[Open-ended]
Q33. When you read the statement in the column to the left, what comes to mind about the following
drugs? PLEASE CHECK ALL THAT APPLY.
It does not

It is

[Additional

Other

include any

environ-

answer

(please

The ingredients

artificial

mentally

options to

specify):

It is all

are undiluted

ingredients.

friendly.

be

natural.

or

developed

unadulterated.

based on
Phase 1
interviews].

Drug JJ is a
“pure”
solution.
Drug KK follows
strict… “purity”
standards.

Thank you for answering those questions. Now, we have just a few more questions about you.
Q34. What is your gender?
Male
Female
Other
Q35. Are you Hispanic or Latino?
Yes
No
Q36. What is your race? You may select one or more races.
American Indian or Alaskan Native
Asian
Black or African American
Native Hawaiian or other Pacific Islander
White
Prefer not to answer

17

Q37. What is the highest level of education you have attained?
Less than high school
High school graduate (or GED)
Some college or technical school (no degree)
College graduate (2- or 4-year degree
Some graduate school
Graduate school degree
Q38. Was your total household income in [YEAR]…?
Less than $20,000
$20,000-$34,999
$35,000-$49,999
$50,000-$74,999
$75,000-$99,999
$100,000-$149,999
$150,000 or more
Prefer not to answer
Q39. How confident are you filling out medical forms by yourself?
Not at all confident
A little bit confident
Somewhat confident
Quite a bit confident
Extremely confident
That concludes the survey. Thank you for your time.
To obtain the most objective responses, the drug names used as examples in this survey
are not for real drugs. For any questions related to prescription drugs that might be relevant
for you, please consult your doctor.

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