Phase 2: Number of Completes

Assessment of Terms and Phrases Commonly Used in Prescription Drug Promotion

Phase 2 Survey - HCP

Phase 2: Number of Completes

OMB: 0910-0895

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0895 can be found here:

2022-01-20 - No material or nonsubstantive change to a currently approved collection

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Terms and Phrases-Phase 2-HCP Survey-Last update 04.14.2020

List of Terms and Phrases for HCPs
1.

Convenient

18. Restores; rebuilds

Straightforward, simple, easy to use

19. Many/most/some/few; majority

Prevent; vs. help prevent; vs. reduce
the incidence

20. Prescription drug promotion vs.
prescription drug advertising

Proven to help vs. proven effective

21. Scientific exchange

Natural

22. Disease progression

Targeted; acts locally; targeted
mechanism of action

23. Overall response rate

Powerful; potent

#1 prescribed

25. Randomized controlled trial

New (as in new product)

10. Novel mechanism of action; first and
only; works differently

24. Response duration
26. Non-inferiority RCT
27. Intent-to-treat analysis
28. Per-protocol analysis

11. First in class
12. FDA-approved
13. Off-label
14. Reverses
15. Individual results may vary
16. Significant (as in statistically significant)
17. Manageable safety profile; established
safety profile; well-studied safety
profile; well-tolerated

Terms and Phrases-Phase 2-HCP Survey-Last update 04.14.2020
October 2019
Eligibility Criteria: This survey is intended for healthcare providers who spend 50% or more of their
time on patient care.
E1.

What percentage of your time do you spend providing direct patient care?
50% or more [Continue]
Less than 50% [Please return blank survey in the envelope provided]

E2.

How many hours a week do you practice medicine?
At least 32 hours [Continue]
Less than 32 hours [Please return blank survey in the envelope provided]

E3.

Have you ever worked for any of the following?
Department of Health and Human Services [Please return blank survey in the envelope
provided]
U.S. Food and Drug Administration [Please return blank survey in the envelope provided]
Market Research Firm [Please return blank survey in the envelope provided]
Pharmaceutical Company [Please return blank survey in the envelope provided]
RTI International [Please return blank survey in the envelope provided]
None of the above [Continue]

Terms and Phrases-Phase 2-HCP Survey-Last update 04.14.2020
Consent Form
Introduction and Purpose
You have been invited to take part in a research study. The purpose of the study is to learn how
healthcare providers 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 on behalf of, and sponsored by, the United States Food and Drug Administration (FDA).
Procedures
You are one of several thousand healthcare providers being asked to participate in this study. If you
agree to participate, the survey should take approximately 20 minutes to complete. 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 learn how healthcare providers understand and interpret information included in
prescription drug advertising.
Risks
There are no known risks to participating in this study. We will not ask you any personal health
questions, but if any questions make you uncomfortable, you can refuse to answer. There is also a
potential risk of loss of confidentiality. Every effort will be made to protect your information, but this
cannot be guaranteed.
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 disclose 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 interviews cannot be linked to a specific participant. You
will not be recontacted about this research study in the future.
Reimbursement
To thank you in advance for your time and participation in the study, we enclosed a $50 check.
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 1-800334-8571, ext. 22098. She can be reached between 9:00 AM and 5:00 PM Eastern 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 page and agree to participate, please proceed to begin the
survey.

Terms and Phrases-Phase 2-HCP Survey-Last update 04.14.2020
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.

[NOTES FOR THE TEAM (TO BE DELETED BEFORE SURVEY ADMINISTRATION)]:
• The survey is long and will be cut to ensure that it is no more than 20 minutes following
administration of the Phase 1 surveys, once we identify priority items.
• Response options presented here are subject to change following Phase 1 interviews.
• We will create two versions in which the order of the terms follows “first to last” and “last to
first” patterning to counterbalance the survey.
• Different lettered drug names represent different drugs. These may be replaced with fictitious
drug names prior to administration of the survey.]

“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.
My patients can take it at a time that works best for them.
It fits into my patients’ lifestyle.
My patients don’t have to stop what they are 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

Other
(please
specify):

Terms and Phrases-Phase 2-HCP Survey-Last update 04.14.2020
Phase 1
interviews.]
Drug B is
“straightforward
to use”.
Drug C is “simple
to use”.
Drug D is “easy to
use”.

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.
5

Terms and Phrases-Phase 2-HCP Survey-Last update 04.14.2020
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.
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.
[Additional answer options to be developed based on Phase 1 interviews]
Other (please specify):__________________

Terms and Phrases-Phase 2-HCP Survey-Last update 04.14.2020
“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 other parts
of the body.

It works at the site
of the headache
but may also travel
to other parts of
the body.

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

Other (please
specify):

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
works
better
than
other
drugs.

It has
longlasting
benefits.

It
works
quickly.

It has
many
side
effects.

It could
be
addictive.

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

Other
(please
specify):

Drug N is a
“powerful”
single-tablet
regimen
7

Terms and Phrases-Phase 2-HCP Survey-Last update 04.14.2020
with a high
barrier to
resistance.”
Drug O is a
“potent”
single-tablet
regimen
with a high
barrier to
resistance.”
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 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…”
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”…
8

Terms and Phrases-Phase 2-HCP Survey-Last update 04.14.2020
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.”
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 prescribe
the drug? PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR BELIEFS. Would it
make you:

1
A lot less likely to
prescribe it

Q13.

3
Neither more nor
less likely to
prescribe it

4
A little more likely
to prescribe it

5
A lot more likely
to prescribe it

How would knowing that a drug is the “#1 prescribed” brand affect other providers’ intentions
to prescribe the drug? PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR BELIEFS.
Would it make them:

1
A lot less likely to
prescribe it

Q14.

2
A little less likely
to prescribe it

2
A little less likely to
prescribe it

3
Neither more
nor less likely to
prescribe it

4
A little more likely
to prescribe it

5
A lot more likely
to prescribe it

What do you think about drug P 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.
9

Terms and Phrases-Phase 2-HCP Survey-Last update 04.14.2020
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):

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

“Drug V is a prescription drug available for the treatment of plaque psoriasis. Drug W is FDA approved.”
Q16.

What do you think about drug V 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.
10

Terms and Phrases-Phase 2-HCP Survey-Last update 04.14.2020
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 W 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 indication, age group, dosage, or route of administration.
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 X 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.”
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.]
11

Terms and Phrases-Phase 2-HCP Survey-Last update 04.14.2020
Other (please specify):__________________
Statement 1 (control – no term assessed): “Compared with placebo, people taking drug Y saw a slight
decrease in respiratory symptoms. It is not certain if drug Y 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 Y 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 Y’s
effectiveness?
Yes
No

Q21.

What do you think about drug Y 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):

Terms and Phrases-Phase 2-HCP Survey-Last update 04.14.2020
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
The drug
are well
has only
understood. 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 Z offers a
“manageable safety
profile.”
Drug AA offers an
“established safety
profile.”
Drug BB offers a “wellstudied safety profile.”
Drug CC is “well
tolerated.”
Statement 1: “Drug Z offers a manageable safety profile.”
Statement 2: “Drug AA offers an established safety profile.”
Statement 3: “Drug BB offers a well-studied safety profile.”
Statement 4: “Drug CC is well-tolerated.”
Q23.

Do these four statements mean the same thing or do they 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
of atrophic
vaginitis.

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

Other
(please
specify):

Drug DD “restores”
vaginal tissue.
13

Terms and Phrases-Phase 2-HCP Survey-Last update 04.14.2020
Drug EE “rebuilds”
vaginal tissue.
Q25.

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: _____________________

Q26.

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 is the “first in class.”
Drug U uses a “novel mechanism of action.”
Drug V is “FDA approved.”
Drug W is used “off label.”
Drug X “reverses”…
“Individual results may vary.”
The difference between drug AA and a
placebo was not “statistically significant.”
Drug FF “restores”…
Drug GG “rebuilds”…
Q27.

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

Terms and Phrases-Phase 2-HCP Survey-Last update 04.14.2020
Drug P is the “#1 prescribed” brand.
Drug Q is “new.”
Drug R “works differently.”
Drug S is the “first and only”…
Drug T is the “first in class.”
Drug U uses a “novel mechanism of
action.”
Drug V is “FDA approved.”
Drug W is used “off label.”
Drug X “reverses”…
“Individual results may vary.”
The difference between drug Y and a
placebo was not “statistically significant.”
Drug FF “restores”…
Drug GG “rebuilds”…

“For [many/a few/some/the majority/most] drug HH cuts the number of monthly migraine days in
half…or more....with some people being migraine free.”
Q28.

How many people out of 100 do you think of when you see each of the following?

Many