Non Substantive Change to Collection

“Market Claims in Direct-to-Consumer Prescription Drug Print Ads”
(OMB Control Number 0910-0824, expires 09/30/2019)
CHANGE REQUEST (83-C)
Date: January 13, 2017
We received OMB approval for ICR [0910-0824] - Market Claims in Direct-to-Consumer
Prescription Drug Print Ads on 9/21/16. This request proposes a change to the sampling
procedure to accommodate a lower than expected incidence rate and wording updates to the
questionnaire.
The purpose of this research is to examine the impact of market claims and quantitative efficacy
information in direct-to-consumer (DTC) print advertising for prescription drugs. The eligible
study population is U.S., non-institutionalized adults age 18 and older that have been diagnosed
with diabetes (as measured by self-report). The selected sample is drawn from Ipsos’s opt-in
online survey panel, i-Say. Panelists identified as having been diagnosed with diabetes are
invited to participate in the survey via email. Panelists who agree to participate are screened to
confirm they have been diagnosed with diabetes. During the pretest, the incidence rate was
lower than expected, meaning that fewer people qualified for the study than anticipated. The
reason is that there are a non-trivial number of individuals who self-identified as having diabetes
at some point in the past but who no longer self-identify as having diabetes. This is most likely
because the panel data is out of date, an issue the contractor is taking steps to correct as a result
of these findings.
To address the potential shortfall, we propose to broaden the survey invitation to members of the
i-Say panel who have not pre-identified themselves as having been diagnosed with diabetes in an
effort to identify more individuals who meet the screening criteria for Pretest 3 and the follow-up
study. Panelists who agree to participate will complete the same screener as pre-identified
panelists, to ensure they have been diagnosed with diabetes. Thus, the final sample for Pretest 3
and the follow-up study will still be comprised of individuals who self-identify as having been
diagnosed with diabetes. The revised estimated burden is 692.8, an increase from the original
estimated burden of 629.1. A revised burden chart follows (see Table 1). Of note, re-collecting
this data will involve no additional cost to the federal government.
Second, we have recently completed work to develop standardized scales for measuring risk and
benefit perceptions in prescription drug advertising (OMB control number 0910-0784). We
would like to update the wording in several of the questions to reflect that work. The new
wording is described in Table 2.

1 

Table 1: Estimated Burden1
Number of
respondents

Number of
responses per
respondent

Sample outgo (pretests and
main survey)

16,384

==

==

==

==

Screener completes

3,062

1

3,062

.03 (2
minutes)

91.9

==

==

==

==

Activity

Eligible

Average
Total annual
burden per
respondents
response

Total
hours

0.5 (30
146.5
minutes)
0.5 (30
Completes, Pretest 2
252
1
252
126.0
minutes)
0.5 (30
Completes, Main Study
495
1
495
247.5
minutes)
0.25 (15
Completes, Pretest 3
108
1
108
27.0
minutes)
Completes, Follow-up
0.25 (15
216
1
216
54.0
Study
minutes)
Total
==
==
==
==
692.8
1
There are no capital costs or operating and maintenance costs associated with this collection of
information.
Completes, Pretest 1

293

1

293

Table 2: Updated Question Wording
Question
Original Wording
Number
7
In your opinion, what is the ad’s message
about how much relief [drug] gives
people from diabetic nerve pain?
10A
In your opinion, what is the ad’s message
about how serious the side effects of
[drug] would be, if it did cause side
effects?

Updated Wording
What is the ad’s message about how
much [drug] would improve your
[condition]?
What is the ad’s message about how
serious [drug]’s side effects are?

10B

In your opinion, what is the ad’s message
What is the ad’s message about how likely it
about how many side effects [drug] might
is that you would experience at least one side
cause, if it did cause you to have side effects? effect if you took [drug]?

13

In your opinion, how much relief does

In your opinion, how much would [drug]
2 

16

17

18

25

25A

25B

[drug] actually give people from their
diabetic nerve pain?
In your opinion, if 100 people take [drug]
how many will have side effects? Please
enter a number in the box below.
In your opinion, how serious would the
side effects of [drug] be, if it did cause
you to have side effects?
In your opinion, how many side effects
might [drug] cause, if it did cause you to
have side effects?
How much relief do you think doctors
believe [drug] gives people from their
[condition]?
How serious do you think doctors would rate
the side effects of [drug], if it did cause you
to have side effects?
How many side effects do you think doctors
believe [drug] might cause, if it did cause
you to have side effects?

improve your [condition]?
In your opinion, how likely is it that you
would experience at least one side effect
if you took [drug]?
In your opinion, how serious are [drug]’s
side effects?
In your opinion, do you think [drug]’s
side effects would be short lived or long
lasting?
How much do you think doctors believe
[drug] would improve your [condition]?
How serious do you think doctors believe
[drug]’s side effects are?
Do you think doctors believe that [drug]’s
side effects would be short lived or long
lasting?

3