Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Risk and Benefit Perception Scale Development, 69121-69124 [2014-27431]
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69121
Federal Register / Vol. 79, No. 224 / Thursday, November 20, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
burden per
response
(in hours)
Number of
responses per
respondent
Number of
respondents
Total burden
(in hours)
Respondents
Form name
Individuals (male and female) aged 18 years and
older.
Survey Module .............
3,583
1
30/60
1,792
Total ...............................................................
.......................................
........................
........................
........................
2,389
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–27467 Filed 11–19–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0373]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Risk and Benefit
Perception Scale Development
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
22, 2014.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
SUMMARY:
OMB control number 0910-New and
title, ‘‘Risk and Benefit Perception Scale
Development.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Risk and Benefit Perception Scale
Development (OMB Control Number
0910-New)
Section 1701(a)(4) of the Public
Health Service Act (PHS Act) (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 1003(d)(2)(c) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 393(b)(2)(c))
authorizes FDA to conduct research
relating to drugs and other FDA
regulated products in carrying out the
provisions of the FD&C Act.
FDA requires that prescription drug
advertisements be balanced in their
presentation of risk and benefit
information. Patients receive
information on drugs not only from
their doctors and pharmacies, through
patient labeling and FDA-mandated
Medication Guides, but also online, on
social networks and via direct-toconsumer (DTC) television and print
advertising. Moreover, research suggests
that consumers struggle with the
concepts of risk and efficacy (Ref. 1) and
often overestimate drug efficacy (Ref. 2).
As a result, it is important for FDA to
understand and accurately measure how
consumers are making sense of this
information and how it impacts
decisions related to prescription drugs.
FDA’s Office of Prescription Drug
Promotion (OPDP) has an active
research program that investigates how
DTC advertising influences consumer
knowledge, perceptions, and behavior.
As OPDP’s research program has
matured, the way in which we measure
risk and benefit perception has evolved
over time. This has resulted in
perception measures that, while
internally valid, tend to vary by study.
Consequently, FDA needs a pool of
reliable and valid measurement items
for assessing consumers’ drug risk and
benefit perceptions—as well as other
elements of prescription drug decision
making—consistently across studies.
The purpose of this project is to create
that measurement pool, thus increasing
the rigor and efficiency of FDA’s
research.
I. Design Overview
We will conduct pretesting prior to
main data collection to assess the
psychometric properties and identify
any measurement challenges (e.g.,
misinterpretation, lack of variance) with
candidate measurement items. We also
will use the pretesting to examine
factors that may affect future study
results and analyses (e.g., response scale
midpoints, moderating variables). We
will conduct two sequential pretest
waves (n=500 per wave; n=1,000 total)
with the following target populations:
(1) Individuals diagnosed with chronic
pain and (2) individuals diagnosed with
hypertension.
EXHIBIT 1—PRETEST STUDY DESIGN
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Medical condition
Wave
Chronic pain
Hypertension
Wave 1 .........................................................................................................................................
Wave 2 .........................................................................................................................................
n=250
n=250
n=250
n=250
500
500
Total ......................................................................................................................................
500
500
1,000
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Federal Register / Vol. 79, No. 224 / Thursday, November 20, 2014 / Notices
In the main study phase, we will
conduct four sequential waves of
iterative testing to fully assess the
measurement properties of the
candidate items and create the final
pool of measurements. We will conduct
the first two waves of the main study
with members of the target populations
(hypertension and chronic pain) to
refine the measurement items for those
groups and the second two waves with
members of the general population who
do not have the target health conditions
to determine if measurement reliability
and validity change when the advertised
drug addresses a condition that study
participants do not have (n=2,500 per
wave; n=10,000).
EXHIBIT 2—ITERATIVE TESTING DESIGN—ILLNESS POPULATION SAMPLE
Chronic pain ad
Drug risk
level
Ad type
Hypertension ad
Drug benefit level
Control
High
Ad type
Low
Drug risk
level
Drug benefit level
Control
High
Low
Wave 1
Print ....................
Television ...........
High .......
Low ........
High .......
Low ........
n=125
n=125
n=125
n=125
n=125
n=125
n=125
n=125
n=125
Print ....................
n=125
Television ...........
High .......
Low ........
High .......
Low ........
n=125
n=125
n=125
n=125
n=125
n=125
n=125
n=125
n=125
High .......
Low ........
High .......
Low ........
n=125
n=125
n=125
n=125
n=125
n=125
n=125
n=125
n=125
n=125
Wave 2
Print ....................
Television ...........
High .......
Low ........
High .......
Low ........
n=125
n=125
n=125
n=125
n=125
n=125
n=125
n=125
n=125
Print ....................
n=125
Television ...........
n=125
EXHIBIT 3—ITERATIVE TESTING DESIGN—GENERAL POPULATION SAMPLE
Chronic pain ad
Drug risk
level
Ad type
Hypertension ad
Drug benefit level
Control
High
Ad type
Low
Drug risk
level
Drug benefit level
Control
High
Low
Wave 3
Print ....................
Television ...........
High .......
Low ........
High .......
Low ........
n=125
n=125
n=125
n=125
n=125
n=125
n=125
n=125
n=125
Print ....................
n=125
Television ...........
High .......
Low ........
High .......
Low ........
n=125
n=125
n=125
n=125
n=125
n=125
n=125
n=125
n=125
High .......
Low ........
High .......
Low ........
n=125
n=125
n=125
n=125
n=125
n=125
n=125
n=125
n=125
n=125
Wave 4
Print ....................
Television ...........
High .......
Low ........
High .......
Low ........
n=125
n=125
n=125
n=125
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II. Procedure
A. Pretests
Each participant will be randomly
assigned to view either a print ad or a
television ad for a fictitious prescription
drug indicated to treat chronic pain or
hypertension and will be asked to
complete a brief online survey assessing
their benefit/risk perceptions,
intentions, and attitudes toward the
drug. Based on the pretest findings, we
will revise and remove candidate items
prior to full-scale testing.
B. Main Study
Each participant will be randomly
assigned to view either a print or
television ad for a fictitious prescription
drug for hypertension or chronic pain
and will be asked to complete a brief
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n=125
n=125
n=125
n=125
n=125
Print ....................
n=125
Television ...........
online survey assessing their benefit/
risk perceptions, intentions, and
attitudes toward the drug. In the first
two main study waves, participants will
view an ad that matches the sample’s
medical condition (chronic pain or
hypertension). In the final two main
study waves, participants will be
randomly assigned to view either the
chronic pain stimuli or the high blood
pressure stimuli.
The entire procedure is expected to
last approximately 30 minutes. This will
be a one-time (rather than annual)
information collection. Note: The survey
length has changed from 20 minutes to
30 minutes since the 60-day notice was
published. This is because cognitive
interviews did not result in as much
reduction in question numbers as
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n=125
originally expected. As this is a
measurement validation study, it is
important to include enough items on
the questionnaire for sufficient
comparison in order to identify those
that perform the best. We have
explained this change in survey length
in responses to comments and have
factored it in to the estimated burden.
In the Federal Register of April 21,
2014 (79 FR 22143), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was received
from the company Eli Lilly, Inc. We
respond to the points in Lilly’s
comment below.
(Comment 1) ‘‘Lilly seeks further
clarity to better understand how FDA
intends to apply the risk and benefit
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Federal Register / Vol. 79, No. 224 / Thursday, November 20, 2014 / Notices
measurement items being developed
through this study. FDA suggests in the
Federal Register notice that the
measurement items would be only used
to enhance future FDA research
initiatives; however, the precise nature
and purpose of such planned research is
unclear. Lilly suggests that any intended
use of the measurement items to
evaluate the effectiveness of drug
advertising disseminated by industry
would be inappropriate and beyond the
jurisdiction and authorities granted to
FDA.’’
(Response) Section 1701(a)(4) of the
Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 903(d)(2)(C) of the FD&C Act (21
U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and
other FDA-regulated products in
carrying out the provisions of the FD&C
Act. We believe that these statutes
provide a broad authority for FDA to
conduct research related to prescription
drug promotion as described in the
information collection request. As
already explained in the information
collection request, the nature and
purpose of this research is ‘‘to
understand and accurately measure how
consumers are making sense of this
information and how it impacts
decisions related to prescription drugs.’’
We believe that this research is crucial
in ensuring that consumers are receiving
prescription drug information that is
truthful and nonmisleading, and that
prescription drugs are not being
misbranded. FDA expects that any other
purpose of this research will become
clear only upon its completion, and
FDA intends to make the research
results and the final scale publiclyavailable.
(Comment 2) ‘‘Although FDA intends
to narrow the pool of survey questions
during the pretesting stage of the
research, we have concerns that the
current questionnaire is extremely
cumbersome and would likely exceed
20 minutes to complete. Further, based
on the currently designed instrument, it
is questionable whether in fact FDA
would have success in respondents’
fully completing the survey.’’
(Response) Since the submission of
the 60-day notice, the cognitive
interviews have been completed (OMB
control number 0910–0695). We did not
reduce the number of items as much as
expected based on those interviews.
Thus, we are recommending changing
the questionnaire to 30-minutes in
length, and burden estimates have been
calculated accordingly. Even so, no
respondent would ever answer the full
list of questions provided in the 60-day
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13:37 Nov 19, 2014
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notice; instead, the full questionnaire is
the pool of items from which the
questionnaire will be developed. We
will test subsets of these candidate
items using a form A/form B approach
so that no respondent ever answers
more than a 30-minute survey. In
addition, some items may only be tested
on one pretest and not the other or in
one wave of a survey. No respondent
would ever see all of these questions.
We take the survey length very
seriously. We will be conducting two
rounds of pretesting to refine the
questionnaire and reduce the number of
items, resulting in 30-minute (or
shorter) questionnaires for the pretests
and main study. We are sensitive to
issues regarding respondent fatigue and
its impact upon completion rates. We
have employed similar online surveys
on several previous studies, and we
have obtained high completion rates,
typically 90 percent or higher. For
example, on a recent study entitled
‘‘Experimental Study: Examination of
Corrective Direct-to-Consumer
Television Advertising’’ (OMB control
number 0910–0737), we had a pool of
1,071 eligible respondents and only 14
of those respondents failed to complete
the survey. We anticipate that the
completion rate for this study will be
similar.
(Comment 3) ‘‘In general, specific
questions proposed in the draft
questionnaire may be unanswerable by
the respondent if not addressed
specifically in the test stimulus. For
example, Q23 ‘‘How long will Drug X/
Drug Y’s negative side effects last once
they begin?’’ If the duration of a drug’s
side effects is not communicated in the
stimulus, data captured would be purely
speculative on the part of the consumer,
especially without inclusion of a ‘‘don’t
know or no opinion’’ option for the
respondent.’’
(Response) Respondents will be
exposed to information about the drug’s
indication and side effects in the ad and
will then be asked to provide their
perceptions of the drug’s effectiveness
and risk profiles. The questions are not
intended to measure factual knowledge
about the fictitious drug. By definition,
one’s perception is a subjective
assessment and thus, does not need to
be tied directly to a verbatim statement
in the advertisement. Whether or not
participants are forming perceptions
about other attributes of the drug, such
as how long side effects last, is an
empirical question and the purpose of
this study. Refining the questions, such
as adding a ‘‘don’t know’’ option, will
be further addressed by pretesting.
(Comment 4) ‘‘In addition to the
redundant and overlapping questions,
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69123
several proposed questions appear to be
unanswerable. The drafted
questionnaire creates a high burden in
complexity and time for the consumer
and may cause significant respondent
fatigue that could result in unreliable or
incomplete data collection. Given these
significant design issues related to the
draft study questionnaire, Lilly suggests
that FDA provide further details on how
the questions in the draft questionnaire
will be narrowed from the pretest stage
to the iterative stage of the research and
further evaluate the burden and
likelihood to complete for the iterative
testing stage.’’
(Response) The pool of questions will
be narrowed and refined through two
methods. The first method involved
cognitive testing of draft measures (for
a full discussion of the cognitive
interviews, see OMB control number
0910–0695). The goal of the cognitive
interviews was to refine and narrow the
measurement pool that will be
subsequently pretested and then tested
in an experimental study. The second
method will involve iterative testing
and analysis of draft measures to
establish scale reliability and internal
validity using survey methods. For a full
discussion of the pretesting and
experimental study, see Section I,
Design and Section II, Procedure.
(Comment 5) ‘‘Additionally, it is not
clear why some batteries of questions,
such as those questions under the
validity testing section (Q63–Q77) are
included. These questions do not seem
aligned with the research objective.’’
(Response) These items are included
for the purpose of testing the convergent
validity of the other items in our item
pool (measures or risk and benefit
perceptions). The items in Q63–Q77
come from the previously validated
Beliefs about Medicines Questionnaire
(BMQ) (Ref. 3). As an example, if the
benefit perception items perform as
intended, they should be highly
correlated with positive beliefs about
medicines, as measured by the BMQ
scale.
(Comment 6) ‘‘Finally, questions 78–
82 seem better placed in a battery of
questions for the screening or consumer
selection phase.’’
(Response) We believe that the
constructs captured by questions 78–82
may moderate the relationship between
ad content and respondents’ risk and
benefit perceptions. We include them
on the survey to keep the screener as
short as possible, which reduces the
burden on individuals who ultimately
do not qualify for the study. They will
not be used for screening as we do not
plan to include or exclude any
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69124
Federal Register / Vol. 79, No. 224 / Thursday, November 20, 2014 / Notices
individuals based on their responses to
these questions.
(Comment 7) ‘‘Lilly suggests that the
survey design be improved to better
align with the research objectives, to
avoid bias and to mitigate extreme
respondent fatigue. Lilly recommends
that FDA modify the data collection
instrument to address the points noted
above and seek additional public
comment on the revised design.’’
(Response) Given our responses and
points of clarification above, we believe
that the current design is rigorous and
meets FDA’s research objectives. The
design allows us to test and validate
measurement items for consumers’ risk
and benefit perceptions. By
randomizing respondents to the various
ads with different benefit and risk
information, we have controlled for
underlying differences in respondent
demographics and thereby have reduced
the potential for selection bias (Ref. 4)
and enhanced study validity. As we
have described above, we also have
designed the study to minimize
respondent fatigue by testing only the
most promising candidate items and by
ensuring a survey length of no more
than 30 minutes.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Hours per response 2
Total hours
Pretest screener ................................
Main study screener .........................
Pretest ...............................................
Main Study ........................................
2,000
20,000
2 1,100
10,200
1
1
1
1
2,000
20,000
1,100
10,200
0.03 (2 minutes) ...............................
0.03 (2 minutes) ...............................
.5 (30 minutes) .................................
.5 (30 minutes) .................................
60
600
550
5,100
Total ...........................................
........................
........................
........................
...........................................................
6,310
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 With online surveys, several participants may be completing the survey at the time that the total target sample is reached. Those participants
are allowed to complete the survey, which can result in the number of completes going slightly over the target number. Thus, if our target is
1,000, we have rounded up by an additional 100 to allow for some overage.
III. References
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The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov.
1. Lipkus, I. M., ‘‘Numeric, Verbal, and
Visual Formats of Conveying Health
Risks: Suggested Best Practices and
Future Recommendations,’’ Medical
Decision Making, 27(5), 696–713 (2007).
2. Aikin, K. J., J. L. Swasy, and A.C. Braman,
‘‘Patient and Physician Attitudes and
Behaviors Associated with DTC
Promotion of Prescription Drugs—
Summary of FDA Survey Research
Results,’’ FDA, Center for Drug
Evaluation and Research, 19 (2004).
3. Horne, R., J. Weinman, and M. Hankins,
‘‘The Beliefs About Medicines
Questionnaire: The Development and
Evaluation of a New Method for
Assessing the Cognitive Representation
of Medication,’’ Psychology and Health,
14, 1–24 (1999).
4. Kunz, R., G. E. Vist, and A. D. Ochman,
‘‘Randomization to Protect Against
Selection Bias in Healthcare Trials,’’ The
Cochrane Library, Issue 2 (2008).
Dated: November 14, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–27431 Filed 11–19–14; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program: Revised Amount of the
Average Cost of a Health Insurance
Policy
The Health Resources and Services
Administration (HRSA) is publishing an
updated monetary amount of the
average cost of a health insurance policy
as it relates to the National Vaccine
Injury Compensation Program (VICP).
Section 100.2 of the VICP’s
implementing regulation (42 CFR Part
100) states that the revised amounts of
an average cost of a health insurance
policy, as determined by the Secretary,
are to be published periodically in a
notice in the Federal Register and filed
with the United States Court of Federal
Claims (the Court). This figure is
calculated using the most recent
Medical Expenditure Panel Survey—
Insurance Component (MEPS–IC) data
available as the baseline for the average
monthly cost of a health insurance
policy. This baseline is adjusted by the
annual percentage increase/decrease
obtained from the most recent annual
Kaiser Family Foundation and Health
Research and Educational Trust (KFF/
HRET) Employer Health Benefits survey
or other authoritative source that may be
more accurate or appropriate.
In 2014, MEPS–IC, available at
www.meps.ahrq.gov, published the
PO 00000
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annual 2013 average total single
premium per enrolled employee at
private-sector establishments that
provide health insurance. The figure
published was $5,571. This figure is
divided by 12-months to determine the
cost per month of $464.25. The $464.25
shall be increased or decreased by the
percentage change reported by the most
recent KFF/HRET, available at
www.kff.org. The percentage increase
from 2013 to 2014 was published at 2
percent. By adding this percentage
increase, the calculated average monthly
cost of a health insurance policy is
$473.54 for 2014.
Therefore, the Secretary announces
that the revised average cost of a health
insurance policy under the VICP is
$473.54 per month. In accordance with
§ 100.2, the revised amount was
effective upon its delivery by the
Secretary to the Court. Such notice was
delivered to the Court on November 13,
2014.
Dated: November 13, 2014.
Mary K. Wakefield,
Administrator.
[FR Doc. 2014–27432 Filed 11–19–14; 8:45 am]
BILLING CODE 4165–15–P
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]]>Agencies
[Federal Register Volume 79, Number 224 (Thursday, November 20, 2014)]
[Notices]
[Pages 69121-69124]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27431]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0373]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Risk and Benefit
Perception Scale Development
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
December 22, 2014.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-New and
title, ``Risk and Benefit Perception Scale Development.'' Also include
the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Risk and Benefit Perception Scale Development (OMB Control Number 0910-
New)
Section 1701(a)(4) of the Public Health Service Act (PHS Act) (42
U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to
health information. Section 1003(d)(2)(c) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA
to conduct research relating to drugs and other FDA regulated products
in carrying out the provisions of the FD&C Act.
FDA requires that prescription drug advertisements be balanced in
their presentation of risk and benefit information. Patients receive
information on drugs not only from their doctors and pharmacies,
through patient labeling and FDA-mandated Medication Guides, but also
online, on social networks and via direct-to-consumer (DTC) television
and print advertising. Moreover, research suggests that consumers
struggle with the concepts of risk and efficacy (Ref. 1) and often
overestimate drug efficacy (Ref. 2). As a result, it is important for
FDA to understand and accurately measure how consumers are making sense
of this information and how it impacts decisions related to
prescription drugs.
FDA's Office of Prescription Drug Promotion (OPDP) has an active
research program that investigates how DTC advertising influences
consumer knowledge, perceptions, and behavior. As OPDP's research
program has matured, the way in which we measure risk and benefit
perception has evolved over time. This has resulted in perception
measures that, while internally valid, tend to vary by study.
Consequently, FDA needs a pool of reliable and valid measurement items
for assessing consumers' drug risk and benefit perceptions--as well as
other elements of prescription drug decision making--consistently
across studies. The purpose of this project is to create that
measurement pool, thus increasing the rigor and efficiency of FDA's
research.
I. Design Overview
We will conduct pretesting prior to main data collection to assess
the psychometric properties and identify any measurement challenges
(e.g., misinterpretation, lack of variance) with candidate measurement
items. We also will use the pretesting to examine factors that may
affect future study results and analyses (e.g., response scale
midpoints, moderating variables). We will conduct two sequential
pretest waves (n=500 per wave; n=1,000 total) with the following target
populations: (1) Individuals diagnosed with chronic pain and (2)
individuals diagnosed with hypertension.
Exhibit 1--Pretest Study Design
----------------------------------------------------------------------------------------------------------------
Medical condition
Wave --------------------------------
Chronic pain Hypertension
----------------------------------------------------------------------------------------------------------------
Wave 1.......................................................... n=250 n=250 500
Wave 2.......................................................... n=250 n=250 500
-----------------------------------------------
Total....................................................... 500 500 1,000
----------------------------------------------------------------------------------------------------------------
[[Page 69122]]
In the main study phase, we will conduct four sequential waves of
iterative testing to fully assess the measurement properties of the
candidate items and create the final pool of measurements. We will
conduct the first two waves of the main study with members of the
target populations (hypertension and chronic pain) to refine the
measurement items for those groups and the second two waves with
members of the general population who do not have the target health
conditions to determine if measurement reliability and validity change
when the advertised drug addresses a condition that study participants
do not have (n=2,500 per wave; n=10,000).
Exhibit 2--Iterative Testing Design--Illness Population Sample
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic pain ad Hypertension ad
--------------------------------------------------------------------------------------------------------------------------------------------------------
Drug benefit level Drug benefit level
Ad type Drug risk ------------------------ Control Ad type Drug risk ------------------------ Control
level High Low level High Low
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wave 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Print......................... High.......... n=125 n=125 n=125 Print........... High......... n=125 n=125 n=125
Low........... n=125 n=125 ........... Low.......... n=125 n=125 ..........
Television.................... High.......... n=125 n=125 n=125 Television...... High......... n=125 n=125 n=125
Low........... n=125 n=125 ........... Low.......... n=125 n=125
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wave 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Print......................... High.......... n=125 n=125 n=125 Print........... High......... n=125 n=125 n=125
Low........... n=125 n=125 ........... Low.......... n=125 n=125 ..........
Television.................... High.......... n=125 n=125 n=125 Television...... High......... n=125 n=125 n=125
Low........... n=125 n=125 ........... Low.......... n=125 n=125
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exhibit 3--Iterative Testing Design--General Population Sample
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic pain ad Hypertension ad
--------------------------------------------------------------------------------------------------------------------------------------------------------
Drug benefit level Drug benefit level
Ad type Drug risk ------------------------ Control Ad type Drug risk ------------------------ Control
level High Low level High Low
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wave 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Print......................... High.......... n=125 n=125 n=125 Print........... High......... n=125 n=125 n=125
Low........... n=125 n=125 ........... Low.......... n=125 n=125 ..........
Television.................... High.......... n=125 n=125 n=125 Television...... High......... n=125 n=125 n=125
Low........... n=125 n=125 ........... Low.......... n=125 n=125
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wave 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Print......................... High.......... n=125 n=125 n=125 Print........... High......... n=125 n=125 n=125
Low........... n=125 n=125 ........... Low.......... n=125 n=125
Television.................... High.......... n=125 n=125 n=125 Television...... High......... n=125 n=125 n=125
Low........... n=125 n=125 ........... Low.......... n=125 n=125
--------------------------------------------------------------------------------------------------------------------------------------------------------
II. Procedure
A. Pretests
Each participant will be randomly assigned to view either a print
ad or a television ad for a fictitious prescription drug indicated to
treat chronic pain or hypertension and will be asked to complete a
brief online survey assessing their benefit/risk perceptions,
intentions, and attitudes toward the drug. Based on the pretest
findings, we will revise and remove candidate items prior to full-scale
testing.
B. Main Study
Each participant will be randomly assigned to view either a print
or television ad for a fictitious prescription drug for hypertension or
chronic pain and will be asked to complete a brief online survey
assessing their benefit/risk perceptions, intentions, and attitudes
toward the drug. In the first two main study waves, participants will
view an ad that matches the sample's medical condition (chronic pain or
hypertension). In the final two main study waves, participants will be
randomly assigned to view either the chronic pain stimuli or the high
blood pressure stimuli.
The entire procedure is expected to last approximately 30 minutes.
This will be a one-time (rather than annual) information collection.
Note: The survey length has changed from 20 minutes to 30 minutes since
the 60-day notice was published. This is because cognitive interviews
did not result in as much reduction in question numbers as originally
expected. As this is a measurement validation study, it is important to
include enough items on the questionnaire for sufficient comparison in
order to identify those that perform the best. We have explained this
change in survey length in responses to comments and have factored it
in to the estimated burden.
In the Federal Register of April 21, 2014 (79 FR 22143), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received from the company
Eli Lilly, Inc. We respond to the points in Lilly's comment below.
(Comment 1) ``Lilly seeks further clarity to better understand how
FDA intends to apply the risk and benefit
[[Page 69123]]
measurement items being developed through this study. FDA suggests in
the Federal Register notice that the measurement items would be only
used to enhance future FDA research initiatives; however, the precise
nature and purpose of such planned research is unclear. Lilly suggests
that any intended use of the measurement items to evaluate the
effectiveness of drug advertising disseminated by industry would be
inappropriate and beyond the jurisdiction and authorities granted to
FDA.''
(Response) Section 1701(a)(4) of the Public Health Service Act (42
U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to
health information. Section 903(d)(2)(C) of the FD&C Act (21 U.S.C.
393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and
other FDA-regulated products in carrying out the provisions of the FD&C
Act. We believe that these statutes provide a broad authority for FDA
to conduct research related to prescription drug promotion as described
in the information collection request. As already explained in the
information collection request, the nature and purpose of this research
is ``to understand and accurately measure how consumers are making
sense of this information and how it impacts decisions related to
prescription drugs.'' We believe that this research is crucial in
ensuring that consumers are receiving prescription drug information
that is truthful and nonmisleading, and that prescription drugs are not
being misbranded. FDA expects that any other purpose of this research
will become clear only upon its completion, and FDA intends to make the
research results and the final scale publicly-available.
(Comment 2) ``Although FDA intends to narrow the pool of survey
questions during the pretesting stage of the research, we have concerns
that the current questionnaire is extremely cumbersome and would likely
exceed 20 minutes to complete. Further, based on the currently designed
instrument, it is questionable whether in fact FDA would have success
in respondents' fully completing the survey.''
(Response) Since the submission of the 60-day notice, the cognitive
interviews have been completed (OMB control number 0910-0695). We did
not reduce the number of items as much as expected based on those
interviews. Thus, we are recommending changing the questionnaire to 30-
minutes in length, and burden estimates have been calculated
accordingly. Even so, no respondent would ever answer the full list of
questions provided in the 60-day notice; instead, the full
questionnaire is the pool of items from which the questionnaire will be
developed. We will test subsets of these candidate items using a form
A/form B approach so that no respondent ever answers more than a 30-
minute survey. In addition, some items may only be tested on one
pretest and not the other or in one wave of a survey. No respondent
would ever see all of these questions.
We take the survey length very seriously. We will be conducting two
rounds of pretesting to refine the questionnaire and reduce the number
of items, resulting in 30-minute (or shorter) questionnaires for the
pretests and main study. We are sensitive to issues regarding
respondent fatigue and its impact upon completion rates. We have
employed similar online surveys on several previous studies, and we
have obtained high completion rates, typically 90 percent or higher.
For example, on a recent study entitled ``Experimental Study:
Examination of Corrective Direct-to-Consumer Television Advertising''
(OMB control number 0910-0737), we had a pool of 1,071 eligible
respondents and only 14 of those respondents failed to complete the
survey. We anticipate that the completion rate for this study will be
similar.
(Comment 3) ``In general, specific questions proposed in the draft
questionnaire may be unanswerable by the respondent if not addressed
specifically in the test stimulus. For example, Q23 ``How long will
Drug X/Drug Y's negative side effects last once they begin?'' If the
duration of a drug's side effects is not communicated in the stimulus,
data captured would be purely speculative on the part of the consumer,
especially without inclusion of a ``don't know or no opinion'' option
for the respondent.''
(Response) Respondents will be exposed to information about the
drug's indication and side effects in the ad and will then be asked to
provide their perceptions of the drug's effectiveness and risk
profiles. The questions are not intended to measure factual knowledge
about the fictitious drug. By definition, one's perception is a
subjective assessment and thus, does not need to be tied directly to a
verbatim statement in the advertisement. Whether or not participants
are forming perceptions about other attributes of the drug, such as how
long side effects last, is an empirical question and the purpose of
this study. Refining the questions, such as adding a ``don't know''
option, will be further addressed by pretesting.
(Comment 4) ``In addition to the redundant and overlapping
questions, several proposed questions appear to be unanswerable. The
drafted questionnaire creates a high burden in complexity and time for
the consumer and may cause significant respondent fatigue that could
result in unreliable or incomplete data collection. Given these
significant design issues related to the draft study questionnaire,
Lilly suggests that FDA provide further details on how the questions in
the draft questionnaire will be narrowed from the pretest stage to the
iterative stage of the research and further evaluate the burden and
likelihood to complete for the iterative testing stage.''
(Response) The pool of questions will be narrowed and refined
through two methods. The first method involved cognitive testing of
draft measures (for a full discussion of the cognitive interviews, see
OMB control number 0910-0695). The goal of the cognitive interviews was
to refine and narrow the measurement pool that will be subsequently
pretested and then tested in an experimental study. The second method
will involve iterative testing and analysis of draft measures to
establish scale reliability and internal validity using survey methods.
For a full discussion of the pretesting and experimental study, see
Section I, Design and Section II, Procedure.
(Comment 5) ``Additionally, it is not clear why some batteries of
questions, such as those questions under the validity testing section
(Q63-Q77) are included. These questions do not seem aligned with the
research objective.''
(Response) These items are included for the purpose of testing the
convergent validity of the other items in our item pool (measures or
risk and benefit perceptions). The items in Q63-Q77 come from the
previously validated Beliefs about Medicines Questionnaire (BMQ) (Ref.
3). As an example, if the benefit perception items perform as intended,
they should be highly correlated with positive beliefs about medicines,
as measured by the BMQ scale.
(Comment 6) ``Finally, questions 78-82 seem better placed in a
battery of questions for the screening or consumer selection phase.''
(Response) We believe that the constructs captured by questions 78-
82 may moderate the relationship between ad content and respondents'
risk and benefit perceptions. We include them on the survey to keep the
screener as short as possible, which reduces the burden on individuals
who ultimately do not qualify for the study. They will not be used for
screening as we do not plan to include or exclude any
[[Page 69124]]
individuals based on their responses to these questions.
(Comment 7) ``Lilly suggests that the survey design be improved to
better align with the research objectives, to avoid bias and to
mitigate extreme respondent fatigue. Lilly recommends that FDA modify
the data collection instrument to address the points noted above and
seek additional public comment on the revised design.''
(Response) Given our responses and points of clarification above,
we believe that the current design is rigorous and meets FDA's research
objectives. The design allows us to test and validate measurement items
for consumers' risk and benefit perceptions. By randomizing respondents
to the various ads with different benefit and risk information, we have
controlled for underlying differences in respondent demographics and
thereby have reduced the potential for selection bias (Ref. 4) and
enhanced study validity. As we have described above, we also have
designed the study to minimize respondent fatigue by testing only the
most promising candidate items and by ensuring a survey length of no
more than 30 minutes.
Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Hours per Total hours
respondents respondent responses response \2\
----------------------------------------------------------------------------------------------------------------
Pretest screener.............. 2,000 1 2,000 0.03 (2 minutes) 60
Main study screener........... 20,000 1 20,000 0.03 (2 minutes) 600
Pretest....................... \2\ 1,100 1 1,100 .5 (30 minutes). 550
Main Study.................... 10,200 1 10,200 .5 (30 minutes). 5,100
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 6,310
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ With online surveys, several participants may be completing the survey at the time that the total target
sample is reached. Those participants are allowed to complete the survey, which can result in the number of
completes going slightly over the target number. Thus, if our target is 1,000, we have rounded up by an
additional 100 to allow for some overage.
III. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov.
1. Lipkus, I. M., ``Numeric, Verbal, and Visual Formats of Conveying
Health Risks: Suggested Best Practices and Future Recommendations,''
Medical Decision Making, 27(5), 696-713 (2007).
2. Aikin, K. J., J. L. Swasy, and A.C. Braman, ``Patient and
Physician Attitudes and Behaviors Associated with DTC Promotion of
Prescription Drugs--Summary of FDA Survey Research Results,'' FDA,
Center for Drug Evaluation and Research, 19 (2004).
3. Horne, R., J. Weinman, and M. Hankins, ``The Beliefs About
Medicines Questionnaire: The Development and Evaluation of a New
Method for Assessing the Cognitive Representation of Medication,''
Psychology and Health, 14, 1-24 (1999).
4. Kunz, R., G. E. Vist, and A. D. Ochman, ``Randomization to
Protect Against Selection Bias in Healthcare Trials,'' The Cochrane
Library, Issue 2 (2008).
Dated: November 14, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27431 Filed 11-19-14; 8:45 am]
BILLING CODE 4164-01-P
