[Federal Register Volume 77, Number 164 (Thursday, August 23, 2012)]
[Notices]
[Pages 51027-51030]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20783]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0892]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Communicating Composite Scores in Direct-to-Consumer
Advertising
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on research entitled, ``Communicating
Composite Scores in Direct-to-Consumer (DTC) Advertising.'' This study
is designed to explore how consumers understand and interpret composite
endpoint scores in DTC ads.
DATES: Submit written or electronic comments on the collection of
information by October 22, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Communicating Composite Scores in Direct-to-Consumer (DTC)
Advertising--(OMB Control Number 0910-NEW)
I. Regulatory Background
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(b)(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.
II. Composite Scores
To market their products, pharmaceutical companies must demonstrate
to FDA the efficacy and safety of their drugs, typically through well-
controlled clinical trials (Refs. 1 and 2). In some cases, drug
efficacy can be measured by a single endpoint, such as high blood
pressure (Ref. 3). Often, however, efficacy is measured by multiple
endpoints that are sometimes combined into an overall score called a
composite score (Refs. 4 and 5). For example, nasal allergy relief is
measured by examining individual symptoms such as runny nose,
congestion, nasal itchiness, and sneezing. Each symptom is measured on
its own. An overall score is computed from the individual symptom
measurements; if a drug has a significantly better overall score than
the comparison group (e.g., placebo), it can be marketed for the relief
of allergy symptoms. However, although a drug may have a significantly
better score overall, it may not have a significantly better score on a
particular aspect (e.g., runny nose). Scientists and medical
professionals have had training to understand the difference between
composite score endpoints and single endpoints, but members of the
general public may not understand the difference.
Given the frequency of DTC advertising, it is important to
determine whether consumers understand composite scores as they are
currently communicated and how best to communicate such scores to lay
audiences in general. Because most DTC prescription drug ads do not
explicitly state that they used composite scores to demonstrate
efficacy or they provide little explanation of how these scores are
calculated, it is also important to understand whether consumers
[[Page 51028]]
recognize how composite scores are used for measuring drug efficacy.
Prior research on composite scores is scant. Therefore, in
September 2011, FDA conducted a focus group study to better understand
how consumers understand the concept of composite scores. Prior to the
focus group, few participants had heard the term ``composite score,''
none were aware of how the scores might be used in clinical trials, and
most participants had difficulty correctly interpreting efficacy
information that was based on composite scores. Once the moderator
explained composite scores to participants, some reassessed their
opinion of the advertised drug's effectiveness and said they thought
that the information on effectiveness was ``much less convincing,'' in
many cases because it was unclear whether the drug would work for a
particular symptom. As a result, some participants said they would want
a drug ad to include more detailed information on the effectiveness of
the drug on each component of the composite score. However, others felt
that the ads already provided enough information on effectiveness and
that adding more statistical details would make the ads more
complicated, thus decreasing the likelihood that consumers would read
them.
The focus group findings suggest that research is required to
examine how the inclusion of increasingly detailed information affects
understanding of composite scores and influences perceptions of
efficacy. This is especially important given the many marketed
prescription drugs that are based on composite outcomes.
We are aware of no quantitative research on best practices for
communicating composite score information to consumers. One related
area of research, communicating health-related information to
consumers, offers two practical recommendations that are particularly
relevant to communicating composite scores in DTC advertisements.
First, because less-numerate and less-literate consumers may not
understand the information as well, examining differences in
comprehension of composite scores by numeracy- and literacy-relevant
demographic characteristics such as education level and age is
important (Refs. 6 and 7). Second, although the literature tends to
suggest limiting the amount of information presented in advertisements
(Refs. 7 to 9), examining the amount of detail that best facilitates
comprehension of composite scores is warranted.
III. Research Purpose
Given the lack of research on consumer understanding of composite
scores and how to best present this information in DTC advertisements,
the main goal of the current research is to evaluate how consumers
interpret and respond to DTC prescription drug advertising that
includes benefit information based on composite scores. Specifically,
this research will explore:
1. Whether consumers are aware of how efficacy is measured for
specific drugs;
2. How well consumers comprehend the concept of composite scores;
3. Whether exposure to DTC advertisements with composite endpoint
benefit information influences consumers' perceptions of a drug's
efficacy and risk; and
4. Different methods for presenting composite endpoint benefit
information in DTC ads to maximize consumer comprehension and informed
decisionmaking.
The research will be conducted in two studies. Using a general
population sample of adults, the first study will be a web-based
survey, with a pre-post design, that will explore consumers' awareness
of how efficacy is measured for drugs and consumers' comprehension of
the concept of composite scores. The second study will be a randomized,
controlled study conducted online using a web-based panel to examine
whether exposure to DTC advertisements with composite endpoint benefit
information influences consumers' perceptions of a drug's efficacy and
risk, and how DTC advertisements can best deliver composite endpoint
benefit information to maximize consumer comprehension and informed
decisionmaking. Questionnaires for both studies are available upon
request.
IV. Design Overview
Study 1. In this phase, individuals in a general population sample
of 1,600 adults of varying education levels will answer an Internet
survey designed to explore whether consumers recognize composite scores
in DTC ads and their understanding of composite endpoint scores. The
survey will be conducted with a probability-based consumer panel of
U.S. adults.
As part of the survey, participants will view a print ad that
contains claims based on composite scores and respond to questions
about the ad to assess whether they recognized that composite scores
were used. Other outcomes will include ad comprehension, perceived
efficacy, and perceived risk as they relate to their understanding of
composite endpoint scores. We will also examine whether and in what
ways participants' perceived efficacy and perceived risk change after
they are given a definition and examples of composite scores. Questions
will also explore consumers' understanding of how the effectiveness of
drugs is measured in general.
This exploratory survey will not be used to test specific
hypotheses. However, we will explore the differences in responses to
the ad before and after information about composite scores is provided.
We will also examine differences in the comprehension of the composite
score concept and in the features of the ad by education level and age
because literature suggests that less-educated and older consumers may
not understand this type of information as well (Ref. 6).
Study 2. Unlike Study 1, Study 2 will be a randomized, controlled
study. Study 2 will examine different ways to present the information
that arises from a composite endpoint and different ways to explain the
concept of a composite score (an educational intervention). Outcome
measures will include consumers' awareness and comprehension of the
composite score concept, perceived drug efficacy, and risk recall.
Participants will be randomly assigned to experimental arms in a 3 x 2
design as shown in table 1.
Table 1--Study Design for Study 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information presentation
---------------------------------------------------------------------------------------------------------------------------------------------------------
Educational intervention General indication List of symptoms Composite definition Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Absent............................ Arm 1 (n=267)................... Arm 2 (n=267).................. Arm 3 (n=267).................. 801
Present........................... Arm 4 (n=267)................... Arm 5 (n=267).................. Arm 6 (n=267).................. 801
---------------------------------------------------------------------------------------------------------------------
[[Page 51029]]
Total......................... 534............................. 534............................ 534............................ 1,602
--------------------------------------------------------------------------------------------------------------------------------------------------------
This study will manipulate two variables: Three types of
information presentations and the presence or absence of an educational
intervention. In terms of information presentation, there are many
aspects of composite endpoint scores that could be communicated and one
research project cannot test them all. In this study, we have chosen to
examine three different information presentations that may or may not
help consumers understand the composite score concept. These different
information presentations were chosen based on a review of the
literature and a review of past DTC submissions.
The three different information presentations are described as
follows:
General Indication. The first information presentation is the
indication of the product. In this condition, participants will see the
drug indication but will not see any explicit statement that the drug's
benefits are based on a composite endpoint. This is a common way that
composite scores are currently communicated. An example of this
presentation is: ``Drug A treats and helps prevent seasonal nasal
allergy symptoms.''
List of Symptoms. The next information presentation will include
the drug indication and all of the symptoms that are used to make up
the composite score. This condition, like the general indication
condition, will not include an explicit statement referencing composite
scores. This is also a common way that composite scores are currently
communicated. An example of this presentation is: ``Drug A treats and
helps prevent seasonal nasal allergy symptoms: Congestion, runny nose,
nasal stuffiness, nasal itching, and sneezing.''
Composite Definition. The final information presentation will
present the indication, describe that the drug's benefits are based on
a composite endpoint, and explicitly define a composite score. To our
knowledge, this would be a new way to communicate composite scores. An
example of this presentation is: ``Drug A treats and helps prevent
seasonal nasal allergy symptoms. Drug A's effectiveness is based on a
composite score. A composite score is a single measure of how well a
drug works based on a combination of factors. Drug A may not be as
effective in addressing each factor individually.''
We will also manipulate whether or not participants see a specific
educational intervention. This intervention was developed from prior
focus groups (OMB Control No. 0910-0677) where it was found to resonate
with participants. It will feature the decathlon as an educational
example of a composite score. For example, ``Drug A's effectiveness is
based on a composite score. A composite score is like a decathlon. In
that event, athletes compete in 10 events, such as the long jump, the
shot put, and the 50 yard dash. An athlete may not win all events, but
if he or she wins some and performs well enough in others, he or she
may be the winner based on a combination of scores for each event.''
We will test whether the educational intervention, the information
presentation, and the interaction of the two affect outcomes such as
consumers' awareness and comprehension of the composite score concept;
perceived drug efficacy; and risk recall. We will test whether numeracy
and literacy moderates any significant relations.
The sample for the second study will include approximately 1,602
participants who have been diagnosed with seasonal allergies. The
protocol will take place via the Internet. Participants will be
randomly assigned to view one print ad for a fictitious prescription
drug that treats seasonal allergies and will answer questions about it.
The entire process is expected to take no longer than 20 minutes. This
will be a one-time (rather than annual) collection of information.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screeners, Study 1.......................... 3,200 1 3,200 0.03 (2 minutes).......................... 96
Pretest, Study 1............................ 200 1 200 0.33 (20 minutes)......................... 66
Main Survey, Study 1........................ 1,600 1 1,600 0.33 (20 minutes)......................... 528
Screeners, Study 2.......................... 3,400 1 3,400 0.03 (2 minutes).......................... 102
Pretest, Study 2............................ 600 1 600 0.33 (20 minutes)......................... 198
Main Study, Study 2......................... 1,602 1 1,602 0.33 (20 minutes)......................... 529
-----------------------------------------------------------------------------------------------------------
Total................................... 10,602 .............. .............. .......................................... 1,519
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The total respondent sample for this data collection is 10,602. For
Study 1, we will sample 200 respondents for pretesting and 1,600
respondents for the full study. For Study 2, we will sample 600
respondents for pretesting and 1,602 participants for the full study.
We estimate the response burden to be no more than 20 minutes, for a
total burden, including screeners, of 1,519 hours.
V. 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
[[Page 51030]]
electronically at http://www.regulations.gov. (FDA has verified the Web
site addresses, but we are not responsible for any subsequent changes
to the Web sites after this document publishes in the Federal
Register.)
1. Lipsky, M.S. and L.K. Sharp, ``From Idea to Market: The Drug
Approval Process,'' Journal of the American Board of Family
Practitioners, vol. 14(5), pp. 362-367, 2001.
2. ``Guidance for Industry: Postmarketing Studies and Clinical
Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug,
and Cosmetic Act,'' (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172001.pdf), 2008.
3. Rutan, G.H., R.H. McDonald, and L.H. Kuller, ``A Historical
Perspective of Elevated Systolic vs. Diastolic Blood Pressure From an
Epidemiological and Clinical Trial Viewpoint,'' Journal of Clinical
Epidemiology, vol. 42(7), pp. 663-673, 1989.
4. Agency for Healthcare Research and Quality, ``Combining Measures
Into Composite or Summary Scores,'' (http://www.ahrq.gov/qual/perfmeasguide/), 2012.
5. American Medical Association, ``Measures Development,
Methodology, and Oversight Advisory Committee: Recommendations to PCPI
Work Groups on Composite Measures,'' (http://www.ama-assn.org/resources/doc/cqi/composite-measures-framework.pdf), 2010.
6. Fagerlin, A. and E. Peters, ``Quantitative Information,'' In: B.
Fishoff, N.T. Brewer, and J.S. Downs (Eds.), Communicating Risks and
Benefits: An Evidence-Based User Guide, Food and Drug Administration,
U.S. Department of Health and Human Services, (http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm268078.htm), 2011.
7. Peters, E., D. Vastfijall, P. Slovic, et al., ``Numeracy and
Decision Making,'' Psychological Science, vol. 17(5), pp. 407-413,
2006.
8. Gurmankin, A. D., J. Baron, and K. Armstrong, ``The Effects of
Numerical Statements of Risk on Trust and Comfort With Hypothetical
Physician Risk Communication,'' Medical Decision Making, vol. 24(3),
pp. 265-271, 2004.
9. Edwards, A., R. Thomas, R. Williams, et al., ``Presenting Risk
Information to People With Diabetes: Evaluating Effects and Preferences
for Different Formats by a Web-Based Randomized Controlled Trial,''
Patient Education Counseling, vol. 63, pp. 336-349, 2006.
Dated: August 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20783 Filed 8-22-12; 8:45 am]
BILLING CODE 4160-01-P