[Federal Register Volume 77, Number 164 (Thursday, August 23, 2012)]
[Pages 51027-51030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20783]



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 

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.

Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
[email protected].

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 
    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 
    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 

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 
    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 

                                                     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 
    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, 
    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]