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Experimental Evaluation of Variations in Content & Format of the Brief Summery in D-T-C Print Advertisements for Prescription Drugs

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B. Collections of Information Employing Statistical Methods

1. Potential Respondent Universe and Sampling Selection

For both studies, eligible participants will be recruited for participation in eight or more geographically dispersed malls serving a variety of socioeconomic classes. Recruited subjects will be screened for: ability to read English, presence of the medical condition of excess weight or obesity, ability to visually process the label (have reading glasses available if necessary), age (18 years of age or older) and education level. They will be asked to participate in a study of consumer product advertising that lasts no more than 20 minutes.

Research has shown that motivated participants tend to engage in more effortful information processing^¹ Individuals who suffer from the medical condition are expected to be more motivated to read the advertisement and the brief summary than individuals who do not suffer from the medical condition. Participants will be randomly assigned to clinical efficacy, side effect frequency, and risk frame conditions. Each participant will see only one experimental advertisement/brief summary.

All respondents will be over 18 years of age and be primary English speakers. A Spanish-language questionnaire will not be developed for this study as virtually all DTC advertising is in English. FDA will conduct the research through an existing contract by FDA’s Center for Food Safety and Nutrition with Synovate, Inc. Approximately 900 interviews will be conducted for the content study and approximately 300 interviews will be conducted for the format study. This constitutes approximately 112 interviews at each of 8 geographically disperse shopping malls in the U.S for the content study and 38 interviews at each of 8 geographically disperse shopping malls in the US for the format study. There will be an equal number of males and females interviewed at each location. Malls will be selected to assure that the respondent universe represents varying degrees of education and other socioeconomic and ethnic variables.

Content Study

The traditional small-print, PI-based brief summary is not the best way to present information to consumers, yet somehow important risk information must be conveyed. One way to improve the current brief summary is to provide context for some of the risk information on the page. Contextual information may help consumers process the information that FDA has determined must appear in the brief summary. For example, in some cases, information about the controllability of an adverse event may be useful. In other cases, information about how adverse events are managed may provide important contextual information. In the current study, we focus on three types of context: the frequency of adverse events, the duration of side effects, and clinical efficacy.

FDA has determined a hierarchy of information that must be placed in the brief summary, including warnings and precautions, contraindications, and drug interactions. Because of the importance of these categories and the work that each review division devotes to their wording, it is unlikely that changes to these sections would have practical significance. The brief summary draft guidance of 2004 does not mention these sections. Conversely, the section formerly titled “adverse events” seems appropriate for manipulation. This section details minor but possibly commonly occurring side effects that patients may experience when taking the drug. In fact, the 2004 draft guidance mentions this section as perhaps too long as currently used, suggesting that large lists of information may detract from more important risk sections.

Thus, in the content study, we will manipulate the minor side effect section, varying the presence of frequency information and, separately, the presence of duration information. We are interested in how these changes influence the understanding of the risks of the product as a whole, particularly the more serious risk sections. If these changes enhance or, at the very least, do not detract from the major risks, then these additions of context may be something to include in future brief summaries. In the best case scenario, we find context that enhances the total picture of the drug and does not interfere with the processing of the major risks.

Additionally, information on the clinical efficacy of the product may influence how consumers process the major risks of the product. By providing information on the “whole picture” of the product, consumers may be more motivated to process the risk profile of the drug. The level of efficacy may also play a role; it is likely that the consideration of the risks will vary depending on whether clinical efficacy is high or low.

Our primary dependent variable is the comprehension of the major risks (i.e., warnings and precautions, contraindications). The major risks are essential to understanding the risk profile of the drug and therefore comprehension of these risks is important for future action or inaction. Secondarily, we are interested in the comprehension of the minor side effects and behavioral intentions of consumers after they read one of the brief summaries. If comprehension of major risks is not impeded and minor side effects are better understood, then contextual information can be considered in future research or regulation.

Primary Research Questions

Will the presence of information on the frequency of minor side effects influence the readers’ comprehension of the major risks? Will the comprehension of major risks vary depending on whether the frequencies are high or low?
Will the presence of information on the temporal duration of minor side effects influence the comprehension of the major risks?
Will the presence of clinical efficacy information influence readers’ comprehension of the major risks? Will the comprehension of the major risks vary depending on whether clinical efficacy is high or low?
Will clinical efficacy and frequency of minor side effects interact to influence comprehension of major risks? Will clinical efficacy and temporal duration interact to influence comprehension of major risks?

Planned design and analysis

Independent Variables and Design

3 x 3 (clinical efficacy x frequency of side effects)

Frequency of Side Effects
Clinical Efficacy		None	High	Low
	None
	High
	Low

3 x 2 (clinical efficacy x presence of duration information)

Duration of Side Effect Information
Clinical Efficacy		Present	Absent
	None
	High
	Low

Covariates:

• Education

• Age

• Gender

• Disease severity

• Baseline ratings of side effect riskiness

• Reading speed

• Health literacy

• Numeracy

Covariates will be used to account for differences in responses related to the characteristics of the respondent and prior attitudes about the inherent riskiness of individual side effects.

Dependent Variables

Primary

• Comprehension of major risks

Secondary

• Comprehension of minor risks

• Behavioral intention

Hypotheses

Including frequency information about minor side effects will enhance the comprehension of major risks. Readers who see high frequencies of minor side effects will show lower comprehension of the major risks than readers who see low frequencies.
Including temporal duration information about side effects will enhance the comprehension of major risks. Readers who see such information will be more likely to comprehend the major risks than readers who do not see duration information.
Including clinical efficacy information will influence the comprehension of major risks. Readers who see clinical efficacy information will show greater comprehension of major risks than readers who are not given any clinical efficacy information. Readers who see low clinical efficacy information will show greater comprehension of major risks than those who see high clinical efficacy information.

Power

The primary dependent variable, comprehension of major risks, will be assessed using a continuous composite score based on four dichotomous items (true/false); recall of the major risks will be based on ten dichotomous items (yes/no). These scores will be used in ANOVA to test for main and interaction effects. To test main effect and interaction hypotheses, the following assumptions were made in deriving the sample size: (1) 0.05 alpha and at least 0.80 power, (2) 1 degree of freedom for the numerator, and (3) an effect size between small and medium.

The power to detect a (conventional) medium effect size (f= .25) for the main effect in a 3 by 3 factorial having equal cell sizes of n=60 per cell and an alpha of .05 is .99. Similarly, the power to detect a medium sized interaction is also excellent (.99).^²

The power to detect a (conventional) small effect size (f= .15) for the main effect in a 3 by 3 factorial having equal cell sizes of n=60 per cell and an alpha of .05 is .88. Similarly, the power to detect a similarly sized interaction is .80.

Thus, based on these assumptions we are confident that we have sufficient power to conduct our planned analyses.

Format Study

In addition to the content of the brief summary, an important component of the readability of the document is its format. Traditionally, sponsors have reproduced the risk-related sections of the physician-directed PI and inserted them onto the adjacent page of the print ad, regardless of the amount of information or the size of the font. This traditional format usually resulted in a document with tiny font written in medical language.

In the current study, we propose three formats as alternatives to the traditional format. Two of these formats were suggested in the draft brief summary guidance of 2004: the FDA-approved PPI version and the highlights version from the content and format rule of 2006. Another format, the Prescription Drug Facts box, was suggested by extensive research conducted on the OTC Drug Facts label. We expect that all three of these formats will result in greater comprehension of risks and the risk/benefit tradeoff as compared with the traditional brief summary format.^³ Given that we know of no research that directly compares these alternative formats in terms of comprehension of risk information, we do not have a hypothesis as to the version that will result in the greatest comprehension.

As in the content study, we will also measure other dependent measure. The format study differs, however, because here all four dependent variables are primary. Comprehension of risk information is valuable, but when examining format differences, we expect that other issues such as self-efficacy, behavioral intention, and even preference will also play a role in the use of the brief summary.

To a larger extent than content, format plays a role in the “stopping-power” of a page, or the degree to which a person decides to read something or not. Part of this power potentially comes from the amount of confidence the person has that they will be able to successfully understand the concepts, thus achieving something from their efforts. Therefore, we will also measure readers’ self-efficacy. Based on work by Bandura^⁴, self-efficacy is participants’ beliefs about, or confidence in, their own ability to exercise personal control over their learning about the product. These questions measure participants’ self-confidence to perform the tasks necessary to use the information in the brief summary (e.g., recognize adverse effects, identify who should not take the drug). In this case, since readers will be familiar with the Prescription Drug Facts format due to current OTC labels, we expect this format to show the greatest self-efficacy.

It is possible that while all three formats mark an improvement over the traditional brief summary, none of them can themselves be distinguished with regard to comprehension, behavioral intention, or self-efficacy. Another variable that might further distinguish these formats is consumer preference. All of the previous measures will be examined in the context of one format. In other words, each participant will see only one format and we will compare responses across participants (often called “between-subjects”). After these variables have been measured, we will show participants all four versions and ask them to rank the versions from most to least preferable. Although comprehension is our key dependent measure, consumer preference is also an important variable to assess for this reason. Little comprehension will occur if people are turned off enough by format factors to avoid the brief summary altogether. We expect consumer preference to correlate with self-efficacy.

It is important to note, however, that in previous studies the Nutrition Facts Label format most preferred by consumers was not the one that resulted in the best comprehension^⁵. If this is the case with the brief summary, comprehension factors will prevail. If not, consumer preference will provide additional differentiating information in the case that several of the formats show similar comprehension.

Primary Research Questions

Will alternative formats influence the comprehension of major risks, behavioral intentions, and/or self-efficacy?
Which format will consumers prefer?

Planned design and analysis

Independent Variables

Type of Format (4 levels)

Traditional

Highlights

Prescription Drug Facts

Question and Answer (Q&A; from Patient Package Insert)

Covariates

• Education

• Age

• Gender

• Health literacy

Covariates will be used to account for differences in responses related to the characteristics of the respondent.

Dependent Variables

• Comprehension of major and minor risks

• Self-efficacy

• Behavioral intention

• Consumer preference

Hypotheses

Readers will show higher comprehension of major risks in the highlights format, the PPI format, and the Prescription Drug Facts format compared with the traditional brief summary format. The particular differences within the alternative formats are exploratory.
Readers will show higher self-efficacy in the highlights format, the PPI format, and the Prescription Drug Facts format compared with the traditional brief summary format. The highest self-efficacy will be shown in the Prescription Drug Facts format.
Readers will exhibit different behavioral intentions in the highlights format, the PPI format, and the Prescription Drug Facts format compared with the traditional brief summary format. The particular differences within the alternative formats are exploratory.
The alternative brief summary formats will be preferred to the traditional brief summary format. Which format is most preferred is exploratory.

Power

To test a main effect hypothesis in a 4 x 1 ANOVA, the following assumptions were made in deriving the sample size: (1) 0.05 alpha and at least 0.80 power, (2) 3 degrees of freedom for the numerator, and (3) an effect size between small and medium. For a (conventional) small to medium effect size (f= .20), the per cell sample size required to detect a difference should be 69.^⁶ Taking into consideration uncommon but unavoidable technical glitches in data collection, we are confident that a sample size of 75 per cell will provide us with adequate power (0.83).

2. Procedures for the Collection of Information

In both the content and the format studies, participants will see one brief summary in the context of an ad for a new (hypothetical) prescription weight loss drug. They will respond to survey questions about their understanding of the risks intended actions when side effects occur and then respond to more specific questions about the statement itself. This method will allow FDA to compare the responses of participants who saw nine (9) different statements. Main dependent variables are: comprehension of the side effects statements, as measured by reasons for calling a physician and/or the FDA; the likelihood of calling FDA, to appreciate prospective workload burden; and the clarity of each statement. The complete questionnaire is included as Attachment A.

3. Methods to maximize response rates and to deal with issues of non-response

Respondents will be recruited and interviewed at 8 shopping malls. Participants will be told they will be evaluating a new product concept. This procedure has been reviewed and approved by FDA’s human subject protection committee (RIHSC).

4. Test Procedures

See Procedures for Collection of Information, above.

5. Individuals Involved in Statistical Consultation and Information Collection

The contractor, Synovate, will collect the information on behalf of the FDA as a task order under the Quick-Turn-Around Research Services contract. Leigh Seaver, Ph.D., is the Senior Study Director for Synovate, telephone (703) 790-9099. Analysis of the information will be conducted primarily by the Research Team, Division of Drug Marketing, Advertising and Communications, Office of Medical Policy, CDER, FDA, and coordinated by Kathryn J. Aikin, Ph.D., 301-796-0569 and Amie C. Braman, Ph.D., 301-796-0574.

ATTACHMENT 1

60-Day FR Notice

[Federal Register: April 25, 2006 (Volume 71, Number 79)]

[Notices]

[Page 23921-23924]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr25ap06-80]

=======================================================================

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0133]

Agency Information Collection Activities; Proposed Collection;

Comment Request; Experimental Evaluation of Variations in Content and

Format of the Brief Summary in Direct-to-Consumer Print Advertisements

for Prescription Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an

opportunity for public comment on a 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,

including each proposed extension of an existing collection of

information, and to allow 60 days for public comment in response to the

notice. This notice solicits comments on two studies of consumer

evaluations of variations in content and format of the brief summary in

direct-to-consumer (DTC) prescription drug print advertisements.

DATES: Submit written or electronic comments on the collection of

information by June 26, 2006.

ADDRESSES: Submit electronic comments on the collection of

[[Page 23922]]

information to: http://www.fda.gov/dockets/ecomments. 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: Karen Nelson, Office Management

Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION:

I. Backround

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, including each

proposed extension of an existing 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 each of 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.

Experimental Evaluation of Variations in Content and Format of the

Brief Summary in DTC Print Advertisements for Prescription Drugs

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 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 act. Under the act, a drug is

misbranded if its labeling or advertising is false or misleading. In

addition, section 502(n) of the act (21 U.S.C. 352(n)) specifies that

advertisements for prescription drugs and biological products must

provide a true statement of information ``in brief summary'' about the

advertised product's ``side effects, contraindications, and

effectiveness.'' The prescription drug advertising regulations (Sec.

202.1(e)(3)(iii) (21 CFR 202.1(e)(3)(iii))) specify that the

information about risks must include ``each specific side effect and

contraindication'' from the advertised drug's approved labeling. The

regulation also specifies that the phrase ``side effect and

contraindication'' refers to all of the categories of risk information

required in the approved product labeling written for health

professionals, including the warnings, precautions, and adverse

reactions sections. Thus, every risk in an advertised drug's approved

labeling must be included to meet these regulations.

In recent years, FDA has become concerned about the adequacy of the

brief summary in DTC print advertisements. Although advertising of

prescription drugs was once primarily addressed to health

professionals, increasingly consumers have become a target audience, as

DTC advertising has dramatically increased in the past few years.

Results of FDA's 2002 survey on DTC advertising (available at http://www.fda.gov/cder/ddmac/researchka.htm

) show that 41 percent of

respondents in 2002 reported they do not usually read any of the brief

summary that accompanies the main print ad. Use of the brief summary

was a function of whether they have an interest in the condition; about

45 percent of those having a particular interest in the advertised drug

read all or almost all of the brief summary. Despite their interest,

about half of these individuals described the brief summary as somewhat

or very hard to understand.

Because the regulations do not specify how to include each risk,

sponsors can use discretion in fulfilling the brief summary requirement

under Sec. 202.1(e)(3)(iii). Frequently, sponsors print in small type,

verbatim, the risk-related sections of the approved product labeling

(also called the package insert, professional labeling, or prescribing

information). This labeling is written for health professionals, using

medical terminology. FDA believes that while this is one reasonable way

to fulfill the brief summary requirement for print advertisements

directed toward health professionals, this method is difficult for

consumers to understand and therefore may not be the best approach to

communicate this important information to them.

In 2004, FDA published a draft guidance entitled ``Brief Summary:

Disclosing Risk Information in Consumer-Directed Print Advertisements''

(available at http://www.fda.gov/cder/guidance/5669dft.htm). This

guidance outlined possible options for improving the communication of

risk information to consumers in specific promotional pieces. When

discussing the current professional prescribing information format, the

guidance states that the ``volume of the material, coupled with the

format in which it is presented... discourages its use and makes the

information less comprehensible to consumers.'' The draft guidance

suggested three possible presentations for the brief summary, including

the current prescribing information format, an approved patient package

insert, or highlights from the physician labeling rule.

In the content study, FDA plans to investigate the role of context

in providing useful risk information to consumers. It has been

theorized that long lists of minor risks may detract from the

understanding of more serious risks, as stated in the draft guidance.

Nonetheless, if the risk information is presented with proper

supporting context, people may find the information facilitates rather

than distracts from the understanding of the risk information. One of

the two proposed studies in this notice will investigate the context

that may contribute to this facilitation.

In addition to context, format also plays a role in the clarity and

understanding of the brief summary. FDA proposes to collect information

on the usefulness of different formats suggested in the draft guidance.

In addition to the patient package insert, which is usually presented

in a question and answer format, FDA proposes to test a consumer-

friendly highlights format, as well as a format based on the drug facts

labeling used for over-the-counter drugs.

Data from these two studies will converge to allow a better

assessment of various ways to present risk information

[[Page 23923]]

in a print advertisement for a prescription drug.

II. Studies

A. Content Study

1. Design Overview

This study will employ a between-subjects crossed factorial design

using a mall-intercept protocol. Ten print advertisements will be

created using two levels of drug side effect information and five

levels of context. Thus, the factors will be the amount of side effect

information (short; long) and amount of supportive context for the side

effect information (paragraph only; paragraph rate; paragraph rate plus

placebo rate; chart rate; chart rate plus placebo rate). Other

information will be constant across conditions. Respondents who self-

identify as being in the target market for the condition will be asked

to read a single print advertisement for a new prescription drug. After

reading the advertisement, they will be asked questions about their

comprehension and evaluation of the information presented in the

advertisement.

2. Factors

a. Participants. Consumers will be screened and recruited by the

contractor to be self-identified as being moderately overweight or

more. We chose to limit our investigation to this one disease condition

(weight loss) because it has a high prevalence rate in the population

(http://www.cdc.gov/nccdphp/dnpa/obesity/faq.htm) and is likely to

occur both in males and females. We chose to accept this decrease in

generalizability to maximize our ability to detect subtle differences

in content variation. Participants will be screened to represent a

range of education levels (some college or less; completed college or

more). Because the task presumes basic reading abilities, all screened

participants will speak English as their primary language and, as

appropriate, have reading glasses available when participating in the

study.

b. Amount of side effect information. The number of side effects

will be varied to create ``short'' and ``long'' levels as follows:

Short: ``Side effects include a, b, and c. This is not a complete

list. Talk to your doctor for more information.''

Long: ``Side effects include a, b, c, d, e, f, g, and h. Talk to

your doctor for more information.''

c. Context. The context for the side effect information will be

varied to create five levels ranging from least supportive to most

supportive as follows:

Paragraph only: Listing of side effects in paragraph form.

Paragraph rate: Listing of side effects and their rate of

occurrence in paragraph form.

Paragraph rate plus placebo rate: Listing of side effects, their

rate of occurrence, and the rate of placebo effects in paragraph form.

Chart rate: Listing of side effects and their rate of occurrence in

table form.

Chart rate plus placebo rate: Listing of side effects, their rate

of occurrence, and the rate of placebo effects in table form.

3. Procedure

Participants will be shown one ad. Then a structured interview will

be conducted with each participant to examine a number of important

perceptions about the brief summary, including perceived riskiness of

the drug, comprehension of information in the brief summary, and

perceived usefulness of brief summary information. Finally, demographic

and health care utilization information will be collected. Interviews

are expected to last approximately 20 minutes. A total of 900

participants will be involved. This will be a one-time (rather than

annual) collection of information.

B. Format Study

1. Design Overview

This study will employ a between-subjects crossed factorial design

using a mall-intercept protocol. Three print advertisements will be

created using three different formats: Question and answer, highlights

(71 FR 3922, January 24, 2006), and drug facts (21 CFR 201.66 and

Appendix A). The information in the formats will be constant across

conditions. Participants who self-identify as being in the target

market for the condition will be asked to read a single print

advertisement for a new prescription drug. After reading the

advertisement, they will be asked questions about their comprehension

and evaluation of the information presented in the advertisement.

2. Factors

a. Participants. Consumers will be screened and recruited by the

contractor to be self-identified as being moderately overweight or

more. As in the content study described previously in this document, we

chose to limit our investigation to one disease condition-weight loss.

Participants will be screened to represent a range of education levels

(some college or less; completed college or more). Because the task

presumes basic reading abilities, all screened participants will speak

English as their primary language and, as appropriate, have reading

glasses available when participating in the study.

b. Type of format. The format of the information in the brief

summary will be varied as follows: Question and answer, highlights, and

drug facts. Please refer to Appendix A for examples of the different

format variations.

3. Procedure

Participants will be shown one ad. Then a structured interview will

be conducted with each participant to examine a number of important

perceptions about the brief summary, including perceived riskiness of

the drug, comprehension of information in the brief summary, and

perceived usefulness of brief summary information. Finally, demographic

and health care utilization information will be collected. Interviews

are expected to last approximately 20 minutes. A total of 300

participants will be involved. This will be a one-time (rather than

annual) collection of information.

FDA estimates that 1,800 individuals will need to be screened to

obtain a respondent sample of 900 for the content study and that 600

individuals will need to be screened to obtain a respondent sample of

300 for the format study. The screener is expected to take 30 seconds,

for a total screener burden of 41 hours. The 1,200 respondents in the

two studies will then be asked to respond to a series of questions

about the advertisement. We estimate the response burden for each of

the two studies to be 20 minutes, for a burden of 396 hours. The

estimated total burden for this data collection effort is 437 hours.

The respondent burden is listed in table 1 of this document.

FDA estimates the burden of this collection of information as

follows:

[[Page 23924]]

Table 1.--Estimated Annual Reporting Burden \1\

----------------------------------------------------------------------------------------------------------------

Annual Frequency Total Annual Hours per

No. of Respondents per Response Responses Response Total Hours

----------------------------------------------------------------------------------------------------------------

1,800 (content study: screener) 1 1,800 .017 31

----------------------------------------------------------------------------------------------------------------

900 (content study: 1 900 .33 297

questionnaire)

----------------------------------------------------------------------------------------------------------------

600 (format study: screener) 1 600 .017 10

----------------------------------------------------------------------------------------------------------------

300 (format study: 1 300 .33 99

questionnaire)

----------------------------------------------------------------------------------------------------------------

Total 437

----------------------------------------------------------------------------------------------------------------

\1\ There are no capital costs or operating and maintenance costs associated with this collection of

information.

Dated: April 18, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. E6-6142 Filed 4-24-06; 8:45 am]

BILLING CODE 4160-01-S

ATTACHMENT 2

Questionnaires

Participant Screener for Content AND Format Studies

Participants.

Adult consumers will be solicited and pre-screened for suitability and presence of condition (excessive weight). Initially, during the screening, participants will be told that the study concerns their opinions about new products. Following the data collection, all participants will be debriefed regarding the study purpose and the fictitious nature of the brand rated.

SCREENER

Hello, my name is ___________ and I work for _______, a research firm…[Standard introduction including confidentiality.]

We would like to get your opinion about some new products on the market. The interview will take about 20 minutes and you will be paid $5 if you qualify. Can I ask you some questions?

S1. Can you read English?

___Yes

___No [eliminate, thank politely]

DO NOT READ Don’t Know 8 [eliminate]

DO NOT READ Refused 9 [eliminate]

S2. In what year were you born? ______

If Year is > 1988 [eliminate, thank politely]

DO NOT READ Don’t Know 8 [eliminate]

DO NOT READ Refused 9 [eliminate]

[Interviewer: Recruit range of ages]

S3a. Do you usually wear glasses or contact lenses for reading or watching television?

A) Yes (ask 3b)

B) No

S3b. Do you have your glasses or contact lenses with you today?

A) Yes

B) No [eliminate]

S4a. Do you consume any of the following products on a regular basis?

_____Fruit juice

_____Coffee

_____Soymilk

S4b. Do you use any of the following products on a regular basis?

_____A dishwasher

_____Swiffer dusting products

_____A microwave oven

S5. Has a doctor or other healthcare provider ever said you have any of the following health problems?

a. Asthma _____Yes _____No [filler]

b. Diabetes _____Yes _____No [filler]

c. You are overweight or you need to lose more than 15 pounds?

_____Yes _____No

d. High blood pressure _____Yes _____No [filler]

[INTERVIEWER: If “no” to c, eliminate]

S6. What was the last grade of school that you completed? (READ CODES IF NECESSARY)

1 Grade school or less

2 Some high school

3 Completed high school

4 Some college

5 Completed college

6 Graduate school or more

7 Other education beyond high school (business, technical, etc)

9 Refused

[Interviewer: recruit range of education level, 30% to be HS education or less]

S7. Are you:

Hispanic or Latino 1

Not Hispanic or Latino 2

DK/Ref 9

S8. Which of these best represents your ethnic group? You may choose one or more. Would you say that you are:

1 American Indian or Alaska Native

2 Asian

3 Black or African-American

4 Native Hawaiian or Other Pacific Islander

5 White

9. (Don’t Read) Ref / DK /NA

S9. [DO NOT READ] Gender: _____Male _____Female

Thank you. I would like to invite you to participate in this study. Please follow me…

Questionnaire, Content Study

Interview Protocol.

{Programming notes}

Questions will be self-administered by participants.

Professional interviewers will be on hand to assist where necessary.

Answers to open-ended questions will be audio recorded.

Computer will track/record reading times and page-switching sequences for all pages.

Test ad will always be in last position.

(Present and explain Informed Consent Form. Participants will be blind to FDA’s sponsorship).

Section I. Interview.

Thank you for agreeing to participate in this study today. Before we start I need to check that the microphone and recording equipment are working properly. Please speak into the microphone and read the sentence that appears on the computer screen. READ THIS OUT LOUD: "The quick brown fox jumps over the lazy dog."

Make sure you are comfortable and can read the screen from where you sit. The screen will show some instructions. Please use the Back and Continue buttons to move backwards and forwards through the instructions at your own pace. When you are ready to begin, simply press the "continue" key and follow the instructions. Any questions?

Q1. Please rate how risky or not risky these physical symptoms are using the scale provided. (randomize)

	Not at all risky	Somewhat risky	Moderately risky	Very risky	Extremely risky
Fainting
Mood swings
Diarrhea
Rash
Nausea
Vomiting
Weakness
Difficulty swallowing

Next you will see some magazine ads for consumer products on the computer screen. We are interested in finding out your opinions on some new products and some you may have seen before. Remember that all of your responses are confidential so please answer as honestly as possible. After you have finished reading these instructions, we will show you the magazine ads. Even though they are on a computer screen, please read them as you would in a magazine if you saw ads for products that you might be interested in for yourself or someone in your family.

You can take as much time as you want to look over this material and you can flip back and forth between pages if that is how you would usually read these ads. When you reach the end of the ads, you will come back to a blank screen.

[show ads]

Q3a. What products do you recall seeing ads for? You may select more than one.

A) Westinghouse

B) Sony

C) Lactaid

D) Oncazil

E) Femara

Q3b. Do you recall seeing an ad for ONCAZIL?

[This only gets asked if respondent does not choose D above]

A) Yes

B) No (show 3c)

Q3c. (display Oncazil ad on screen) Do you recall seeing this ad?

[This only gets asked if respondent chooses NO in 3b]

A) Yes

B) No [TERMINATE ]

Q4. What condition does ONCAZIL treat?

A) Asthma – breathing difficulties

B) Weight condition – weight control

C) High Cholesterol – control cholesterol

D) Fungus – athlete’s foot

E) Osteoporosis – brittle bones

Q5. What type of product is ONCAZIL? Please choose one answer. Is this:

A) An herbal supplement that you can buy in a drug or grocery store

B) A medicine that you can only get with a prescription from a doctor, or

C) An “over-the-counter” drug that you can buy without a prescription from a doctor

Q9. For each item, please rate how likely or not likely you are to do each of the following behaviors (randomize)

	Not at all likely	Somewhat not likely	Neither likely nor unlikely	Somewhat likely	Extremely likely
a. Talk to my doctor about ONCAZIL
b. Ask my doctor about getting a sample of ONCAZIL
c. Look for more information about ONCAZIL
d. Ask my doctor to prescribe ONCAZIL

Q10. As best you can, answer each of these questions based on the information presented in the advertisement for Oncazil. For each item, indicate whether the statement is true or false or if you are not sure. (randomize)

	True	False	Not Sure
a. You cannot take ONCAZIL if you have had a stroke.
b. If you take some kinds of over-the-counter cough medicines at the same time you take ONCAZIL, your blood pressure may go up
c. Your blood pressure can go down to dangerous levels if you take antifungal medicines with ONCAZIL
d. Seizures are a known side effect of taking ONCAZIL.
e. You can take ONCAZIL if you are pregnant
f. Patients with a history of kidney disease can take ONCAZIL if they are monitored by a doctor.
g. Antibiotics may become less effective if you use ONCAZIL at the same time.
h. You can take ONCAZIL if you have narrow-angle glaucoma
i. You must be at least 18 years old to take ONCAZIL
j. ONCAZIL is for people with a body mass index (BMI) of 25 or greater

Q11. Answer each question as best you can based on the information in the ad. [randomize]

	Yes	No	Not Sure
a. The ad tells me how likely I am to experience a benefit from using ONCAZIL
b. Rash is a more frequent side effect of ONCAZIL than nausea
c. The ad tells me how likely I am to experience a side effect from using ONCAZIL
d. All side effects will go away within one week of taking ONCAZIL
e. All side effects will last the entire time I am taking ONCAZIL

Q12. Please indicate your level of agreement or disagreement with the following statements. [randomize]

	Strongly Agree	Agree	Neither Agree nor Disagree	Disagree	Strongly Disagree
a. The information in the ad is believable
b. The risks and negative effects seem reasonable compared with the benefits and positive effects of ONCAZIL
c. The benefits and positive effects of ONCAZIL outweigh the risks and negative effects
d. I could deal with the side effects if I lost weight with ONCAZIL
e. Even losing a lot of weight would not be enough to balance the risks and negative effects from ONCAZIL

INTERVIEWER: Hand page 2 of print ad to participant.

Q13. Imagine you have taken ONCAZIL. Think about each situation presented below. Answer each question as best you can based on the information on this page of the ad. [randomize] [this section should be timed]

	Yes	No	Not Sure
a. Since you have been on ONCAZIL, you have felt that your thinking skills are slowed. Based on what you read, could this be a side effect of ONCAZIL?
b. You have been taking medicine for kidney disease. Can you take ONCAZIL?
c. Based on what you read, is it ok to take Tylenol (acetaminophen) while taking ONCAZIL?
d. You have just learned you have Hepatitis-C (a disease that affects your liver). Should you take ONCAZIL?

Q16. Are you currently taking a prescription medicine for weight control?

A) Yes

B) No (do not ask Q19)

C) Don't know or uncertain

Q17) What is your height? Your best guess is fine.

A) Feet _________

B) Inches _________

Q18. What is your weight in pounds? Your best guess is fine.

A) Weight ________

Q19. Before you started treatment, how severe was your weight condition? Would you describe it as:

A) Very mild

B) Mild

C) Moderate

D) Serious

E) Very serious

Q20. How severe is your weight condition now? Would you describe it as:

A) Very mild

B) Mild

C) Moderate

D) Serious

E) Very serious

Q21. In general, how much do you feel you know about your medical condition? Would you say you know:

A) A lot

B) A good bit

C) Some

D) Only a slight amount

E) Nothing at all

Q22. Have you ever...


had liver damage?	Yes	No	Don't Know
had a heart attack or stroke?	Yes	No	Don't Know
had kidney disease?	Yes	No	Don't Know
had the flu recently?	Yes	No	Don't Know

Q23. Have you ever seen any advertising for Oncazil before today?

A) Yes

B) No

The respondent's response will be digitally recorded in their own words.

INTERVIEWER: Now I'm going to ask you to say some words out loud that sometimes appear on medicines. The list contains some "easy to read” words, and some “hard to read” words, so just do your best to say as many of these words as you can. Remember, almost everyone will have trouble reading many of these words so don't be upset if some words are difficult -- just do your best! If a word is too difficult, just say "blank" and go on to the next word in the list. I want to hear you read as many words as you can from these lists. Speak directly into the microphone. Begin with the first word on this page and read aloud. When you come to a word you cannot read, do the best you can or say “blank” and go on to the next word.

Q24) fat flu pill dose eye stress smear nerves germs meals disease cancer caffeine attack kidney hormones herpes seizure bowel asthma rectal incest

The respondent's response will be digitally recorded in their own words.

Q25) fatigue pelvic jaundice infection exercise behavior prescription notify gallbladder calories depression miscarriage

pregnancy arthritis nutrition menopause appendix abnormal syphilis hemorrhoids nausea directed

The respondent's response will be digitally recorded in their own words.

Q26) allergic menstrual testicle colitis emergency medication occupation sexually alcoholism irritation constipation

gonorrhea inflammatory diabetes hepatitis antibiotics diagnosis potassium anemia obesity osteoporosis impetigo

Q27. Imagine that you flip a fair coin 1,000 times. What is your best guess about how many times the coin would come up heads in 1,000 flips?

___ times out of 1,000

Q28. In the BIG BUCKS LOTTERY, the chance of winning a $10 prize is 1%. What is your best guess about how many people would win a $10 prize if 1,000 people each buy a single ticket to BIG BUCKS LOTTERY?

____ person(s) out of 1,000

Q29. In ACME PUBLISHING SWEEPSTAKES, the chance of winning a car is 1 in 1,000. What percent of tickets to ACME PUBLISHING SWEEPSTAKES will win a car?

____ %

Q30. Gender (Record by observation; do not read)

1 Male 2 Female

[End time: ___________________ ]

You have been very helpful. Thank you very much for your participation!

Questionnaire, Format Study

Interview Protocol.

{Programming notes}

Questions will be self-administered by participants.

Professional interviewers will be on hand to assist where necessary.

Answers to open-ended questions will be audio recorded.

Computer will track/record reading times and page-switching sequences for all pages.

Test ad will always be in last position.

(Present and explain Informed Consent Form. Participants will be blind to FDA’s sponsorship).

Section I. Interview.

You will see a magazine ad for a new consumer product on the computer screen. Remember that all of your responses are confidential so please answer as honestly as possible. After you have finished reading these instructions, we will show you the magazine ad. Even though it is on a computer screen, please read it as you would in a magazine if you saw an ad for a product that you might be interested in for yourself or someone in your family.

The ad is two pages long. You will have XX minutes to read the ad. The computer will automatically shut off the picture if you are not finished in that time. When you are ready to begin, simply press the "continue" key and follow the instructions. Any questions?

Q3a. What product do you recall seeing an ad for? You may select more than one.

A) Westinghouse

B) Sony

C) Lactaid

D) Oncazil

E) Femara

Q3b) Do you recall seeing an ad for ONCAZIL?

[This only gets asked if respondent does not choose D above]

A) Yes

B) No (show 3c)

Q3c (display Oncazil ad on screen) Do you recall seeing this ad?

[This only gets asked if respondent chooses NO in 3b]

A) Yes

B) No [TERMINATE ]

Q4. What condition does ONCAZIL treat?

A) Asthma – breathing difficulties

B) Weight condition – weight control

C) High Cholesterol – control cholesterol

D) Fungus – athlete’s foot

E) Osteoporosis – brittle bones

Q5. What type of product is ONCAZIL? Please choose one answer. Is this:

A) An herbal supplement that you can buy in a drug or grocery store

B) A medicine that you can only get with a prescription from a doctor, or

C) An “over-the-counter” drug that you can buy without a prescription from a doctor

Q9. For each item, please rate how likely or not likely you are to do each of the following behaviors (randomize)

	Not at all likely	Somewhat not likely	Neither likely nor unlikely	Somewhat likely	Extremely likely
a. Talk to my doctor about ONCAZIL
b. Ask my doctor about getting a free sample of ONCAZIL
c. Look for more information about ONCAZIL
d. Ask my doctor to prescribe ONCAZIL

	True	False	Not Sure
a. You cannot take ONCAZIL if you have had a stroke.
b. If you take some kinds of over-the-counter cough medicines at the same time you take ONCAZIL, your blood pressure may go up
c. Your blood pressure can go down to dangerous levels if you take antifungal medicines with ONCAZIL
d. ONCAZIL should only be used by people with a BMI of 25 or higher
e. You can take ONCAZIL if you are pregnant
f. Patients with a history of kidney disease can take ONCAZIL if they are monitored by a doctor.
g. ONCAZIL may become less effective if you use antibiotics at the same time.
h. You can take ONCAZIL if you have narrow-angle glaucoma
i. You must be at least 18 years old to take ONCAZIL
j. ONCAZIL is for people with a body mass index (BMI) of 25 or greater

INTERVIEWER: Hand print ad to participant.

Q11. Imagine you have taken ONCAZIL. Think about each situation presented below. Answer each question as best you can based on the information on this page of the ad. [randomize] [this section should be timed]

	Yes	No	Not Sure
a. Since you have been on ONCAZIL, you have felt that your thinking skills are slowed. Based on what you read, could this be a side effect of ONCAZIL?
b. You have been taking medicine for kidney disease. Can you take ONCAZIL?
e. Based on what you read, is it ok to take Tylenol (acetaminophen) while taking ONCAZIL?
f. You have just learned you have Hepatitis-C (a disease that affects your liver). Should you take ONCAZIL?

Q12. Please indicate your level of agreement or disagreement with the following statements. [randomize]

	Strongly Agree	Agree	Neither Agree nor Disagree	Disagree	Strongly Disagree
a. I am very willing to read the information on this page.
b. The information on this page is believable
c. This page is not at all useful in helping me decide to talk with my doctor about ONCAZIL
d. The risks and negative effects seem reasonable compared with the benefits and positive effects of ONCAZIL
e. It is very hard to find information on this page.
f. The benefits and positive effects of ONCAZIL outweigh the risks and negative effects
g. The side effect section is presented in an easy-to-read format
h. I could deal with the side effects if I lost weight with ONCAZIL
i. The format and layout of this page is very clear
j. I do not like the way the information on the page is presented.
k. Even losing a lot of weight would not be enough to balance the risks and negative effects from ONCAZIL
l. I would be unsure relying on the information in this page.
m. The important information on this page stood out very well.
n. The way the information was presented on this page was useful.

Based on your reading of the information on this page, please tell me how confident you are that you could do the following tasks from 0 (no confidence at all) to 10 (complete confidence). [random start]

Q13a. Recognize any bad reactions.

0 ---- 1 ---- 2 ---- 3 ---- 4 ---- 5 ---- 6 ---- 7 ---- 8 ---- 9 ---- 10