Investigation of Issues Related to Direct-to-Consumer (DTC) Advertising

DRAFT – 1/04/11

Moderator’s Guide

Disease Information in DTC Ads

Focus Group preparation notes:

Objective and Task

Objective: To explore consumers’ perceptions of disease information, prescription drug effectiveness, and the messages they receive from direct-to-consumer advertising of prescription drugs.

Task Purpose: To conduct qualitative testing with consumers to explore the contextual factors (i.e., reactions, usefulness, preferences, and understanding) that relate to the perceptions of symptoms and disease treatment in DTC advertising of prescription drugs.

Data Collection

Setting: Eight (4 high education, 4 low education) in-person focus groups will take place in focus group facilities in the metropolitan Washington, DC area as well as other cities across the country to be determined. Focus groups will last approximately 90 minutes. A trained moderator will lead the discussion. Interviews will be audio taped and transcribed.

Consenting: Written consent will be obtained from each participant at the beginning of each focus group.

Process: The focus group will comprise the following steps.

1. Welcome:

1. Informed consent—facility personnel will briefly review the consent form and obtain each participant’s written consent.

2. Welcome—the moderator will thank the participants for taking the time to participate and explain further the purpose of the focus group.

3. Warm-Up—the moderator will establish some ground rules and ask participant a few questions about their current medication use.

2. Focus Group Discussion. The moderator will use examples of print, television, and internet DTC advertising to engage participants in the current topic and to spark discussion.

3. Closing. The moderator will summarize the findings with the participant and ask for final thoughts.

Stimuli needed for this group:

• Psoriasis speaks TV ad

• Women’s heart disease print ad

• Abilify print ad

• Fosrenol brochure copy

Informed Consent Procedure

[Give participant informed consent form.] Here are two copies of an informed consent form. Please take a moment to review it and if you agree to it, please sign one copy. The other copy is for you to keep for your records. It contains a telephone number you can call if you have any questions after our interview is over.

• The consent form states that you agreed to participate in a group discussion about the presentation of information about prescription drugs.

• Your identity and anything you personally say here will remain confidential. Your name, address, and phone number will not be given to anyone, and no one will contact you after this group discussion is completed. When I write my report, I will not refer to you by name. We will look at the results of the discussions as a group, not individually.

• Your decision to take part in this research study is completely voluntary. You can refuse to answer any question during the study and you can stop participating at any time. If you decide to participate and later change your mind, you will not be contacted again or asked for further information.

• Most importantly, there are no right or wrong answers. We want to know your opinions and what you think about the materials.

• I would like to audio record our discussion to ensure accuracy. I am going to take notes during our conversation, but I would like to go back and review our discussion to make sure that I have everything correct. Do I have your permission to audio record our discussion today?

• Finally, do you have any questions before we begin?

WELCOME

Thank you for taking the time to join us today. Your participation is very important. I am _______ from Harvrey Marketing/ICF Macro, a marketing research organization. The purpose of this group is to get your thoughts about advertising for prescription drugs that you may see on television, in magazines and newspapers, and on the internet. As part of our discussion today, you will see some examples of advertising and answer some questions about them. Your feedback is very important to us and may ultimately be used to help the Department of Health and Human Services make the ads more user-friendly. Our discussion will last about two hours.

I am an independent consultant hired to moderate these discussions. As such, I do not have a vested interest in receiving any particular point of view. I simply want to have an active and lively discussion with all of you.

I. Ground Rules

A. You have been asked here to offer your views and opinions; everyone’s participation is important

B. Audio/observers

C. Speak one at a time

D. No side conversations

E. No right or wrong answers

F. It is OK to be critical. If you dislike something or disagree with something that is said, I want to hear about it.

G. All answers will be kept private to the extent provided by law, so feel free to speak your mind.

II. Participant Introductions

To begin, I would like to have you go around the table and introduce yourselves. Please give me:

a. your first name only

b. hobbies

c. the last concert you saw live

III. Introduction to DTC Advertising

We all see a lot of advertising—on television, in magazines and newspapers, on the internet. We see a lot of advertising for medical products, including over-the-counter and prescription drugs, dietary supplements, medical devices, and health foods. There are also ads that are designed to give general information about a disease or medical condition or make you aware that treatments exist for a disease or condition. These ads discuss a particular disease or health condition, but do not mention any specific drug or device.

1. Can you think of some examples of these general disease or health condition ads?

2. What sort of general disease or health condition ads would you like to see?

Disease Awareness Ads

1. Show Psoriasis Speaks TV ad and Women’s Heart Disease print ad. For each ad, ask the following:

1. What are your initial reactions to this ad?

2. What does it say or imply about treatments for this health condition?

3. What is this ad asking you to do?

4. What would you do if you saw this ad? (or, “How likely are you to do that?” following up on the previous question)

5. What kind of organization runs these ads?

6. Do you think companies ever run these ads? [they do]

7. [Prompt on company-run ads] What does the company hope to get out of these ads?

Combination Disease Awareness/Product Ads

Show Abilify print ad and Fosrenol brochure. For each piece, ask the following:

1. What are your initial reactions to this [ad or brochure]?

2. What does it say or imply about treatments for this health condition?

a. What is it about the [ad or brochure] that makes you think that?

3. What does it say or imply about the product in the [ad or brochure]?

b. What is it about the [ad or brochure] that makes you think that?

4. Do you find the health condition information useful in an [ad or brochure] that discusses a particular product? In what way or why not?

5. How closely is the information about the health condition connected to/linked to the information about the product?

a. What would you change about the [ad or brochure] to make the information appear more connected?

b. What would you change about the [ad or brochure] to make the information appear less connected?

After all pieces have been looked at and discussed:

1. How could drug companies give you health condition information without making you think their drug cures the health condition or treats the bigger consequences?

a. How could it be done in one ad?

b. How could it be done in two separate ads?

2. (Moderator: Only if time permits). We’ve talked a lot about disease and health condition information targeted to adults. What if these ads were about diseases that children get or health conditions that children have? (Moderator: If examples needed: Cerebral palsy, Type I diabetes, lice, etc.)

1. How do you feel about ads that talk about conditions that affect children?

2. Does anything in your opinion about health condition information in these ads change if children are the patients for the drug products?

3. In general, how do you feel about ads for products that treat conditions in children?

5. False Close

Moderator checks with observers to see if they have additional questions or clarifications.

5. Close

Thank you for spending your time with us tonight. Your comments are very helpful.

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