Moderator Guide - Phase 2 - Patient

FDA Caregiver Study

Phase 2 – Focus Group Moderator Guide

Patient Version

The focus group will be comprised of the following steps:

1. Consent Form: Ask participants to read and sign the consent form.

2. Welcome:

   1. Welcome - The moderator will welcome the participants and explain the purpose of the focus group session.

   2. Ground rules -The moderator will provide guidance to ensure that participants are allowed to speak without interruption by other participants.

3. Warm-up: Participants will introduce themselves and provide a little information about themselves.

4. Discussion: In the focus group, participants will discuss the following topics:

   1. Quality of the ad storyboard

   2. Clarity of messages in the storyboard

   3. Relevance of the proposed ad to participants

   4. Perceptions of drug risks and benefits presented in the storyboard

   5. Elements of the storyboard that participants are likely to discuss with partner

5. Closing

Welcome (5 min)

Thank you for coming today. I’m _____, and I’m from RTI International. The purpose of this focus group is to give feedback on an advertisement for new product.

Your experience and perspectives are very important to us, and I genuinely appreciate your time today. This session will last about 90 minutes.

First, I want to cover two housekeeping items:

• Audio Taping. You have probably noticed the microphones in the room. They are here because we are audio taping today’s session. At the end of all our focus groups, we want to summarize our findings. I want to give you my full attention and not take a lot of notes, so I will refer to the tape when writing the summary.

• Client Observation. Behind me is a one-way mirror. Some of the people working on this project are observing this discussion so that they can hear your opinions. However, your identity and anything you say will remain confidential. Your names will not be given to anyone, and no one will contact you after this group is over. When we summarize these groups, we will not refer to anyone by name.

Before we begin, I want to review a few ground rules for today’s group discussion:

1. Honest Opinions. Most importantly, there are no right or wrong answers. We want to know your honest opinions, and those opinions might differ. This is fine. We want to hear your honest thoughts on the topics we discuss.

2. Speaking. Please try to speak one at a time. I may occasionally interrupt you when two or more people are talking in order to be sure everyone gets a chance to talk and that we capture your responses accurately.

3. Cell Phones. As a courtesy to everyone, please silence or turn off your cell phones, PDAs, and pagers.

4. Restrooms. If you need to go to the restroom during the discussion, please feel free to leave; however, I’d appreciate it if you would go one at a time.

5. Questions. Do you have any questions before we begin?

Warm up (5 min)

I would like to begin our discussion by asking you to introduce yourself. Please tell us:

• Your first name

• Where you grew up

• Complete this sentence: “I pay attention to a TV ad when…”

First Impressions, Key Messages, and Ad Quality (20 Minutes)

For our first activity, I’d like to get your first impressions of a new product ad. Everyone in this group was selected because you have been diagnosed with asthma, and we’d like to learn more about how you view ads for health-related products. We are going to show you what we call a “storyboard:” that is, a rough sketch of what the final ad will look like.

Here’s the draft ad.

[Present storyboard to participants.]

Question	Probe
Before we move any further, let’s talk about the ad you just saw. What were the three main messages you took away from the ad?	Why did those messages stand out to you?
What was your first impression of this ad?	Why did you feel that way about it? What words or phrases were memorable? Why? What visuals were memorable? Why? What words or phrases bothered you? Why? What visuals bothered you? Why?

Let’s review the storyboards again. Please take a few minutes to review them carefully because we will be discussing the storyboards throughout this session and, later on, will ask you to remember information from the ad. [Distribute color storyboard copies to participants. Allot five minutes for review.]

I’d like to hear about your overall impression of this ad and how it compares to other prescription drug ads you’ve seen.

Question	Probe
What makes this ad different from other drug ads you’ve seen on TV?	What makes this ad similar to other drug ads? What did you like about this ad? What did you dislike about it? What parts of the ad seem unrealistic?
What makes this drug different from other asthma drugs you’ve seen advertised?	What makes it similar to other asthma drugs? What do you like about the advertised drug? What do you dislike about it?

Ad Relevance (15 Minutes)

Next, I’d like to talk about how relevant this ad is to you and your health.

Question	Probe
In your opinion, who is this ad trying to reach?	Why do you think the ad is targeted toward that group of people?
How relevant is this ad to you and your lifestyle?	How relevant is the ad to you and your asthma? How often do you participate in the type of activities shown in the ad? How often does your asthma prevent you from participating in those activities? What activities does your asthma prevent or limit you from participating in?
Tell me why Zarins is or is not a drug for someone like you.	What could be different about Zarins to make it a better drug for you? Based on the ad, how do you think Zarins would affect your asthma if you took it? Based on the ad, how do you think Zarins would affect your ability to participate in the activities you mentioned earlier?

Benefit and Risk Perceptions (15 Minutes)

[Collect storyboards from participants.] At this point, I’d like to collect the storyboards from everyone. We’ve talked about your impressions of the ad. Now let’s talk about some of the messages in the ad and what you remember about them.

Question	Probe
What do you remember about the benefits of Zarins?	Which benefits stand out to you? Why? Which benefits are easiest for you to remember? Which benefits do you like the most? How do Zarins’ benefits compare to the benefits of other asthma drugs?
What do you remember about the risks and side effects of Zarins?	Which risks and side effects stand out to you? Why? Which risks and side effects are easiest for you to remember? Which risks and side effects are most concerning to you? How do Zarins’ risks and side effects compare to the risks and side effects of other asthma drugs?
How truthful do you think the ad is about Zarins’ benefits, risks, and side effects?	[If appropriate] What makes you think the benefit information in the ad might not be true? [If appropriate] What makes you think the risk and side effect information in the ad might not be true? What would you change in the ad to make the information more believable?

Partner Discussions (20 Minutes)

We’ve talked a lot about the ad itself. Now I’d like to talk a bit about what you might do after viewing this ad on TV.

Question	Probe
What actions would you want to take after viewing this ad (e.g., ask doctor about drug, look for more information about drug)?	[If appropriate] What about the ad makes you want (or not want) to talk to your doctor? [If appropriate] What about the ad makes you want (or not want) to seek more information? [If appropriate] What about the ad makes you want (or not want) to request a prescription? [If appropriate] Why wouldn’t you want to take any action after seeing this ad?
How likely would you be to talk with your spouse/partner about the drug after viewing this ad?	What is it about the ad that would make you want (or not want) to discuss the drug with your partner? What specifically would you and your partner discuss? What aspects of the drug would you be most likely to tell your partner about?
How likely would you be to talk with your partner about the ad itself?	What is it about the ad that would make you want (or not want) to discuss it with your partner? What specifically would you and your partner discuss? What parts of the ad would you be most likely to tell your partner about?
Consider this situation: You’re watching TV alone and this Zarins ad comes on TV. What would happen? Now imagine that you’re watching TV with your partner and this Zarins ad comes on TV. What would happen?	How would your attention to the ad differ in these two situations? What else would be different in these two situations? What would your partner do in the second situation?

Closing (10 minutes)

We’ve spent a lot of time talking today about your thoughts and opinions on this one advertisement. I’d like to ask just a few last questions as we wrap up today’s discussion.

Question	Probe
Overall, how involved is your partner in your asthma care?	How does this compare with how involved you’d like your partner to be in your asthma care? Who else—besides your partner and your doctor—do you talk to about your asthma care? Who else—besides your partner and your doctor—would you talk to about the Zarins ad?
Is there anything else we should know that we didn’t discuss today?

I think that covers all of our questions for today. The purpose of this study is to learn how consumers interpret prescription drug ads. In order to get a real-life reaction, we used pretend products in this study. Zarins is not real a product and is not available for sale. Please see your healthcare provider for any questions about asthma and its treatment.

Thank you again for participating in today’s group. Your input was extremely valuable, and we really appreciate your time.