Risk and Benefit Perception Scale Development Focus Groups

FDA Measures Study

Focus Group Moderator Guide

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. What factors affect prescription drug decisions

   2. How these factors relate to one another and collectively influence decisions

   3. What decision points exist along the pathway to prescription drug usage

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 learn more about how people make health decisions.

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

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 directly from you. However, your identity and anything you say will remain confidential. Your names, addresses, and phone numbers will not be given to anyone, and no one will contact you after this group is over. When I write a summary of these groups, I 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 know what each of you thinks about the issues 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 responses are accurately recorded.

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

• The most important thing you do to stay healthy

Idea Association (25 mins)

First, I’d like to spend some time hearing what you think about some phrases. I’m going to put a phrase on the flip chart, and I’d like you to tell me what it means to you. Remember: This isn’t a test, and there are no right or wrong answers.

Phrase		Probes
Prescription Drugs		What are your initial reactions to this phrase? What do you think of when you hear the term “prescription drug”? How do you think people close to you feel about prescription drugs?
Drug Risks		What are your initial reactions to this phrase? What comes to mind when you hear the term “drug risk”? What are some examples of drug risks? What drug risks concern you, even if you’ve never personally experienced them?
Drug Benefits		What are your initial reactions to this phrase? What comes to mind when you hear the term “drug benefits”? What are some examples of drug benefits? Tell me about a drug benefit you or someone close to you has experienced.
Drug Efficacy		What are your initial reactions to this phrase? What comes to mind when you hear “drug efficacy”? What are some examples of drug efficacy? How is drug efficacy different from drug benefits?

Decision Process Walkthrough (45 mins)

Now I’d like to move on to a new activity.

Everyone in this group was selected because they’re currently taking a prescription drug, and we’d like to learn more about what things you consider when you’re deciding whether to take a drug. During this exercise, please think about the prescription drug that you’ve started taking most recently.

Question		Probes
Walk me through how you decided to take this medication.		What were the steps you took? In what order did these steps happen?
What things influenced your decision to take a prescription drug for your condition?		How did you decide which specific drug to take? What drug characteristics (e.g., side effects, dosing) were influential? What personal beliefs or experiences (e.g., past side effects) were influential? What outside factors (e.g., family recommendations) were influential? How influential were advertisements for prescription drugs? What information did they provide?
How much did you seek out information about the drug (or different drug options)?		At what point did you look for this information? Where did you look for this information?
How involved was your healthcare provider in the decision to take a prescription drug for your condition?		How involved was your provider in the decision of which specific drug to take?
What else—besides the items we already discussed—played a role in your decision to take a prescription drug?		What else played a role in your decision of which drug to take?
When in this process did you ultimately decide to take a prescription drug for your condition?		When in this process did you decide which drug to take? Once you decided to take a drug, what were your next steps (e.g., request sample, ask for prescription, consult doctor)?
Let’s take a look at the flip chart. Which of these items were most important in your decision?		Which items were least important?
[IF DECISION TO STOP TAKING A DRUG IS MENTIONED] What things would influence your decision to stop taking a drug?		How is this decision different than the decision to start a drug?

Moderated Discussion (30 Minutes)

Next, I’d like to spend some time exploring a few things that might influence your decision to take a prescription drug.

Question		Probes
How important is how well the drug works in your decision of whether to take the drug?		[IF HIGH] Why is it important? [IF LOW] Why is it not important? How do you figure out how well a drug works if you haven’t personally taken it? What would change your opinion of how well a drug works?
How important are other drug benefits—besides how well it works—in your decision of whether to take the drug?		[IF HIGH] Why are these benefits important? [IF LOW] Why aren’t these benefits important? What are some other benefits that come to mind? How do you figure out the benefits of a drug if you haven’t personally taken it?
How important are a drug’s side effects and risks in your decision of whether to take the drug?		[IF HIGH] Why are they important? [IF LOW] Why are they not important? Imagine that you have to choose between two drugs Drug #1: Minor side effects, but you’re very likely to have them. Drug #2: Serious side effects, but very small chance you’d have them. Which drug would you choose? Why? How do you know the side effects or risks of a drug you haven’t personally taken? What would change your opinion of a drug’s side effects or risks?
Imagine that a close friend is taking a prescription drug, and you’d like to learn more about it.		How would you ask your friend about how well the drug works? How would you ask your friend about the drug’s other benefits? How would you ask your friend about the drug’s side effects?

Characteristics Activity (5 min)

Finally, I’d like to ask a few questions about your own health and healthcare.

Question		Probes
How many prescription drugs are you currently taking?
In general, how valuable or not valuable do you think prescription drugs are?
In general, how valuable or not valuable do you think prescription drug advertising is?
What are your most trusted sources of health information?		Which sources do you use most often? How often do you use these sources? How much do you rely on your healthcare provider for health information?
On a scale of 1 to 10, with 1 being “terrible” and 10 being “the best”, how would you rate your relationship with your primary healthcare provider?		Why is that? How much do you rely on this healthcare provider for health information?

Closing (5 min)

Is there anything else we should know that we didn’t discuss today?

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