Form 0920-0222 (25BG) 0920-0222 (25BG) Focus Grouip Protocol

Attachment 4: Focus group protocol

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[NOTE: The focus group discussions will use the following protocol as a general guide. However, as is typical with focus groups, the moderator will allow the discussion to proceed naturally, and therefore the protocol may not be administered either completely or chronologically.]

1. Introduction

Welcome. My name is ____________. Before we start, I want to make sure that you understand who we are and why you’re here. We are the Collaborating Center for Questionnaire Design and Evaluation Research in the National Center for Health Statistics at the Centers for Disease Control and Prevention (CDC) and our expertise is the design, refinement, and testing of surveys.

2. Overview and Group Rules

Before we continue, I’d like to go over some general information, establish some ground rules for our focus group, and tell you about the confidentiality procedures we have in place.

I would like you to know that in our focus group today, you don’t have to reveal anything that you are not comfortable revealing.

For purposes of the group discussion, we’d like you to pick a name that you would like to be called– a first name is fine, it doesn’t even have to be your real name. [ASK THEM TO FILL OUT NAME CARDS.]

The consent form you just signed assures you that we will keep your information confidential. We would also like to ask everyone to treat this focus group as confidential. That is, if you learn anything private about another member of the group, we ask that you do not share this information with anyone outside of this room. Although we are required by federal law to keep information private, we cannot guarantee that everyone else will honor your privacy. All we can do is ask that people please agree to that. And again, you should never feel obligated to share any information that you are not comfortable sharing.

We are planning to [video/audio] record this focus group. This is for note-taking purposes in case we miss anything that was said. We will use the recording to double-check our notes and make sure they are complete. Only National Center for Health Statistics and contractor staff who work on this project will have access to these recordings.

One of the great things about this discussion is the “group dynamic” – ideas that one person raises will remind someone else of a related issue. That’s great, feel free to speak up. But please don’t interrupt each other. We ask that there be only one speaker at a time so that responses can be accurately recorded. You may have more or less to say about some topics than others, and that’s OK too.

Don’t feel like you have to agree or disagree with anyone in this room. We want to hear about your personal experiences and thoughts, and it’s OK to disagree with someone else. But please be respectful of the opinions or experiences of others in the room.

Sometimes groups start talking about subjects that are off the main topic. That’s natural; but please don’t be offended if we steer the conversation back to the material we need to cover.

As a courtesy to everyone, please turn off cell phones. The focus group will last no longer than 90 minutes. We will not have breaks built into it, but should you need to go to the restroom during the focus group, please feel free to leave. However, I would appreciate it if you would go one at a time.

Does anyone have any questions before we get started?

[Note to reviewers—as is custom for CCQDER focus group projects, the focus groups will be iterative, with the content of each helping to refine and expand the protocols of future discussions. As such, this protocol includes a list of topics the facilitators intend to cover during the discussion, and not a detailed list of questions.]

3. Awareness

   1. Awareness of drugs

   2. How did they first learn about them?

   3. Awareness of different brands? Generic names?

   4. Awareness of how drug is administered?

   5. Awareness of side effects or complications

   6. Awareness of cost

   7. Do you know someone using GLP-1R agonists? How many people?

4. Perceptions and stigma

   1. Should these medications be covered by insurance for people whose main reason for taking it is (to treat diabetes/(prevent cardiovascular disease)/(to lose weight)?

   2. Reasons for not ever taking

   3. Potential stigma of regaining weight

5. Clinician advice and use

   1. Advised to take medication by a HCP?

   2. Prescribed the medication by HCP?

   3. Ever used

      1. What age did they first take the medication?

   4. Current use

      1. Have they thought about stopping? Why?

   5. If stopped, how long was use? Why did they stop? Did you regain weight? How much?

   6. If not taking it, why not? How likely would they be to use it in the future? Why?

   7. Indications for use

      1. What is the main reason for taking this medication?

      2. Is there another reason for taking this medication?

   8. Side effects experience

6. Affordability and access

1. How did you pay for the medication? Or if not taking, how would you pay for the medication cost?

2. How easy or difficult is/was it for you to afford to pay for these drugs?

3. Who prescribed the medication?

4. If not from an HCP, then where did you obtain the medication?

5. If not taking it now, could you obtain it if you wanted to?

6. Did you try to get the medication, but were unable to?

7. During the past 12 months, were any of the following true for you?

   1. You skipped your medication doses because it was unavailable due to shortages.

   2. You took less medication than needed because it was unavailable due to shortages.

   3. You delayed buying medication because it was unavailable due to shortages.

7. Wrap-up

OK. We are out of time. Does anyone have any last thoughts or questions?

I want to thank all of you for coming today and sharing your opinions. The information you’ve shared today will be very useful in determining how we ask about GLP-1 R agonists medications and associated issues in national surveys.