Focus Group Moderator Guide - Pain WORD

March of Dimes: Treating for Two

Phase I – Virtual Focus Group Guide

Preconception Consumer Group 1 -(Master Guide: Pain)

Overview. The focus group will comprise the following steps:

1. Consent Form: Participants will read the consent form and check the box indicating their agreement to participate.

2. Waiting Room. Participants will gather in the waiting room 10-15 minutes before the group is scheduled to start and will review the housekeeping items.

3. 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 able to respond with minimal distractions.

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

   1. Current medication use

   2. Changes to medication use during pregnancy

   3. Sources of information about medication use before and during pregnancy

   4. Reactions to message about medication use

5. Closing

Housekeeping Items (Waiting Room)

Before the group begins, we want to share a few housekeeping items:

1. TECHNICAL PROBLEMS. If you experience technical problems, please call 1-888-525-5026 (select option 2) for technical support.

2. TRANSCRIPT. After the focus group, we’ll print a transcript of our discussion that will help us summarize the key points that you raise. It will not include anyone’s full name or identifying information.

3. CONFIDENTIALITY / PRIVACY. Anything you say in today’s discussion will remain secure. Your names, addresses, and phone numbers will not be given to anyone. We will conduct follow-up interviews with some participants. Within a week, you may be contacted about participating in a follow-up interview.

Welcome (2 min)

Thanks for joining us today. I’m _____, and I’m from RTI International. We’re a non-profit research organization based in North Carolina. We are working with the Centers for Disease Control and Prevention (CDC) and March of Dimes to conduct virtual focus groups about medication use during pregnancy.

We brought you here today because you all have something really exciting in common--you’re all planning a pregnancy sometime in the near future.

Another thing that you all have in common is that you currently take prescription medications to treat pain. I know that it can be difficult for some people to talk about treatments for pain. We’re very interested in your perspectives of managing this condition during pregnancy.

The purpose of today’s group is to learn more about your thoughts about medication use during your future pregnancy.

The session will last about 90 minutes.

First, I want to share a few ground rules for today’s discussion:

1. YOUR OPINION. There are no right or wrong answers in today’s discussion. We want to know your honest opinions and experiences, even if they differ from other people’s experiences.

2. ANSWER ALL QUESTIONS. After we ask a general question, we will frequently ask several follow-up questions. Please answer both the questions and follow-up questions.

3. BUILDING ON OTHERS’ COMMENTS. When building on another person’s comments—for example, when agreeing with them—be sure to reference the name of person who made the original comment. (For example: “@ Ellen – I completely agree!”)

4. MINIMIZE DISTRACTIONS. Please make sure that you are in a place where you can participate without any distractions. Please turn off your beepers, cell phones, pagers, televisions, radios, and anything else that may make it difficult to concentrate.

5. RESTROOMS. Feel free to use the restroom during our discussion if needed. You don’t need to tell us you will be away from your computer; please just return to the discussion as quickly as possible.

6. QUESTIONS. Does anyone have any questions before we begin?

Questions

Probes or Follow-Ups

Warm-up Question

Thanks for joining us! Let’s start by typing in your first name and something about yourself or your family.

• If you already have children, what are some of the things you like about being a mom? Those of you who don’t have any children yet, what do you look forward to most about being a mom?

Introductory Questions

Like I mentioned before, you all have experience managing pain with prescription medication. I am going to ask you some questions about your experiences, particularly about medication use.

1. What are the biggest benefits you get from taking your medication used to treat pain, in general?

2. What are the downsides, if any, to taking your medication, in general?

3. Have any of you thought about if or how your medication use would change during pregnancy?

4. Have any of you already made a change to your medication because you are planning a pregnancy?

5. When do you think would be the best time to start thinking about your medication use (whether it would change or not) related to planning a pregnancy?

6. Would you meet with your doctor? What types of doctors would you talk to? Pharmacist, OB/GYN, midwife, family doctor?

7. For those of you considering making a change to your medication before you get pregnant, what factors are you considering? For those of you who don’t think you will make a change to your medication, what factors did you consider?

• When you are pregnant do you think there will be different benefits?

• Do you think there will be different downsides when you are pregnant? Probe: Downsides for mom? Downsides for baby?

• For those of you who think it might change, how do you think it might change?

• For those of you who don’t think your medication would change, tell me more about your thinking.

• Have any of you worked with your doctor to create a treatment plan? Have any of you searched for information online? Please tell me more about that.

• Have any you had different doctors tell you different information? If you received conflicting information, how did you make a decision about your medication? What types of doctors gave you the conflicting information?

• Did you look for information about the safety of the medication during pregnancy? If so, who did you ask or where did you look for that information?

• What information were you able to get about the medication’s safety? Is there other information you wanted but didn’t receive or couldn’t find?

8. You all mentioned several types of doctors you might talk to. Do you think your doctor(s) has enough knowledge about your medication and pregnancy to address your questions?

9. Could you share any other information you have received from your doctors about medication use during preconception/pregnancy?

10. If you have a question regarding your medication use during pregnancy, which doctor(s) do you think you will contact?

11. Besides your doctor(s), where else did you look for guidance about medication use while planning a pregnancy?

12. How do you decide what information you can trust?

• Which type of doctors have the most information to give you? [OB/GYN, midwife, specialist, pharmacist]

• If the risk of a medication is unknown, how does that affect how you make decisions about taking or not taking it?

• If you lack information on the risk of a medication, how will that affect your decisions during pregnancy? (continue to take medication(s), discontinue medication(s)) How will you make a decision about what to do?

• Family/friends, health websites, online health communities, phone apps, TV, and text messaging?

• Whose specific opinion regarding medication use during preconception/pregnancy matters most to you?

• How do you decide which sources are more likely to be trustworthy or are giving you more accurate information than others?

• How do you handle conflicting information?

• Do you share information with other women or family members? If yes, how?

Messaging Testing

For the next set of questions, we are going to ask your opinion on some messages that you might read on a pregnancy webpage or materials available to you at your doctor’s office about medication use during preconception/pregnancy.

Message 1a

Talk with your doctor if you are pregnant and you have taken any medicine or are thinking of taking any medicine. This includes prescription and over-the-counter medications, as well as dietary or herbal products.

1. What are your initial reactions to this message?

• What is the main point of this message?

• Is there anything that is confusing or difficult to understand? If so, what?

  1. What does “talk with your doctor” mean to you in this context?

  2. What do “over-the-counter medications” mean to you in this context?

• Is there information missing from this message that you think should be included?

2. How relevant is this message to you?

   1. How helpful do you think would a message like this be to you?

   2. How, if at all, do you think it might influence your decision making?

Message 1b.

The following message is an addition to the previous message (Message 1a).

Since no medicine is 100 percent safe for all women, it’s a good idea to check with your doctor. The conversation with the doctor will help you weigh the risks and benefits of any medication used during pregnancy.

3. What are your initial reactions to this additional information?

   1. Does this additional information change your reaction to the first part of the message? If so, how?

   2. Is there anything that is confusing or difficult to understand? If so, what?

1. What does “100 percent safe” mean to you in this context?

2. Who do you think the statement “100 percent safe” refers to – the mother or the fetus?

3. What does “weigh the risks and benefits” mean to you in this context?

Message 2a.

Pregnant women should not stop or start taking any type of medication that they need without first talking with a doctor.

4. What are your initial reactions to this message?

• What is the main point of this message?

• Is there anything that is confusing or difficult to understand? If so, what?

  1. What does “medication that they need” mean to you in this context?

  2. What does “first talking with your doctor” mean to you in this context?

  3. What do you expect your doctor to do?

• Is there information missing from this message that you think should be included?

5. How relevant is this message to you?

   1. How helpful do you think would a message like this be to you?

   2. How, if at all, do you think it might influence your decision making?

Message 2b.

The following message is an addition to the previous message (Message 2a).

This is particularly important early in your pregnancy. Pregnant women should avoid taking anything during your first trimester when your developing baby is most vulnerable.

6. What are your initial reactions to this additional information?

   1. How does this additional information change your reaction to the first part of the message?

   2. Is there anything that is confusing or difficult to understand? If so, what?

1. What does “avoid taking anything during your first trimester” mean to you in this context?

2. What does “when your baby is most vulnerable” mean to you in this context?

Message 3a.

If you are planning a pregnancy and are using any medications, please talk to your doctor about which medications are necessary and should be continued.

7. What are your initial reactions to this message?

• What is the main point of this message?

• Is there anything that is confusing or difficult to understand? If so, what?

  1. What does “planning a pregnancy” mean to you in this context?

  2. What does “which medications are necessary” mean to you in this context?

• Is there information missing from this message that you think should be included?

8. How relevant is this message to you?

   1. How helpful do you think would a message like this be to you?

   2. How, if at all, do you think it might influence your decision making?

Message 3b.

The following message is an addition to the previous message (Message 3a).

If you are planning to have a baby and are using any medications, please talk to your doctor about which medications are necessary and should be continued. Unnecessary medications early in your pregnancy can hurt your baby.

9. What are your initial reactions to this additional information?

   1. How does this additional information change your reaction to the first part of the message?

   2. Is there anything that is confusing or difficult to understand? If so, what?

1. What does “unnecessary medications” mean to you in this context?

2. What does “early in your pregnancy” mean to you in this context?

Closing Question

10. Is there anything else you would like to share about how information given to women about medication use during preconception/pregnancy could be improved?

Closing (1 min)

Thank you again for participating in today’s group. Your experiences and input were extremely valuable in helping us to understand how women make decisions about medication use before and during pregnancy.

I’d like to remind you of two phone numbers you can call if you have any questions about the study. If you have any questions about your rights as a study participant, you may call Molly Lynch toll-free at 1-866-RTI-1958 then extension x22709 or you can call RTI's Office of Research Protection at (919) 316-3358 in Durham, NC or 1-866-214-2043 (a toll-free number).

As a token of appreciation for your interest, you will receive a check in the amount of $50. You should receive it within 5-7 business days. If you do not receive the check, please contact Molly Lynch at 1-800-334-8571 (extension 22709).

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