Focus Group Research with Physicians Regarding Drug Risk/Benefit Analysis in Variations of Display Pages of Print Direct-to-Consumer Prescription Drug Advertisements

Appendix A -- Moderator’s Guide and Participant Screener

Moderator’s Guide

Physician Focus Groups – Understanding of Drug Efficacy

Contractor: Decision Partners

I. Introduction to Group (~5 min)

A. Introduction of Moderator

1. Independent consultant hired to moderate these discussions

2. No vested interest in any particular point of view

B. Ground Rules

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

2. Audio and videotaping/observer(s)

3. Speak one at a time

4. No side conversations

5. No right or wrong answers

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

7. All answers are confidential to our research team, so feel free to speak your mind

C. Brief Explanation of the Focus Group Purpose/Introduction to Topic

Tonight we are going to be talking about decisions you face as a health care provider. We may touch on a number of topics that relate to your practice. Feel free to bring up ideas and issues as you see fit.

II. Participant Introductions (~5 min)

1. Please go around the table and introduce selves

1. First name (only!)

2. Type of practice you are in

3. What kind of patients do you typically see?

III. Making Decisions about Treatment Options (~20 min)

Moderator:

For GP’s: We’re going to focus our discussion today on patients who have come to you with insomnia or who you have treated for or diagnosed with insomnia.

For Specialists: We’re going to focus our discussion today on patients you have diagnosed with or treated for rheumatoid arthritis/insomnia.

1. {Warm-up Question}: So that I understand a bit better as we move forward, what do you think is the most difficult challenge in treating someone with rheumatoid arthritis/insomnia?

1. Can you walk me through how you choose which treatment option to use?

1. Probe: When do you select a non-pharmacological treatment, such as behavioral modification, over a drug treatment?

2. When you’ve decided on pharmacological treatment, how do you decide which drugs to consider?

B. Now I’d like you to think about a difficult case you faced recently (such as in the last month), one where your options were unclear.

1. What made this case difficult?

2. What things did you consider when making the decision to prescribe or not prescribe a specific drug in this case?

IV. Effectiveness of Treatment Options (~15 min)

A. Now, still thinking about this recent difficult case, let’s talk about how you judge how effective a particular drug is.

1. What things do you consider in making this judgment?

Probe: Is this a judgment that’s fixed or does this judgment change from patient to patient?

2. What factors influence your judgment about whether a drug is effective?

B. Now think about how confident or uncertain you are in your assessment of effectiveness (both drug treatments and non-pharmacological treatments)?

1. What factors lead to this confidence or lack of confidence?

2. What may lead to uncertainty about effectiveness?

3. How do you reduce this uncertainty?

4. How do you communicate this uncertainty to patients?

V. Communicating Effectiveness Information to Patients (~15 min)

We often talk about the risks of a prescription drug treatment but not the effectiveness. By effectiveness, I’d like to focus on how well a drug treatment works in the real world. Today we would like you to focus on the benefit portion of the drug products you use in practice.

I would now like to discus how you communicate with patients about drug effectiveness.

A. How do you discuss expected results and effectiveness with patients?

Probe: How extensive is this discussion?

1. What are the biggest challenges you experience when talking to patients about effectiveness?

2. How do you talk about uncertainty about effectiveness?

3. If constraints such as time were not a factor, how extensively would you talk about this information with patients?

4. Ideally, how would you present this information or how would this information be presented?

Moderator: Write responses on flipchart.

5. Moderator: If the following have not been mentioned:

Do you in practice discuss:

1. Likelihood /odds for this particular patient

2. Meaning of “results may vary”

3. Effective treatment for symptoms only

4. Comparative effectiveness

2. How, if at all, do you talk to your patients about the risk/benefit tradeoff?

1. What is the typical response of a patient to this information?

2. If you do not talk about the risk/benefit tradeoff, why not?

VI. Learning about Drug Benefits (~25 min)

In this next exercise, we’re going to explore how you as a prescriber learn about effectiveness and benefits of particular drugs. After you’ve had a chance to gather your thoughts separately, we will use the flipchart to collect the ideas.

1. Who or what sources of information do you use to learn about the effectiveness or benefits of a drug product? Please take a few moments to write down your thoughts and ideas on the paper in front of you.

(Moderator: Have participants jot down ideas on blank sheet of paper in front of them. Collect these sheets after group ends)

2. Now I’d like to get some of your sources and ideas on this flipchart.

(Moderator: Have participants call out sources and write them down on flipchart. Collect flipchart(s) after group ends)

3. First, I’d like you to rank order these from most credible, or trustworthy, to least. Give the most credible a 1 and so forth.

(Moderator: With group discussion, get a ranking on flipchart. Participants may also rank individually on paper)

4. Now I’d like you to think about which source is most influential to you in your daily practice, where you have time pressures and other constraints. Please now rank the sources in terms of which influence you the most given the realities of daily practice.

Moderator: if approved drug label (prescribing information, physician information) is not listed as a source on either list, ask: No one has mentioned the drug label. Where would you place that source on these lists? OR: Why did that source not make one of these lists?

E. Specifically regarding effectiveness information in the approved drug label:

1. What do you find most useful about it?

2. What do you find least useful about it?

3. What suggestions do you have for improving the communication of effectiveness information in the label?

4. How would you present information in the label about effectiveness?

VII. Wrap Up Questions (~5 min)

1. Is there anything unique about the effectiveness of treatment of [insomnia, RA] that might differ from other medical conditions?

2. Does anyone have any other thoughts about anything that was discussed today?

VIII. False Close

Moderator will go to observation room to see if there are any additional questions that should be asked.

IX. Thank you/Closure

Physician Focus Groups – Understanding of Drug Efficacy

Recruitment Criteria

Two focus groups will be conducted with physicians.

• Recruit 24 physicians who engage in patient care at least 50% of the time (12/group for an expected 8-10 to show).

• Group 1: Rheumatologists/rheumatology specialists

• Group 2: General care practitioners who have treated insomnia patients in the last month

• Each group discussion is expected to require approximately 90 minutes

• Each participant will receive $300.

Physician Focus Groups – Understanding of Drug Efficacy

Participant Screener

What is your medical specialty?

• General practice/Family practice/Family medicine (ask Q2)

• Rheumatology (skip Q2)

• Other [TERMINATE]

How often do you treat patients for insomnia each month on average?

• Very often

• Somewhat often

• Not very often

• Almost never [TERMINATE]

Note gender:

• Male

• Female