Rapid Message Testing with Consumer Panel - Public Service Announcement Video about Generic Drugs

Generic Drugs Blue PSA Video

Cognitive Interview Guide

Introduction

Hello, my name is INTERVIEWER NAME and I work for Westat, a research company in Rockville, Maryland. Thank you for taking the time to be a part of this study.

Westat is working with the U.S. Food and Drug Administration, or FDA, to see what people think about a new video they created. The FDA is interested in getting opinions about the information we are about to show you.

They want to know that the information makes sense, is easy to understand, and that all people understand it the same way. If you agree to be interviewed, we will email you a link to the video on YouTube. After you watch the video, I will ask you some questions about your thoughts and feelings about the information. Any ideas you have are okay.

Do you have access to a computer right now where you can check your email?

IF YES, CONTINUE

IF NO GIVE THEM TIME TO GET TO A COMPUTER

Color Key:

Purple – Section headings and titles

Black –Text for interviewer to read

Red – Interviewer instructions (not to be read aloud)

Green – Research questions (for interviewer’s information, not to be read aloud)

Informed Consent

Before we get started, there are a few things I need to tell you. This is a research project, and this interview is voluntary. That means that if you do not want to answer any questions just tell me and I’ll go to the next one. It is okay if you want to stop after we start. Just let me know.

All of your answers and everything you say will be kept confidential. Confidential means that we will not share your name or other information that could be used to figure out who you are. The interview will take about 30 minutes and you will get $35 E-Rewards Currency for your time. We would like to record our conversation if you are okay with that. The recording helps us to make sure we hear everything you say correctly. Only the people who work on this research project will be able to listen to the recording and see our notes. The recordings and our notes will be destroyed after we finish the project. IF FDA STAFF ARE ON THE PHONE: I want you to know that some people from the FDA who work on this research project are listening to this interview to see if there are ways to make the information better.

Before we start, do you have any questions? Do you agree to be interviewed? Is it okay with you if I record the interview?

TURN ON RECORDER. The date and time is ____________. Now that I am recording, I want to ask again, is it okay if I record this interview?

Background Questions and Video Review

Before we talk about the information I mailed to you, I have a few questions.

What is your general sense of how generic drugs compare to brand name drugs?

IF NEEDED:

• Do you think generic drugs have the same or different ingredients as brand name drugs?

• Do you think they are safer, as safe, or not as safe as brand name drugs?

• Do you think they cost more, the same, or less than brand name drugs?

You told us when you volunteered for this interview that you regularly take drugs for a health condition. Have you heard of generic versions available for the drugs you take?

• IF YES, GO TO NEXT PROBE.

• IF NO OR DON’T KNOW, SKIP TO WATCHING THE VIDEO.

Do you currently take the generic version(s) of your drugs?

• IF YES, What made you decide to take the generic version of your drugs? How confident are you in the generic version of your drug? By confident, we mean that you believe your drug is just as safe and works just as well as a brand name drug.

• IF NO, Would you consider switching to the generic version(s) of your drugs if they are available? Why or why not?

• IF DON’T KNOW, SKIP TO WATCHING THE VIDEO.

WATCHING THE VIDEO

Now please open your email. Do you see a link to a YouTube video? Please take a minute to click on the link and watch the video. Please stay on the phone while watching the video. When you are done, I have some questions for you about the video.

CHECK IN AFTER 45 SECONDS.

CONCURRENT OBSERVATIONS/INSTRUCTIONS.

NOTE ANY OF THE FOLLOWING BEHAVIORS TO RECORD IN NOTES OR PROBE ON RETROSPECTIVELY:

• Any verbal reaction to images or messages in the video.

• Any verbal expressions of confusion, surprise, discomfort, offense. Note which images or messages evoked any of these reactions.

RETROSPECTIVE GENERAL PROBES

TO BE ADMINISTERED AFTER RESPONDENT FINISHES WATCHING THE VIDEO.

RESEARCH QUESTIONS

Does the video increase overall understanding of generic drugs as a safe and effective treatment choice?

Does the video reduce perceptions of generic drugs as inferior to their brand name alternatives?

Does the video improve patient attitudes toward adhering to generic drugs?

Do participants recognize the call to action of talking with their doctor about generics?

Thank you for watching the video. Now I’m going to ask you some questions about it.

First, just tell me your overall thoughts about the video.

What do you like about this video?

What don’t you like?

DESIGN AND LAYOUT

Would you say the amount of information in this video was too little, just right, or too much? What makes you say that?

What do you think about the cartoon characters used? IF NEEDED, The characters are “blue”, the doctor, and the pharmacist.

How do you feel about this information being shown to you using cartoon characters?

IF NEEDED:

• Would you prefer using actors or some other way of showing you the information?

• How well did you feel like you could relate to the cartoon characters (even though they aren’t human)?

DO NOT MENTION BUT NOTE WHETHER R EQUATES “BLUE” WITH DEPRESSION

What images do you remember from the video? IF NEEDED, The pills, the checklist, the money, the Rx bottle, etc. What do you think about them?

If you saw this on a TV in your doctor’s office or at the airport, or came across it online, what would you do? IF NEEDED, Watch it, ignore it, act on it, etc. What is it about the video that would make you do that?

CONTENT

Now let’s talk about what this video has to say.

Who do you think this video is for?

• Do you feel like it’s for you? Why or why not?

The video tells a story, did you happen to notice that? IF YES, In your own words, can you tell me what the story was?

What is the overall, main message that the video is trying to tell you?

• What, if anything, is it asking you to do?

• What is the most important message of the video?

• Is the most important information clear?

Do you think the characters in the video do a good job, an okay job, or a bad job of getting the main message across? What makes you say that? IF NEEDED, SHOW IMAGES OF: the characters “blue” (0:01), the doctor (0:01), and the pharmacist (0:13).

Do you think the images in the video do a good job, an okay job, or a bad job of getting the main message across? What makes you say that? IF NEEDED, SHOW IMAGES OF: the pills (0:07), the checklist (0:10; 0:18), the money (0:22), the Rx bottle (0:15), etc.

ASK IF IN BACKGROUND QUESTIONS R HAS HEARD OF GENERIC VERSION OF THEIR DRUG, After looking at this, what new information, if any, have you learned about generic drugs?

Do you have any other questions about generic drugs? IF YES, What are they?

ASK IF IN BACKGROUND QUESTIONS R SAID THEY ALREADY TAKE GENERICS:

Before watching the video, you said you already take a generic version of a drug. Now that you’ve watched, how do you feel about your drug? Do you feel more or less confident in the generic drug you take, or about the same? (By confident, we mean that you believe your drug is just as safe and works just as well as a brand name drug.)

ASK IF IN BACKGROUND QUESTIONS R SAID THEY DO NOT TAKE A GENERIC VERSION OF THEIR DRUG BUT WOULD CONSIDER SWITCHING TO A GENERIC:

Before watching the video, you said that you WOULD think about switching to a generic version of your drug. Now that you’ve watched, how likely are you to switch? Please respond on a scale of 1 to 5 where 1 is not at all likely and 5 is extremely likely.

• What makes you say {PARTICIPANT’S SCALE NUMBER}?

• IF R IS 4 or 5 ON THE SCALE, If you were interested in switching right now, how would you do that, based on the information in the video?

ASK IF IN BACKGROUND QUESTIONS R SAID THEY DO NOT TAKE A GENERIC VERSION OF THEIR DRUG AND WOULD NOT CONSIDER SWITCHING TO A GENERIC DRUG:

Before watching the video, you said you would NOT think about switching to a generic version of your drug. Now that you’ve watched the video, how likely are you to switch? Please respond on a scale of 1 to 5 where 1 is not at all likely and 5 is extremely likely.

• What makes you say {PARTICIPANT’S SCALE NUMBER}?

• IF R IS 4 or 5 ON THE SCALE, What did you see in the video that made you think that?

• If you were interested in switching to a generic version of your drug right now, how would you do that, based on the information in the video?

• IF R IS 1-3 ON THE SCALE, it seems like the video did not change your opinion. Is there anything the video should have said that could have changed your opinion?

VIDEO IMPROVEMENTS

Do you have any other suggestions for improving the video?

• Is there any information that is NOT needed or can be removed? IF YES, What information?

• Is there any information that could be added? IF YES, What information?

• Is there anything that could be stated more clearly? IF YES, What could be stated more clearly?

PROBE ON ANY OUTSTANDING ISSUES FROM OBSERVATION (INFORMATION THAT R SEEMED CONFUSED ABOUT).

Closing and Incentive

IF OBSERVERS ARE PRESENT, CHECK TO SEE IF THEY HAVE FURTHER QUESTIONS.

Those are all the questions I have for you. Is there anything we haven't talked about that you would like to tell me?

DISCUSS ANY RESPONDENT COMMENTS.

Thank you for your time.

STOP TAPE RECORDER.

FDA RAPID: Year 1/Message 3, Blue PSA 8