Risk and Benefit Perception Scale Development Focus Groups

Focus Groups as Used by the Food and Drug Administration

Appendix A_Screener

Risk and Benefit Perception Scale Development Focus Groups

OMB: 0910-0497

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FDA Measures Study

Focus Group Participant Screener

Introduction

Hello, my name is _______________ and I’m from [name of company]. I’m calling on behalf of RTI International, a non-profit research organization, about a research study. I’m not selling or promoting any product.

The purpose of this study is to learn more about how people find information on and make decisions about prescription drugs. We will be conducting several focus groups on this topic in [city]. To see if you are eligible, I’d like to ask you some questions. If you are eligible and choose to participate, all of your comments will be kept private and we will reimburse you $75 at the end of the focus group. May I proceed?

Yes CONTINUE

No [Thank respondent and end call.]



Eligibility Questions

  1. What year were you born?

_____

1994 or Earlier CONTINUE

1995 or Later TERMINATE



  1. Are you currently taking any prescription drugs (including birth control)?

_____

Yes CONTINUE

No TERMINATE



  1. How many prescription drugs do you currently take?

_____

One CONTINUE TO 4A

More than one CONTINUE TO 4B




4A. [If taking only one drug] When did you start taking this prescription drug?

Within the last 6 months


CONTINUE

More than 6 months to one year ago


CONTINUE (HOLD)

More than one year ago


TERMINATE



4B. [If taking more than one drug] Please think about the drug you started taking most recently. When did you start taking this prescription drug?

Within the last 6 months


CONTINUE

More than 6 months to one year ago


CONTINUE (HOLD)

More than one year ago


TERMINATE



  1. For what condition (or conditions) are you taking this drug?


SCREEN FOR A MIX (ESPECIALLY MIX OF CHRONIC AND ACUTE)



  1. Which of the following best describes your situation? [Read options below]

This is the only prescription drug I have ever taken for [condition]


CONTINUE TO Q7 (NEW USER)

I used to take another prescription drug for [condition], but I switched to this one


CONTINUE TO Q6B (SWITCHING USER)

I take more than one prescription drug for [condition]


CONTINUE TO Q6C



EXCLUDE FOLLOWING CONDITIONS (Q5):

  • Psychosis, Personality disorders, Delusion disorder, Alzheimer’s, Dementia

EXCLUDE FOLLOWING CONDITIONS (Q5), ONLY IN NEW USERS:

  • Bipolar disorder, Panic disorder, Schizophrenia, Post-traumatic stress disorder (PTSD)





6B. When did you stop taking the other prescription drug for [condition]?

Within the last 6 months


CONTINUE

More than 6 months to one year ago


CONTINUE (HOLD)

More than one year ago


TERMINATE



6C. Were you prescribed these drugs for [condition] at the same time?

Yes – I was prescribed the drugs at the same time


CONTINUE (NEW USER)

No – I was prescribed the drugs at different times


CONTINUE (ADDING USER)



  1. How involved were you in the decision to take this prescription drug? [Read options below]

My healthcare provider made the decision with no input from me


CONTINUE

My healthcare provider made the decision with some input from me


CONTINUE

My healthcare provider and I were equally involved in the decision


CONTINUE

I made the decision with some input from my healthcare provider


CONTINUE

I made the decision with no input from my healthcare provider


CONTINUE

SCREEN FOR A MIX



  1. What is your current occupation?


Healthcare Provider (e.g., Physician, Nurse, Counselor) TERMINATE

Pharmaceutical Employee (e.g., Pharma Rep) TERMINATE

Researcher / Scientist TERMINATE

All Other Occupations CONTINUE



  1. Have you participated in a focus group on any topic in the last 6 months?

_____

Yes TERMINTATE

No CONTINUE



  1. What is your sex?

Male


CONTINUE

Female


CONTINUE

SCREEN FOR A MIX



  1. Which of these racial groups best describes you? [Read options below]

White


CONTINUE

Black / African American


CONTINUE

American Indian or Alaskan Native


CONTINUE

Asian


CONTINUE

Native Hawaiian or Pacific Islander


CONTINUE

Other


CONTINUE

SCREEN FOR A MIX



  1. What is the highest level of education you have attained?

Less than high school


CONTINUE

High school graduate (or GED)


CONTINUE

Some college or technical school (No degree)


CONTINUE

College graduate (2- or 4-year degree)


CONTINUE

Some graduate school (No degree)


CONTINUE

Graduate school degree


CONTINUE

SCREEN FOR A MIX






Focus Group Invitation:

Thank you for answering all of my questions. Based on your responses, you appear eligible to participate in our study and join one of our focus groups.


Please note two important facts:

  1. Each focus group will include individuals with different illnesses and medication conditions. Not everyone in the group will have the same condition as you.

  2. During the group, we will ask you to talk about your medical condition and the medication that you’re taking for it.


Each focus group will last about two hours and should be very interesting. No one will try to sell you anything, and no one would call you later because you participated. We would reimburse you $75 at the end of the discussion for your time and participation. We can invite only a few individuals to take part, and if it’s okay, we would like to audio tape the discussion. Can I schedule your participation?


The focus groups will take place on [DATES AND TIMES TBD]. Which date and time would work best for you?


Focus Group: 1 2

Your participation in this study is very important. If for some reason you will not be able to attend, please let us know right away. You can call us anytime at [insert phone number], and if we are not here, please leave a message.


Closing for Ineligible Participants:

I’m sorry, but you are not eligible for this study. There are many possible reasons why people are not eligible. These reasons were decided earlier by the researchers. However, thank you for your interest in this study and for taking the time to answer our questions today.


Participant Information


NAME: ________________________________________________________

ADDRESS: ________________________________________________________

CITY: ________________________________________________________

ZIP CODE: ________________________________________________________

EMAIL ________________________________________________________

What is the best time to reach you? What is the best telephone number to reach you at that time?

BEST TIME TO BE REACHED: ________________________________________

BEST PHONE NUMBER: ______________

Is there another time and number we can try if we miss you?

ALTERNATE PHONE NUMBER:



Recruiter: ____________________


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File TitleFDA Online Study
AuthorJackie Amoozegar
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File Created2021-02-01

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