OMB No: 0910-0695 Expiration Date: 3/31/2024
Paperwork Reduction Act Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0695. The time required to complete this portion of the information collection is estimated to average 5 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.
Adult Virtual Focus Group Screening Questionnaire
Prescription Drug Device Perspectives
Hello, this is _____________ from [RECRUITMENT FIRM NAME], a market research firm. May I please speak to_____________?
Hello. We are working with RTI International, a nonprofit research organization on a research study sponsored by the Food and Drug Administration, or FDA. We are recruiting online focus group participants who use prescription drug devices like auto-injectors, to discuss their experiences with using this prescription drug device. FDA believes it is important to get feedback from many people about these devices, and we would like to get your opinions and hear about your experiences using an autoinjector. We are not selling any products.
During the focus group, you will also be asked to hold an autoinjector and answer some questions about the device. If you are scheduled to participate, we will mail you a package of materials for you to use during the online focus group discussion. The package will include two autoinjectors. The autoinjectors will be trainer devices and will not contain medicine or a needle and cannot be discharged. You will be only be asked to hold and look at the device.
We are holding an online focus group using Zoom on [DATE]. The focus group starts at [TIME] and will last about 90 minutes. The discussion will be video and audio recorded, and project team members may also join to observe the discussion. You will be given $125 as a token of our appreciation for your participation.
May I ask you a few questions to see if you qualify?
Yes – Continue.
No – Thank and end call.
Read: An autoinjector is a medical device designed to deliver a dose of a particular prescription drug. Most autoinjectors are spring-loaded syringes that include a needle to inject the medicine.
1 Yes
2 No
Do you take care of someone in your family who has a current prescription from a doctor for an autoinjector?
1 Yes IF Q1=YES, Continue to Q3, IF Q1=NO, Continue to Q4
2 No IF Q1=NO, Terminate, IF Q1=YES, CONTINUE TO q3
IF Q1=YES, ASK What is the brand name of the autoinjector you use? [DO NOT READ LIST] [Note: if a brand is NOT listed below, and the participant is confident it is an autoinjector, assign them as a hold and contact RTI]
Participant must mention an autoinjector from this list to be included
ADRENACLICK Terminate
AIMOVIG Terminate
ATROPEN Terminate
AUVI-Q Terminate
AVONEX PEN Terminate
BYDUREON BCISE Terminate
EPIPEN ASSIGN TO EpiPen User group
EPIPEN JR. ASSIGN TO EpiPen User group
EVZIO Terminate
IMITREX STATdose Terminate
OTREXUP Terminate
RASUVO Terminate
REBIF / REBIJECT Terminate
SURECLICK, ENBREL Terminate
XYOSTED Terminate
ZEMBRACE SymTouch Terminate
Epinephrine Injection USP (autoinjector) ASSIGN TO EpiPen User group
Sumatriptan Injection USP (autoinjector) Terminate
Both an EpiPen, EpiPen Jr., Epinephrine Injection USP AND another AI ASSIGN TO EpiPen User group
IF Q2=YES, ASK What is the brand name of the autoinjector your family member uses? [DO NOT READ LIST]
EpiPen, EpiPen Jr., Epinephrine Injection USP ASSIGN TO EpiPen Caregiver group
All others Terminate IF THEY DO NOT QUALIFY FOR THE EPIPEN USER OR OTHER AI USER GROUPS
[If someone qualifies for multiple groups, assign them to whichever group has fewer confirmed participants]
Market Research Exclusion
Have you ever worked for …? [READ LIST]
Any office, division, or agency within the Department of Health and Human Services (HHS) TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
A pharmaceutical company TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
A marketing or market research company TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
A healthcare company or in the healthcare field TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
A medical device company TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
Have you participated in an interview or focus group in the past 3 months? [READ LIST]
Yes ASK 6A.
No Continue
IF Q6=YES, ASK 6A. Was the focus group related to prescription or over-the-counter medicines or did it have anything to do with your medical condition?
Yes TERMINATE [MAKE NOTE OF THE TOPIC AND GO TO INELIGIBLE CLOSING SCRIPT]
No MAKE NOTE OF THE TOPIC AND MONTH AND Continue to Q7
Demographics
What is your gender? [RECRUIT A MIX]
Male
Female
Prefer not to answer
No
Yes
Prefer not to answer
What is your race? [READ LIST IF NECESSARY AND RECRUIT A MIX]
White
Black or African American
Asian
Native Hawaiian or Other Pacific Islander
American Indian or Alaskan Native
Prefer not to answer
What is the highest level of education that you have completed? [RECRUIT A MIX]
Less than high school diploma
High school graduate or GED
Some college or 2-year degree
College degree
Postgraduate degree
We need to send you a package of materials for you to use during the online focus group discussion. Can you provide a mailing address where you can receive these materials?
Yes Continue
No TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
During the online focus group discussion, you will be asked to review written materials and offer your opinions, so I need to ask, “Do you have a medical or nonmedical condition that affects your ability to read or understand written materials in English?”
Yes TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
No Continue
For study purposes, the online focus group will be recorded and the video will be live streamed to study team members. If you participate, you will be asked to keep your video on during the focus group discussion. Are you okay with us recording and live streaming the focus group?
Yes Continue
No TERMINATE [GO TO INELIGIBLE CLOSING SCRIPT]
Closing Scripts
Ineligible - Closing Script
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.
Eligible – Closing Script
Great! You qualify for our study. The virtual discussion group will be held on [DATE] at [TIME] and will last about 90 minutes. You will receive $125 as a token of our appreciation for your participation.
Would you like to participate in the group discussion at [TIME] on [DATE]?
Yes – Continue to scheduling script.
No – Thank the adult and end call.
Eligible – Scheduling script
May I please have your mailing address, e-mail address, and telephone number? We will use this information to mail you a package containing focus group materials. We will also e-mail you with instructions about how to prepare for the online focus group on [DATE/TIME].
I will also send you an email with the informed consent form for the study. Please read the form carefully and reply indicating whether you agree or decline to participate. You won’t be able to participate unless we get your response.
We will send you a package containing focus group materials, which you can set aside until the day of your focus group. Please look for this package within the next [TIME FRAME] days. If you do not receive the package in the next [X] days, please contact us.
I will also call you a day or two before your scheduled focus group to remind you. If you need to reschedule or cancel your appointment, please contact me at <email; phone>. We will destroy all contact information at the conclusion of the focus groups. [Verify contact information]
Follow-up
**NOTE** THIS PAGE MUST BE STORED SEPARATELY FROM THE SCREENER AND DATA. PLEASE DESTROY UPON COMPLETION OF FOCUS GROUPS.
NAME: ____________________________________________________________
ADDRESS: ________________________________________________________
CITY: _________________________________________________
ZIP CODE: _________________________________________________
E-MAIL_______________________________________________________
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 TIME:
ALTERNATE PHONE NUMBER:
Thank you. That’s all the questions I have today. If you have any questions or find that you are unable to attend, please call [recruiter’s phone number] as soon as possible. Thank you again for your time. We look forward to seeing you at [TIME] on [DATE].
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Alexander, Jennifer |
| File Modified | 0000-00-00 |
| File Created | 2022-07-01 |