Focus Groups on ENDS: Device Types, User Experiences, and Product Appeal

OMB# 0910-0796 | Exp. 6/30/2018

RTI/FDA Tobacco Focus Groups
Screening Questionnaire

E-Cigarette

Hello, this is _____________ from [FACILITY NAME], a local market research firm. May I please speak to_____________?

(Hello, this is _____________ from [FACILITY NAME], a local market research firm.) We are working with RTI International, a nonprofit research organization, and the Food and Drug Administration (FDA) on a research study about tobacco products, and would like to include your opinions. I want to assure you that we are not from a tobacco company or a company that sells quit-smoking aids.

We are holding a group discussion on [DATE] with approximately 9 other people. The discussion group starts at [TIME] and will last no longer than 90 minutes. For study purposes, the group discussion will be audio recorded, and FDA project team members may observe the discussion in person or through videostreaming.

In appreciation for your participation, you will be reimbursed for your time, effort, and travel expenses. Participation in the groups is completely voluntary. Would it be OK if I ask you a few questions now in order to see if you are eligible to be in one of the groups?

Yes – Continue.

No – Thank and end call.

1. What is your age?

______________ [Record age and group into category]

<18  TERMINATE

18-29  CONTINUE FOR YOUNG ADULT GROUP

30 and older  CONTINUE FOR ADULT GROUP

The next questions are about electronic nicotine products such as e-cigarettes, vape pens, personal vaporizers and mods, e-cigars, e-pipes, e-hookah, and hookah pens. These products are battery-powered and produce vapor instead of smoke.  They typically use a nicotine liquid, although the amount of nicotine can vary and some may not contain any nicotine at all.  Some common brands include Vuse, Blu, Logic, MarkTen, NJOY, and eGo.

1. Have you ever heard of an electronic nicotine products (such as e-cigarettes)?

Yes Continue.

No Terminate.

2. Have you ever tried electronic nicotine products (such as e-cigarettes), even just one time?

Yes Continue.

No Terminate.

If yes: Do you currently use electronic nicotine products (such as e-cigarettes)…

Every day

Some days

Rarely Terminate

Not at all Terminate

There are different types of electronic nicotine products. The first type are the same size and shape as tobacco cigarettes and are sometimes called “cigalikes”. They can be bought as one-time, disposable products; some of these are rechargeable and use pre-filled cartridges.

A second type of electronic nicotine product (sometimes called “tank systems”) do not look like cigarettes – they are often bigger and allow the user to refill with e-liquid. These devices often can be customized and modified in different ways.

2a. Think about the product you use most of the time, would you say the device you use is the:

First type (“cigalike”) Recruit for cigalike group

Second type (”tank system”) Recruit for tank group

Not sure Terminate

I don’t have a device that I use most of the time Terminate

3. In the past 5 years, have you or any member of your household worked for any of the following? (Read list. If yes to any, thank the respondent and terminate.)

A tobacco or cigarette company (including a vape shop or tobacco specialty store)

A public health or community organization involved in communicating the dangers of smoking or the benefits of quitting

A marketing, advertising, or public relations agency or department

The Federal Government (Read list. If yes to any, thank the respondent and terminate.)

The U.S. Food and Drug Administration (FDA)

The National Institutes of Health (NIH)

The Centers for Disease Control and Prevention (CDC)

The Substance Abuse and Mental Health Services Administration (SAMHSA)

The Centers for Medicare & Medicaid Services (CMS)

4. Have you or any member of your household ever lobbied on behalf of the tobacco industry?

Yes Thank the respondent and terminate.

No Continue.

5. Have you or any member of your household personally represented or worked on behalf of a tobacco company in connection with a tobacco lawsuit?

Yes Thank the respondent and terminate.

No Continue.

6. Have you participated in any paid market research in the past 6 months?

Yes Thank the respondent and terminate.

No Continue.

7. For study purposes, if you participate, the discussion group will be recorded. The moderator will not ask any sensitive questions. Are you okay with us recording your group discussion?

Yes Continue.

No Thank the respondent and terminate.

8. What is your sex?

Male

Female

9. What is the highest level of education that you have completed? (Read list.)

Less than high school diploma Continue.

High school graduate or GED Continue.

Some college or 2-year degree Continue.

College degree Continue.

Postgraduate degree Continue.

10. Are you of Hispanic or Latino origin?

Yes

No

11. What is your race? (Read list. Recruit a mix to show per group.)

White

Black or African American

Asian

Native Hawaiian or other Pacific Islander

American Indian or Alaskan Native

[DON’T READ] Hispanic

[DON’T READ] Other

12. Finally, during the focus group discussion, you will be asked to review written materials and offer your opinions; therefore, I need to ask whether you have a medical or nonmedical condition that affects your ability to read and/or understand written materials in English?

Yes Thank the respondent and terminate.

No Continue.

Great! You qualify for our study. The discussion group will be held on [DATE] at [TIME] and will last about 90 minutes. For your time and opinions, you will receive $75 at the end of the session. We request that you bring with you the electronic nicotine product you told me you use most often.

13. Would you like to participate in the group discussion at [TIME] on [DATE]?

Yes Continue.

No Thank the respondent and terminate.

Great! May I please have your mailing and/or e-mail address to send you a confirmation letter with directions? [Verify address and phone number.]

Thank you. That’s all the questions I have today. Please try to arrive at least 15 minutes before the starting time. If you have any questions or find that you are unable to attend, please call [facility’s phone number] as soon as possible. Thank you again for your time. We look forward to seeing you at [TIME] on [DATE].

Read if necessary:

If you have any questions about the study, you may contact Jennifer Alexander of RTI at 301-770-8219. If you have concerns about how participants are being treated in the study, you may contact RTI’s Office of Research Protection toll-free at 1-866-214-2043.

We are asking for your contact information only for the purpose of sending you a reminder letter and giving you a call to remind you of the discussion group. We will destroy all contact information at the conclusion of the 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:

**NOTE** THIS PAGE MUST BE STORED SEPARATELY FROM THE SCREENER AND FOCUS GROUP DATA. PLEASE DESTROY UPON COMPLETION OF FOCUS GROUP.

Thank you. That’s all the questions I have today. Please try to arrive at least 15 minutes before the starting time. If you have any questions or find that you are unable to attend, please call [facility’s phone number] as soon as possible. Thank you again for your time. We look forward to seeing you at [TIME] on [DATE].

Read if necessary:

If you have any questions about the study, you may contact Jennifer Alexander of RTI at 1‑301‑770‑8219. If you have concerns about how participants are being treated in the study, you may contact RTI’s Office of Research Protection toll-free at 1-866-214-2043.

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