Naloxone Pilot Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 2)

Data to Support Drug Product Communications as Used by the FDA

Attachment D Group 4 Screener Adults

Naloxone Pilot Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 2)

OMB: 0910-0695

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CONFER TASK 2

Subject ID




-






Attachment D

LABEL COMPREHENSION STUDY

GROUP 4 SCREENER




TELEPHONE RECRUITMENT SCRIPT


Hello, my name is _______________ and I’m from [NAME OF RECRUITMENT FIRM]. I’m calling on behalf of RTI International and Concentrics Research about a study that is being sponsored by the U.S. Food and Drug Administration (FDA). We are looking for people to take part in a research study to review a label for a medicine that may be available over-the-counter soon, meaning without a prescription. We are not selling or promoting any medicine.

The study involves being in a one-time individual, in-person interview lasting no more than 45 minutes. The session will include looking at a list of medical terms and answering some questions about instructions for the medicine. The interview will be audio recorded, and project team members may observe the interview either in-person or by live streaming. You will be given $50 [FORM TBD BY RECRUITMENT FIRM; CASH/CHECK ARE TYPICAL] at the end of the interview to reimburse you for your time and travel expenses.

To see if you qualify for this study, I need to ask you some questions that will take a few minutes of your time. The risk of others knowing your answers to the questions is minimal. To keep your information private, we will store your answers and contact information in separate, locked filing cabinets. This information will be destroyed at the end of the study. May I proceed with my questions?

Yes CONTINUE [Thank respondent and proceed to Q1.]

No [Thank respondent and end call.]


  1. How old were you on your last birthday?



_____






Over Age 18 CONTINUE

Under Age 18 TERMINATE (Closing Script and Contact Information Sheet)

Don’t know/refused TERMINATE (Closing Script and Contact Information Sheet)

SCREEN FOR A MIX OF AGES

  • 18 – 29 years old

  • 30 – 49 years old

  • 50 – 64 years old

  • 65+ years old





  1. Are you currently employed by [insert options 1-6 below]? (Check all that apply)


A marketing or research company


TERMINATE (Closing Script and Contact Information Sheet)

An advertising agency or public relations firm


TERMINATE (Closing Script and Contact Information Sheet)

A pharmacy or pharmaceutical company


TERMINATE (Closing Script and Contact Information Sheet)

A manufacturer of medicines


TERMINATE (Closing Script and Contact Information Sheet)

A managed care or health insurance company


TERMINATE (Closing Script and Contact Information Sheet)

A healthcare practice


TERMINATE (Closing Script and Contact Information Sheet)

A hospital emergency room


TERMINATE (Closing Script and Contact Information Sheet)

None of the above


CONTINUE

Refused


TERMINATE (Closing Script and Contact Information Sheet)







  1. Have you ever worked for [insert options 1-4 below]? (Check all that apply)

Department of Health and Human Services


TERMINATE (Closing Script and Contact Information Sheet)

U.S. Food and Drug Administration


TERMINATE (Closing Script and Contact Information Sheet)

RTI International


TERMINATE (Closing Script and Contact Information Sheet)

Concentrics Research


TERMINATE (Closing Script and Contact Information Sheet)

None of the above


CONTINUE

Refused


TERMINATE (Closing Script and Contact Information Sheet)



  1. Have you ever been trained or worked as a healthcare professional?


Yes


TERMINATE (Closing Script and Contact Information Sheet)

No


CONTINUE

Refused


TERMINATE (Closing Script and Contact Information Sheet)



  1. Have you been in any market research study, product label study, or clinical trial in the past 12 months?


Yes


TERMINATE (Closing Script and Contact Information Sheet)

No


CONTINUE

Don’t know


TERMINATE (Closing Script and Contact Information Sheet)

Refused


  • TERMINATE (Closing Script and Contact Information Sheet)



  1. What is your gender? [Do not read response categories.]



Male


GO TO Q4

Female


CONTINUE

Other


GO TO Q4

Refused


CONTINUE

SCREEN FOR MIX OF MALE/FEMALE



  1. [IF FEMALE] Are you currently pregnant?



Yes


CONTINUE

No


CONTINUE

AIM FOR 1-2



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

________________________Degree

[DO NOT READ LIST – ASSIGN RESPONSE TO EDUCATION LEVEL BELOW]

Less than high school


CONTINUE

High school graduate (HS diploma or GED)


CONTINUE

Some college (no degree)


CONTINUE

College (2-year) degree (Associate degree)


CONTINUE

College (4-year) degree (e.g., BA, BS, AB)


CONTINUE

Some post-college


CONTINUE

Advanced or post-graduate degree (e.g., Masters, MD, PhD)


CONTINUE

Refused


CONTINUE



  1. How confident are you in filling out medical forms by yourself?


Extremely


CONTINUE

Quite a bit


CONTINUE

Somewhat


CONTINUE

A little bit


CONTINUE

Not at all


CONTINUE

Don’t know


  • TERMINATE (Closing Script and Contact Information Sheet)

Refused


  • TERMINATE (Closing Script and Contact Information Sheet)




  1. How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?


Never


CONTINUE

Rarely


CONTINUE

Sometimes


CONTINUE

Often


CONTINUE

Always


CONTINUE

Don’t know


CONTINUE

Refuse


CONTINUE



  1. Can you read, speak and understand English?


Yes


CONTINUE

No


TERMINATE (Closing Script and Contact Information Sheet)

Refused


TERMINATE (Closing Script and Contact Information Sheet)




  1. Do you normally wear corrective lenses, contacts, or glasses to read?


Yes


CONTINUE

No


CONTINUE

Refused


  • TERMINATE (Closing Script and Contact Information Sheet)



  1. Do you have any other problems with your eyes that would prevent you from being able to read?


Yes


TERMINATE (Closing Script and Contact Information Sheet)

No


CONTINUE

Refused


  • TERMINATE (Closing Script and Contact Information Sheet)


DEMOGRAPHIC QUESTIONS


  1. Please answer the next two questions about your ethnicity and race.

Are you Hispanic or Latino?

Yes


CONTINUE

No


CONTINUE

Refused


CONTINUE



  1. What is your race? (Please select one or more from the following):

[READ LIST IF NECESSARY– ASSIGN RESPONSE TO ONE OR MORE GROUPS BELOW]

American Indian / Alaska Native


CONTINUE

Asian


CONTINUE

Black or African American


CONTINUE

Native Hawaiian / other Pacific Islander


CONTINUE

White


CONTINUE

Some other race


DOCUMENT:

Refused


  • CONTINUE

SCREEN FOR MIX



  1. Was your total household income in 2016…?

Less than $20,000


CONTINUE

$20,000 - $34,999


CONTINUE

$35,000 - $49,999


CONTINUE

$50,000 - $74,999


CONTINUE

$75,000 - $99,999


CONTINUE

$100,000 - $149,999


CONTINUE

$150,000 or more


CONTINUE

Refused


  • CONTINUE



Note: Use the Closing Script and Contact Information sheet to schedule an interview.

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorDolina, Suzanne
File Modified0000-00-00
File Created2021-01-21

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