Prescription Drug Use Related Software Study (CDER)

Appendix A: Online Screeners

OMB Control No: 0910-0695 Expiration Date: March 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 information collection is estimated to average 60 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.

Recruitment Screener and Focus Group Invitation for Eligible PCPs

We are recruiting for an upcoming online focus group study sponsored by the U.S. Food and Drug Administration (FDA). The study is not selling or promoting any products. Participants will be asked to share their opinions about prescription drugs. Participants will need to have access to a computer with high-speed internet and a webcam. Eligible participants will receive [$250] for completing the study.

We need you to answer a few questions to determine if you are eligible for the study. Are you interested in participating?

• YES  CONTINUE TO SCREENER

• NO  Thank you for your time. END SURVEY.

SCREENER

1. Are you board certified in any of the following clinical specialties?

• Internal Medicine  CONTINUE

• General Practitioner  CONTINUE

• Family Medicine  CONTINUE

• None of the Above  END AND GO TO INELIGIBLE SCRIPT

2. In an average week, what percent of your time is spent on direct patient care, such as seeing patients and reviewing their medical records?

• 50 Percent or More  CONTINUE

• Less than 50 Percent  END AND GO TO INELIGIBLE SCRIPT

3. On average, about how many patients per month do you treat who have been diagnosed with diabetes?

• 0  END AND GO TO INELIGIBLE SCRIPT

• 1 to 4  CONTINUE

• 5 to 10  CONTINUE

• 11 or more  CONTINUE

• Don’t know  END AND GO TO INELIGIBLE SCRIPT

4. Do you work full-time for any of the following?

   • A market research firm  END AND GO TO INELIGIBLE SCRIPT

• An advertising firm  END AND GO TO INELIGIBLE SCRIPT

• A pharmaceutical company  END AND GO TO INELIGIBLE SCRIPT

• U.S. Dept. of Health and Human Services  END AND GO TO INELIGIBLE SCRIPT

• NONE OF THE ABOVE  CONTINUE

5. Have you participated in a focus group or interview-based research in the past 3 months?

• YES  END AND GO TO INELIGIBLE SCRIPT

• NO  CONTINUE

6. You will need to be in front of a laptop or desktop computer with a high-speed internet connection in order to participate in the focus group. It will not work on a smartphone or tablet. Are you able have a laptop or desktop computer with high-speed internet access during the focus group?

• YES  CONTINUE

• NO  END AND GO TO INELIGIBLE SCRIPT

7. And does your computer have a webcam and audio?

• YES TO BOTH  CONTINUE

• NO TO EITHER OR BOTH  END AND GO TO INELIGIBLE SCRIPT

8. The focus group will be conducted via virtual platform and will be audio and video recorded. The discussion will be observed by project staff remotely. During the focus group, to protect your privacy, we will only use your first name. Are you willing to be audio and video recorded?

• YES  CONTINUE

• NO  END AND GO TO INELIGIBLE SCRIPT

9. How many years have you been practicing medicine? [INFORMATION ONLY]

• Fewer than 5 Years

• 5 To 14 Years

• 15 To 24 Years

• 25 Years or Longer

10. Which of these categories best describes where you practice? [INFORMATION ONLY]

• Office-based (e.g., private practice, HMO)

• Clinic

• In-patient care (e.g., nursing home, hospice care)

• Other (specify):

11. What sex were you assigned at birth?: [RECRUIT A MIX]

• Male

• Female

• Prefer not to answer

12. Which of the following best describes your ethnicity? [RECRUIT A MIX]

• Hispanic

• Non-Hispanic

• Prefer not to answer

13. Which of the following best describes your race? You may choose one or more categories. [RECRUIT A MIX]

• White

• Black or African American

• Asian

• Native Hawaiian or other Pacific Islander

• American Indian or Alaska Native

• Prefer not to answer

14. What is your age? [RECRUIT A MIX]

• Younger than 35

• 35-45

• 46-55

• 56-65

• 66 or Older

AFTER COMPLETING QUESTION 13, ELIGIBLE PARTICIPANTS GO DIRECTLY TO INVITATION.

INELIGIBLE SCRIPT: Thank you very much for your interest. Unfortunately, you do not qualify for this study, but we hope to include you in a future study.

FOCUS GROUP INVITATION FOR ELIGIBLE PCPs

Thank you! We’d like to invite you to participate in a Web-based focus group that will last approximately 60 minutes. During the focus group, we will ask you to log into a secure web platform where the moderator will lead the discussion with participants. Other research staff from Westat and FDA may also be observing. In addition, the focus group will be audio and video recorded to facilitate data analysis. At the conclusion of the group, you will be compensated [$250] for your participation.

Are you willing to participate?

• YES  CONTINUE

• NO  “Thank you for your time.”

Terrific! A member of our team will be contacting you by telephone to arrange a date and time that works best with your schedule. Please provide the best number to reach you.

Telephone:

Thank you again for your time and your willingness to participate in this study. Our staff will be contacting you in a few days.

OMB Control No: 0910-0695 Expiration Date: March 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 information collection is estimated to average 60 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.

Recruitment Screener and Focus Group Invitation for Consumers

Recruitment Screener for Consumers

We are recruiting for an upcoming online focus group study sponsored by the Food and Drug Administration (FDA). The study is not selling or promoting any products. You will be asked about your opinions about different types of prescription drugs. Participants will need to have access to a computer with audio capabilities (or a telephone) and the internet during the focus group. Eligible participants will receive [$75] for completing the study.

We need you to answer a few questions to determine if you are eligible for the study. Are you interested in participating?

• YES  CONTINUE TO SCREENER

• NO  Thank you for your time. END SURVEY.

SCREENER

1. Are you age 18 years or older?

• YES  CONTINUE

• NO  END AND GO TO INELIGIBLE SCRIPT

2. Are you comfortable speaking and reading English?

• YES  CONTINUE

• NO  END AND GO TO INELIGIBLE SCRIPT

3. Have you been diagnosed with diabetes by a healthcare provider?

• YES  CONTINUE

• NO  END AND GO TO INELIGIBLE SCRIPT

4. Are you currently receiving treatment for diabetes? Treatment may include insulin or another medication.

• YES  CONTINUE

• NO  END AND GO TO INELIGIBLE SCRIPT

5. Do you work for any of the following?

   • A market research firm  END AND GO TO INELIGIBLE SCRIPT

• An advertising firm  END AND GO TO INELIGIBLE SCRIPT

• A pharmaceutical company  END AND GO TO INELIGIBLE SCRIPT

• U.S. Dept. of Health and Human Services  END AND GO TO INELIGIBLE SCRIPT

• NONE OF THE ABOVE  CONTINUE

6. Have you participated in a focus group or interview-based research in the past 3 months?

• YES  END AND GO TO INELIGIBLE SCRIPT

• NO  CONTINUE

7. You will need to be in front of a laptop or desktop computer with a high-speed internet connection [IF NEEDED: If you need to dial a telephone to connect to the internet, you do not have a high-speed connection.] in order to participate in the focus group. It will not work on a smartphone or tablet. Are you able have a laptop or desktop computer with high-speed internet access during the focus group?

• YES  CONTINUE

• NO  END AND GO TO INELIGIBLE SCRIPT

8. And does your computer have a webcam and audio?

   • YES TO BOTH  CONTINUE

   • NO TO EITHER OR BOTH  END AND GO TO INELIGIBLE SCRIPT

9. All focus groups will be conducted via virtual platform and will be audio and video recorded. The focus group will be observed by project staff remotely. During the focus group, to protect your privacy, we will only use your first name. Are you willing to be audio and video recorded?

• YES  CONTINUE

• NO  END AND GO TO INELIGIBLE SCRIPT

10. What sex were you assigned at birth?: [RECRUIT A MIX]

• Male

• Female

• Prefer not to answer

11. Which of the following best describes your ethnicity? [RECRUIT A MIX]

• Hispanic

• Non-Hispanic

• Prefer not to answer

12. Which of the following best describes your race? You may choose one or more categories. [RECRUIT A MIX]

• White

• Black or African American

• Asian

• Native Hawaiian or other Pacific Islander

• American Indian or Alaska Native

• Prefer not to answer

13. What is your age? [RECRUIT A MIX]

• Younger than 35

• 35-45

• 46-55

• 56-65

• 66 or Older

AFTER COMPLETING QUESTION 13, ELIGIBLE PARTICIPANTS GO DIRECTLY TO INVITATION.

INELIGIBLE SCRIPT: Thank you very much for your interest. Unfortunately, you do not qualify for this study, but we hope to include you in a future study.

FOCUS GROUP INVITATION FOR ELIGIBLE CONSUMERS

Thank you! We’d like to invite you to participate in a Web-based focus group with individuals with diabetes that will last approximately 60 minutes. During the focus group, we will ask you to log into a secure web platform where a moderator will lead the discussion and you will be asked about your experiences with diabetes and your opinions about different types of prescription drugs. Other research staff from Westat and FDA may also be observing. The focus group will be video recorded to facilitate data analysis. At the conclusion of the group, you will be compensated [$75] for your participation.

Are you willing to participate?

• YES  CONTINUE

• NO  “Thank you for your time.”

Terrific! A member of our team will be contacting you by telephone to arrange a date and time that works best with your schedule. Please provide the best number to reach you.

Telephone:

Thank you again for your time and your willingness to participate in this study. Our staff will be contacting you in a few days.