Physician Interviews on FDA-Approved Labeling

Appendix B:
Screener

Any text in angle brackets “< >” indicates part of the script that will change based on the participant, or situation. The intended content (or content options) are indicated in the brackets.

Hello, my name is ____ from L&E Research. Thank you for your interest in the study. Before we continue, I want to let you know that the interviews will be conducted online and will be livestreamed so that other members of the study team and FDA can observe. The interview will be audio-recorded and transcribed. All audio files and transcript files will be kept on password protected computers at RTI and FDA and will only be accessible to study staff.

To protect your privacy, we ask that you only use your first name during the interview, and that you do not disclose personal information about yourself. Your name will not be associated with the audio file or transcript of your interview, and no one at FDA will have your full name or contact information. RTI project staff will have your phone number so that they can contact you if needed about your appointment. They will delete the records containing this information after your interview has been completed.

If you qualify and agree to participate:

1. Do you consent to having your interview audio-recorded?

Yes		 CONTINUE
No		 TERMINATE

2. Do you consent to having your interview livestreamed?

Yes		 CONTINUE
No		 TERMINATE

3. Are you currently practicing medicine?

Yes		 CONTINUE
No		 TERMINATE

4. Have you ever worked for…?

Department of Health and Human Services		 IF YES, TERMINATE
Market Research Firm		 IF YES, TERMINATE
Pharmaceutical company		 IF YES, TERMINATE
RTI International		 IF YES, TERMINATE

5. Are you a…?

Primary Care Physician (Family Practice, Internal Medicine, General Practitioner)		 CONTINUE (Go to Q7)
Specialist (physician)		 CONTINUE (Go to Q6)
All Other Types		 TERMINATE

6. What is your primary area of specialization (e.g., Internal Medicine, Gastroenterology)?

(Open-ended)

(Screen for a mix)

7. What percentage of your time do you spend providing direct patient care (e.g. see patients in the office, see patients in the hospital, perform surgery/procedures)?

(Open-ended)

(Screen for a mix)

8. Approximately how many prescriptions do you write per week?

Less than 50		 TERMINATE
50 or more		 CONTINUE

9. Have you participated in an interview or focus group during the past three months?

Yes		 TERMINATE
No		 CONTINUE

10. How long have you been practicing medicine?

Less than 5 years		 CONTINUE
5-10 years		 CONTINUE
11-20 years		 CONTINUE
21-30 years		 CONTINUE
31 or more years		 CONTINUE
SCREEN FOR A MIX

11. How would you classify your practice?

Solo		 CONTINUE
Small group practice (2-10 HCPs)		 CONTINUE
Large group practice (>10 HCPs)		 CONTINUE
SCREEN FOR A MIX

12. Do you practice at an academic or teaching hospital?

Yes		 CONTINUE
No		 CONTINUE

13. What is your gender?

Male		 CONTINUE
Female		 CONTINUE
Prefer not to answer		 CONTINUE
SCREEN FOR APPROXIMATELY ½ OF EACH

14. Are you Hispanic or Latino?

Yes		 CONTINUE
No		 CONTINUE
Prefer not to answer		 CONTINUE
SCREEN FOR A MIX

15. Which of these groups best describes you? You may answer more than one.

White		 CONTINUE
Black / African American		 CONTINUE
American Indian or Alaskan Native		 CONTINUE
Asian		 CONTINUE
Native Hawaiian or Pacific Islander		 CONTINUE
Prefer not to answer		 CONTINUE
SCREEN FOR A MIX

16. In what state(s) are you currently practicing?

____________		 CONTINUE
SCREEN FOR A MIX BASED ON THE FOLLOWING REGIONS: Northeast: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New Jersey, New York, and Pennsylvania South: Delaware, Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, Washington D.C., West Virginia Alabama, Kentucky, Mississippi, and Tennessee, Arkansas, Louisiana, Oklahoma, and Texas Midwest: Illinois, Indiana, Michigan, Ohio, and Wisconsin, Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, and South Dakota West: Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, and Wyoming, Alaska, California, Hawaii, Oregon, and Washington

Closing Scripts

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.

Invitation Script for Eligible Participants

Thank you for answering our questions. We would like to invite you to take part in the study. If you agree to participate, we can schedule your online video interview now. Interviews will be conducted <DATES>online. The interview will take 60 minutes and you will receive a check for [$200 for PCPs or $300 for specialists] within 4-6 weeks of completing your interview in appreciation of your time.

Would you like to schedule your interview?

Yes  CONTINUE to scheduling.

No  [Thank you for your interest.]

SCHEDULE INTERVIEW, THEN READ:

Great, we have you scheduled for an interview on <DATE/TIME>. I will be sending you a confirmation email with this date and time that will include instructions for accessing the interview. I will also be sending 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. I will also call you a day or two before your scheduled appointment to remind you. If you need to reschedule or cancel your appointment, please contact me at <email; phone>.

Do you have any questions?

IF YES, ADDRESS QUESTIONS

IF NO, THANK PARTICIPANT AND END CALL