Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements (Cognitive Interviews)

Data to Support Drug Product Communications as Used by the FDA

FDA DISCLOSURE - COGNITIVE TESTING SCREENER 6-9-2015

Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements (Cognitive Interviews)

OMB: 0910-0695

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FDA Disclosure Study


Cognitive Testing – Recruitment Screener


[Ask to speak to an adult age 18 or older living in the household.]


Hello, my name is _______________ and I’m from [name of company]. I’m calling on behalf of RTI International, a non-profit research organization, about a study being sponsored by a public health agency. We’re calling to recruit people to take part in a research study about advertisements. We are not selling or promoting any product. The study involves reviewing a few advertisements on a computer and answering some questions about what you watched.


RTI will be conducting interviews with several people, and we would like to see if you are eligible. We have various time slots available and will work with you to find a time that fits your schedule. The interview will last up to one hour. In appreciation for your participation, you will be reimbursed for your time, effort, and travel expenses.


To see if you are eligible for this study, I need to ask you a few questions. All of your responses will be kept private. My questions will only take a few minutes. May I proceed?


Yes CONTINUE

No [Thank respondent and end call.]



1. Have you ever been told by a doctor that you have any of the following conditions?


Diabetes


  • TERMINATE IF HIGH CHOLESTEROL, INSOMNIA, OR DEPRESSION ARE NOT CHECKED

Asthma


  • TERMINATE IF HIGH CHOLESTEROL, INSOMNIA, OR DEPRESSION ARE NOT CHECKED

Osteoporosis


  • TERMINATE IF HIGH CHOLESTEROL, INSOMNIA, OR DEPRESSION ARE NOT CHECKED

Allergies


  • TERMINATE IF HIGH CHOLESTEROL, INSOMNIA, OR DEPRESSION ARE NOT CHECKED

High Cholesterol


  • Continue [High Cholesterol Group]

Insomnia


  • Continue [Insomnia Group]

Depression


  • Continue [Depression Group]

[if Respondents check more than one condition, assign them to the lowest prevalence condition first. The prevalence order is depression < insomnia < high cholesterol]



2. How old were you on your last birthday? ______________

[ASSIGN RESPONSE TO AGE RANGE BELOW]

17 or younger


  • TERMINATE

18-20


  • CONTINUE

21-29


  • CONTINUE

30-39


  • CONTINUE

40-49


  • CONTINUE

50-59


  • CONTINUE

60 or older


  • CONTINUE

[ATTEMPT MIX]

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

________________________Degree

[ASSIGN RESPONSE TO EDUCATION LEVEL BELOW]

Less than high school


  • CONTINUE

High school graduate


  • CONTINUE

Some college


  • CONTINUE

College (2-year) degree


  • CONTINUE

College (4-year) degree


  • CONTINUE

Some post-college


  • CONTINUE

Post-college degree


  • CONTINUE


[AIM FOR AT LEAST ONE-THIRD OF TOTAL RESPONDENTS WITH SOME COLLEGE OR LESS. NO MORE THAN TWO WITH A 4-YEAR COLLEGE DEGREE OR MORE]



4. How would you describe your race?

American Indian / Alaskan Native


  • CONTINUE

Asian


  • CONTINUE

Black or African American


  • CONTINUE

Native Hawaiian / Pacific Islander


  • CONTINUE

White


  • CONTINUE

Other


  • CONTINUE



[NO MORE THAN FIVE PARTICIPANTS OF A SINGLE RACE]


5. What is your sex?


Male


  • CONTINUE

Female


  • CONTINUE


[ATTEMPT 5/4 SPLIT]


6. Do you currently work in or for…


Market research company


TERMINATE

Department of Health and Human Services


TERMINATE

Pharmaceutical company


TERMINATE

A job that involves direct patient care (e.g., doctor, nurse)


TERMINATE

RTI International


TERMINATE

None of the above


CONTINUE


Invitation for Eligible Participants:


Thank you for answering all of my questions. We would like to invite you to take part in an informal, personal interview. The interviews are being scheduled on [DATES].

The discussion will last up to one hour. No one will attempt to sell you anything, and no one will call you for other studies as a result of your participation in this study. In appreciation for your time, effort, and travel expenses, you will receive $75 at the time of the interview. This is an important research effort, and we hope that you will be part of it. I also want to let you know that the interviews will be audio recorded. They will only be listened to by project staff and will be deleted at the end of the project.

Can we schedule your attendance?

Yes CONTINUE

No [Thank respondent and end call]

[IF ELIGIBLE AND AVAILABLE, SCHEDULE INTERVIEW]


During the interview, we will ask you to review some sample advertisements and read a survey about the advertisements. If you wear reading glasses, please remember to bring them to the interview.



Closing for Ineligible Participants:


Thank you for answering our questions. At this time, you are not eligible to be in this study. However, we appreciate your willingness to help us. Have a good day.


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitleFormative Research, Evaluation Planning, and Evaluating HIV Prevention Social Marketing Campaigns
AuthorJennifer Uhrig
File Modified0000-00-00
File Created2021-01-21

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