Establishing a Baseline for Consumer Knowledge about Medical Product Benefits and Risks

Confidential – Draft – Internal Deliberative

Consumer Perceptions of the Benefits and Risks of Medicines

Participant Screener

Recruiting Goals

• Six groups in each location (Washington, DC and Sacramento, CA). See table below for specifications at each location. A total of 12 focus groups will use this moderator’s guide.

• Four groups will be with chronic users of prescriptions medications, four groups with intermittent users of prescription medications, and four groups of parents or caretakers of children (infants to age 16).

• The groups will be segmented by level of education. Prepare the moderator for the possibility that they may not be able to cover the details of all the topics.

• The chronic users groups and the intermittent user groups will be with adults over 35 years old. The parents and caretakers group will be with adults age 21 and older.

• Each group will be a mix of men and women. There should be no fewer than 3 to 4 members of each gender (male, female) in each group. Participants will be advised during the screening process that these will be mixed gender groups.

• Each group will be a diverse mix of races and ethnicities. The groups should reflect the demographics of the surrounding areas. Overall, there should be an approximately even split between white and black non-Hispanic, and Hispanic participants.

• All participants must be able to read, understand, and speak English.

• Participants cannot have participated in a focus group or a similar study in the past six months. Participation in phone surveys is allowable.

• 12 recruits per group in order to get 8-10 to participate.

• Participants will receive $75 stipends.

• Each focus group will last approximately 90 minutes and will be audio and videotaped.

• Participants do not have to answer any questions that they do not want to, but are encouraged to participate in the groups. The identity of the participants will remain confidential.

• Food and Drug Administration staff will observe the groups.

Schedule

	Date & Time	Location	Education	Medication Use
Group I		Washington, DC	Lower education	Chronic
Group II		Washington, DC	Lower education	Intermittent
Group III		Washington, DC	Lower education	Parent/Caregiver
Group IV		Washington, DC	Higher education	Chronic
Group V		Washington, DC	Higher education	Intermittent
Group VI		Washington, DC	Higher education	Parent/Caregiver
Group VII		Sacramento, CA	Lower education	Chronic
Group VIII		Sacramento, CA	Lower education	Intermittent
Group IX		Sacramento, CA	Lower education	Parent/Caregiver
Group X		Sacramento, CA	Higher education	Chronic
Group XI		Sacramento, CA	Higher education	Intermittent
Group XII		Sacramento, CA	Higher education	Parent/Caregiver

P articipant Screener for Adult Focus Groups

Hello, my name is __________________ and I'm calling about a market research study in your area. We are recruiting for an upcoming focus group in which participants will be asked to share their thoughts and feelings about medicines.

Would you mind answering a few questions? All of the information you provide will remain confidential.

Screening Questions

Q1. Have you taken any prescription drugs in the past 6 months, that is, since (month) 200x? We are talking about any prescription drugs. These could include, for example, antibiotics, prescription hormones of any sort, birth control pills, drugs to control diabetes, heart disease or mental health disorders, prescription pain relief drugs, etc.

• Yes  continue

• No  eliminate [thank respondent politely]

Q2. In the last six months, have you taken at least one prescription drug on a regular basis, such as daily, weekly, or monthly?

• Yes  assign to Chronic user group

• No  continue

Q3. In the last six months, have you taken a prescription drug occasionally or on an “as needed” basis? A few examples of this would be taking an antibiotic for a few days to a few weeks for an infection; or taking a painkiller as needed for migraines, or to control pain following a minor injury or surgery.

• Yes  assign to Intermittent user group

• No  continue

Q4. Do you have primary responsibility for caring for a child (who is less than 16 years old) as part of your immediate family?

• Yes  continue

• No  eliminate

Q4a. In the last 6 months, has that child taken at least one prescription drug on a regular basis, such as daily, weekly, or monthly?

• Yes  assign to Caregiver group

• No  eliminate [thank respondent politely]

Q5. Do you or someone from your immediate family work or have worked or are retired from any of the following:

• Market Research Firm  eliminate [thank respondent politely]

• The Food and Drug Administration,  eliminate [thank respondent politely]

• The National Institutes of Health  eliminate [thank respondent politely]

• Pharmaceutical Company  eliminate [thank respondent politely]

• Physician office, hospital, clinic, or pharmacy  eliminate [thank respondent politely]

• The Department of Health and Human Services  eliminate [thank respondent politely]

• A State Health Department  eliminate [thank respondent politely]

Q6. Have you participated in a focus group within the past six months?

[Interviewer: participation in telephone surveys is allowable]

• Yes  eliminate [thank respondent politely]

• No  continue

Demographic Questions

Q7. Determine gender

• Male

• Female

Q8. How old are you? __________ years. (if under 21, eliminate and thank politely)

Q9. What is the highest level of education that you have completed?

• Less than high school  lower education group

• High school graduate or GED  lower education group

• Technical/vocational school  lower education group

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• Some college credit, but less than
  1 year  higher education group

• 1 or more years of college, no degree  higher education group

• Associate’s degree (AA, AS)  higher education group

• Bachelor’s degree (BA, AB, BS)  higher education group

• Master’s, doctoral, or professional
  school degree (MA, MS, MEd, MEng,
  MBA, MSW, PhD, MD, JD,
  DVM, EdD)  higher education group

Q10. Are you Hispanic or Latino?

• Yes

• No

Q11. What is your race? Please select one or more.

• White

• Black or African American

• American Indian or Alaska Native

• Asian

• Native Hawaiian or Pacific Islander

• Other [Specify] ________

• Refused

We would like to invite you to participate in a focus group to discuss issues relating to medicines with 8 to 10 other participants. The focus group will take place on (Day), (Date), at [6:00 or 8:00 p.m.] at [site location]. The discussion will last approximately an hour and a half and will include both men and women. The group will be audio and video taped and observed by staff from the federal Food and Drug Administration. However, your participation and everything you say during the discussion will be confidential. The FDA will not have your full names and will keep all tapes locked up until they are destroyed. You will receive $75 cash for your time. Additionally we will serve you [insert type of food served] before the group discussion will start. Will you be available to participate at this time?

• Yes  continue

• No  [Thank the person for his/her time]

I would like to send you a confirmation letter and directions to the focus group facility. Can you please tell me your mailing address (or fax number) and a phone number where you can be reached:

Name: ______________________________________

Address: __________________________________________________________

City: _______________________ State: _________ Zip: ______________

Phone: _______________________

Email: _______________________

Date of focus group: __________________ Time: ________________

We are only inviting a few people, so it is very important that you notify us as soon as possible if for some reason you are unable to attend. Please call [recruiter] at [telephone number] if this should happen. We look forward to seeing you on [date] at [time]. If you use reading glasses, please bring them with you to the focus group.

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