Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient Focus Groups 2020
Data to Support Drug Product Communications
Recruitment Screener - Phone
Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient Focus Groups 2020
OMB: 0910-0695
OMB#
0910-0695 
Exp. 02/28/2021
Patient Focus Groups Screener
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 and the expiration date is 02/28/2021. The time required to complete this information collection is estimated to average 5 minutes per response to answer the questions to determine eligibility. [Only read above if respondent asks about the OMB control number] |
Biosimilars Patient Study
Introduction
Hello, my name is _____________ from Survey Healthcare Globus. May I please speak to_____________? I’m calling to invite you to participate in an online focus group sponsored by the U.S. Food and Drug Administration to get your feedback on health-related materials about a specific type of medicine.
The groups will be led by a researcher through an online video platform, and if you’re eligible for the group, you can participate from home using a computer and web camera. The discussion will last about 90 minutes, and you will receive a $75 honorarium once the sessions are finished and the project has concluded.
Can I ask you a few questions now to see if you are eligible?
Core Eligibility Questions
What is your age?
Age 18 or older |
|
CONTINUE |
Under 18 |
|
TERMINATE |
___ years
Have you ever worked…? [Read list. Accept multiple responses.]
For a drug or pharmaceutical company
TERMINATE
For a market research or marketing company, including RTI International or Survey Healthcare Globus
TERMINATE
For the U.S. federal government (not including as a member of the military)
TERMINATE
As a medical professional (such as a physician, nurse, or pharmacist)
TERMINATE
None of the above
CONTINUE
When was the last time you participated in an interview or a focus group for a research study?
Within the past six months
TERMINATE
More than six months ago
CONTINUE
Never
CONTINUE
Do you have high-speed Internet access at home? That is, are you able to stream video without any difficulty?
-
Yes
CONTINUE
No
TERMINATE
To participate in this study, you will need two things: (1) a desktop or laptop computer (not just a tablet or smartphone) and (2) a webcam. Can you meet these requirements?
-
Yes
CONTINUE
No
TERMINATE
During the focus group discussion, you will be asked to review written materials and offer your opinions. Do you have any vision, hearing or speaking problems that would affect your ability to see the materials, hear the instructions, or comment on them?
Yes
No
CONTINUE
Are you comfortable speaking and reading English independently and without an interpreter?
Yes
CONTINUE
No
TERMINATE
For study purposes, the focus group will be audio and video recorded. Are you okay with being recorded and being visible on screen to a small number of research team members?
-
Yes
CONTINUE
No
TERMINATE
Audience Segmentation Questions
Now I’d like to ask you about your health. Has a healthcare professional ever diagnosed you with any of the following medical conditions? [Read list of conditions. Only read detailed description of a condition if requested by individual. Accept multiple responses.]
Ankylosing spondylitis / Spondyloarthritis Inflammatory disease that can cause vertebrae in the spine to fuse. |
|
Ask Q10, then CONTINUE to Q15 |
Psoriatic arthritis A form of arthritis that affects some people who have psoriasis. |
|
Ask Q10, then CONTINUE to Q15 |
Rheumatoid arthritis A chronic inflammatory disorder that can affect joints and other body systems. |
|
Ask Q10, then CONTINUE to Q15 |
Cancer A variety of conditions involving abnormal cell growth. |
|
Ask Q10, then CONTINUE to Q11 |
Crohn’s disease A bowel disease involving inflammation of the digestive tract. |
|
Ask Q10, then CONTINUE to Q15 |
Ulcerative colitis A bowel disease that affects the large intestine with inflammation and ulcers or sores. |
|
Ask Q10, then CONTINUE to Q15 |
Eczema / Atopic dermatitis A skin condition involving itchy rashes. |
|
Ask Q10, then CONTINUE to Q15 |
Psoriasis A chronic skin condition where cells build up rapidly on the skin, forming itchy and sometimes painful scaly red patches. |
|
Ask Q10, then CONTINUE to Q15 |
Type 1 diabetes A chronic condition in which the pancreas produces little or no insulin. |
|
Ask Q10, then CONTINUE to Q13 |
Type 2 diabetes A disease that occurs when not enough insulin is produced or when your body has difficulty using insulin properly. |
|
Ask Q10, then CONTINUE to Q13 |
None of the above |
|
SKIP to Q15 |
How long ago were you diagnosed with [condition]? [Ask for each condition selected by respondent]
Segmentation Questions – Cancer
Which type(s) of cancer were you diagnosed with? [Accept multiple responses]
Breast
CONTINUE
Colorectal
CONTINUE
Kidney
CONTINUE
Leukemia
CONTINUE
Lung
CONTINUE
Lymphoma
CONTINUE
Myeloma
CONTINUE
Skin
CONTINUE
Other (please specify)
Have you ever been diagnosed by a healthcare professional with neutropenia, a blood-related side effect of chemotherapy?
Yes |
|
CONTINUE to Q15 |
No |
|
CONTINUE to Q15 |
Segmentation Questions – Diabetes
How long have you been using insulin to treat your diabetes? [Read list]
Less than one month
CONTINUE
One month to less than one year
CONTINUE
One year to less than three years
CONTINUE
Three years or more
CONTINUE
Not currently taking insulin
SKIP to Q15
How often do you usually take insulin? [Read list]
Once per day or more |
|
CONTINUE to Q15 |
Less than once per day |
|
SKIP to Q15 |
Segmentation Questions – Children with Diabetes
Are you the parent or guardian of a child who has been diagnosed with diabetes by a healthcare professional? If so, which type of diabetes?
Yes, type 1 diabetes
CONTINUE
Yes, type 2 diabetes
CONTINUE
No
SEE Q20 INSTRUCTIONS
What is this child’s age?
-
Age 18 or older
TERMINATE IF Q9=None of the above
Under 18
CONTINUE
How involved are you in managing your child’s diabetes (e.g., scheduling doctor’s appointments, making medication decisions, administering insulin)? Would you say you are...? [Read list]
Extremely involved
CONTINUE
Frequently involved
CONTINUE
Somewhat involved
SEE Q20 INSTRUCTIONS
Not at all involved
SEE Q20 INSTRUCTIONS
How long has your child been using insulin to treat his or her diabetes? [Read list]
For more than one month |
|
CONTINUE |
For less than one month |
|
SEE Q20 INSTRUCTIONS |
Not currently taking insulin |
|
SEE Q20 INSTRUCTIONS |
How often does your child take insulin? [Read list]
Once per day or more |
|
SEE SKIP PATTERN BELOW |
Less than once per day |
|
SEE SKIP PATTERN BELOW |
[Skip pattern:
If individual’s responses have checked one or more of the yellow boxes, proceed to Q20.
If individual’s responses have checked only the green boxes, skip to Q25.
If no yellow or green boxes selected, terminate and display closing script.]
MEDICATION QUESTIONS
Now I’d like to ask about medications that you take for your health conditions. Have you ever taken one or more of the following medications to treat [list medicines for a max of three condition(s) based on responses for Q9 and Q11, one at a time]?
[Read list of medications for each applicable medical condition. Do NOT read “Biologic Medications” and “Biosimilar Medications” headers.]
[Record multiple responses. If respondent states a preference to read the list of their medications rather than having recruiter read the list, please adjust accordingly. Once respondent says “Yes” to five medications, stop reading list and proceed to Q21.]
[RECRUIT AT LEAST 20% TAKING AT LEAST ONE BIOSIMILAR]
-
Selected one or more medications
CONTINUE
Did not select any medications for applicable conditions
TERMINATE
List of Medications for Q20
Condition |
Medications Brand Name [pronunciation] [generic Name] |
Ankylosing Spondylitis/ Spondyloarthritis |
|
Psoriatic Arthritis |
|
Rheumatoid Arthritis |
|
Cancer (leukemia) |
|
Cancer (blood – including lymphoma and myeloma) |
|
Cancer (lung) |
|
Cancer (skin—melanoma, squamous cell carcinoma, basal cell carcinoma) |
|
Cancer (colorectal) |
|
Cancer (breast) |
|
Cancer (kidney) |
|
Cancer (other types) |
|
Neutropenia (from cancer treatment) |
|
Crohn's Disease |
|
Ulcerative Colitis |
|
Eczema/Atopic Dermatitis |
|
Psoriasis |
|
Are you currently taking [list biologics selected in Q20, one at a time]? [Record response for each medication]
Yes
CONTINUE
No
SKIP TO Q23 IF NO TO ALL MEDS
How long have you been taking [list biologics currently taking, one at a time]? [Record response for each medication]
Less than one month
TERMINATE
One month to less than three months
CONTINUE to Q25
Three months to less than six months
CONTINUE to Q25
Six months to less than two years
CONTINUE to Q25
Two years to less than five years
CONTINUE to Q25
Five years or more
CONTINUE to Q25
When did you last take [list biologics selected in Q20 that individual is not current taking, one at a time]? [Record response for each medication]
Within the last month
CONTINUE
One month to less than three months ago
CONTINUE
Three months to less than six months ago
CONTINUE
Six months ago or more
TERMINATE
How long did you take [list of biologics selected in Q20 that individual is not currently taking, one at a time] when you were still using it? [Record response for each medication]
Less than one month
TERMINATE
One month or longer
CONTINUE to Q25
Would you be comfortable discussing these medications in a focus group?
Yes |
|
ELIGIBLE |
No |
|
TERMINATE |
Demographic Questions
What is the highest level of education that you have completed? [Read list]
Less than high school diploma
High school graduate or GED
Technical or Associates degree (2-year)
Some college but not a degree
4-year degree
Graduate or professional degree [RECRUIT NO MORE THAN 14% OF SAMPLE]
What type of health insurance do you currently have? [Read list. Accept multiple responses]
Private insurance through an employer, group health plan, broker, or agent
Private insurance through a Federal or state marketplace plan
Medicaid or Medicare [RECRUIT AT LEAST 30% OF TOTAL SAMPLE NON-PRIVATE]
Veterans Affairs, Tricare, or the Department of Defense [RECRUIT AT LEAST 30% OF TOTAL SAMPLE NON-PRIVATE]
Currently uninsured
Other [please specify]: _______________________
What is your race? You may select more than one. [Read list. Accept multiple responses]
White [RECRUIT NO MORE THAN 80% OF SAMPLE]
Black or African American
Asian
Native Hawaiian or Other Pacific Islander
American Indian or Alaska Native
Are you of Hispanic, Latino, or Spanish origin?
Yes [RECRUIT AT LEAST 15% OF SAMPLE]
No
In which state do you live? [Record response, then sort into corresponding Census region]
-
Record participant response: ________
Midwest - IL, IN, IO, KS, MI, MN, MO, NE, ND, OH, SD, WI [RECRUIT AT LEAST 20% OF SAMPLE]
Northeast - CT, MA, ME, NH, NJ, NY, PA, RI, VT [RECRUIT AT LEAST 20% OF SAMPLE]
South - AL, AR, DC, DE, FL, GA, KY, LA, MD, MS, NC, OK, SC, TN, TX, VA, WV [RECRUIT AT LEAST 20% OF SAMPLE]
West - AK, AZ, CA, CO, HI, ID, NM, MT, OR, UT, NV, WA, WY [RECRUIT AT LEAST 20% OF SAMPLE]
What was your total household income before taxes during the past 12 months? Your response will be kept private.
$30,001 to $65,000
$65,001 to $99,999
More than $100,000
Prefer not to answer
What is your sex?
Closing Scripts
Ineligible - Closing Script
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.
Eligible – Closing Script
Thank you for answering my questions. You qualify for our study. Next, I’d like to schedule you for a focus group. The focus group will last about 90 minutes. You will receive a $75 honorarium once the sessions are finished and the project has concluded. Specific instructions for obtaining your honorarium will be sent to your email at the conclusion of the research. Survey Healthcare Globus uses third party providers, such as TangoCard and PayPal, to provide the honorarium.
Are you available at [TIME] on [DATE]? [READ GROUP TIME OF RELEVANT CONDITION]
Yes CONTINUE and schedule participant for appropriate group
No Are you available at [TIME] on [DATE]? [READ ALTERNATIVE GROUP TIMES OF RELEVANT CONDITION, IF AVAILABLE]
Yes CONTINUE and schedule participant for appropriate group
No RECORD RESPONSE, RETAIN PARTICIPANT AS AN ALTERNATE, AND END CALL
The e-mail address I have on file for you is [E-MAIL ADDRESS] and phone number is [PHONE NUMBER]. Are those still correct? [UPDATE IF NEEDED]
We will reach out with a confirmation email and phone call with instructions to join the focus group on [DATE/TIME]. We will also use this information to send you a reminder email and to call and remind you of the focus group one day before the group.
Thank you. We appreciate your participation in this study.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Alexander, Jennifer |
| File Modified | 0000-00-00 |
| File Created | 2021-01-14 |
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