Pretest and Main Study

Text Analysis Study Screeners

OMB Control No.: 0910-0910

Expiration Date: 11/30/2025

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 time required to complete this information collection is estimated to average 5 minutes per response, including the time for reviewing instructions 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. This survey is being conducted on behalf of the U.S. Food and Drug Administration.

CONSUMER SCREENER

[AGE]

S1. How old were you on your last birthday?

[OPEN-ENDED]

[IF <18, TERMINATE]

[IF ≥18, CONTINUE]

[OCCUPATION]

S2. Do you currently or have you ever worked in any of the following occupations? (Select all that apply.)

1. Healthcare provider (e.g., physician, nurse, counselor, physical therapist)

2. Pharmaceutical employee (e.g., pharma representative)

3. Department of Health and Human Services employee

4. Market research employee or advertising employee

5. None of the above [EXCLUSIVE]

[IF S2=1, 2, 3, 4, OR BLANK, SET EFLAG=0 “Ineligible” – TERMINATE]

[IF S2=5, CONTINUE]

[EDUCATION]

S3. What is the highest level of education you have completed?

1. Less than high school

2. High school graduate (high school diploma or GED)

3. Some college, but no degree

4. Associate’s degree (2-year)

5. Bachelor’s degree (4-year) (example: BA, BS)

6. Advanced or postgraduate degree (example: MA, MD, DDS, JD, PhD, EdD)

[GENDER]

S4. What is your gender?

1. Male

2. Female

3. Prefer not to answer

[CONTINUE]

[ETHNICITY]

S5. Are you Hispanic or Latino?

1. Yes

2. No

3. Prefer not to answer [EXCLUSIVE]

[CONTINUE]

[RACE]

S6. What is your race? You may select one or more races.

1. American Indian or Alaska Native

2. Asian

3. Black or African American

4. Native Hawaiian or Pacific Islander

5. White

6. Prefer not to answer [EXCLUSIVE]

[CONTINUE]

[HEALTH LITERACY]

S7. How confident are you filling out medical forms by yourself?

1. Not at all

2. A little bit

3. Somewhat

4. Quite a bit

5. Extremely

[CONTINUE]

[FAMILIARITY WITH FOREIGN LANGUAGES]

S8. Are you proficient/fluent in any language other than English (for example, Spanish, French, or Latin)?

1. No

2. Yes

[IF S8=1, SKIP TO S10]

[IF S8=2 CONTINUE]

S9. Please select any language in which you are proficient/fluent:

Language	Proficient/fluent
Latin
Spanish
French
Italian
Portuguese
Other Language (specify):____

 

S10. Have you ever been diagnosed with any of the following conditions by a medical professional? Please select “yes” for all that apply:

[PROGRAMMERS: KEEP ALPHABETICAL]

Medical Condition	Yes
Asthma or allergic rhinitis
Attention Deficit Hyperactivity Disorder (ADHD)
Benign prostatic hyperplasia (men only)
Chronic pain or arthritis
Dementia associated with Alzheimer’s disease
Elevated intraocular pressure
Excessive facial hair
Eye swelling and pain
Heartburn or acid reflux
Hemophilia
High blood pressure
Hypothyroid disease
Insomnia
Low testosterone
Lung disease
Major depressive disorder
Osteoporosis
Overactive bladder
Plaque psoriasis
Prevention of organ rejection
Type 2 diabetes
Urinary problems

[DISPLAY IF EFLAG=0 ‘INELIGIBLE’]

[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.

[DISPLAY CONSENT SCREEN IF EFLAG=1 ‘ELIGIBLE’]

PARTICIPANT IS TAKEN TO THE INFORMED CONSENT SCREEN: IF PARTICIPANT AGREES TO PARTICIPATE, THEY WILL BE TAKEN TO THE SURVEY

HEALTH CARE PROVIDER SCREENER

[HEALTH PROFESSIONAL]

S1. Are you a medical or health professional?

1. Yes

2. No

[IF S1=YES, CONTINUE]

[IF S1=NO, TERMINATE]

[OCCUPATION]

S2. Have you ever worked for…? (Select all that apply)

1. Department of Health and Human Services

2. U.S. Food and Drug Administration

3. Market research firm

4. RTI International

5. None of the above

[IF S2=1, 2, 3, 4, OR BLANK, SET EFLAG=0 “Ineligible” – TERMINATE]

[IF S2=5, CONTINUE]

S3. Have you ever been employed by a pharmaceutical company (not counting consulting work)?

1. Yes

2. No

[IF S3=1, TERMINATE]

[IF S3=2, CONTINUE]

[TYPE OF PROVIDER]

S4. Are you a…?

1. Primary Care Physician (Family Practice, Internal Medicine, General Practitioner)

2. Physician’s Assistant

3. Nurse Practitioner

4. Specialist

5. All other types

[IF S4=1 CONTINUE]

[IF S4=2, 3, 4 or 5, TERMINATE]

[% TIME ON PATIENT CARE]

S5. What percentage of your time do you spend providing direct patient care?

1. Less than 50%

2. 50% or more

[IF S5=1, TERMINATE]

[IF S5=2, CONTINUE]

[YEARS IN PRACTICE]

S6. How long have you been practicing medicine?

1. 5 years or less

2. 6-10 years

3. 11-20 years

4. 21-30 years

5. 31 or more years

[CONTINUE]

[SIZE OF PRACTICE]

S7. How would you classify your practice?

1. Solo

2. Small group practice (2-10 HCPs)

3. Large group practice (>10 HCPs)

[CONTINUE]

[TYPE OF PRACTICE]

S8. Is your practice part of an academic or healthcare system?

1. Yes

2. No

[CONTINUE]

[GENDER]

S9. What is your gender?

1. Male

2. Female

3. Prefer not to answer

[CONTINUE]

[ETHNICITY]

S10. Are you Hispanic or Latino?

1. Yes

2. No

3. Prefer not to answer [EXCLUSIVE]

[CONTINUE]

[RACE]

S11. What is your race? You may select one or more races.

1. American Indian or Alaska Native

2. Asian

3. Black or African American

4. Native Hawaiian or Pacific Islander

5. White

6. Prefer not to answer [EXCLUSIVE]

[CONTINUE]

[STATE OF PRACTICE]

S12. In what state are you currently practicing? If you practice in more than one state, please select the state where the majority of your practice is located:

[PROGRAM AS SINGLE PUNCH DROP DOWN MENU (ALL STATES LISTED)]

[FAMILIARITY WITH FOREIGN LANGUAGES]

S13. Are you proficient/fluent in any language other than English (e.g., Spanish, French, Latin)?

1. No

2. Yes

[IF S13=1, SKIP TO S15]

[IF S13=2 CONTINUE]

S14. Please select any language in which you are proficient/fluent:

Language	Proficient/fluent
Latin
Spanish
French
Italian
Portuguese
Other Language (specify):____

 

S15. In your regular practice, do you treat patients with any of the following conditions? [PROGRAMMERS: KEEP ALPHABETICAL]

Medical Condition	Yes
Asthma or allergic rhinitis
Attention Deficit Hyperactivity Disorder (ADHD)
Benign prostatic hyperplasia (men only)
Chronic pain or arthritis
Dementia associated with Alzheimer’s disease
Elevated intraocular pressure
Excessive facial hair
Eye swelling and pain
Heartburn or acid reflux
Hemophilia
High blood pressure
Hypothyroid disease
Insomnia
Low testosterone
Lung disease
Major depressive disorder
Osteoporosis
Overactive bladder
Plaque psoriasis
Prevention of organ rejection
Type 2 diabetes
Urinary problems

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.

[DISPLAY CONSENT SCREEN IF EFLAG=1 ‘ELIGIBLE’]

PARTICIPANT IS TAKEN TO THE INFORMED CONSENT SCREEN: IF PARTICIPANT AGREES TO PARTICIPATE, THEY WILL BE TAKEN TO THE SURVEY