Individual Interview Study of Healthcare Provider Perceptions of Boxed Warnings

Participant Screener

OMB Control No.:0910-0695

Expiration Date: 2/28/2021

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 timing required to complete this information collection is estimated to average 5 minutes per response, including the time for reviewing the instructions and completing and reviewing the collection of information.

FDA Prescribers’ Perceptions of Boxed Warnings

Screener with Programming Notes

PROGRAMMER:

• Program progresses through the questioning in a “one-way” manner; participants should not be able to return to questions after they have answered them.

• Responses to all questions are voluntary; if respondent does not answer a question, the respondent should stay on the same page and be shown the “MISSING ANSWER(S)” validation, after which they should be allowed to move to the next page. If any of the screener questions are missing after validations, please terminate.

• Include one additional variable in the dataset not shown in this document: Respondent_ID (a unique identifier).

• If ineligible, please show THANK AND TERMINATE MESSAGE on NEW SCREEN:

“Thank you for your time. You do not qualify to participate in the current study. Please continue to check for opportunities to participate in research through Lightspeed Health.”

[INTRO TEXT]

Thank you for your interest in participating in this study to understand how healthcare professionals make prescribing decisions. Please make sure to answer all of the following questions during this initial screening process to determine if you are eligible to participate in this study.

Prescriber. Are you a healthcare professional with prescribing authority?

[SINGLE PUNCH]

Yes, I am a physician. 01

Yes, I am a nurse practitioner. 02

Yes, I am a physician assistant. 03

No 04

[IF Prescriber=04 (“No”), THEN INELIGIBLE. THANK AND TERMINATE.]

[NEW SCREEN]

Area. Which best describes your medical specialty?

[SINGLE PUNCH]

Emergency medicine 01

Endocrinology 02

Family medicine 03

General medicine 04

Hepatology 05

Infectious disease 06

Internal medicine 07

Obstetrics and gynecology 08

Pediatric medicine 09

Psychiatry 10

Other 11

[IF Area=01 (“Emergency medicine”), 02 (“Endocrinology”)”, 09 (“Pediatric medicine”), 10 (“Psychiatry”), or 10 (“Other”), THEN INELIGIBLE. THANK AND TERMINATE.]

[IF Prescriber=02 (“Nurse practitioner”), or 03 (“Physician assistant”) AND Area does not = 03 (“Family medicine”), 04 (“General medicine”), or 06 (“Internal medicine”), or 08 (“Obstetrics and gynecology”), THEN INELIGIBLE. THANK AND TERMINATE.]

[SOFT QUOTA FOR AREA]

Category	Subgroup	Soft Quota
Primary Care Providers	Physicians	21
	Nurse Practitioners & Physician Assistants	5
Specialists	OB/GYNs	13
	Infectious Disease Specialists or Hepatologists	13

[NEW SCREEN]

Activity. What do you consider as your major professional activity?

[SINGLE PUNCH]

Office-based practice 01

Hospital-based practice 02

Resident 03

Medical teaching 04

Medical research 05

Administration 06

Other 07

[IF Activity=03 (“Resident”), 04 (“Medical teaching”), 05 (“Medical research”), 06 (“Administration”), or 07 (“Other”), THEN INELIGIBLE. THANK AND TERMINATE.]

[NEW SCREEN]

TimePtCare. About how much time do you spend on direct patient care?

[SINGLE PUNCH]

Less than 20% 01

20–50% 02

50–70% 03

More than 70% 04

[IF TimePtCare=01 (Less than 20%), THEN INELIGIBLE. THANK AND TERMINATE.]

[IF Area=04 (Family medicine), 05 (General medicine), or 09 (Internal medicine) AND TimePtCare < 03 (50–70%), THEN INELIGIBLE. THANK AND TERMINATE.]

[NEW SCREEN]

RxVolume. Over the course of a week, about how many prescriptions do you write?

[SINGLE PUNCH]

Less than 50 per week 01

50 to 99 per week 02

100 to 149 per week 03

More than 150 per week 04

[IF RxVolume=01 (“Less than 50 per week”), THEN INELIGIBLE. THANK AND TERMINATE.]

[NEW SCREEN]

CdnFamiliarity. Please indicate whether you have treated each of the following clinical conditions in the last 30 days.

[MULTIPLE PUNCH, options are Yes/No]

Asthma 01

HIV Infection 02

Inflammatory Bowel Diseases 03

Osteoporosis 04

Postmenopausal Atrophic Vaginitis/Vulvovaginal Atrophy 05

Chronic Hepatitis C Viral Infection 06

[SOFT QUOTA FOR CDNFAMILIARITY]

Condition	Soft Quota
Responded “Yes” (01) to “Postmenopausal Symptoms” (05)	≥ 23
Responded “Yes” (01) to “Viral Hepatitis” (06)	≥ 23
Responded “No” (00) to “Postmenopausal Symptoms” (05)	≤ 3
Responded “No” (00) to “Viral Hepatitis” (06)	≤ 3

[NEW SCREEN]

PriorResearch. When, if ever, was the last time you participated in a marketing research study?

[SINGLE PUNCH]

Within the past three months 01

More than three months ago 02

Never 03

[IF PriorResearch=01 (“Within the past three months”), THEN INELIGIBLE. THANK AND TERMINATE.]

[NEW SCREEN]

Age. What is your age?

[OPEN-END NUMERICAL]

years old

PracticeYears. How many years have you been practicing medicine?

[OPEN-END NUMERICAL]

years

[NEW SCREEN]

Race. Which of the following best describes your race/ethnicity? Mark all that apply

[MULTIPLE PUNCH]

		NO	YES
Race_1.	American Indian or Alaska Native	00	01
Race_2.	Asian	00	01
Race_3.	Black or African American	00	01
Race_4.	Hispanic or Latino	00	01
Race_5.	Native Hawaiian or Other Pacific Islander	00	01
Race_6.	White	00	01
Race_7.	Ethnicity not listed	00	01

[NEW SCREEN]

Gender. What is your gender?

[SINGLE PUNCH]

Male 01

Female 02

Prefer not to answer 03

[NEW SCREEN]

Location. In what kind of location is your practice?

[SINGLE PUNCH]

Urban 01

Suburban 02

Rural 03

[IF INELIGIBLE DISPLAY (THANK AND TERMINATE)]

Thank you for your time. You do not qualify to participate in the current study. Please continue to check for opportunities to participate in research through Lightspeed Health.

[DISPLAY IF ELIGIBLE]

You are eligible to participate in the current study. Please click the button below to read through our consent form and then take the next steps to schedule your interview through Lightspeed Health.

[CONTINUE TO CONSENT FORM]