Screener and Main Study

Targeted Mechanism of Action Presentations in Prescription Drug Promotion

Final Questionnaire tracked changes May 2023

Screener and Main Study

OMB: 0910-0908

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Targeted Mechanism of Action Presentations in Prescription Drug Promotion

Main Study Survey


[DISPLAY] (CQHIDINFO_1)

Thank you for your interest in this research study. The purpose of the study is to learn more about prescription drug websites. First, we need to ask you a few screening questions to see if you are eligible to participate.


If you are eligible and agree to participate, you will look at a web page for a new prescription drug and then answer some survey questions about what you saw.


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 currently valid OMB control number. The valid OMB control number for this information collection is 0910-0908, and the expiration date is 11/30/2025. The time required to complete this information collection is estimated to average 20 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.


OMB control number: 0910-0908; Expiration: 11/30/2025


[PROGRAMMER: NEXT SCREEN]


[SCREENER]

[AGE]


[PN: Q ASKED OF COHORT = CONSUMER AND COHORT = HCP]


[SINGLE PUNCH]

S1. What is your age? ______ (QT=OEN) (PN: RANGE: 0 - 100)

[PROGRAMMER: S1 < 18 or > 99 SET EFLAG=0 ‘INELIGIBLE’ – TERMINATE]


[PROGRAMMER: NEXT SCREEN]


[SEX]


[PN: Q ASKED OF COHORT = CONSUMER AND COHORT = HCP]


[SINGLE PUNCH]

S2. What is your sex? (QT=SS)

1 Male

2 Female

3 Prefer not to answer


[PROGRAMMER: NEXT SCREEN]


[OCCUPATION]

[PN: Q ASKED OF COHORT = CONSUMER AND COHORT = HCP]


[SINGLE PUNCH]

S3. What is your current occupation? (QT=SS)

1 Healthcare provider (e.g., physician, nurse, physician assistant)

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

3 Market research employee/advertising employee

4 Employee of the Department of Health and Human Services

5 All other occupations


[PROGRAMMER: IF COHORT = CONSUMER AND S3 !== 5 ‘All other occupations’, SET EFLAG=0 ‘INELIGIBLE’ – TERMINATE after S9; GO TO S5_C]


[PROGRAMMER: IF COHORT = HCP AND S3 !== 1 ‘HCP’, SET EFLAG=0 ‘INELIGIBLE’ – TERMINATE after S9, GO TO S8]


[PROGRAMMER: NEXT SCREEN]


[PROGRAMMER: DISPLAY S4_C IF COHORT = CONSUMER]


[HEALTHCARE PROFESSIONAL EXCLUSION CONSUMER]

[PN: Q ASKED OF CONSUMERS]


[SINGLE PUNCH]

S4_C. Have you completed any formal training as a healthcare professional? (QT=SS)


1 Yes

2 No

3 Not sure


[PROGRAMMER: IF COHORT = CONSUMER AND S4_C = 1 ‘Yes’ or 3 ‘Not sure’, SET EFLAG=0 ‘INELIGIBLE’ – TERMINATE after S9; GO TO S5_C]


[PROGRAMMER: NEXT SCREEN]


[EDUCATION]

[PN: Q ASKED OF COHORT = CONSUMER]


[SINGLE PUNCH]


S5_C. What is the highest level of school you have completed or the highest degree you have received? (QT=SS)

1 Less than high school

2 High school graduate—high school diploma or the equivalent (for example, GED)

3 Some college but no degree

4 Vocational or technical school degree

5 Associate’s degree in college

6 Bachelor’s degree (for example, BA, AB, BS)

7 Advanced or postgraduate degree (for example, master’s degree, MD, DDS, JD, PhD, EdD)


[PROGRAMMER: After S5_C GO TO S8]


[PROGRAMMER: NEXT SCREEN]


[PROGRAMMER: DISPLAY IF COHORT = HCP]


[HEALTHCARE PROVIDER TYPE]

[PN: Q ASKED OF COHORT = HCP]


[SINGLE PUNCH]

S4_P. Which of the following best describes your profession? (QT=SS)

1 Medical doctor/physician

2 Physician assistant

3 Nurse practitioner

4 Other


[PROGRAMMER: IF S4_P = 4 ‘Other’, SET EFLAG=0 ‘INELIGIBLE’ – TERMINATE after S9; GO TO S8. IF S4_P=1, SHOW S5_P. IF S4_P=2 or 3, SHOW S5_NPPA]


[PROGRAMMER: NEXT SCREEN]


[MEDICAL FIELD]

[PN: Q ASKED OF COHORT = HCP]


[SINGLE PUNCH]

(PN: ASK IF S4_P=1. IF S4_P=2 OR 3, SKIP TO S5_NPPA)

S5_P. Which one of the following categories best describes your primary area of specialization? Select one answer. (QT=SS)

1 Primary care provider

2 Hematologist

3 Hematologist/oncologist

4 Medical oncologist

5 Pediatric oncologist

6 Surgical oncologist

7 Radiation oncologist

8 Other


[PROGRAMMER: IF S5_P = 1 ‘Primary care provider’ or 2 ‘Hematologist’ or 3 ‘Hematologist/oncologist’ or 4 ‘Medical oncologist or 5 ‘Pediatric oncologist,’ or 6 ‘Surgical oncologist’ or 7 ‘Radiation oncologist’ GO TO S6_P]

[PROGRAMMER: IF S5_P = 8 ‘Other’ SET EFLAG=0 ‘INELIGIBLE’ – TERMINATE after S9; GO TO S8]


[PN: Q ASKED OF COHORT = HCP]

(PN: ASK IF S4_P=2 OR 3; IF S4_P=1, SKIP TO S6_P)

S5_NPPA. In what specialty areas do you currently practice? Select all that apply. (QT=MS)

S5_NPPA1 Primary care [IF S5_NPPA2 IS NOT CHOSEN AS WELL SET EFLAG=0 ‘INELIGIBLE’ TERMINATE after S9; GO TO S8]

S5_NPPA2 Oncology

S5_NPPA3 Pediatrics [IF S5_NPPA2 IS NOT CHOSEN AS WELL SET EFLAG=0 ‘INELIGIBLE’ – TERMINATE after S9; GO TO S8]

S5_NPPA4 Geriatrics [IF S5_NPPA2 IS NOT CHOSEN AS WELL SET EFLAG=0 ‘INELIGIBLE’ – TERMINATE after S9; GO TO S8]

S5_NPPA5 Critical care [IF S5_NPPA2 IS NOT CHOSEN AS WELL SET EFLAG=0 ‘INELIGIBLE’ – TERMINATE after S9; GO TO S8]

S5_NPPA6 Mental health [IF S5_NPPA2 IS NOT CHOSEN AS WELL SET EFLAG=0 ‘INELIGIBLE’ – TERMINATE after S9; GO TO S8]

S5_NPPA7 Other [IF S5_NPPA2 IS NOT CHOSEN AS WELL SET EFLAG=0 ‘INELIGIBLE’ – TERMINATE after S9; GO TO S8]

[PROGRAMMER: NEXT SCREEN]


[SINGLE PUNCH]


[PRESCRIPTION WRITTEN]

[PN: Q ASKED OF COHORT = HCP]

S6_P. On average, how many prescriptions for oncology medications do you write in a typical month? (QT=OEN). (PN: RANGE 0 – 2000)

____ prescriptions


[PROGRAMMER: IF S6_P <1, SET EFLAG=0 ‘INELIGIBLE’ – TERMINATE after S9; GO TO S8]


[PROGRAMMER: NEXT SCREEN]


[DIRECT PATIENT CARE]

[NUMERICAL FIELD; SET RANGE 0 – 100]


[PN: Q ASKED OF COHORT = HCP]

S7_P. In a typical week, what percentage of your time is spent on direct patient care, such as seeing patients and reviewing their medical records? If you are not sure, please provide your best guess. (QT=OEN) (RANGE: 0 – 100%)

_____%


[PROGRAMMER: IF S7_P < 45, SET EFLAG=0 ‘INELIGIBLE’ – TERMINATE after S9; GO TO S8]


[PROGRAMMER: NEXT SCREEN]


[ETHNICITY]

[PN: Q ASKED IF COHORT = CONSUMER AND COHORT = HCP]


[SINGLE PUNCH]

S8. Are you Hispanic or Latino? (QT=SS)

1 Yes

2 No

3 Prefer not to answer


[PROGRAMMER: NEXT SCREEN]


[RACE]

[PN: Q ASKED OF CONSUMERS AND COHORT = HCP]


[MULTIPLE PUNCH]


[PROGRAMMER: Multi-punch response items should be saved to dataset as binary variables with response options: 1=’Selected’ OR 0=’Not selected’.]

(PN: PUNCHING UPDATE)

  1. WHITE’ - THOSE WHO SELECT ‘WHITE’ ONLY (CODE 5)

  2. MIXED RACE’ - IF ANY OF CODES 1, 2, 3, 4 OR 6 SELECTED, OR IF ‘WHITE’ SELECTED WITH ANY OF CODES 1 -4 OR 6)

  3. Prefer not to answer (s9_7) – CREATE AND NAME AS ‘PREFER NOT TO ANSWER (MISSING)’


S9. What is your race? Select all that apply. (QT=MS)

S9_1. American Indian or Alaska Native

S9_2. Asian

S9_3. Black or African American

S9_4. Native Hawaiian or other Pacific Islander

S9_5. White

S9_6. Prefer not to answer [EXCLUSIVE]


[PROGRAMMER: IF S9_7 = 1 ‘Selected’, DISABLE OPTIONS S9_1 – S9_6]


[PROGRAMMER: NEXT SCREEN]


[DISPLAY ‘Thank and Terminate’ IF EFLAG=0 ‘INELIGIBLE]


[Thank and Terminate]

We’re sorry, but you are not eligible for this study. There are many possible reasons why people are not eligible for this study. 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.


[IF EFLAG=0 ‘INELIGIBLE, END HERE]


[PROGRAMMER: NEXT SCREEN]


You are eligible to participate in the study.


OMB control number: 0910-0908; Expiration: 11/30/2025


[PROGRAMMER: NEXT SCREEN]


What is the Research About?

Thank you for your interest in this research study. The research involves looking at a website for a healthcare product and completing an online questionnaire. Viewing the website and completing the survey will take approximately 20 minutes. All aspects of the study may not be revealed until the end.

What Is the Purpose of This Study?

The purpose of the study is to learn more about websites for healthcare products. You are one of about <IF PRETEST: “360,” IF MAIN STUDY: “540”> <IF CONSUMERS: “people,” IF HCPs: “healthcare professionals”> in the United States who are being asked to take part in this survey.

Who Is Leading the Study?

RTI International, an independent nonprofit research organization, is conducting this study on behalf of, and funded by, the Department of Health and Human Services. RTI is working with Toluna to conduct this survey but is not affiliated with Toluna in any way.

Do I Have to Take Part in This Study?

Your participation in this study is completely voluntary, and you have the right to stop at any time or to refuse to answer any question. If you decide to participate and later change your mind, you will not be contacted again or asked for further information.

What Are the Possible Risks?

We do not expect that any of the survey questions will make you uncomfortable, but if they do, you can refuse to answer any question. There is also a potential risk of loss of confidentiality. Every effort will be made to protect your information, but this cannot be guaranteed.

Will I Benefit From Taking Part in This Study?

There are no direct benefits to you for participating in this study. However, you will be helping with an important research project.

Will I Receive Any Payment for Taking Part in This Study?

You will receive <IF CONSUMERS: “$1.50 in points,” IF ONCOLOGISTS: “$70,” IF PCPs, PAs, or NPs: “$50”> for completing this survey.

Who Will See the Information I Give?

Many precautions have been taken to protect your information. All information collected in this survey will be kept confidential to the extent provided by law. You will never be identified by name. The information obtained from all of the surveys will be combined into a summary report so that details of individual questionnaires cannot be linked to a specific participant. When we analyze the results, your responses will be combined with responses from other people taking part in the study. You will not be identified in any published or presented materials. The information collected in this study may be used or shared for future research studies.

Will I Be Contacted in the Future About This Study?

You will not be contacted in the future about this research after your participation ends.

What If I Have Questions?

If you have questions about this survey, please contact your panel provider through your member website for assistance. You will need to mention the Project # [SurveyNumber], and someone will direct your questions to the appropriate researchers at RTI. If you have questions about your rights as a participant, you can call RTI’s Office of Research Protection toll-free at 1-866-214-2043.

[PROGRAMMER: NEXT SCREEN]


[CONSENT]

[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH] CQ_CONSENT

CONSENT. If you have read the previous screens and agree to participate, please click the Yes button. If not, click the No button.

1 Yes, I agree to participate. [Go to ‘Randomization’]

2 No, I do not agree to participate. [End survey]

[PROGRAMMER: IF CONSENT = 1 ‘Yes’, GO TO ‘Randomization’]


[PROGRAMMER: IF CONSENT !== 1 ‘Yes’, SET EFLAG=0 ‘INELIGIBLE’ – TERMINATE]


(PN: DO NOT REMOVE SPEEDERS AND SLOW RESPONDENTS, JUST FLAG THEM IN THE DATA)


[PROGRAMMER: NEXT SCREEN]


[RANDOMIZATION]


(PN: PLEASE SEE THE PROVIDED RANDOMIZATION SCHEMES)


[PROGRAMMER: Randomly assign participants to one of 12 experimental conditions. Record assignment in variable XCONDITION with possible values shown in table below.


(PN: THE WEBPAGE SHOULD BE ON ONE SCREEN DISPLAYED CONTINUOUSLY SO THAT THE RESPONDENTS CAN SCROLL UP AND DOWN).

XCONDITION Value

XCONDITION Label

PDF name - Consumers

PDF name - HCPs

1

Disclosure present, Claim present, No graphic

TMoA_webpage-CONSUMER-C1-4-11-22_200DPI-REVb

TMoA_webpage-PROVIDER-C1-4-11-22_200DPI

2

Disclosure present, Claim present, Accurate graphic

TMoA_webpage-CONSUMER-C2-4-11-22_200DPI-REVb

TMoA_webpage-PROVIDER-C2-4-11-22_200DPI-REVb

3

Disclosure present, Claim present, Misleading graphic

TMoA_webpage-CONSUMER-C3A-4-11-22_200DPI-REVb

TMoA_webpage-PROVIDER-C3A-4-11-22_200DPI-REVb

4

Disclosure present, Claim absent, No graphic

TMoA_webpage-CONSUMER-C4-4-11-22_200DPI-REVb

TMoA_webpage-PROVIDER-C4-4-11-22_200DPI

5

Disclosure present, Claim absent, Accurate graphic

TMoA_webpage-CONSUMER-C5-4-11-22_200DPI-REVb

TMoA_webpage-PROVIDER-C5-4-11-22_200DPI-REVb

6

Disclosure present, Claim absent, Misleading graphic

TMoA_webpage-CONSUMER-C6A-4-11-22_200DPI-REVb

TMoA_webpage-PROVIDER-C6A-4-11-22_200DPI-REVb

7

Disclosure absent, Claim present, No graphic

TMoA_webpage-CONSUMER-C7-4-11-22_200DPI

TMoA_webpage-PROVIDER-C7-4-11-22_200DPI

8

Disclosure absent, Claim present, Accurate graphic

TMoA_webpage-CONSUMER-C8-4-11-22_200DPI-REVb

TMoA_webpage-PROVIDER-C8-4-11-22_200DPI-REVb

9

Disclosure absent, Claim present, Misleading graphic

TMoA_webpage-CONSUMER-C9A-4-11-22_200DPI-REVb

TMoA_webpage-PROVIDER-C9A-4-11-22_200DPI-REVb

10

Disclosure absent, Claim absent, No graphic

TMoA_webpage-CONSUMER-C10-4-11-22-200DPI

TMoA_webpage-PROVIDER-C10-4-11-22_200DPI

11

Disclosure absent, Claim absent, Accurate graphic

TMoA_webpage-CONSUMER-C11-4-11-22_200DPI-REVb

TMoA_webpage-PROVIDER-C11-4-11-22-REVb

12

Disclosure absent, Claim absent, Misleading graphic

TMoA_webpage-CONSUMER-C12A-4-11-22_200DPI-REVb

TMoA_webpage-PROVIDER-C12A-4-11-22_200DPI-REVb


PROGRAMMER: Some script and questions have conditional piping in item stems or response options that will depend on the population, as captured in the COHORT variable. The conditional text appears in curly brackets “{ }” with the following rules:

Conditional text

COHORT

Display

{people/healthcare providers}

1 ‘CONSUMERS’

People

2 ‘HCP’

Healthcare providers

{friend/patient}

1 ‘CONSUMERS’

Friend

2 ‘HCP’

Patient

{recently been diagnosed with cancer. You are actively looking for available treatments/a patient who has been diagnosed with cancer. You are actively looking for available treatments for that patient.}

1 ‘CONSUMERS’

Recently been diagnosed with cancer. You are actively looking for available treatments.

2 ‘HCP’

A patient who has been diagnosed with cancer. You are actively looking for available treatments for that patient.

{Cancers of the urinary tract/metastatic urothelial cancer}

1 ‘CONSUMERS’

Cancers of the urinary tract

2 ‘HCP’

Metastatic urothelial cancer

{LEYTROL targets Nectin-4, a cell surface protein found on bladder cancer cells./LEYTROL is designed to target Nectin-4, an adhesion protein highly expressed on bladder cancer cells.}

1 ‘CONSUMERS’

LEYTROL targets Nectin-4, a cell surface protein found on bladder cancer cells.

2 ‘HCP’

LEYTROL is designed to target Nectin-4, an adhesion protein highly expressed on bladder cancer cells.

{patients/providers}

1 ‘CONSUMERS’

Patients

2 ‘HCP’

Providers

{ask a doctor about/prescribe}

1 ‘CONSUMERS’

Ask a doctor about

2 ‘HCP’

Prescribe

{High blood sugar/hyperglycemia}

1 ‘CONSUMERS’

High blood sugar

2 ‘HCP’

Hyperglycemia

{Most people don’t know how a prescription drug will affect them until they’ve taken the drug. But we’d like you to make your best guess based on the web page you just saw. Please answer the following questions based on what you saw on the web page./Please answer the following questions based on what you saw on the web page rather than prior knowledge of this class of medications. ]

1 ‘CONSUMERS’

Most people don’t know how a prescription drug will affect them until they’ve taken the drug. But we’d like you to make your best guess based on the web page you just saw. Please answer the following questions based on what you saw on the web page.

2 ‘HCP’

Please answer the following questions based on what you saw on the web page rather than prior knowledge of this class of medications.

{LEYTROL is not a real product and is not available for sale. The purpose of this study is to learn about reactions to prescription drug information. To get a real-life reaction, we used a fictitious product in this study. Please see your healthcare provider for questions about bladder cancer./LEYTROL is not a real product and is not available for sale. The purpose of this study is to learn about reactions to prescription drug information. To get a real-life reaction, we used a fictitious product in this study.}

1 ‘CONSUMERS’

LEYTROL is not a real product and is not available for sale. The purpose of this study is to learn about reactions to prescription drug information. To get a real-life reaction, we used a fictitious product in this study. Please see your healthcare provider for questions about bladder cancer.

2 ‘HCP’

LEYTROL is not a real product and is not available for sale. The purpose of this study is to learn about reactions to prescription drug information. To get a real-life reaction, we used a fictitious product in this study.

{patients/healthcare providers}


1 ‘CONSUMERS’

Patients

2 ‘HCP’

Healthcare providers

{family members or close friends / patients}

1 ‘CONSUMERS’

Family members or close friends

2 ‘HCP’

Patients

(PN: DATA FILE FORMATS – EXCEL AND SPSS)

[PROGRAMMER: NEXT SCREEN]


[STIMULI INSTRUCTIONS]


CQHIDINFO_2

On the next screen, you will see a picture of a web page for a new prescription drug.


To make drug websites more helpful, we want to learn about how {people/ healthcare providers} think about drug information.


As you review the web page, imagine you have {recently been diagnosed with cancer. You are actively looking for available treatments/a patient who has been diagnosed with cancer. You are actively looking for available treatments for that patient.}

Please take as much time as you need to read the information on the web page. Once you advance past the web page, you will not be able to return to it. Please make sure you have reviewed the entire web page before advancing. Keep in mind you may need to scroll down to see the entire page.


Once you finish viewing the web page, please click the ‘Next’ button.


[DISPLAY ASSIGNED AD] [SUPPRESS “CONTINUE” BUTTON FOR 20 SECONDS]




[MAIN SURVEY]


[PROGRAMMER: NEXT SCREEN]


[PN: Q ASKED OF CONSUMER AND HCP]

[PN: Q1 IS A REQUIRED QUESTION]


Q1. Were you able to view the web page? (QT=SS)


__Yes

__No [Terminate]

__Not sure [Terminate]


[PROGRAMMER: For remaining questions, if respondent does not provide a response, prompt with, “Are you sure you don’t want to provide a response?” before allowing to continue.]


[PROGRAMMER: NEXT SCREEN] CQHIDINFO_3

Now, please answer the following questions based on the web page you saw.


[PROGRAMMER: NEXT SCREEN]

[INDICATION RECOGNITION]



[PN: FROM Q2 ONWARDS PLEASE INCLUDE A SOFT PROMPT WHEN RESPONDENT TRIES TO SKIP/REFUSE THE QUESTION: Are you sure you do not want to provide an answer? Your answers are important to us.]


[PN: Q ASKED OF CONSUMER AND HCP]

Q2. According to the web page you saw, LEYTROL is approved to treat patients with which medical condition(s)? Check all that apply. (QT=MS)

[PROGRAMMER: RANDOMIZE RESPONSE OPTIONS]


1 Multiple myeloma

2 Non-Hodgkin lymphoma

3 Bladder cancer

4 {Cancers of the urinary tract/metastatic urothelial cancer}

5 Colon cancer

6 Lung cancer


[PROGRAMMER: NEXT SCREEN]


[MOA COMPREHENSION]


[PN: Q ASKED OF CONSUMER AND HCP]


Q3. Imagine you wanted to help a {friend/patient} understand how LEYTROL works in the body to treat bladder cancer. Based on the information you saw on the web page, please describe how LEYTROL works to your {friend/patient}. (QT=OE)


(Please be as detailed and specific as possible when entering your answer in the space provided.)




[PROGRAMMER: NEXT SCREEN]


[MOA POSITIVE AND NEGATIVE EVALUATIONS]


[PN: Q ASKED OF CONSUMER AND HCP]

Q4. Please rate how you feel about the information on the web page that described how LEYTROL works. (QT=SS)


In my opinion, the information on the web page that described how LEYTROL works was … (QT=TT1SC)


(PN: AS THIS QUESTION IS NOT MANDATORY, RESPONDENTS MAY NOT CHOOSE TO ANSWER ALL OPTIONS. FLAG AS STRAIGHTLINER ONLY IF RESPONDENT MAKES SAME SELECTION FOR ALL 7 OPTIONS. DO NOT REMOVE FROM DATA OR TERMINATE)


[PN: SOFT PROMPT SHOULD APPEAR IF ANY OF THE ITEMS ARE NOT ANSWERED; SOFT PROMPT SHOULD ONLY BE SHOWN ONCE]


[PROGRAMMER: RANDOMIZE ORDER OF ITEMS Q4_1 to Q4_7]




1

2

3

4

5

6


Q4_1

Confusing

Clear

Q4_2

Complex

Straightforward

Q4_3

Unimportant

Important

Q4_4

Misleading

Honest

Q4_5

Not believable

Believable

Q4_6

Not trustworthy

Trustworthy

Q4_7

Inaccurate

Accurate


[BALANCE OF RISKS AND BENEFITS ON THE WEB PAGE]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]


Q5. Please think about the information you saw on the web page. Did the web page place more emphasis on the risks or more emphasis on the benefits of LEYTROL? (QT=TT1SC)


1

More emphasis on risks

2

3

4


5

6

More emphasis on benefits


[PROGRAMMER: NEXT SCREEN]


[RISK RECOGNITION]


[PN: Q ASKED OF CONSUMER AND HCP]

[PN: SOFT PROMPT SHOULD APPEAR IF ANY OF THE ITEMS ARE NOT ANSWERED; SOFT PROMPT SHOULD ONLY BE SHOWN ONCE]



Q6. Please check which of the following were mentioned on the web page as risks or side effects of taking LEYTROL. Even if you think a statement is true, please select it only if it was mentioned on the web page. (QT=TT1)


[PROGRAMMER: RANDOMIZE ORDER OF ITEMS]

Mentioned on the web page

Not mentioned on the web page

Don’t know

Q6_1. Diarrhea




Q6_2. Fatigue




Q6_3. Peripheral neuropathy




Q6_4. {High blood sugar/hyperglycemia}




Q6_5. Thoughts of suicide (FOIL)




Q6_6. Insomnia (FOIL)




[PROGRAMMER: NEXT SCREEN]


[MOA COMPREHENSION]


[PN: Q ASKED OF CONSUMER AND HCP]


[PROGRAMMER: KEEP ‘Please indicate whether you think the statement below is true or false based on the information you saw on the web page.’ AT THE TOP OF Q7 THROUGH Q11]


[PROGRAMMER: RANDOMIZE Q7 THROUGH Q11]


[SINGLE PUNCH]



Q7. LEYTROL does not harm healthy cells in the body. (QT=SS)

  • True

  • False


[PROGRAMMER: NEXT SCREEN]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]


Q8. LEYTROL kills cancer cells by releasing medicine inside the cell. (QT=SS)

  • True [Correct]

  • False


[PROGRAMMER: NEXT SCREEN]


[PN: Q ASKED OF CONSUMERS AND HCP]


[SINGLE PUNCH]


Q9. LEYTROL only attaches to cancer cells. (QT=SS)

  • True

  • False [Correct]



[PROGRAMMER: NEXT SCREEN]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]


Q10. LEYTROL works differently from chemotherapy. (QT=SS)

  • True [Correct]

  • False


[PROGRAMMER: NEXT SCREEN]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]


Q11. LEYTROL targets both healthy cells and cancer cells if they have a specific protein called Nectin-4. (QT=SS)

  • True [Correct]

  • False


[PROGRAMMER: NEXT SCREEN]


[PROGRAMMER: KEEP THIS PARAGRAPH AT THE TOP OF Q12 THROUGH Q23]

{Most people don’t know how a prescription drug will affect them until they’ve taken the drug. But we’d like you to make your best guess based on the web page you just saw. Please answer the following questions based on what you saw on the web page./Please answer the following questions based on what you saw on the web page rather than prior knowledge of this class of medications.}


[PERCEIVED BENEFIT - MAGNITUDE]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]


Q12. How beneficial do you think LEYTROL is at treating patients with bladder cancer? (QT=TT1SC)

1

Not at all beneficial

2

3

4

5

6

Extremely beneficial


[PROGRAMMER: NEXT SCREEN]


[PERCEIVED EFFICACY]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]


Q13. How effective do you think LEYTROL is at killing cancer cells? (QT=TT1SC)

1

Not at all effective

2

3

4

5

6

Extremely effective


[PROGRAMMER: NEXT SCREEN]


[PERCEIVED RISK - MAGNITUDE]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]



Q14. How serious are LEYTROL’s side effects? (QT=TT1SC)

1

Not at all serious

2

3

4

5

6

Extremely serious


[PROGRAMMER: NEXT SCREEN]


[PROGRAMMER: KEEP ‘To what extent do you agree or disagree with the following statement:’ AT THE

TOP OF Q15 THROUGH Q20]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]


Q15. Because of the way LEYTROL works, patients with bladder cancer who take LEYTROL will experience only minor side effects. (QT=TT1SC)


1

Strongly disagree

2

3

4

5

6

Strongly agree


[PROGRAMMER: NEXT SCREEN]


[PERCEIVED BENEFIT – TRADEOFF]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]



Q16. The benefits of LEYTROL outweigh any side effects it may have. (QT=TT1SC)

1

Strongly disagree

2

3

4

5

6

Strongly agree


[PROGRAMMER: NEXT SCREEN]


[PERCEIVED EFFICACY – COMPARATIVE]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]


[PROGRAMMER: RANDOMIZE Q17 and Q18]


Q17. Compared with other similar prescription drugs that treat bladder cancer, LEYTROL is more effective at killing cancer cells. (QT=TT1SC)


1

Strongly disagree

2

3

4

Neither agree nor disagree

5

6

7

Strongly agree


[PROGRAMMER: NEXT SCREEN]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]


Q18. Compared with other similar prescription drugs that treat bladder cancer, LEYTROL is less likely to harm healthy cells. (QT=TT1SC)


1

Strongly disagree

2

3

4

Neither agree nor disagree

5

6

7

Strongly agree



[PROGRAMMER: NEXT SCREEN]


[PERCEIVED RISK– COMPARATIVE]


[PN: Q ASKED OF CONSUMER AND HCP]


[PROGRAMMER: RANDOMIZE Q19 THROUGH Q21]


[SINGLE PUNCH]


Q19. LEYTROL’s side effects are just as serious as the side effects of other similar prescription drugs for bladder cancer. (QT=TT1SC)


1

Strongly disagree

2

3

4

Neither agree nor disagree

5

6

7

Strongly agree


[PROGRAMMER: NEXT SCREEN]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]


Q20. LEYTROL’s side effects are more tolerable than the side effects of other similar prescription drugs that treat bladder cancer. (QT=TT1SC)


1

Strongly disagree

2

3

4

Neither agree nor disagree

5

6

7

Strongly agree



[PROGRAMMER: NEXT SCREEN]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]


Q21. Please indicate which of the following is true. If you are unsure, please provide your best guess. (QT=SS)


  • People will experience fewer side effects with LEYTROL than they would with other similar prescription drugs that treat bladder cancer.

  • People will experience just as many side effects with LEYTROL as they would with other similar prescription drugs that treat bladder cancer.

  • People will experience more side effects with LEYTROL than they would with other similar prescription drugs that treat bladder cancer.


[PROGRAMMER: NEXT SCREEN]


[PROGRAMMER: RANDOMIZE Q22 and Q23]


[PERCEIVED EFFICACY– COMPARATIVE]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]



Q22. To what extent do you agree or disagree with the following statement: (QT=TT1SC)


LEYTROL is more effective than other similar prescription drugs that treat bladder cancer.


1

Strongly disagree

2

3

4

Neither agree nor disagree

5

6

7

Strongly agree


[PROGRAMMER: NEXT SCREEN]


[PERCEIVED RISK– COMPARATIVE]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]



Q23. To what extent do you agree or disagree with the following statement: (QT=TT1SC)


LEYTROL is safer than other similar prescription drugs that treat bladder cancer.


1

Strongly disagree

2

3

4

Neither agree nor disagree

5

6

7

Strongly agree


[PROGRAMMER: NEXT SCREEN]


[AD-PROMPTED ACTIONS]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]


Q24. If one of your {family members or close friends / patients} were considering using a prescription drug for bladder cancer, how likely would you be to mention LEYTROL to them? (QT=TT1SC)

1

Not at all likely

2

3

4

5

6

Extremely likely



[PN: Q ASKED OF CONSUMER]


[SINGLE PUNCH]



Q25_C. If I were to take a prescription drug for bladder cancer, I would consider taking LEYTROL. (QT=TT1SC)

1

Strongly disagree

2

3

4

5

6

Strongly agree



[PN: Q ASKED OF HCP]


[SINGLE PUNCH]



Q25_P. If I had patients with bladder cancer, I would consider prescribing LEYTROL. (QT=TT1SC)


1

Strongly disagree

2

3

4

5

6

Strongly agree


[PROGRAMMER: NEXT SCREEN]


[PERCEIVED INFORMATION USEFULNESS]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]

Q26. To what extent do you agree or disagree with the following statement: (QT=TT1SC)

This web page provides {patients/providers} with essential information for deciding whether to {ask a doctor about/prescribe} LEYTROL.


1

Strongly disagree

2

3

4

5

6

Strongly agree


[PROGRAMMER: NEXT SCREEN]


[PN: Q ASKED OF CONSUMER AND HCP]

Q27. The following information may or may not have been on the web page you saw.


{LEYTROL targets Nectin-4, a cell surface protein found on bladder cancer cells./LEYTROL is designed to target Nectin-4, an adhesion protein highly expressed on bladder cancer cells.}”

Did you see the information above below on the web page? (QT=SS)

1 Yes

2 No

3 Not sure


[PROGRAMMER: NEXT SCREEN]


[PN: Q ASKED OF CONSUMER AND HCP]

Q28. The following information may or may not have been on the web page you saw.

LEYTROL could also affect healthy cells.”

Did you see the information above below on the web page? (QT=SS)

1 Yes

2 No

3 Not sure


[PROGRAMMER: NEXT SCREEN]


[PROGRAMMER: ASK Q28B if Q28 = 1 “Yes”]

Q29. You indicated that the information below was on the web page you saw. (QT=SS)

LEYTROL could also affect healthy cells.”

How was the information presented on the web page?

1 Through text

2 Through images

3 Through both text and images


[PROGRAMMER: NEXT SCREEN]


[ATTITUDE TOWARD THE DRUG]


(PN: ASK ALL)

[PN: Q ASKED OF CONSUMER AND HCP]



Q30. Please tell us how you feel about LEYTROL. LEYTROL is… (QT=TT1SC)


[SINGLE PUNCH]


[PN: SOFT PROMPT SHOULD APPEAR IF ANY OF THE ITEMS ARE NOT ANSWERED; SOFT PROMPT SHOULD ONLY BE SHOWN ONCE]


[PROGRAMMER: RANDOMIZE ORDER OF ITEMS]



1

2

3

4

5

6


Q30_1. A bad product

A good product

Q30_2. Harmful

Helpful

Q30_3. Useless

Useful



[PROGRAMMER: NEXT SCREEN]



[HEALTH LITERACY]


[SINGLE PUNCH]


[PN: Q ASKED OF CONSUMER]



Q31_C. How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy? (QT=SS)

  1. Never

  2. Rarely

  3. Sometimes

  4. Often

  5. Always


[PROGRAMMER: NEXT SCREEN]


[PAST EXPERIENCE WITH DISEASE]



[PN: Q ASKED OF CONSUMER]


[SINGLE PUNCH]



Q32_C. Have you ever been diagnosed as having cancer? (QT=SS)


1 Yes

2 No


[PROGRAMMER: NEXT SCREEN]


[FAMILIARITY WITH CANCER TREATMENT]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]



Q33. How familiar are you with prescription drugs or treatments for cancer? (QT=TT1SC)


1

Not at all familiar

2

3

4

5

6

Very familiar


[PROGRAMMER: NEXT SCREEN]


[PN: Q ASKED OF HCP]


Q34. Please rate your current knowledge about targeted therapies for cancer treatments on a scale of 0 to 10, where 0 means knowing nothing and 10 means knowing everything you could possibly know about the topic.  _____ (QT=TT1SC)


[PROGRAMMER: NEXT SCREEN]


[BELIEFS ABOUT MEDICINES]


[PN: Q ASKED OF CONSUMER]




[PN: SOFT PROMPT SHOULD APPEAR IF ANY OF THE ITEMS ARE NOT ANSWERED; SOFT PROMPT SHOULD ONLY BE SHOWN ONCE]


Q35_C. We would like to ask you about your personal views on prescription medicines in general. These are statements other people have made about medicines. Please indicate the extent to which you agree or disagree with them by checking the appropriate box. There are no right or wrong answers. We are interested in your personal views. (QT=TT1SC)


[PROGRAMMER: RANDOMIZE ORDER OF ITEMS]


1

Strongly disagree

2

Disagree

3

Neither agree nor disagree

4

Agree

5

Strongly agree

Q35_C1. Medicines help many people to live better lives. [Reverse Code]






Q35_C2. Natural remedies are safer than medicines.






Q35_C3. Medicines do more harm than good.






Q35_C4. If doctors had more time with patients, they would prescribe fewer medicines.






Q35_C5. Most medicines are addictive.






Q35_C6. All medicines are poisons.







[PROGRAMMER: NEXT SCREEN]


[PROMOTION DISTRUST]


[PN: Q ASKED OF CONSUMER AND HCP]


[SINGLE PUNCH]



Q36. In general, how trustworthy do you find prescription drug promotion materials that are marketed to {patients/healthcare providers}? (QT=SC)

1 Not at all trustworthy

2 Somewhat trustworthy

3 Moderately trustworthy

4 Very trustworthy

5 Completely trustworthy


[PROGRAMMER: NEXT SCREEN]



[YEARS IN PRACTICE]


[PN: Q ASKED OF HCP]



Q37_P. How many years have you been in practice post-residency? If you did not do a residency, how many years have you been in practice? (QT=OEN)

_______ years [RANGE: 0 to 80]


[PROGRAMMER: NEXT SCREEN]


[PN: SHOWN TO CONSUMER AND HCP]


[DEBRIEF]



{LEYTROL is not a real product and is not available for sale. The purpose of this study is to learn about reactions to prescription drug information. To get a real-life reaction, we used a fictitious product in this study. Please see your healthcare provider for questions about bladder cancer./LEYTROL is not a real product and is not available for sale. The purpose of this study is to learn about reactions to prescription drug information. To get a real-life reaction, we used a fictitious product in this study.}


You have been very helpful. Thank you very much for your participation!



File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorJohnson, Mihaela
File Modified0000-00-00
File Created2023-09-02

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