HCP Survey - Main Study

Healthcare Provider Perception of Boxed Warning Information Survey

Appendix C - Estrogen Survey

HCP Survey - Main Study

OMB: 0910-0890

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APPENDIX C


Healthcare Provider Perception of Boxed Warning Information Survey

Survey Questionnaire: Vulvar and Vaginal Atrophy Scenario

Version: 10/23/20



Prescriber Survey to Assess Boxed Warnings Perceptions

Survey Questionnaire: Vulvar and Vaginal Atrophy

(Questions used for pre-testing condition are included at the end)



Introductory Script:

Thank you for your participation in this survey. The first few questions will focus on the condition of vulvar and vaginal atrophy in menopause, which you may also know as postmenopausal atrophic vaginitis.

//PROGRAMMING NOTES: Display each question on its own separate screen. Do not allow participants to go back on any screen. Include soft prompts for all items. //


Question Type: Single Punch

Question Q1

Variable Name: Q1

Variable Label: Q1 Familiarity with treating VVA

Question Text: How experienced are you with treating vulvar and vaginal atrophy?


Value

Value Label

1

Not at all experienced

2

Slightly experienced

3

Somewhat experienced

4

Experienced

5

Very experienced

--99

Refused




Question Type: Single Punch

Question 2

Variable Name: Q2

Variable Label: Q2 Number of patients typically seen

Question Text: How many patients do you typically see for treatment of vulvar and vaginal atrophy?


Value

Value Label

1

One to two patients a week, or fewer

2

Several patients a week

3

Several patients a day

98

Unsure/Don’t know

--99

Refused





Question Type: Single Punch

Question Q3

Variable Name: Q3

Variable Label: Q3 Bothersomeness of symptoms

Question Text: In general, how bothersome are symptoms of vulvar and vaginal atrophy reported by most of your patients who have the condition?


Value

Value Label

1

Not at all bothersome

2

Slightly bothersome

3

Somewhat bothersome

4

Bothersome

5

Very bothersome

98

Unsure/Don’t know

--99

Refused




Question Type: Single Punch

Question Q4A

Variable Name: Q4A

Variable Label: Q4A Experience prescribing vaginal inserts

Question Text: Which of the following is true of your prescribing vaginal inserts (e.g., Vagifem, Imvexxy) for the treatment of vulvar and vaginal atrophy?


Value

Value Label

1

I have written new prescriptions for this product

2

I have only prescribed a refill for this product

3

I have never prescribed this product

98

Unsure/don’t know

-99

Refused


// PROGRAMMING NOTE: SKIP 4B if 4A = 2, 3, 4, or 98//


Question Type: Single Punch

Question Q4B

Variable Name: Q4B

Variable Label: Q4B Frequency of prescribing vaginal inserts

Question Text: On average, how often do you prescribe vaginal inserts (e.g., Vagifem, Imvexxy) for the treatment of vulvar and vaginal atrophy?


Value

Value Label

1

I prescribe this product one or more times a week

2

I prescribe this product a few times a month

3

I prescribe this product a few times a year

98

Unsure/Don’t know

-99

Refused




Question Type: Multi-Punch

Question Q5

Variable Name: Q5

Variable Label: Q5 Which treatments recommend or prescribe in a month

Question Text: Which of the following other treatments would you recommend or prescribe in a typical month? (Select all that apply.)


Value

Value Label

Variable Label

Q5_1

Over-the-counter products (e.g., personal lubricant)

Q5_1 Typical treatment: OTC products

Q5_2

Vaginal estrogen rings (e.g., Estring, Femring)

Q5_2 Typical treatment: Estrogen rings

Q5_3

Vaginal estrogen creams (e.g., Premarin, Estrace)

Q5_3 Typical treatment: Estrogen creams

Q5_4

Topical estrogen gels (e.g., Estrogel, Divigel)

Q5_4 Typical treatment: Estrogen gels

Q5_5

Oral estrogens (e.g., Premarin)

Q5_5 Typical treatment: Oral estrogens

Q5_6

Estrogen transdermal patches (e.g., Alora, Estraderm)

Q5_6 Typical treatment: Estrogen patch

Q5_7

Other prescription product that does not contain estrogen

Q5_7 Typical treatment: Other prescription product w/o estrogen

Q5_8

Other (specify)

Q5_8 Typical treatment: Other


Value

Value Label

1

Selected

0

Not selected





For the next few questions, we would like you to consider your patients who are postmenopausal women with vulvar and vaginal atrophy and are complaining of symptoms such as vaginal itching and discomfort or pain during intercourse. They have previously tried over-the-counter ointments with little success.

// PROGRAMMING NOTE: [SHOW SCENARIO AT THE TOP OF THE SCREEN FOR QUESTION 6]//




Question Type: Single Punch

Question Q6

Variable Name: Q6

Variable Label: Q6 Likelihood of discussing inserts

Question Text: How likely are you to discuss vaginal inserts, such as Vagifem or Imvexxy, as a potential option for these patients?


Value

Value Label

1

Very unlikely

2

Unlikely

3

Somewhat likely

4

Likely

5

Very likely

-99

Refused




Question Type: Single Punch

Question Q7

Variable Name: Q7

Variable Label: Q7 Risk assessment of vaginal inserts

Question Text: Which of the following statements describe your assessment of the safety of vaginal inserts used to treat vulvar and vaginal atrophy?


Value

Value Label

1

Risks are minimal for almost all patients

2

Risks are minimal for most patients, but are significant for some patients

3

Risks are significant for most patients

4

I am not familiar enough with vaginal inserts to make an assessment

-99

Refused




Question Type: Single Punch

Question Q8A

Variable Name: Q8A

Variable Label: Q8A Assessment of inserts vs. oral estrogen

Question Text: Which statement best describes your assessment of the safety of vaginal inserts compared to oral estrogen products?


Value

Value Label

1

Vaginal inserts are safer than oral estrogen products

2

Vaginal inserts are less safe than oral estrogen products

3

Vaginal inserts are no more and no less safe than oral estrogen products

4

The safety of vaginal inserts versus oral estrogen products has not been established

5

I am not familiar enough with vaginal inserts to make an assessment

-99

Refused




Question Type: Single Punch

Question Q8B

Variable Name: Q8B

Variable Label: Q8B Assessment of inserts vs. transdermal estrogen

Question Text: Which statement best describes your assessment of the safety of vaginal inserts compared to transdermal estrogen products?


Value

Value Label

1

Vaginal inserts are safer than transdermal estrogen products

2

Vaginal inserts are less safe than transdermal estrogen products

3

Vaginal inserts are no more and no less safe than transdermal estrogen products

4

The safety of vaginal inserts versus transdermal estrogen products has not been established

5

I am not familiar enough with vaginal inserts to make an assessment

-99

Refused





Question Type: Single Punch

Question Q8C

Variable Name: Q8C

Variable Label: Q8C Benefits/risks of inserts

Question Text: Which statement best describes your general perspective on the benefits versus risks of vaginal inserts for patients with vulvar and vaginal atrophy.


Value

Value Label

1

The benefits of vaginal inserts outweigh the risks for most patients

2

The benefits of vaginal inserts outweigh the risks for some, but not most, patients

3

The benefits of vaginal inserts outweigh the risks for very few patients

4

I am not familiar enough with vaginal inserts to make an assessment

-99

Refused




Question Type: Multi-Punch

Question Q9

Variable Name: Q9

Variable Label: Q9 Factors most important when choosing to prescribe vaginal inserts

Question Text: Which of the following factors play the most important role when deciding whether or not to prescribe vaginal inserts to a patient with vulvar and vaginal atrophy? Please choose the three factors that you consider to be most important.


//PROGRAMMING NOTE: ALLOW PARTICIPANTS TO SELECT UP TO THREE ANSWERS//


[RANDOM ORDER EXCEPT FOR OTHER] [//Multi-punch//]


Variable Name

Variable Text

Variable Label

Q9_1

Considerations of this patient’s ability to use the product as prescribed

Q9_1 Factor: Patient ability to use

Q9_2

This patient’s understanding of and comfort with the risks of this medication

Q9_2 Factor: Understanding and comfort with risks

Q9_3

This patient’s previous experience with treatments (over-the-counter and prescription)

Q9_3 Factor: Patient’s previous experience

Q9_4

This patient’s medical and health context (e.g., medical history, comorbidities, family history)

Q9_4 Factor: Medical and health context

Q9_5

Considerations of this patient’s access to the product (e.g., cost, insurance)

Q9_5 Factor: Patient access

Q9_6

Extent, duration, and severity of this patient’s symptoms

Q9_6 Factor: Symptoms

Q9_7

Patient’s preference for a mode of administration

Q9_7 Factor: Patient preference for administration

Q9_8

Potential duration of treatment use/course

Q9_8 Factor: Duration

Q9_9

Other (please specify)

Q9_9 Factor: Other



Value

Value Label

1

Selected

0

Not selected

Question Type: Multi-Punch

Question Q10

Variable Name: Q10

Variable Label: Q10 Top three questions from patients about using vaginal inserts

Question Text: What are the top three comments or questions you have you heard from patients about using vaginal inserts to treat vulvar and vaginal atrophy? (Select up to three.)


//PROGRAMMING NOTE: ALLOW PARTICIPANTS TO SELECT UP TO THREE ANSWERS//


[//Multi-punch//]


Variable Name

Variable Text

Variable Label

Q10_1

Pros about vaginal inserts’ application method

Q10_1 Pros application method

Q10_2

Hearing positive things about how well vaginal inserts work

Q10_2 Heard positive things

Q10_3

Whether vaginal inserts may be safer than other estrogen treatments

Q10_3 Inserts safer than other estrogen

Q10_4

A desire to try something new

Q10_4 Try something new

Q10_5

Cons about vaginal inserts’ application method

Q10_5 Cons application method

Q10_6

Concerns about insurance coverage or cost

Q10_6 Insurance coverage/cost

Q10_7

Hearing negative things about how well vaginal inserts work

Q10_7 Hearing negative things

Q10_8

Concerns about using an estrogen treatment

Q10_8 General concerns re: estrogen

Q10_9

Other (specify)

Q10_9 Other


Value

Value Label

1

Selected

0

Not selected




Question Type: Multi-Punch

Question Q11

Variable Name: Q11

Variable Label: Q11 Top three topics talk to patients about vaginal inserts

Question Text: What are the top three topics that you prioritize when talking to your patients about vaginal inserts as a treatment option?


//PROGRAMMING NOTE: ALLOW PARTICIPANT TO SELECT UP TO THREE ANSWERS//


[RANDOM ORDER EXCEPT FOR LAST OPTION] [//Multi-punch//]


Variable Name

Variable Text

Variable Label

Q11_1

How the product works

Q11_1 Talking top 3: How product works

Q11_2

Expected benefits of the product

Q11_2 Talking top 3: Expected benefits

Q11_3

Common side effects of the product

Q11_3 Talking top 3: Common side effects

Q11_4

Rare but serious side effects of the product

Q11_4 Talking top 3: Rare serious effects

Q11_5

Patient’s medical history (e.g., personal history or family history, possible co-morbidities)

Q11_5 Talking top 3: Medical history

Q11_6

The importance of using the product as directed

Q11_6 Talking top 3: Importance of use as directed

Q11_7

Other (Specify)

Q11_7 Talking top 3: Other


Value

Value Label

1

Selected

0

Not selected




//PROGRAMMING NOTE: If Q11D selected, display Q11_RISKS. OTHERWISE, PROCEED TO Q12 //


Question Type: Open End Essay

Question 11_RISKS

Variable Name: Q11_RISKS

Variable Label: Q11_RISKS Side effects discussed

Question Text: You said that you discuss rare but serious side effects of the product. What potential side effects do you discuss?


Shape1





Question Type: Multi-Punch

Question Q12

Variable Name: Q12

Variable Label: Q12 How monitor for safety risks and side effects after prescribing vaginal inserts

Question Text: How do you most commonly monitor your patients for potential safety risks and side effects after prescribing vaginal inserts for vulvar and vaginal atrophy? Select all that apply.


Variable Name

Value

Variable Label

Q12_1

I schedule routine follow-up appointments with patients.

Q12_1 Monitor: Follow-up appointment

Q12_2

I instruct patients to get bloodwork before follow-up appointment.

Q12_2: Monitor: Bloodwork

Q12_3

I instruct patients to call and schedule an appointment if they experience side effects.

Q12_3 Monitor: Appointment if side effects

Q12_4

I leave it to the patient to follow up if they feel a need to.

Q12_4 Monitor: Leave up to patient

Q12_5

A follow-up appointment is not necessary.

Q12_5 Monitor: Follow-up not necessary

Q12_6

Other (specify)

Q12_6 Monitor: Other


Value

Value Label

1

Selected

0

Not selected



Question Type: Grid

Question Q13

Variable Name: Q13

Variable Label: Q13 How often look for information on vaginal inserts

Question Text: How often do you look for information about vaginal inserts or other products from the following sources:


[RANDOM ORDER]


Variable Name

Variable Text

Variable Label

Q13_ 1

Medical journals

Q13_1 Info: Medical journals

Q13_2

Medical websites or software (e.g. UpToDate, Epocrates, Medscape)

Q13_2 Info: Medical websites or software

Q13_3

Drug company/pharmaceutical representatives or their website

Q13_3 Info: Drug company rep or website

Q13_4

Go online/use a search engine (e.g., Google)

Q13_4 Info: Online search

Q13_5

Professional medical societies (e.g., publications, guidelines)

Q13_5 Info: Professional medical societies

Q13_6

Conferences

Q13_6 Info: Conferences

Q13_7

Discussion with colleagues (e.g., in person, email)

Q13_7 Info: Discussion w/ colleagues

Q13_8

FDA website or other FDA sources of information (e.g., email, alerts)

Q13_8 Info: FDA

Q13_9

Other government agencies (e.g., NIH, CDC)

Q13_9 Info: Other government agencies


Value

Value Label

1

Never

2

Rarely

3

Sometimes

4

Often




//[SHOW QUESTION AT THE TOP OF THE SCREEN FOR QUESTION 14]//


The next question refers to boxed warnings, commonly referred to as black box warnings, on the product labeling for Vagifem, a vaginal tablet, and other estrogen products.



Question Type: Multi-Punch

Question Q14

Variable Name: Q14

Variable Label: Q14 Primary role of boxed warning

Question Text: In your opinion, what is the primary role of a boxed warning? Choose up to three options.


//Random Order, except last three

//PROGRAMMING NOTE: ALLOW PARTICIPANT TO UP TO SELECT THREE ANSWERS//


Variable Name

Variable Text

Variable Label

Q14_1

To highlight if the product has risk of serious or life-threatening adverse effects

Q14_1 BW Primary Role: Highlight most serious risks

Q14_2

To provide information that should be factored into a decision to prescribe the product

Q14_2 BW Primary Role: Provide prescribing information

Q14_3

To provide an overview of the safety profile of the product

Q14_3 BW Primary Role: Provide safety profile overview

Q14_4

To disclose clinical trial and other product safety testing information

Q14_4 BW Primary Role: Clinical trial and safety testing

Q14_5

To provide information that prescribers should be communicating to patients

Q14_5 BW Primary Role: Info to communicate to patients

Q14_6

To provide information on how to safely use the product

Q14_6 BW Primary Role: Info on how to safely use product

Q14_7

I do not see a role for them

Q14_7 BW Primary Role: No role for BW

Q14_8

Other (specify)

Q14_8 BW Primary Role: Other

Q14_9

Unsure/Don’t know

Q14_9 BW Primary Role: Unsure/Don’t know


Value

Value Label

1

Included

0

Not included





//PROGRAMMING NOTE: SHOW PARAGRAPH ON ITS OWN PAGE//

The next set of questions will ask you more specifically about the boxed warning and prescribing information for Vagifem to treat vulvar and vaginal atrophy. This boxed warning appears on all prescription estrogen products.


//PROGRAMMING NOTE: “NEXT” BUTTON TO PROCEED TO Q15//




Question Type: Single Punch

Question Q15

Variable Name: Q15

Variable Label: Q15 Familiarity with BW for Vagifem and other estrogen products

Question Text: How would you rate your familiarity with the boxed warning information for Vagifem and other estrogen products?


Value

Value Label

1

Not at all familiar

2

Slightly familiar

3

Somewhat familiar

4

Familiar

5

Very familiar

-99

Refused





Question Type: Single Select Grid

Question Q16

Variable Name: Q16

Variable Label: Q16 Risks recalled from vaginal insert boxed warning

Question Text: Which of the following risks do you recall being included in the boxed warning for vaginal inserts? Please indicate a response for each risk.


[RANDOM ORDER EXCEPT FOR LAST OPTION]


Variable Name

Variable Text

Variable Label

Q16_1

Endometrial cancer

Q16_1 Risks: Endometrial cancer

Q16_2

Endometrial hyperplasia

Q16_2 Risks: Endometrial hyperplasia

Q16_3

Dementia

Q16_3 Risks: Dementia

Q16_4

Stroke

Q16_4 Risks: Stroke

Q16_5

Deep vein thrombosis (DVT)

Q16_5 Risks: Deep vein thrombosis

Q16_6

Breast cancer

Q16_6 Risks: Breast cancer

Q16_7

Gallbladder disease

Q16_7 Risks: Gallbladder disease

Q16_8

Hypercalcemia

Q16_8 Risks: Hypercalcemia

Q16_9

Visual abnormalities

Q16_9 Risks: Visual abnormalities

Q16_10

Elevated blood pressure

Q16_10 Risks: Elevated blood pressure

Q16_11

Other (specify)

Q16_12 Risks: Other


Value

Value Label

1

Included

2

Not included

98

Don’t know




//PROGRAMMING NOTE: SHOW PARAGRAPH ON ITS OWN PAGE, THEN CLICK NEXT TO VIEW BOXED WARNING//

We would like to show you some of the boxed warning information for Vagifem, which is available in the FDA-approved prescribing information. This boxed warning information appears on the labeling for all estrogen products. Please take a few moments to review this information.

//PROGRAMMING NOTE: SHOW THE BOXED WARNING ON ITS OWN PAGE, CAPTURE TIME SPENT ON BOXED WARNING//



[View boxed warning information]1

//PROGRAMMING NOTE: HAVE A “NEXT” BUTTON AT THE BOTTOM OF THE BOXED WARNING PAGE TO PROCEED TO QUESTION 17//

Question Type: Single Punch

Question Q17

Variable Name: Q17

Variable Label: Q17 Usefulness of BW for Vagifem

Question Text: How useful is the information in the boxed warning for Vagifem?


Value

Value Label

1

Not at all useful

2

Slightly useful

3

Somewhat useful

4

Useful

5

Very useful

-99

Refused




Question Type: Single Punch

Question Q18

Variable Name: Q18

Variable Label: Q18 Assessment of risk framing in Vagifem BW

Question Text: What is your assessment of the way the risks of Vagifem are framed in the boxed warning?


Value

Value Label

1

Strongly understates risk

2

Somewhat understates risk

3

Provides appropriate assessment of risk

4

Somewhat overstates risk

5

Strongly overstates risk

6

Other (specify)

-99

Refused






Question Type: Single Punch

Question Q19

Variable Name: Q19

Variable Label: Q19 Assessment of benefits versus risks Post-BW

Question Text: Which statement best reflects your opinion on the relative benefits versus risks of vaginal inserts for patients with vulvar and vaginal atrophy.


Value

Value Label

1

The benefits of vaginal inserts outweigh the risks for most patients

2

The benefits of vaginal inserts outweigh the risks for some, but not most, patients

3

The benefits of vaginal inserts outweigh the risks for very few patients

4

I am not familiar enough with vaginal inserts to make an assessment

-99

Refused




Question Type: Multi-Punch

Question Q20

Variable Name: Q20

Variable Label: Q20 How improve Vagifem boxed warning

Question Text: What would improve the boxed warning for Vagifem, in your opinion? (Select all that apply.)


Variable Name

Variable Text

Variable Label

Q20_1

Nothing, the warning is fine the way it is

Q20_1 Improve BW: Nothing

Q20_2

Better evidence to support risk information

Q20_2 Improve BW: Better risk info evidence

Q20_3

Decrease the amount of information given/fewer words

Q20_3 Improve BW: Decrease amount of info/shorten

Q20_4

Simpler language

Q20_4 Improve BW: Simpler language

Q20_5

Formatting improvements (e.g., use of boldface)

Q20_5 Improve BW: Formatting

Q20_6

Increase the amount of information (e.g., statistics, more details)

Q20_6 Improve BW: Increase amount of info

Q20_7

Other (Specify)

Q20_7 Improve BW: Other (specify)

Q20_8

Make exclusive

Q20_8 Improve BW: Unsure/Don’t know

//Q20_8: Make exclusive//


Value

Value Label

1

Included

0

Not included


Question Type: Open-End Essay

Question Q21

Variable Name: Q21

Variable Label: Q21 Specific feedback on Vagifem BW information

Question Text: Please provide any specific feedback on the boxed warning information for Vagifem.


Shape2



//PROGRAMMING NOTE: SHOW SENTENCE ON ITS OWN PAGE, THEN CLICK NEXT TO VIEW Q22//

Please now consider boxed warnings in general, not only the one you saw for Vagifem.



Question Type: Grid

Question Q22

Variable Name: Q22

Variable Label: Q22 Degree agree or disagree with BW statements

Question Text: To what degree do you agree or disagree with the following statements about boxed warnings in general (in other words, across all classes of prescription drugs)?


[RANDOM ORDER for 1-6]


Variable Name

Variable Text

Variable Label

Q22_1

Boxed warnings are very common on the products that I prescribe

Q22_1 Agree/Disagree: BW are very common on products I prescribe

Q22_2

Boxed warnings do not generally factor heavily into my decisions on whether to prescribe a product

Q22_2 Agree/Disagree: BW do not generally factor heavily

Q22_3

I think carefully before prescribing a product with a boxed warning if other treatments are available

Q22_3 Agree/Disagree: I think carefully before prescribing BW product if others available

Q22_4

I counsel my patients differently when prescribing a product with a boxed warning

Q22_4 Agree/Disagree: Counsel patients differently with BW

Q22_5

My patients rarely know whether a product would have a boxed warning or not

Q22_5 Agree/Disagree: Patients rarely know if product has BW

Q22_6

My patients are worried or scared when they see boxed warnings

Q22_6 Agree/Disagree: Patients worried/scared when they see BW


Value

Value Label

1

Strongly disagree

2

Disagree

3

Neither agree nor disagree

4

Agree

5

Strongly agree

98

Unsure/Don’t know





Question Type: Single Punch

Question Q23

Variable Name: Q23

Variable Label: Q23 General favorability of BW

Question Text: How favorable is your opinion of boxed warnings in general (across all classes of prescription drugs)?


Value

Value Label

1

Very unfavorable

2

Somewhat unfavorable

3

Neither unfavorable nor favorable

4

Somewhat favorable

5

Very favorable

98

Unsure/Don’t know

-99

Refused




Question Type: Open End Essay

Question Q24

Variable Name: Q24

Variable Label: Q24 Suggestions for better using BW to highlight safety info

Question Text: In general, what suggestions do you have on how to better use boxed warnings as a tool to highlight important safety information?


Shape3




//PRETEST ONLY//

//DISPLAY TEXT//

We would like your feedback on the survey that you completed. This will help FDA improve the survey for future use with healthcare providers.

Question Type: Single Punch

Question P1

Variable Name: P1

Variable Label: P1 One session completion

Question Text: Were you able to complete the survey in one session?



Value

Value Label

1

Yes

0

No



Question Type: Single Punch

Question P2

Variable Name: P2

Variable Label: P2 Participant Experience with Survey

Question Text: How would you rate your experience taking the survey?



Shape4


Value

Value Label

1

Poor

2

Fair

3

Good

4

Very good

5

Excellent

-99

Refused




Question Type: Open End Essay

Question P3

Variable Name: P3

Variable Label: P3 Difficulty answering question

Question Text: Were there any questions you had difficulty answering? If yes, please explain.


Shape5


Question Type: Open End Essay

Question P4

Variable Name: P4

Variable Label: P4 Other feedback

Question Text: What other suggestions of feedback about this survey would you like to share?


Shape6




//DISPLAY FOR BOTH PRETEST AND MAIN STUDY//

Thank you for taking this survey. Your time is greatly appreciated.

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