HCP Survey - Main Study

Healthcare Provider Perception of Boxed Warning Information Survey

Appendix C - Survey Estrogen

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


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 1

How experienced are you with treating vulvar and vaginal atrophy?


Variable Label: Q1 Familiarity with treating VVA


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

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


Variable Label: Q2 Number of patients typically seen


Value

Value Label

1

One to two patients each 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 3

In general, how bothersome are symptoms of vulvar and vaginal atrophy for most of your patients who have the condition?


Variable Label: Q3 Bothersomeness of symptoms


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 4A

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


Variable Label: Q4A Experience prescribing vaginal inserts


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 4B

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


Variable Label: Q4B Frequency of prescribing vaginal inserts


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 5

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

Value

Value Label

Variable Label

1

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

Q5_1 Typical treatment: OTC products

2

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

Q5_2 Typical treatment: Estrogen rings

3

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

Q5_3 Typical treatment: Estrogen creams

4

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

Q5_4 Typical treatment: Estrogen gels

5

Oral estrogens (e.g., Premarin)

Q5_5 Typical treatment: Oral estrogens

6

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

Q5_6 Typical treatment: Estrogen patch

7

Other prescription product that does not contain estrogen

Q5_7 Typical treatment: Other prescription product w/o estrogen

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 vulvo-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 6

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


Variable Label: Q6 Likelihood of discussing inserts


Value

Value Label

1

Very unlikely

2

Unlikely

3

Somewhat likely

4

Likely

5

Very likely

-99

Refused

Question Type: Single Punch


Question 7

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


Variable Label: Q7 Risk assessment of vaginal inserts


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 8A

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


Variable Label: Q8A Assessment of inserts vs. oral estrogen


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 8B

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


Variable Label: Q8B Assessment of inserts vs. transdermal estrogen


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 8C

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


Variable Label: Q8C Benefits/risks of inserts


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 9

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. [//Multi-punch//]


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


[RANDOM ORDER EXCEPT FOR OTHER]


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 10

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.) [//Multi-punch//]


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


[RANDOM ORDER, EXCEPT FOR OTHER]


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 11

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

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

Variable Label: Q11_RISKS Side effects discussed

Shape1



Question Type: Multi Punch


Question 12

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. [//Multi-punch//]

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 13

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 on the product labeling for Vagifem, a vaginal tablet, and other estrogen products.






Question Type: Multi-Punch


Question 14

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 the most serious potential risks of the product

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 15

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


Variable Label: Q15 Familiarity with BW 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: Multi Punch

Question 16

Which of the following risks do you recall being included in the boxed warning for vaginal inserts? Select all that apply.


[RANDOM ORDER EXCEPT FOR LAST TWO OPTIONS] [//Multi-punch//]


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

None of the above

Q16_11 Risks: None of the above

Q16_12

Other (specify)

Q16_12 Risks: Other


Value

Value Label

1

Included

2

Not included

3

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//



[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 17

How useful is the information in the boxed warning for Vagifem?


Variable Label: Q17 Usefulness of BW 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 18

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


Variable Label: Q18 Assessment of risk framing in Vagifem BW


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 19

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


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


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 20

What would improve the boxed warning for Vagifem, in your opinion? (Select all that apply.) [//Multi-punch//]


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

Unsure/Don’t know

Q20_8 Improve BW: Unsure/Don’t know


Value

Value Label

1

Included

2

Not included


Question Type: Open-End Essay


Question 21

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


Variable Label: Q21 Specific feedback on Vagifem BW information


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 22

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

Q22_7

Other (specify)

Q22_7


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 23

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


Variable Label: Q23 General favorability of BW


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 24

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


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

Shape3


//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

Were you able to complete the survey in one session?

Variable Label: P1 One session completion

Value

Value Label

1

Yes

0

No





Question Type: Open End Essay

Question P2

Did you rely on other sources (e.g., Google, colleagues, etc.) to answer questions you found difficult to answer? If yes, please explain.


Variable Label: P2 Other sources

Shape4


Question Type: Open End Essay

Question P3

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


Variable Label: P3 Difficulty answering question

Shape5


Question Type: Open End Essay

Question P4

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


Variable Label: P4 Other feedback

Shape6




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

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