Appendix C - Questionnaire

Medical Conference Attendees’ Observations about Prescription Drug Promotion

Appendix C - Questionnaire

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FDA Medical Conference Attendee Study

Survey Questionnaire



[Introduction]

Thank you for agreeing to participate in this study today. This study is about medical conferences. By medical conferences, we mean conferences for clinicians, scientists, researchers, and other professionals who work in the field of medicine.


We will show you a video of a new product being promoted at a medical conference and then ask you some questions about it. We will also ask you some questions about your experiences at medical conferences. The survey will take about 20 minutes to complete.


Make sure you are comfortable and can read the screen clearly. The survey will include a video, so please make sure the sound on your device is active and the volume is turned up.


Section 1. Sample Exhibit Hall Interaction


Now we’d like you to watch a short video (2 minutes) about an interaction at a medical conference exhibit hall. Imagine that you are visiting this exhibit hall promotional booth at a recent conference and having this interaction with the person staffing the booth.


Following the video, please click the Continue button to answer some questions about the video. Please note that the video may take 15-30 seconds to start playing.


[DISPLAY ASSIGNED VIDEO] [SUPPRESS “CONTINUE” BUTTON UNTIL VIDEO FINISHES PLAYING]


Now, we would like you to answer the following questions based on the video you watched.


[Stimuli Exposure]

  1. Were you able to view the video?

  • Yes

  • No Terminate

  • Not sure Terminate


[Stimuli Exposure - Audio]

  1. The video included both audio and subtitles. Did you listen to the audio?

  • Yes, listened to audio

  • No, read subtitles only







[Perceived Source Credibility, Expertise, Attractiveness, Likeability, Familiarity, and Communication Skills]

  1. Please think about the person staffing the promotional booth in the video and answer the following questions. The staff person was…


[Randomize order]

1

2

3

4

5

6


  1. Insincere

Sincere

  1. Untrustworthy

Trustworthy

  1. Not an expert

Expert

  1. Inexperienced

Experienced

  1. Unfriendly

Friendly

  1. Pushy

Not pushy

  1. Poor communicator

Good communicator


[Perceived Source Expertise]

  1. Please think about the person staffing the promotional booth in the video and rate their expertise on the following dimensions.


[Randomize order]

1

Very little expertise

2


3


4


5

Great deal of expertise

  1. Product expertise (i.e., knowledgeable about products produced by their organization)






  1. Medical expertise (i.e., knowledgeable about clinical practice)







[Source Credential Recall]

  1. Which of the following credentials did the promotional booth staff member have?

  • Medical degree (e.g., MD, RN)

  • Research degree (e.g., PhD)

  • Law degree (e.g., JD)

  • Business degree (e.g., MBA)

  • Other health-related degree (e.g., nutrition)

  • No degree / Unknown


The video included information about [drug name]. Please answer the following questions based on the information in the video.





[Perceived Risk – Magnitude]

  1. How serious are [drug name]’s side effects?

1

Not at all serious

2

3

4

5

6

Extremely serious


[Perceived Efficacy – Magnitude]

  1. If a patient took [drug name], it would probably help their [medical condition] a lot.

1

Strongly disagree

2

3

4

5

6

Strongly agree


[Perceived Efficacy – Comparative]

  1. [Drug name] is more effective than other prescription drugs that treat [medical condition].

1

Strongly disagree

2

3

4

5

6

Strongly

agree


[Perceived Risk – Comparative]

  1. [Drug name] is safer than other prescription drugs that treat [medical condition].

1

Strongly disagree

2

3

4

5

6

Strongly

agree


[Attitude toward Drug]

  1. Please rate how you feel about [drug name].


[Randomize order]

1

2

3

4

5

6


  1. Bad option

Good option

  1. Harmful

Helpful

  1. Useless

Useful


[Intention to Prescribe]

  1. How likely would you be to prescribe [drug name] to a patient based only on the information in the video?

1

Not at all likely

2

3

4

5

6

Extremely

likely


[Disclosure Recognition]

  1. Which of the following statements, if any, were in the video? If you think a statement was in the video, click on that box to select it. Please select all that apply.


[Randomize order]

In the Video

Not In the video

  1. In clinical studies, patients retrospectively reported nausea and vomiting severity following initiation of treatment.



  1. Nomestra should be given 30 minutes before the patient will be at high risk for nausea, then every 8 hours after that for up to 7 days.



  1. In clinical studies, more than 50% of participants concurrently used a standard of care medication (dexamethasone) in addition to the investigational agent or placebo.



  1. Nomestra is contraindicated in individuals with end-stage renal disease.




[Disclosure Perception – Perceived Clinical Importance]

  1. How important would this statement be if you were deciding whether [drug name] is a good option for your patients?


In clinical studies, patients retrospectively reported nausea and vomiting severity following initiation of treatment.”

1

Not at all important

2

3

4

5

6

Extremely important


[Disclosure Interpretation]

13-A. Imagine you wanted to explain to a friend or family member what the statement displayed below means. Please explain the statement in your own words.


In clinical studies, patients retrospectively reported nausea and vomiting severity following initiation of treatment.”


[Open-ended text format]



Section 2. Recent Conference Behaviors


The next set of questions asks about the [conference name] that you recently attended.


[Recent Conference – Attendance Mode]

  1. What mode did you use to attend this year’s [conference name]? Please select all that apply.

  • In-person attendance

  • Video attendance

  • Phone attendance

  • Other (please specify)




[Recent Conference – Level of Engagement]

  1. How did your level of engagement in this year’s [conference name] compare with your level of engagement in previous years?

  • Attended more sessions than previous years

  • Attended the same number of sessions as previous years

  • Attended fewer sessions than previous years

  • This was my first year attending this conference


[Recent Conference – Virtual Exhibit Hall Presence]

  1. [If selected “Video,” “Phone,” or “Other” for Q14] You indicated that you attended some portion of [conference name] by video, phone, or another virtual method.


For those who attended virtually, did [conference name] offer an exhibit hall or other opportunities for interacting with industry representatives outside of conference sessions?

  • Yes

  • No

  • Not sure


[Display Q17, Q17-A, and Q17-B on same screen]


[Recent Conference – Virtual Exhibit Hall Description]

  1. [If selected “Yes” for Q16] Please answer the following questions about the exhibit hall or setting where virtual attendees were able to interact with industry representatives. Be as specific as possible.


17-A. [If selected “Yes” for Q16] When were virtual attendees able to interact with industry representatives (e.g., between sessions, during social hours)?

[Open-ended text format]


17-B. [If selected “Yes” for Q16] What interface did virtual attendees use to interact with industry representatives (e.g., video chat, special software)?

[Open-ended text format]


[Recent Conference – Level of Engagement with Industry Representatives]

  1. How did your level of engagement with industry representatives outside of conference sessions at this year’s [conference name] compare with your level of engagement in previous years?

  • More interaction than previous years

  • Similar interaction as previous years

  • Less interaction than previous years

  • This was my first year attending this conference







[Recent Conference Activity Attendance]

  1. Which of the following activities did you attend at [conference name]? Please select ­all that apply.


[Randomize order]

Attended

Did Not Attend

  1. Symposia / Oral sessions



  1. Workshops



  1. Poster sessions



  1. Social events



  1. Business/section meeting



  1. Promotional booths in exhibit hall




[Recent Conference Drug Presentations]

  1. Below are the activities you attended at [conference name]. During which of these activities were existing or emerging prescription treatments mentioned?


[Programming note: Show only activities selected in Q19]

[Randomize order]

Discussed

Not Discussed

  1. Symposia / Oral sessions



  1. Workshops



  1. Poster sessions



  1. Social events



  1. Business/section meeting



  1. Promotional booths in exhibit hall




[Perceptions of Recent Conference Information – Exhibit Halls]

  1. How did you feel about the information presented by industry representatives outside of conference sessions at [conference name]? In general, the information presented was…


[Randomize order]

1

2

3

4

5

6


  1. Inaccurate

Accurate

  1. Confusing

Clear

  1. Useless

Useful

  1. Not scientifically sound

Scientifically sound


  • I did not interact with industry representatives outside of conference sessions







[Perceived Risk/Benefit Balance of Recent Conference Information – Exhibit Halls]

  1. How much of the information presented by industry representatives outside of conference sessions at [conference name] offered a fair and balanced presentation of treatment benefits and risks?


1

None

2

A little

3

About half

4

Most

5

All


  • I did not interact with industry representatives outside of conference sessions


[Perceived Clinical Knowledge of Industry Representatives – Exhibit Halls]

  1. How would you rate the clinical knowledge of industry representatives you spoke with outside of conference sessions at [conference name]?


1

Not at all knowledgeable

2

3

4

5

6

Extremely knowledgeable


  • I did not interact with industry representatives outside of conference sessions


[Perceptions of Recent Conference Information – Conference Sessions]

  1. How do you feel about the information presented in symposia, oral, and poster sessions at [conference name]? In general, the information presented was…


[Randomize order]

1

2

3

4

5

6


  1. Inaccurate

Accurate

  1. Confusing

Clear

  1. Useless

Useful

  1. Not scientifically sound

Scientifically sound


[Perceived Risk/Benefit Balance of Recent Conference Information – Conference Sessions]

  1. How much of the information presented in symposia, oral, and poster sessions at [conference name] offered a fair and balanced presentation of treatment benefits and risks?


1

None

2

A little

3

About half

4

Most

5

All


[Claim Skepticism at Recent Conference]

  1. Did any of the presentations at [conference name] include claims about prescription treatments that made you skeptical from a scientific or clinical perspective?

  • Yes

  • No

  • Don’t remember


[Elements of Claim Skepticism at Recent Conference]

  1. [If “Yes” to Q26] What elements in the presentations made you skeptical? Please select all that apply.

[Randomize order of response options, except “other”]

  • Claims about treatment risks

  • Claims about treatment efficacy

  • Claims about unapproved (i.e., off-label) uses

  • Claims about clinical data or research findings

  • Other (please specify)


[Reasons for Claim Skepticism at Recent Conference]

  1. [If “Yes” to Q26] Why were you skeptical of these claims? Please select all that apply.

[Randomize order of response options, except “other”]

  • Claims were delivered by an industry representative

  • Claims did not align with my own clinical experience

  • Claims sounded too good to be true

  • Other (please specify)


[Disclosures at Recent Conference]

  1. How many of the sessions and activities that you attended at [conference name] mentioned


[Randomize order]

1

None

2

A few

3

About half

4

Most

5

All

  1. Prescription treatments that are already approved?






  1. Prescription treatments that are in clinical trials but not yet approved?






  1. Unapproved (i.e., off-label) uses of prescription treatments?






  1. The limitations of data presented?






  1. The sponsor of the research (or other potential conflicts of interest)?






  1. Studies that show different results than those currently presented?






  1. Risks of prescription treatments?








Section 3. Typical Conference Behaviors


The following questions ask about your activities at medical conferences in general. When answering these questions, please think about your medical conference attendance prior to COVID-19.



[Typical Conference Attendance Frequency]

  1. How many medical conferences do you attend in a typical year?

[Numeric drop down menu, ranging from 0 to 10+]


[Typical Reasons for Conference Attendance]

  1. What are the reasons you attend medical conferences? Please select all that apply.


[Randomize order]

  1. Present research


  1. Learn about the new and emerging medical issues


  1. Obtain CME credits


  1. Talk or meet with industry representatives


  1. Network with other healthcare professionals


  1. Collect materials for clinical reference or personal knowledge


  1. Participate in entertainment activities


  1. Learn about new treatments, devices, technology, or procedures


  1. Other (please specify_______________)



[Typical Factors that Influence Conference Selection]

  1. What factors influence which conferences you attend? Please select all that apply.


[Randomize order]

  1. Conference topic/focus


  1. Venue/location


  1. Date and duration


  1. Scheduled speakers


  1. CME credits


  1. Host organization


  1. Previous attendance


  1. Registration fees / costs


  1. Other (please specify_______________)




[Typical Conference Activity Attendance]

  1. How often do you attend the following activities when you go to medical conferences?


[Randomize order]

Never

Rarely

Sometimes

Most of the time

Always

  1. Symposia / Oral sessions






  1. Workshops






  1. Poster sessions






  1. Social events






  1. Business/section meeting






  1. Promotional booths in exhibit hall







[Typical Reasons for Exhibit Hall Visits]

  1. [Skip if answered “never” to Q34f] You mentioned that you visit promotional booths in medical conference exhibit halls. What are your reasons for visiting? Please select all that apply.


[Randomize order]

  1. Learn about new treatments, devices, technology, or procedures


  1. Obtain giveaway items


  1. Enter drawings/raffles


  1. Eat or drink refreshments


  1. Network with other healthcare professionals


  1. Other (specify_______________)



[Typical Time Spent in Exhibit Hall]

  1. [Skip if answered “never to Q34f] On average, how much time do you spend in the exhibit hall each day during a typical medical conference?

____ hours and ____ minutes per day


[Typical Time Spent Talking to Industry Reps]

  1. [Skip if answered “never” to Q34f] When visiting exhibit halls, how much time do you spend talking to industry representatives at each promotional booth?

_____ minutes per booth



[Typical Materials Collected from Exhibit Halls]

  1. [Skip if answered “never” to Q34f] How often do you collect the following materials when you visit promotional booths in exhibit halls?


[Randomize order]

Never

Rarely

Sometimes

Most of the time

Always

  1. Peer-reviewed journals






  1. Product brochures and other promotional materials






  1. Unpublished articles






[Typical Exhibit Hall Materials Read – Volume]

  1. [Skip if answered “never” for all Q38 sub-items or if answered “never” to Q34f] Of the materials you collect from promotional booths in exhibit halls, how many do you typically read?


1

None

2

A few

3

About half

4

Most

5

All


[Typical Perceived Usefulness of Exhibit Hall Materials]

  1. [Skip if answered “never” for all Q38 sub-items or if answered “never” to Q34f] In general, how useful do you find the materials that you collect from promotional booths in exhibit halls?


1

Not at all useful

2


3


4


5

Extremely useful


[Typical Exhibit Hall Materials – Clinical Use]

  1. [Skip if answered “never” for all Q38 sub-items or if answered “never” to Q34f] How often do you make use of the materials that you collect from promotional booths in exhibit halls in your clinical practice?


1

Never

2

Seldom

3

Occasionally

4

Often

5

All the time


[Interest in Emerging Therapies]

  1. How interested are you in conference presentations or sessions that discuss the following topics?


[Do not randomize order]

Not at all interested

1

2

3

4

5

Extremely interested

6

  1. New treatments

  1. New uses for existing treatments

  1. Emergent clinical data



Section 4. Participant Characteristics


[Years in Practice]

  1. How many years have you had prescribing authority as a healthcare provider? Please round to the nearest year.

_____ years


[Medical Specialty]

  1. What is your primary area of specialization?

[Drop down list, including primary care]

The next two questions ask about a normal week. A normal week is a week with a typical caseload, with no holidays, vacations, or conferences.


[Display Q46 and Q47 on same screen]


[Patient Load]

  1. How many patients do you see in a normal week? This includes in-person and virtual visits for both acute and continuous care patients. If you are not sure, please provide your best guess.

_____ patients


[Prescription Volume]

  1. How many prescriptions do you write in a normal week? This includes both refills and new prescriptions. If you are not sure, please provide your best guess.

_____ prescriptions


[Clinical Settings]

  1. In which medical settings do you currently practice? Please select all that apply.

  • Community hospital

  • Academic hospital

  • Outpatient clinic

  • Private/group practice

  • Other outpatient setting (e.g., infusion center)

  • Other (please specify)


[Practice Location]

  1. What is the ZIP code where your practice is located? If you practice in more than one location, please answer for the location where you practice most often.

(Open-ended numeric)


[Experience with Drug Representatives/Companies]

  1. Thinking about the past 3 months, please indicate the number of times you interacted with industry representatives in the following ways.


Activities

[Randomize order]

Number of Interactions

  1. Met with representatives in your workplace

__

  1. Attended lunch with representatives

__

  1. Received promotional items

__

  1. Received drug samples

__

  1. Met with representatives virtually (e.g., video, phone)

__





[Pharma Consulting]

  1. In the past year, have you performed any paid consulting activities for pharmaceutical or device companies?

  • Yes

  • No


[Pharma Consulting - Amount]

  1. [If “Yes” to Q51] Approximately how much were you paid last year by pharmaceutical and device companies?

$______


[Age]

  1. Please tell us your age.

___ years old


[Ethnicity]

  1. Are you Hispanic or Latino?

  • Yes

  • No


[Race]

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

  • American Indian or Alaska Native

  • Asian

  • Black or African American

  • Native Hawaiian or other Pacific Islander

  • White

  • Refuse to answer


[Gender]

  1. What is your gender?

  • Male

  • Female



Debriefing


Thank you for completing this survey. You have been very helpful.


The purpose of this study is to learn about reactions to drug advertising at medical conferences. In order to get a real-life reaction, we used a fictitious drug product in the video. [Drug name] is not a real product and is not available for sale.


Thank you again for your participation!

Research authorized by Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)). Confidentiality protected by 5 U.S.C. 552(a) and (b) and 21 CFR part 20.

OMB Control #0910-0901 Expires 8/31/2024

19


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