Appendix B - Questionnaire

Physician Survey of Research Data about Prescription Drugs

Introduction

Thank you for participating in this survey. On the next screen, you will be shown some informational material about a prescription drug.

Please read the material. After you finish, you will be asked some questions about it.

Pharmaceutical Information Material

nOTE: The following terminology will be used to distinguish between the different versions of the stimuli. Please note that respondents will always see the full stimuli before being shown a blurred version.

Condition	STIMULI TERM	STIMULI DESCRIPTION
1	STIM1	Full stimuli (2 pages)
	STIM1_A	Disclosure box at top of page 1 with torn edge border
	STIM1_B	Page 2 of stimuli
2	STIM2	Full stimuli
	STIM2_A	Disclosure box at top of page with torn edge border
3	STIM3	Full stimuli
	STIM3_A	Disclosure box at top of page with torn edge border
4	STIM4	Full stimuli
	STIM4_A	Disclosure box at top of page with torn edge border
5	STIM5	Full stimuli

Please scroll down to read all the material. {DISPLAY FOR CONDITION1: It is two pages long.} When you have finished reading it, please click on “Next.”

DISPLAY STIM1, STIM2, STIM3, STIM4, STIM5, BASED ON EXPERIMENT ASSIGNMENT

Q1_disclosure statement_confirm view

NOTE: This item is intended to confirm the respondent was able to see the material.

1. Were you able to view the material?

• Yes

• No  END

Q2_disclosure statement_recall

NOTE: Respondents will not be able to go back to material to answer questions. Each item will be presented individually on the screen.

FILL FOR [DRUG] FOR CANCER = imiquimod

FILL FOR [DRUG] FOR DIABETES = dapagliflozin

FILL FOR [DISEASE] FOR CANCER CONDITION = lentigo maligna

FILL FOR [DISEASE] FOR DIABETES CONDITION = type 1 Diabetes

1. Please answer the following questions based on what you remember from the materials you reviewed.

SHOW FOR CONDITIONS 1-4:

a. Based on what you read, is the use of [DRUG] for [DISEASE] approved according to the current US Prescribing Information?

• Yes

• No

• I’m not sure

PROCEED TO 2B.

SHOW FOR CONDITION 5:

a. Did the study you read mention whether the use of [DRUG] for [DISEASE] is approved according to the current US Prescribing Information?

• Yes

• No

• I’m not sure

PROCEED TO 2B.

SHOW FOR aLL CONDITIONs:

b. Based on what you read, are there study results that support the use of [DRUG] for [DISEASE]?

• Yes

 CONDITIONS 1, 4, 5: PROCEED TO 2C

 CONDITIONS 2-3: SKIP TO 2D

• No

 CONDITIONS 1-3: SKIP TO 2D

 CONDITIONS 4-5: SKIP TO 2F

• I’m not sure

 CONDITIONS 1-3: SKIP TO 2D

 CONDITIONS 4-5: SKIP TO 2F

SHOW FOR CONDITIONs 1, 4, 5 (IF INDICATED BY 2b SKIP PATTERN):

c. Thinking about the study that supported the use of [DRUG] for [DISEASE], was there a discussion of the study’s limitations?

• Yes

• No

• I’m not sure

CONDITION 1: PROCEED TO 2D

CONDITIONS 4-5: SKIP TO 2F

SHOW FOR CONDITIONs 1-3:

d. Did the materials mention study results that do not support the use of [DRUG] for [DISEASE]?

• Yes

 CONDITION 1: SKIP TO QUESTION 3

 CONDITIONS 2-3: PROCEED TO 2E

• No

 CONDITION 1: SKIP TO QUESTION 3

 CONDITIONS 2-3: SKIP TO QUESTION 3

• I’m not sure

 CONDITION 1: SKIP TO QUESTION 3

 CONDITIONS 2-3: SKIP TO QUESTION 3

SHOW FOR CONDITIONs 2-3 (IF INDICATED BY 2D SKIP PATTERN):

e. Did the materials provide a citation for a study that did not support the use of [DRUG] for [DISEASE]?

• Yes

• No

• I’m not sure

SKIP TO QUESTION 3

SHOW FOR CONDITIONs 4-5, ONCOLOGIST RESPONDENTS:

f. Did the study describe a retrospective records review of the use of [DRUG] for [DISEASE]?

• Yes

• No

• I’m not sure

PROCEED TO QUESTION 3

SHOW FOR CONDITIONs 4-5, PCP RESPONDENTS:

f. Did the study describe the use of [DRUG] as an adjunct to adjustable insulin therapy for [DISEASE]?

• Yes

• No

• I’m not sure

PROCEED TO QUESTION 3

Q3_contrary data_validity

3. How confident are you in the validity of the conclusion that the authors draw about the use of [DRUG] for [DISEASE]?

• Not at all confident

• A little confident

• Somewhat confident

• Very confident

• Extremely confident

Meaning, Influence, and Opinion Items

DISPLAY FOR CONDITION 1:

The next question asks specifically about the box at the top of the first page. This is the same material you viewed earlier.

[DISPLAY STIM1_A disclosure box on top of page 1 with torn edge margin]

DISPLAY FOR CONDITIONS 2-4:

The next questions ask specifically about the information in the box at the top of the page. This is the same material you viewed earlier.

NOTE: We will not refer to the text as a “disclosure statement,” but will reference it descriptively (i.e., “the information in the box”).

[DISPLAY STIM2_A, STIM3_A, STIM4_A disclosure box with torn edge margin]

NOTE: The stimuli WITH TORN EDGE will be displayed for the remainder of the items in this section for Conditions 2-4.

DISPLAY FOR CONDITION 5:

The next questions ask about the same material you viewed earlier.

[DISPLAY STIM5 entire stimuli]

NOTE: The stimuli will be displayed for the remainder of the items in this section for Condition 5.

ONLY ASK ITEM 4 FOR CONDITIONS 1-4:

Q4_disclosure statement_meaning

NOTE: ASKED ONLY OF CONDITIONS 1-4

DISPLAY STIM1_A, STIM2_A, STIM3_A, STIM4_A

PROGRAMMING: Stimuli and item will be displayed on the same screen

PROGRAMMING: Open-ended text box

4. In your own words, how would you explain the information in the box to a colleague?

ASK Q5 FOR ALL CONDITIONS:

Q5_disclosure statement_likely

DISPLAY STIM1_A, STIM2_A, STIM3_A, STIM4_A, STIM5

PROGRAMMING: Stimuli and item will be displayed on the same screen

PROGRAMMING: Fill for Conditions 1-4 = “box”; condition 5 = “material”

5. If you were considering prescribing [DRUG] to a patient with [DISEASE], how important would the information in the [DISPLAY FILL] be in your decision-making??

• Not at all important

• A little important

• Somewhat important

• Very important

• Extremely important

DISPLAY INTRODUCTION AND Q6 FOR CONDITION 1 ONLY:

The next question asks specifically about the second page of the material. This is the same material you viewed earlier.

[DISPLAY STIM1_B]

NOTE: Page 2 of the stimuli will be displayed for the remainder of the items in this section for Condition 1.

Q6_disclosure statement_likely 2nd page

NOTE: ASKED ONLY OF CONDITION 1

DISPLAY STIM1_B

PROGRAMMING: Stimuli and item will be displayed on the same screen

6. If you were considering prescribing [DRUG] to a patient with [DISEASE], how important would the information in the second brief report be in your decision-making??

• Not at all important

• A little important

• Somewhat important

• Very important

• Extremely important

DISPLAY Q7-10 FOR ALL CONDITIONS

Q7_disclosure statement_useful

DISPLAY STIM1_B, STIM2_A, STIM3_A, STIM4_A, STIM5

PROGRAMMING: Stimuli and item will be displayed on the same screen

PROGRAMMING: Fill for Condition 1 = “on page 2”; Conditions 2-4 = “in the box”; Condition 5 = “in the material”

7. If you were considering prescribing [DRUG] for [DISEASE], how useful would the information [DISPLAY FILL] be?

• Not at all useful

• A little useful

• Somewhat useful

• Very useful

• Extremely useful

Q8_disclosure statement_clear

DISPLAY STIM1_B, STIM2_A, STIM3_A, STIM4_A, STIM5

PROGRAMMING: Stimuli and item will be displayed on the same screen

PROGRAMMING: Fill for Condition 1 = “on page 2”; Conditions 2-4 = “in the box”; Condition 5 = “in the material”

8. How clearly is the information presented [DISPLAY FILL]?

• Not at all clear

• A little clear

• Somewhat clear

• Very clear

• Extremely clear

Q9_disclosure statement_credible

DISPLAY STIM1_B, STIM2_A, STIM3_A, STIM4_A, STIM5

PROGRAMMING: Stimuli and item will be displayed on the same screen

PROGRAMMING: Fill for Condition 1 = “on page 2”; Conditions 2-4 = “in the box”; Condition 5 = “in the material”

9. How credible is the information presented [DISPLAY FILL]?

• Not at all credible

• A little credible

• Somewhat credible

• Very credible

• Extremely credible

Q10_disclosure statement_more info

DISPLAY STIM1_B, STIM2_A, STIM3_A, STIM4_A, STIM5

PROGRAMMING: Stimuli and item will be displayed on the same screen

PROGRAMMING: Fill for Condition 1 = “on page 2”; Conditions 2-4 = “in the box”; Condition 5 = “in the material”

10. After reviewing the information [DISPLAY FILL], how likely are you to search for additional information about use of [DRUG] for [DISEASE]?

• Not at all likely

• A little likely

• Somewhat likely

• Very likely

• Extremely likely

Stimuli Assessment

Please note that this section will only be included in cognitive testing and the PREtest. this will allow us to identify issues with the stimuli before the actual study.

FOR CONDITIONS 1-4 DISPLAY THE FOLLOWING:

The next questions ask about the entire material.

[DISPLAY STIMULI]

DISPLAY Q11-13 FOR ALL CONDITIONS

Q11_ stimuli_missing info specify

DISPLAY STIM1, STIM2, STIM3, STIM4, STIM5

PROGRAMMING: Stimuli and item will be displayed on the same screen

PROGRAMMING: Ask only of those who answered yes to Q10
PROGRAMMING: Open-ended text box

11. What additional information, if any, did you need in order to consider prescribing [DRUG] for [DISEASE]?

Q12_ stimuli_difficulty

NOTE: ONLY INCLUDED IN TESTING (cognitive & PRETEST)

DISPLAY STIM1, STIM2, STIM3, STIM4, STIM5

PROGRAMMING: Stimuli and item will be displayed on the same screen

12. How difficult was it for you to answer these questions about the material you read?

• Not at all difficult

• A little difficult

• Somewhat difficult

• Very difficult

• Extremely difficult

Q13_ stimuli_difficulty specify

NOTE: ONLY INCLUDED IN TESTING (cognitive & PRETEST)

DISPLAY STIM1, STIM2, STIM3, STIM4, STIM5

PROGRAMMING: Stimuli and item will be displayed on the same screen

PROGRAMMING: Ask only of those who answered somewhat, very, or extremely difficult to Q12

PROGRAMMING: Open-ended text box

13. Please describe what made it difficult.

Prescribing Decisions

The next questions ask about how you decide to prescribe an approved drug for an indication that has not yet been approved by FDA, often called “off-label use.”

Q14_OFF-LABEL USE: freq offlabel

14. How often do you prescribe a drug for an off-label use?

• Once a week or more often

• Several times each month

• Several times each year

• Less than once a year

• I have never prescribed a drug for an off-label use

Q15_OFF-LABEL USE: practice_freq

PROGRAMMING: Ask only to participants who indicated prescribing off-label in Q14

15. Compared to you, how often do others in your practice prescribe a drug for off-label use?

• More often

• Less often

• About the same

• No other HCPs with prescribing authority in practice

Q16_OFF-LABEL USE: practice_yes/no

PROGRAMMING: Ask only of those who indicated having never prescribing off-label in Q14

16. Do others in your practice prescribe drugs for off-label use?

• Yes

• No

• I don’t know

• No other HCPs with prescribing authority in practice

Q17_OFF-LABEL USE: Info sources

PROGRAMMING: Ask only to participants who indicated prescribing off-label in Q13

17. Where do you typically first hear or learn about an off-label use for a prescription drug?

Q18_OFF-LABEL USE: Info sources_freq use

PROGRAMMING: Ask only to participants who indicated prescribing off-label in Q14

PROGRAMMING: Randomize ordering of items a-g, leaving “other specify” (h) last

18. How often do you use the following sources to learn about off-label uses for a drug?

	Never	Rarely	Sometimes	Often	Very Often
Colleagues					
Key opinion leaders or thought leaders in the field					
Medical journals					
Google or other online search engines					
Medical reference websites such as UpToDate or Epocrates					
Professional medical association conferences and communications					
Pharmaceutical companies					
Professional guidelines, please specify					
Other, please specify					

Q19_OFF-LABEL USE: Infosources_ likely use

PROGRAMMING: Ask only to participants who indicated having never prescribing off-label in Q14

PROGRAMMING: Randomize ordering of items a-g, leaving “other specify” (h) last

19. How likely are you to use the following sources to learn about off-label uses for a drug?

	Not at all likely	A little likely	Somewhat likely	Very likely	Extremely likely
Colleagues					
Key opinion leaders or thought leaders in the field					
Medical journals					
Google or other online search engines					
Medical reference websites such as UpToDate or Epocrates					
Professional medical associations conferences and communications					
Pharmaceutical companies					
Professional guidelines, please specify
Other, please specify					

Q20_OFF-LABEL USE: Infos ources_ seen support

20. Thinking of the studies you have seen in the past, how often have you seen study findings that support an off-label use of a drug?

• Never

• Rarely

• Sometimes

• Often

• Very often

Contrary data

Q21_contrary data_seen CONTRADICTORY

21. Thinking of the studies you have seen in the past, how often have you seen study findings that contradict an off-label use of a drug?

• Never

• Rarely

• Sometimes

• Often

• Very often

Q22_CONTRARY DATA_SEEN INCONCLUSIVE

22. Thinking of the studies you have seen in the past, how often have you seen study findings that have inconclusive support for an off-label use of a drug?

• Never

• Rarely

• Sometimes

• Often

• Very often

Q23_contrary data_support study aspects

PROGRAMMING: Randomize ordering of items a-h, leaving “other specify” (i) last

23. How important is it to you to know about the following aspects of a study about an off-label use of a drug?

	Not at all important	A little important	Somewhat important	Very important	Extremely important
Study population					
Study design, e.g., randomized controlled study, observational study					
Sample size					
Findings related to safety of the off-label use					
Findings related to side effects of the off-label use					
Study sponsor					
Number of studies that contradict or are inconclusive about an off-label use of a drug					
Findings related to effectiveness of the off-label use					
Other, please specify:					

Q25_contrary data_circumstances

NOTE: This question would be used in cognitive testing and/or pre-testing to develop a closed-ended survey question.

24. Under what circumstances would it be most important for you to know about studies that contradict or are inconclusive about an off-label use of a drug?

Q26_contrary data_contrary sources

PROGRAMMING: Randomize ordering of each response option, leaving the “other specify” option last

25. Of the following sources, please rank the top three which you would most likely use to learn about studies that contradict or are inconclusive about an off-label use of a prescription drug.

Please write 1, 2, or 3 in the boxes below to rank your top three choices.

• Colleagues

• Key opinion leaders or thought leaders in the field

• Medical journals

• Google or other online search engines

• Medical reference websites such as UpToDate or Epocrates

• Professional medical association conferences and communications

• Pharmaceutical companies

• Professional guidelines, please specify:

• Other, please specify:
  

Debrief

Thank you for taking part in this survey.

The materials presented in this survey were created specifically for this study and do not represent actual publications.

OMB Control # Expires XX/XX/XXXX 21