Last updated 5/13/11
Physician Questionnaire
Sample: Primary care physicians
N = 500
• Half will see the treatment claim; half will see the prevention claim (random assignment)
• Half will see a small difference between drug and placebo rate; half will see a large difference between drug and placebo rate (random assignment)
|
|
Type of Claim |
|
|
|
Treatment Claim |
Prevention Claim |
Difference between Drug and Placebo |
Small Difference |
n = 125 |
n = 125 |
Large Difference |
n = 125 |
n = 125 |
|
Total N = 500
*Administer informed consent procedures*
Physician Questionnaire:
[PROGRAMMER: Record time in milliseconds spent on each screen (including questions) throughout protocol.]
[PROGRAMMER: Randomly assign participants to conditions as described above.]
Introductory language on at least three screens (to obtain baseline reading speeds).
Thank you for taking time from your busy schedule to contribute to this research. Your answers will remain confidential.
This study is about alternative methods of presenting prescription drug information. You will review information on a new (fictitious) product and make prescribing decisions as well as answer questions about the information you saw.
[PROGRAMMER: New screen]
On the next screen you will see the highlights section of the prescribing information for a fictitious new prescription drug, Milarix (lexisalicylic acid and milaristatin calcium). The document contains hyperlinks. This means you will be able to read the important information in the highlights section and explore each section in further detail by clicking on the section that interests you.
[PROGRAMMER: New screen]
Please read through this prescribing information as you would if you were learning about any new prescription-only product for the first time.
[PROGRAMMER: Display highlights section that will have hyperlinks to further information about each section. Record time spent on highlights section, time spent on each section, and order of sections chosen.]
(Perceived Benefit)
[PROGRAMMER: Randomize the order of Q1 and Q2]
Q1. If this were a real drug, how likely would you be to prescribe this drug to your patients?
Very likely
Somewhat likely
Somewhat unlikely
Very unlikely
Q1a. What about the drug caused you to select that answer? (open-ended)
Possible codes:
Efficacy
Safety
Convenience
Too new
Other
Q2. Based on the prescribing information you read, how effective would Milarix (lexisalicylic acid and milaristatin calcium) be for your patients?
1 2 3 4 5 6 7
Not at all Moderately Very
effective effective effective
Q3. Based on the prescribing information you read, how well would Milarix (lexisalicylic acid and milaristatin calcium) work for your patients?
1 2 3 4 5 6 7
Not at all Moderately Very
well well well
Q4. (open-ended) Please explain why you rated the effectiveness of Milarix (lexisalicylic acid and milaristatin calcium) as you did.
Possible codes:
Efficacy
Safety
Convenience
Too new
Other
(Perceived Safety)
[PROGRAMMER: Randomize the order of Q5 and Q6]
Q5. Based on the prescribing information you read, how safe would Milarix (lexisalicylic acid and milaristatin calcium) be for your patients?
1 2 3 4 5 6 7
Not at all Moderately Very
Safe safe safe
Q6. Based on the prescribing information you read, how risky would Milarix (lexisalicylic acid and milaristatin calcium) be for your patients?
1 2 3 4 5 6 7
Not at all Moderately Very
risky risky risky
(Perceived Comparative Benefit)
[PROGRAMMER: Randomize the order of Q7 and Q8]
Q7a. Compared with other drugs that treat chronic pain, how effective do you think Milarix (lexisalicylic acid and milaristatin calcium) is?
1 2 3 4 5 6 7
Not at all Moderately Very
effective effective effective
Q7b. Compared with other drugs that reduce the risk of heart attack, how effective do you think Milarix (lexisalicylic acid and milaristatin calcium) is?
1 2 3 4 5 6 7
Not at all Moderately Very
effective effective effective
(Perceived Comparative Safety)
Q8a. Compared with other drugs that treat chronic pain, how safe do you think Milarix (lexisalicylic acid and milaristatin calcium) is?
Not at all Moderately Very
Safe safe safe
Q8b. Compared with other drugs that reduce the risk of heart attack, how safe do you think Milarix (lexisalicylic acid and milaristatin calcium) is?
1 2 3 4 5 6 7
Not at all Moderately Very
effective effective effective
[PROGRAMMER: New screen]
Now you will see the same prescribing information that you saw earlier. Please refer to this prescribing information again, this time focusing specifically on how effective this drug is.
[PROGRAMMER: Display highlights section that will have hyperlinks to further information about each section. Record time spent on highlights section, time spent on each section, and order of sections chosen.]
Please answer the following specific questions based on what you learned from the Milarix (lexisalicylic acid and milaristatin calcium) prescribing information.
[PROGRAMMER: Participants who see treatment version will see Q9; participants who see prevention version will see Q10]
Q9. Based on the prescribing information you read, what is your sense of how much this product will reduce pain symptoms on average?
1 2 3 4 5 6 7
Not much Moderately A great
at all deal
Q10. Based on the prescribing information you read, what is your sense of what amount of reduction in heart attack risk can be expected with this drug?
1 2 3 4 5 6 7
Not much A moderate A great deal
reduction amount of reduction of reduction
[PROGRAMMER: All participants see Q11]
Q11. What about the information caused you to respond as you did in the last question? (open-ended)
Possible codes:
Efficacy
Safety
Convenience
Too new
Other
(Specific Benefit Accuracy)
[PROGRAMMER: For Questions 12-13, participants in the treatment study will see only questions 12T-13T. Participants in the prevention study will see only questions 12P-13P. In both cases, randomize the order of Q12-Q13]
Q12T. According to the information you just read, if 100 people take Milarix (lexisalicylic acid and milaristatin calcium), how many will experience less pain?
______ people (fill in the blank. PROGRAMMER: set acceptable range from 0 to 100)
Q13T. According to the information you just read, if 100 people take no treatment, how many will experience less pain?
______ people (fill in the blank. PROGRAMMER: set acceptable range from 0 to 100)
Q12P. According to the information you just read, if 100 people take Milarix (lexisalicylic acid and milaristatin calcium), how many will have a heart attack?
______ people (fill in the blank. PROGRAMMER: set acceptable range from 0 to 100)
Q13P. According to the information you just read, if 100 people take no treatment, how many will have a heart attack?
______ people (fill in the blank. PROGRAMMER: set acceptable range from 0 to 100)
[PROGRAMMER: New screen]
Now you will see four different versions of a magazine ad directed at patients. The ad is for another drug, a fictitious drug for high cholesterol, Votrea (trevastatin calcium). These four different versions represent different ways to present the data from the prescribing information to patients.
[PROGRAMMER: New screen]
Q14. There are many ways to present scientific data. Some are better than others. After looking at each of the four versions, please rank them from best to worst in terms of how well the ad represents the scientific information. In other words, your first selection will be the one you believe best represents the data, your second choice will be the one you believe is the second-best, and so forth.
To view each version in more detail, please click on the page and it will enlarge. You will be able to zoom in and out for your ease of viewing.
[PROGRAMMER:
1. Display all four versions of Votrea ad on screen. As participants click on a version, bring that version to a full screen view. Maintain some sort of zoom capacity so that participants can enlarge sections for ease of reading. Please adjust instructions to participants as appropriate, depending on the procedure you put in place.
2. Please arrange a format whereby participants can then select each version in their chosen order.
3. A randomly selected half of the participants will see treatment claim versions of the ad:
Version name 1
Version name 2
Version name 3
Version name 4
A randomly selected half of participants will see prevention claim versions of the ad:
Version name 5
Version name 6
Version name 7
Version name 8
]
Q14a. (open-ended) What about the different versions caused you to rank them this way?
Possible codes:
Format
Layout
Numbers
Text
Other
Q15. Now, looking at the same four versions, please rank these in order of ease of understanding for the typical patient. In other words, your first selection will be the version you think the typical patient will most readily understand, your second selection will be the second-most understandable version, and so forth.
[PROGRAMMER: Execute the same procedure as above. Participants will see the same versions in Q16 and Q17.]
Q15a. (open-ended) What about the different versions caused you to rank them this way?
Possible codes:
Format
Layout
Numbers
Text
Other
[PROGRAMMER: Randomize Qs 16-17. Q16 and 16a should be on the same screen at the same time. Q17 and 17a should be on the same screen at the same time.]
Please indicate your agreement with the following statements.
Q16. I can effectively communicate risk numerically (probability, percent).
Strongly agree
Somewhat agree
Somewhat disagree
Strongly disagree
Q16a. I consider this important to my practice.
Strongly agree
Somewhat agree
Somewhat disagree
Strongly disagree
Q17. I can effectively communicate risk qualitatively (‘high,’ ‘low’).
Strongly agree
Somewhat agree
Somewhat disagree
Strongly disagree
Q17a. I consider this important to my practice.
Strongly agree
Somewhat agree
Somewhat disagree
Strongly disagree
Q18. (Objective numeracy) Now here are some questions that require you to use numbers to solve the problem. Some are easy and others are more difficult. No calculators please- we’d like you to answer on your own.
[PROGRAMMER: DO NOT randomize Q18a-c]
Imagine that you flip a fair coin 1,000 times. What is your best guess about how many times the coin would come up heads in 1,000 flips?
___ times out of 1,000 [PROGRAMMER: set acceptable range from 0 to 1,000]
In the BIG BUCKS LOTTERY, the chance of winning a $10 prize is 1%. What is your best guess about how many people would win a $10 prize if 1,000 people each buy a single ticket to BIG BUCKS LOTTERY?
________ people [PROGRAMMER: set acceptable range from 0 to 1,000]
In ACME PUBLISHING SWEEPSTAKES, the chance of winning a car is 1 in 1,000. What percent of tickets to ACME PUBLISHING SWEEPSTAKES will win a car?
___ percent
Now please answer the following questions for classification purposes.
Q19. What year were you born? ______________
Q20. How many years have you been in practice? _________
Q21. Thinking about prescriptions of all kinds, about how many prescriptions do you write in an average week, including hospital and institutional orders?
_____ per week
Q22. How many prescriptions for chronic pain do you write in an average week?
_____ per week
Q23. How many prescriptions for cardiovascular outcomes do you write in an average week?
_____per week
Q24. About what percentage of your patients are you treating for chronic pain?
_____%
Q25. About what percentage of your patients are you treating for cardiovascular risk factors?
_____%
Q26. How would you rate your familiarity with prescription treatments for chronic pain?
Very familiar
Somewhat familiar
Somewhat unfamiliar
Not familiar at all
Q27. How would you rate your familiarity with prescription treatments for improving cardiovascular outcomes?
Very familiar
Somewhat familiar
Somewhat unfamiliar
Not familiar at all
Q28. How many hours in a typical week do you use the internet for work purposes, if at all?
_____ hours
Q29. How many hours in a typical week do you use the internet for personal use, if at all?
_____ hours
Q30. Are you part of any of the following health-care arrangements? You may say yes to more than one. (check all that apply)
A solo practice
A small group practice or partnership
A multispecialty group practice
A health maintenance organization or HMO
A preferred provider list or network of physicians
None of the above
Q31. Overall, how would you say direct-to-consumer advertising has affected your patients and your practice?
Very positively
Somewhat positively
Has not affected the quality at all
Somewhat negatively
Very negatively
Q32. What caused you to answer as you did in the previous question? (open-ended)
Possible codes:
Helps dialog
Hinders dialog
Takes too much time
Creates false expectations
Other
Thank you for taking the time to participate in this study. This study has been designed by the Food and Drug Administration to explore the ways physicians use approved prescription drug labels in an attempt to improve these documents for future use. Your participation has been valuable.
| File Type | application/msword |
| File Title | Physician Questionnaire |
| Author | BRAMANA |
| Last Modified By | BRAMANA |
| File Modified | 2011-05-13 |
| File Created | 2011-05-13 |