Tradeoff Analysis Appendix E Interview Guide

Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion

Tradeoff Analysis Appendix E Interview Guide

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Appendix E

Cognitive Interview Guide



OMB Control No. 0910-NEW

Expiration date: xx/xx/xxxx


According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-NEW and the expiration date is xx/xx/xxxx. The time required to complete this information collection is estimated to average 60 minutes per response, including the time for reviewing instructions and completing and reviewing the collection of information.


Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.


Cognitive Interview Guide


My name is _____________, and I work for a company called RTI International based in North Carolina, and we are doing today’s study for the Food and Drug Administration, or the “FDA”. Today we want to get your opinions about a survey.

Before we begin, a few things:

  • I only know your first name, so be sure to not mention your last name in today’s discussion.

  • Everything you say will be kept confidential to the extent allowable by law.

  • Your participation is voluntary, and you can end the interview at any time, or refuse to answer any question, without penalty.

  • So that I have your full attention, be sure to mute your cell phone and limit distractions.

  • I have a couple colleagues who are also on the call today, including from FDA. They are here only to listen to your opinions and they will not participate in our discussion.

  • To make sure I capture all your opinions today, I’m going to record today’s session. Are you okay if I start recording now? [IF YES, START RECORDING.]

Do you have any questions for me, including any questions about the consent form that you read before today’s study?

OK, you have an important role today. You are going to be looking at a draft survey and giving us your opinions about the questions. Your role is important because you can help us find problems with the questions before we send the survey to more people. If you read a question and you find it confusing, then it is very likely other people will also be confused once the survey goes out to more people.

Today, I’m less interested in what your answers are – I’m more interested in how you come up with your answers. So I want you to “think aloud”. For example, if I asked you how many house plants are in your house or apartment, rather than just saying “3”, you might say “Well there are two in the kitchen and one in the living room. We also have a 4th plant in our living room but it’s a fake, but I’m not including that.” Does that make sense?


First, we would like to ask a series of questions about you and your experience with {plaque psoriasis \ type 2 diabetes}.


[Target Health Condition-Duration]

[radio; single punch]

A1_C. How long has it been since you were first diagnosed with {plaque psoriasis \ type 2 diabetes}?

1 Less than 5 years

2 6 – 10 years

3 11 – 15 years

4 16 – 20 years

5 More than 20 years


[Target Health Condition-Perceived Severity]

[SCALE]

A2_C. In your opinion, how severe is your {plaque psoriasis \ type 2 diabetes}?

1

Not at all severe

2

A little

severe

3

Moderately severe

4

Very

severe

5

Extremely severe


Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear about this question? [If yes, what?]

  • How did you come up with your answer?




[Target Health Condition-Controlled]

[SCALE]

A3. Please rate your agreement or disagreement with the following statement.

I am able to keep my {plaque psoriasis \ type 2 diabetes} under control most of the time.

1

Strongly disagree

2

Somewhat disagree

3

Neither agree nor disagree

4

Somewhat agree

5

Strongly agree


Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear about this question? [If yes, what?]

  • What does “under control” mean to you?

  • What does “most of the time” mean to you?



[Target Health Condition-Rx Familiarity]

[SCALE]

A4. How familiar are you with prescription drugs {\ other than insulin} that treat {plaque psoriasis \ type 2 diabetes}?

1

Not at all familiar

2

A little

familiar

3

Moderately familiar

4

Very

familiar

5

Extremely familiar


Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear about this question? [If yes, what?]

  • How did you come up with your answer?

  • What drugs are you familiar with?




[Target Health Condition -Rx]

[radio; single punch]

A5. Are you currently taking, or have you ever taken, any prescription drugs {for plaque psoriasis \ other than insulin for type 2 diabetes}?

1 Currently taking

2 Have taken in the past but not currently taking

3 Have never taken [Skip to A7]



Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear about this question? [If yes, what?]

  • Which drugs are you taking today?


A6_P. What forms of prescription drugs have you used to treat your plaque psoriasis? (Select all that apply)

A6_P_1. Cream, gel, or ointment put directly on the skin

A6_P_2. Pill or tablet taken by mouth

A6_P_3. Given through a shot under the skin (examples: prefilled pen, syringe)

A6_P_4. Given over a period of time through a needle placed in a vein in your arm (example: infusion or IV)

A6_P_5. Other (please specify)

A6_P_5_Open. [TEXT FIELD]



[IF A6_P_5 ‘Other’ is selected, DISPLAY Text Field A6_P_5_Open.]


Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear about this question? [If yes, what?]

  • Do all of the response options make sense?

  • What do you think is the difference between “shot under the skin” vs. “Given over a period of time through a needle placed in a vein”

  • Are there common forms of drugs that are missing that you think we should add so that people don’t have to select “other”?




[Diabetes-RxType]

[Checkbox; multi-punch]

A6_D. What forms of prescription drugs have you used to treat your type 2 diabetes? (Select all that apply)

A6_D_1. Pill or tablet taken by mouth

A6_D_2. Given through a shot under the skin with a prefilled pen

A6_D_3. Given through a shot under the skin with a syringe

A6_D_4. Other (please specify)

A6_D_4_Open. [TEXT FIELD]


[IF A6_D_4 ‘Other’ is selected, DISPLAY Text Field for A6_D_4_Open.]


Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear about this question? [If yes, what?]

  • Do all of the response options make sense?

  • What do you think is the difference between “shot under the skin with a prefilled pen” vs. “shot under the skin with a syringe”

  • Are there common forms of drugs that are missing that you think we should add so that people don’t have to select “other”?



[Health Insurance]

[radio; single punch]

A7. Are you now covered by any form of health insurance or health plan? This includes a private insurance plan through your employer, a plan that you purchased yourself, or a government program like Medicare or Medicaid.

1 Yes

2 No [Skip to Section B]

998 Don’t know [Skip to Section B]

[IF A7 = 1 ‘Yes’ GO TO A8, ELSE SKIP TO Section B]




[Rx Coverage]

[Radio; single punch]

A8. Does your current insurance plan help pay for prescription drugs?

1 Yes

2 No

998 Don’t know


[IF COHORT = 1 ‘Plaque psoriasis’, GO TO Section B_P (Plaque Psoriasis);

ELSE IF COHORT = 2 ‘T2 diabetes, GO TO Section B_D (Type 2 diabetes)]


Cognitive Interview Probes

  • Does your plan specifically pay for the [diabetes/psoriasis] drugs you need? [If NO] If not, how does that affect your answer?



[----------------------------------------New screen----------------------------------------]



[SECTION B_P (plaque Psoriasis). INTRODUCTION TO ATTRIBUTE DESCRIPTIONS]


The purpose of this study is to learn about your preferences for prescription drugs used to treat plaque psoriasis. In this section, we will describe 4 characteristics of psoriasis medicines:

  • Skin clearance after 4 months

  • Risk of rare but serious side effects

  • How the drug is taken

  • Additional information about the drug

As we describe each drug characteristic, we will ask you some questions about how you feel about it. Later in the survey, we will ask you to choose between psoriasis drugs that differ from one another based on these characteristics.


Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear in this text?


[Randomize THE Order In which Sections B1_P through B4_P are shown to respondentS.]


[----------------------------------------New screen----------------------------------------]

[SECTION B1_P (PSORIASIS). SKIN CLEARANCE]


Skin clearance after 4 months

Psoriasis is a health condition that can cause thick, scaly patches to form on the skin. Doctors sometimes prescribe psoriasis medicines to help their patients with psoriasis have clearer skin. One way to describe how well a prescription drug for psoriasis works is the chance that it will lower the amount of redness, thickness, scaling, and how much skin is covered by these patches, for example, by at least 90%.

In this study, we will ask you to consider the following 3 levels for the chance of seeing 90% clearer skin:

  • 4 out of 10 patients will see at least 90% clearer skin

  • 6 out of 10 patients will see at least 90% clearer skin

  • 8 out of 10 patients will see at least 90% clearer skin


[Importance-Psoriasis - SkinClearance]

[SCALE]

B1_P. How important to you is the chance that a psoriasis drug will give you 90% clearer skin?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important


Cognitive Interview Probes

  • First in the introduction text, is there anything that others may find confusing or unclear? [If yes, what?]

  • In the question, is there anything that others may find confusing or unclear? [If yes, what?]

  • What does “at least 90% clearer skin” mean to you?

  • In your own words, what is the question asking you?

  • How did you come up with your answer?



[----------------------------------------New screen----------------------------------------]

[SECTION B2_P (Psoriasis). Rare But Serious Side Effects]


Rare but serious side effects

Psoriasis drugs can have rare but serious side effects. In this study, we will ask you to consider different combinations of the following serious side effects:

  • Life-threatening allergic reactions

  • Serious infections that may lead to hospitalization or death

Signs of life-threatening allergic reactions may include trouble breathing or swallowing, raised bumps (hives), rash or itching, swelling of the face, lips, tongue, throat, or arms.

Serious infections that may lead to hospitalization or death. The infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread through the body.

[Importance-Psoriasis-Risks]

[SCale]

B2_P. How important are the rare but serious side effects of a psoriasis drug to you?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important


Cognitive Interview Probes

  • First in the introduction text, is there anything that others may find confusing or unclear? [If yes, what?]

  • In the question, is there anything that others may find confusing or unclear? [If yes, what?]

  • In your own words, what is the question asking you?

  • How did you come up with your answer?



[----------------------------------------New screen----------------------------------------]

[SECTION B3_P (Psoriasis). How the drug is taken]


How the drug is taken

Prescription drugs for plaque psoriasis come in many forms. In this study, we will ask you to consider drugs that are taken in one of the 4 following ways:

  • Pill taken by mouth

  • Cream, gel, or ointment put directly on your skin

  • Prefilled pen or syringe. Given through a shot under your skin

  • Infusion or IV. Given over a period of time through a needle placed in a vein in your arm


[Importance-Psoriasis-HowTaken]

[Scale]

B3_P. How important to you is the way you take a psoriasis drug?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important



Cognitive Interview Probes

  • First in the introduction text, is there anything that others may find confusing or unclear? [If yes, what?]

  • In the question, is there anything that others may find confusing or unclear? [If yes, what?]

  • In your own words, what is the question asking you?

  • How did you come up with your answer?


[----------------------------------------New screen----------------------------------------]

[SECTION B4_P (Psoriasis): Additional Information]



Additional information about the drug

Prescription drugs may come with additional information about the product. We will ask you to consider the 4 following claims:

  • Improved adherence in patients

  • Doctor preferred

  • #1 preferred by patients

  • Convenient


[Importance-Psoriasis-AddedInfo]

[SCALE]

B4_P. How important to you is the additional information about a psoriasis drug?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important


[IF COHORT = 1 ‘Plaque Psoriasis’, GO TO SECTION C_P (Plaque Psoriasis)]


Cognitive Interview Probes

  • First in the introduction text, is there anything that others may find confusing or unclear? [If yes, what?]

  • The introduction says “additional information”. Do you think “information” is the right word to use here?

  • In the first bullet, what does the word “adherence” mean to you?

  • In the question, is there anything that others may find confusing or unclear? [If yes, what?]

  • In your own words, what is the question asking you?

  • How did you come up with your answer?


[----------------------------------------New screen----------------------------------------]


[SECTION B_D (DIABETES). INTRODUCTION TO ATTRIBUTE DESCRIPTIONS]



The purpose of this study is to learn about your preferences for prescription drugs used to treat type 2 diabetes. In this section, we will describe 5 characteristics of diabetes medicines:

  • Change in your average blood sugar level after 6 months

  • How the drug is taken

  • How often the drug is taken

  • Risk of rare but serious side effects

  • Additional information about the drug

As we describe each drug characteristic, we will ask you some questions about how you feel about it. Later in the survey, we will ask you to choose between diabetes drugs that differ from one another based on these characteristics.

Cognitive Interview Probes

  • In this text, is there anything that others may find confusing or unclear? [If yes, what?]



[Randomize THE Order In which Sections B1_D through B5_D are shown to respondent.]




[----------------------------------------New screen----------------------------------------]

[SECTION B1_D (DIABETES). CHANGE IN A1c]



Change in average blood sugar level after 6 months

Doctors sometimes prescribe medicines to help people with type 2 diabetes control high blood sugar levels. A1C is a blood test that measures your average blood sugar level over the past 3 months. The goal for most people with type 2 diabetes is an A1C of 7.0% or less. However, your doctor may have set a different personal goal for you based on many things, such as your age or other medical conditions.

In this study, we will ask you to consider the following 3 levels of improved blood sugar:

  • Lower your A1C by 0.5 points

  • Lower your A1C by 1.0 point

  • Lower your A1C by 2.0 points

Cognitive Interview Probes

  • First in the introduction text, is there anything that others may find confusing or unclear? [If yes, what?]

  • In the question, is there anything that others may find confusing or unclear? [If yes, what?]

  • In your own words, what is the question asking you?

  • How did you come up with your answer?



[Importance-Diabetes-ChangeA1C]

[Scale]

B1_D. How important to you is the amount that your A1C average blood sugar level can be lowered by a diabetes drug?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important




[----------------------------------------New screen----------------------------------------]

[SECTION B2_D (DIABETES): HOW THE DRUG IS TAKEN]



How the drug is taken

Prescription drugs to improve blood sugar come in many forms. In this study, we will ask you to consider drugs that are taken in one of the 3 following ways:

  • Pill taken by mouth

  • Given through a shot under your skin with prefilled pen

  • Given through a shot under your skin with a syringe


[Importance-Diabetes-HowTaken]

[Scale]

B2_D. How important to you is the way you take a diabetes drug?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important



Cognitive Interview Probes

  • First in the introduction text, is there anything that others may find confusing or unclear? [If yes, what?]

  • In the question, is there anything that others may find confusing or unclear? [If yes, what?]

  • In your own words, what is the question asking you?

  • How did you come up with your answer?


[----------------------------------------New screen----------------------------------------]

[SECTION B3_D (Diabetes): HOW OFTEN THE DRUG IS TAKEN]



How often the drug is taken

In this study, we will ask you to consider drugs that differ based on how often you need to take them in one of the 4 following ways:

  • Three times a day

  • Two times a day

  • One time a day

  • One time a week



[Importance-Diabetes-Frequency]

[Scale]

B3_D. How important to you is how often you need to take a diabetes drug?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important



Cognitive Interview Probes

  • First in the introduction text, is there anything that others may find confusing or unclear? [If yes, what?]

  • In the question, is there anything that others may find confusing or unclear? [If yes, what?]

  • In your own words, what is the question asking you?

  • How did you come up with your answer?


[----------------------------------------New screen----------------------------------------]

[SECTION B4_D (Diabetes). Rare But Serious Side Effects]


Rare but serious side effects

Type 2 diabetes drugs can have rare but serious side effects. In this study, we will ask you to consider different combinations of the following serious side effects:

  • Life-threatening allergic reactions

  • Dying from heart disease

Signs of life-threatening allergic reactions may include trouble breathing or swallowing, raised bumps (hives), swelling of the face, lips, tongue, throat, or arms, burning eyes, skin pain, red or purple rash with blistering and peeling.

People taking some types of diabetes drugs have a greater chance of dying from heart disease compared to people treated with diet alone.



[Importance-Diabetes-Risks]

[SCALE]

B4_D. How important are the rare but serious side effects of a diabetes drug to you?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important





Cognitive Interview Probes

  • First in the introduction text, is there anything that others may find confusing or unclear? [If yes, what?]

  • In the question, is there anything that others may find confusing or unclear? [If yes, what?]

  • In your own words, what is the question asking you?

  • How did you come up with your answer?




[----------------------------------------New screen----------------------------------------]

[SECTION B5_D (diabetes): Additional Information]



Additional information about the drug

Prescription drugs may come with additional information about the product. We will ask you to consider the 4 following claims:

  • Improved adherence in patients

  • Doctor preferred

  • #1 preferred by patients

  • Easy to use


[Importance-Diabetes-AddedInfo]

[SCALE]

B5_D. How important to you is the additional information about a diabetes drug?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important


[IF COHORT = 2 ‘Type 2 Diabetes’, GO TO SECTION C_D (Diabetes)]

Cognitive Interview Probes

  • First in the introduction text, is there anything that others may find confusing or unclear? [If yes, what?]

  • The introduction says “additional information”. Do you think “information” is the right word to use here?

  • In the first bullet, what does the word “adherence” mean to you?

  • In the question, is there anything that others may find confusing or unclear? [If yes, what?]

  • In your own words, what is the question asking you?

  • How did you come up with your answer?




[----------------------------------------New screen----------------------------------------]

[SECTION C_P. PSORIASIS DISCRETE CHOICE EXPERIMENT (DCE)]

[DCE INTRO - Psoriasis]


The purpose of this section is to assess your preferences for prescription drugs that are used to treat adults with moderate to severe plaque psoriasis.

On the next few screens, we will show you several comparisons of prescription drugs to treat moderate to severe plaque psoriasis. The drugs are different from one another based on the 4 characteristics we discussed earlier: skin clearance after 4 months; rare but serious side effects; how the drug is taken; and additional information about the drug.

In all other ways, the drugs are the same, except for the characteristics we show you. For example, every drug has the same common side effects including upper respiratory infection, cough, stuffy nose, sore throat, headache, and diarrhea. This is not the complete list of possible side effects. All the drugs are FDA approved and cost the same.

Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]

  • What is your understanding of the task you need to do?



[----------------------------------------New screen----------------------------------------]

When completing the rest of the survey, please consider the following situation:

Suppose that your doctor says that your current psoriasis treatment is not working as well as they would like. Your doctor recommends that you try a prescription drug to help you have clearer skin.



Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]




[----------------------------------------New screen----------------------------------------]

[DCE PRACTICE QUESTION-INTRO - Psoriasis]


Before we start the survey, we’d like you to complete a practice question to get familiar with the task.

On the next screen, we will show you information about two drugs. Both drugs are prescription medicines used to treat moderate to severe plaque psoriasis in adults. The names of the drugs have been changed for this study.

Based on the information shown, please select which of the two drugs you would prefer to take.


[----------------------------------------New screen----------------------------------------]

Based on the information below, which drug would you choose to treat your plaque psoriasis?


Drug A

Drug B

Skin clearance after 4 months

8 out of 10 patients will see at least 90% clearer skin

2 out of 10 patients will see at least 90% clearer skin

Rare but serious side effects

Serious infections that may lead to hospitalization or death

Serious infections that may lead to hospitalization or death

How the drug is taken

Pill taken by mouth

Pill taken by mouth

Additional information about the drug

Doctor preferred

Doctor preferred



[DCE-TRAINING - Psoriasis]

[Radio; single punch]

C0_P. Which drug would you choose to treat your plaque psoriasis?

  1. Drug A [Go to ‘Drug A Debrief’ screen]

  2. Drug B [Go to ‘Drug B Debrief’ screen]


[if C0_P = 1 ‘Drug A’, Go to ‘drug a debrief’ screen;]

[Programmer:

  • IF C0_P = 1 ‘Drug A’, GO TO ‘Drug A Debrief - Psoriasis’ screen

  • IF C0_P = 2 ‘Drug B’, GO TO ‘Drug B Debrief - Psoriasis’ screen]



Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]

  • Tell me how you came up with your answer?

  • Earlier, the intro said that you could assume all attributes other than those listed in the table are the same between the two drugs, including costs and FDA approval. Are there any other characteristics of the two drugs that you need to be reminded are the same to make an accurate comparison?






[----------------------------------------New screen----------------------------------------]

[DRUG A DEBRIEF - PSORIASIS]

In this question, both drugs were exactly the same except that Drug A was more effective at achieving skin clearance compared to Drug B. You chose the more effective option.

In the following questions, the drugs we show you will differ in more than one way. Please look very carefully at each drug and consider which option you would actually choose.

Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]




[----------------------------------------New screen----------------------------------------]


[DRUG B DEBRIEF - PSORIASIS]

Please read these questions carefully. In this question, both drugs were exactly the same except that Drug A was more effective at achieving skin clearance compared to Drug B. You chose the less effective option.

In the following questions, the drugs we show you will differ in more than one way. Please look very carefully at each drug and consider which option you would actually choose.

Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]



[----------------------------------------New screen----------------------------------------]

Now you’re ready to take the rest of the survey. You’ll see more questions like the one you just answered.

In each question, we’ll ask you to choose between two drugs. For each pair, the drugs will differ from each other in more than one way. Please read the information about each drug carefully and consider which option you would choose to treat your plaque psoriasis. Make sure that you consider all 4 characteristics of both drugs in your answers.

Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]




[----------------------------------------New screen----------------------------------------]


[WILL UPDATE WHEN EXPERIMENTAL DESIGN COMPLETE]

[PROGRAMMER:

  • Each respondent will complete 8 choice tasks in this section. Show the choice tasks on 8 separate screens.

  • Each task will resemble the question below.

  • Populate the attribute levels in the drug profiles – empty cells in columns labeled Drug A or Drug B – in each choice task according to the experimental design in the Excel file, <File_name>.xlsx.

  • Randomize the order of attributes in each DCE choice task

  • Label the questions C1_P – C8_P.]



Based on the information below, which drug would you choose to treat your plaque psoriasis?


Drug A

Drug B

Skin clearance after 4 months



Rare but serious side effects



How the drug is taken



Additional information about the drug





[DCE - Psoriasis]

[Radio; single punch]

C1_P - C8_P. Which drug would you choose to treat your plaque psoriasis?

  1. Drug A

  2. Drug B



Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]

  • Tell me how you came up with your answer?

  • Do you have enough information to come up with an answer? [If no, what is missing?]

[----------------------------------------New screen----------------------------------------]


[AFTER QUESTION C4_P, DISPLAY THE FOLLOWING TEXT]

Make sure that you consider all 4 characteristics of both drugs in your answers. You are halfway through this part of the survey! Please keep going! Your answers are important.

[IF COHORT = 1 ‘Plaque psoriasis’, GO TO C(K+2)]


[----------------------------------------New screen----------------------------------------]

[SECTION C_D. DIABETES DISCRETE CHOICE EXPERIMENT (DCE)]

[DCE INTRO – Diabetes]


The purpose of this section is to assess your preferences for prescription drugs other than insulin that are used along with diet and exercise to improve blood sugar in adults with type 2 diabetes.

On the next few screens, we will show you several comparisons of prescription drugs to treat type 2 diabetes. The drugs are different from one another based on the 5 characteristics we discussed earlier: change in average blood sugar level; how the drug is taken; how often the drug is taken; rare but serious side effects; and additional information about the drug.

In all other ways, the drugs are the same, except for the characteristics we show you. For example, you will not need to change how often you check your blood sugar levels (with a finger stick, for example) for any of the drugs. Also, every drug has the same common side effects including headache, nausea, dizziness, stomach pain, tiredness, cough, and sore throat. This is not the complete list of possible side effects. All the drugs are used along with diet and regular exercise, are FDA approved, and cost the same.

Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]

  • What is your understanding of the task you need to do?




[----------------------------------------New screen----------------------------------------]

When completing the rest of the survey, please consider the following situation:

Suppose that your doctor says that your current diabetes treatment plan is not working to keep your blood sugar under control. Your doctor recommends that you try a prescription drug to help lower your A1C.

Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]




[----------------------------------------New screen----------------------------------------]

[DCE PRACTICE QUESTION-INTRO - Diabetes]


Before we start the survey, we’d like you to complete a practice question to get familiar with the task.

On the next screen, we will show you information about two drugs. Both drugs are prescription medicines used to improve blood sugar in adults with type 2 diabetes. The names of the drugs have been changed for this study.

Based on the information shown, please select which of the two drugs you would prefer to take.


[----------------------------------------New screen----------------------------------------]

Based on the information below, which drug would you choose to treat your type 2 diabetes?


Drug A

Drug B

Change in average blood sugar level

Lower A1C by 2.0 points

Example: Change in A1C from 8.5 to 6.5

Lower A1C by 0.5 points Example: Change in A1C from 8.5 to 8.0


How the drug is taken

Pill taken by mouth

Pill taken by mouth

How often the drug is taken

One time a day

One time a day

Rare but serious side effects

Life-threatening allergic reactions

Life-threatening allergic reactions

Additional information about the drug

Easy to use

Easy to use



[DCE-TRAINING - Diabetes]

[Radio; single punch]

C0_D. Which drug would you choose to treat your type 2 diabetes?

  1. Drug A [Go to ‘Drug A Debrief’ screen]

  2. Drug B [Go to ‘Drug B Debrief’ screen]



[if C0_D = 1 ‘Drug A’, Go to ‘drug a debrief’ screen;]

[Programmer:

  • IF C0_D = 1 ‘Drug A’, GO TO ‘Drug A Debrief - Diabetes’ screen

  • IF C0_D = 2 ‘Drug B’, GO TO ‘Drug B Debrief - Diabetes’ screen]



Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]

  • Tell me how you came up with your answer?

  • Earlier, the intro said that you could assume all attributes other than those listed in the table are the same between the two drugs, including costs and FDA approval. Are there any other characteristics of the two drugs that you need to be reminded are the same to make an accurate comparison?




[----------------------------------------New screen----------------------------------------]

[DRUG A DEBRIEF - DIABETES]

In this question, both drugs were exactly the same except that Drug A was more effective at lowering your average blood sugar levels compared to Drug B. You chose the more effective option.

In the following questions, the drugs we show you will differ in more than one way. Please look very carefully at each drug and consider which option you would actually choose.

Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]




[----------------------------------------New screen----------------------------------------]


[DRUG B DEBRIEF - DIABETES]

Please read these questions carefully. In this question, both drugs were exactly the same except that Drug A was more effective at lowering your average blood sugar levels compared to Drug B. You chose the less effective option.

In the following questions, the drugs we show you will differ in more than one way. Please look very carefully at each drug and consider which option you would actually choose.

Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]



[----------------------------------------New screen----------------------------------------]



Now you’re ready to take the rest of the survey. You’ll see more questions like the one you just answered.

In each question, we’ll ask you to choose between two drugs. For each pair, the drugs will differ from each other in more than one way. Please read the information about each drug carefully and consider which option you would choose to treat your type 2 diabetes. Make sure that you consider all 5 characteristics of both drugs in your answers.

Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]


[----------------------------------------New screen----------------------------------------]


[WILL UPDATE WHEN EXPERIMENTAL DESIGN COMPLETE]

[PROGRAMMER:

  • Each respondent will complete 8 choice tasks in this section. Show the choice tasks on 8 separate screens.

  • Each task will resemble the question below.

  • Populate the attribute levels in the drug profiles – empty cells in columns labeled Drug A or Drug B – in each choice task according to the experimental design in the Excel file, <File_name>.xlsx.

  • Randomize the order of attributes in each DCE choice task

  • Label the questions C1_D – C8_D.]



Based on the information below, which drug would you choose to treat your type 2 diabetes?


Drug A

Drug B

Change in average blood sugar level





How the drug is taken



How often the drug is taken



Rare but serious side effects



Additional information about the drug





[DCE - Diabetes]

[Radio; single punch]

C1_D – C8_D. Which drug would you choose to treat your type 2 diabetes?

  1. Drug A

  2. Drug B


Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]

  • Tell me how you came up with your answer?

  • Do you have enough information to come up with an answer? [If no, what is missing?]




[----------------------------------------New screen----------------------------------------]


[AFTER QUESTION C4_D, DISPLAY THE FOLLOWING TEXT]

Make sure that you consider all 5 characteristics of both drugs in your answers. You are halfway through this part of the survey! Please keep going! Your answers are important.


[----------------------------------------New screen----------------------------------------]

[PROGRAMMER: All Participants]

[UX]

[Grid; SINGLE PUNCH]


C9. The following statements refer to the questions that asked you to choose between {plaque psoriasis \ type 2 diabetes} drugs. Please indicate if you agree or disagree with the statements in the grid below.


1

Strongly disagree

2

Somewhat disagree

3

Neither agree nor disagree

4

Somewhat agree

5

Strongly agree

C9_1. The questions were easy to understand

C9_2. I found it easy to answer all the questions

C9_3. I answered all the questions in a way consistent with my preferences


Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]

  • What does “The questions were easy to understand” mean to you?

  • What does “I found it easy to answer all the questions” mean to you?

  • What does “I answered all the questions in a way consistent with my preferences” mean?


[----------------------------------------New screen----------------------------------------]


Lastly, here are some questions that require you to use numbers to solve the problem. Some are easy, and others are more difficult. Please don’t use a calculator: We’d like you to answer on your own. Remember, almost everyone will have trouble with these questions, so don’t be upset if some are difficult—just do your best!

[SECTION D. NUMERACY]

[NumeracyCoin]

[Numerical Field; integer range 0 – 1,000]


D1. 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?

[Numerical Entry] times out of 1,000

Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]



[NumeracyLotto]

[Numerical Field; integer range 0 – 1,000]


D2. 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?

[Numerical Entry] people

Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]



[NumeracySweepstakes]

[Numerical Field]


D3. 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?

[Numerical Entry] percent

Cognitive Interview Probes

  • Is there anything that others may find confusing or unclear? [If yes, what?]


[----------------------------------------New screen----------------------------------------]

[EXIT SCREEN]


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

The purpose of this study is to learn how prescription drug information shape people’s preferences. The drugs we showed you do not actually exist. Please see your medical doctor or other health care professional for questions about your health or {plaque psoriasis \ type 2 diabetes}.

[When participant clicks out of EXIT SCREEN, insert timestamp in data to record time ‘SURVEYTIME_END’]

E-41


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorBrewington, Micaela
File Modified0000-00-00
File Created2023-09-02

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