Tradeoff Analysis Appendix B Screeners PretestMainStudy

Appendix B

Pretest/Main Study Screeners

Pretest/Main Study Screeners:

Diagnosed Consumers

IMPORTANT GLOBAL PROGRAMMING NOTES:

• This annotated questionnaire is color coded:

• BLUE = The main text of programming notes and logical operators

• RED= Value names and labels, which are not meant to appear on screen. These correspond to parameters set in the data shell

• GREY= Variable names (i.e., question numbers). These correspond to variable names in the data shell

• BLACK= Question stems, response options and instructions that are meant to appear on screen

• Insert a no back prompt for every screen throughout the survey

• Include a variable named “CASEID” in the dataset to record a unique identification number for each subject.

• Include a variable named “COGTEST” in the dataset to record whether the participant is accessing the survey for the cognitive interview phase. This variable can take one of two values: COGTEST= 1 ‘Yes, cognitive interview phase’ or COGTEST = 0 ‘No, not cognitive interview phase’.

  • If COGTEST = 1, skip screener and consent, start at Section A.

• Include a variable named “EFLAG” in the dataset to record eligibility, where 1 ‘Eligible’ and 0 ‘Ineligible’. Set initial value for all cases to EFLAG = 1 ‘Eligible’.

• Include a variable named “COHORT” in the dataset to record which version of the DCE participants will complete. This variable can take one of two values: COHORT = 1 ‘Psoriasis’ or COHORT = 2 ‘Diabetes’. See programming note at start of Section A.

  • Dynata will invite respondents to participate in either the psoriasis version of the study or the type 2 diabetes version. The screener will confirm whether each respondent meets the eligibility criteria for his/her respective group.

  • If a respondent is eligible for both versions of the study, they should be assigned to COHORT = 1 ‘Psoriasis’ unless that target sample size for that study has been met.

• Include a variable named “BLOCK” in the dataset to assign/record which set of DCE tasks participants will complete. This variable can take integer values from 1 to 200. See programming note at top of Section A.

  • After the consent screen and before Section C, Dynata will randomly assign participants a value from 1 – 200 for “BLOCK”.

• Include a variable named “TIME_TOTAL” in the dataset to record the total amount of time in milliseconds that each respondent takes to complete the survey.

• Include soft prompts for all questions. If a question is skipped, display the following prompt (or if Dynata survey platform has default soft prompt language, use that): “You have not answered one or more questions on this screen. Please make a selection before continuing.” Prompt once, and then allow respondent to continue.

[IMPORTANT: Do not change question numbers/names after version submitted for programming. Changing question numbers will cause delays and potentially errors in the program.]

[PROGRAMMER: Include a placeholder for the OMB control number and expiration date, which will need to appear at the bottom of every screen. It should be as unobtrusive as possible: OMB control #: XXXX-XXXX; Exp: MM/DD/YYYY]

[PROGRAMMER: Some questions have conditional piping in item stems or response options that will depend on the study cohort, as captured in the COHORT variable (defined above). The conditional text appears in curly brackets “{ }” with the following rules:

Conditional text	COHORT	Display
{plaque psoriasis \ type 2 diabetes}	1 ‘Psoriasis’	plaque psoriasis
	2 ‘Diabetes’	type 2 diabetes
{\ other than insulin}	1 ‘Psoriasis’
	2 ‘Diabetes’	other than insulin
{for plaque psoriasis \ other than insulin for type 2 diabetes}	1 ‘Psoriasis’	for plaque psoriasis
	2 ‘Diabetes’	other than insulin for type 2 diabetes
{four \ five}	1 ‘Psoriasis’	four
	2 ‘Diabetes’	five
{$5.00 \ $4.00}	1 ‘Psoriasis’	$5.00
	2 ‘Diabetes’	$4.00

Example: For the bracketed text {plaque psoriasis \ type 2 diabetes}, IF COHORT= 1 ‘Psoriasis’, then display “plaque psoriasis” in place of the bracketed text.

[PROGRAMMER: For question sections that would require more complicated piping, we instead created two distinct sets of questions designated by the suffix _P or _D. The skip logic for those questions is given in separate programming notes.]

[QUOTA REQUIREMENTS:

• 20% of completes must have low health literacy, defined as S11 >= 3]

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 5 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.

[SCREENER]

[Age]

[NUMERICAL FIELD; INTEGER RANGE 0 – 100]

S1. What is your current age?

[Numerical Entry]  [Must be 18 or more to be Eligible]

[IF S1 < 18, set EFLAG = 0 ‘Ineligible’]

[Language]

[radio; single punch]

S2_C. Do you read and speak English fluently?

1 Yes  [Must select 1 ‘Yes’ to be Eligible]

2 No

[IF (S2_C = 2 ‘No’ OR S2_C = NULL), set EFLAG = 0 ‘Ineligible’]

[Occupation_Health]

[radio; single punch]

S3_C. Do you currently work in any of the following occupations?

1 Medical doctor

2 Any other type of health care provider (example: nurse, physician assistant)

3 None of the above  [Must select 3 ‘None…’ to be Eligible]

[IF (S3_C = 1 ‘Medical doctor’ OR S3_C = 2 ‘Any other…’ OR S3_C = NULL), set EFLAG = 0 ‘Ineligible’]

[Occupation_Orgs]

[Checkbox; multi-punch]

S4_C. Do you currently work for any of the following organizations? (Select all that apply)

S4_C _1. US Department of Health and Human Services

S4_C _2. Pharmaceutical company

S4_C _3. Market research firm

S4_C _4. RTI International

S4_C _5. None of the above  [Must select S4_C_5 to be Eligible]

[Programmer:

• IF S4_C_5 ‘None of the above’ is selected, disable other response options

• IF S4_C_5 ‘None of the above’ NOT selected, set EFLAG = 0 ‘Ineligible’]

[Diagnosis]

[Checkbox; multi-punch]

S5_C. Has a doctor, nurse, or other health professional ever told you that you had any of the following health conditions? (Select all that apply)

S5_C_1. Allergies

S5_C_2. Asthma

S5_C_3. Chronic pain

S5_C_4. High blood pressure

S5_C_5. High cholesterol

S5_C_6. Plaque psoriasis  [S5_C_6 ‘Plaque psoriasis’ - Eligible]

S5_C_7. Type 2 diabetes  [S5_C_7 ‘T2 diabetes’ - Eligible]

S5_C_8. None of the above

[Programmer:

• IF S5_C_8 ‘None of the above’ is selected, disable other response options

• IF S5_C_6 ‘Plaque psoriasis’ is NOT selected AND S5_C_7 ‘Type 2 diabetes’ is NOT selected, set EFLAG = 0 ‘Ineligible’]

[Gender]

[radio; single punch]

S6_C. What is your gender?

1 Male

2 Female

998 Prefer not to answer

[Screen for a mix WHERE S6_C = 1 ‘Male’ or S6_C = 2 ‘female’]

[Ethnicity]

[radio; single punch]

S7_C. What is your ethnicity?

1 Hispanic or Latino

2 Not Hispanic or Latino

[Screen for a mix on s7_C]

[Race]

[CHECKBOX; MULTI-PUNCH]

S8_C. What is your race? (Select all that apply)

S8_C_1. American Indian or Alaska Native

S8_C_2. Asian

S8_C_3. Black or African American

S8_C_4. Native Hawaiian or Other Pacific Islander

S8_C_5. White

[Screen for a mix on S8_C]

[Educational Attainment]

[radio; single punch]

S9_C. What is the highest degree or level of school you have completed?

1 Less than high school

2 High school graduate or GED

3 Some college but no degree

4 Associate degree (for example: AA, AS)

5 Bachelor’s degree (for example: BA, BS)

6 Postgraduate or advanced professional degree (for example: MA, MS, PhD, MD, DDS, JD)

[Screen for a mix on s9_C]

[State]

[DROPDOWN: SinGLE PUNCH]

S10_C. In what state do you currently live?

[Drop-down menu U.S. states + District of Columbia + U.S. Territories]

[Health-Literacy]

[radio; single punch]

S11_C. How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?

1 Never

2 Rarely

3 Sometimes

4 Often

5 Always

[Low health literacy quota: 20% of completes with s11 >= 3]

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

[DISPLAY ‘Thank and Terminate’ IF EFLAG=0 ‘INELIGIBLE’]

[Thank and Terminate]

We’re sorry, but you are not eligible for this study. There are many possible reasons why people are not eligible for this study. These reasons were decided earlier by the researchers. However, thank you for your interest in this study and for taking the time to answer our questions today.

[IF EFLAG=0 ‘INELIGIBLE, END HERE]

Pretest/Main Study Screeners:

Physicians

IMPORTANT GLOBAL PROGRAMMING NOTES:

• This annotated questionnaire is color coded:

• BLUE = The main text of programming notes and logical operators

• RED= Value names and labels, which are not meant to appear on screen. These correspond to parameters set in the data shell

• GREY= Variable names (i.e., question numbers). These correspond to variable names in the data shell

• BLACK= Question stems, response options and instructions that are meant to appear on screen

• Insert a no back prompt for every screen throughout the survey

• Include a variable named “CASEID” in the dataset to record a unique identification number for each subject.

• Include a variable named “COGTEST” in the dataset to record whether the participant is accessing the survey for the cognitive interview phase. This variable can take one of two values: COGTEST = 1 ‘Yes, cognitive interview phase’ or COGTEST = 0 ‘No, not cognitive interview phase’.

  • IF COGTEST = 1, skip screener and consent, start at Section A.

• Include a variable named “EFLAG” in the dataset to record eligibility, where 1 ‘Eligible’ and 0 ‘Ineligible’. Set initial value for all cases to EFLAG = 1 ‘Eligible’.

• Include a variable named “COHORT” in the dataset to record which version of the DCE participants will complete. This variable can take one of two values: COHORT = 1 ‘Psoriasis’ or COHORT = 2 ‘Diabetes’. See programming note at start of Section A.

  • Dynata will invite respondents to participate in either the psoriasis version of the study or the type 2 diabetes version. The screener will confirm whether each respondent meets the eligibility criteria for his/her respective group.

  • If a respondent is eligible for both versions of the study, they should be assigned to COHORT = 1 ‘Psoriasis’ unless that target sample size for that study has been met.

• Include a variable named “BLOCK” in the dataset to assign/record which set of DCE tasks participants will complete. This variable can take integer values from 1 to 200. See programming note at top of Section A.

  • After the consent screen and before Section C, Dynata will randomly assign participants a value from 1 – 200 for “BLOCK”.

• Include a variable named “TIME_TOTAL” in the dataset to record the total amount of time in milliseconds that each respondent takes to complete the survey.

• Include soft prompts for all questions. If a question is skipped, display the following prompt (or if Dynata survey platform has default soft prompt language, use that): “You have not answered one or more questions on this screen. Please make a selection before continuing.” Prompt once, and then allow respondent to continue.

[IMPORTANT: Do not change question numbers/names after version submitted for programming. Changing question numbers will cause delays and potentially errors in the program.]

[PROGRAMMER: Include a placeholder for the OMB control number and expiration date, which will need to appear at the bottom of every screen. It should be as unobtrusive as possible: OMB control #: XXXX-XXXX; Exp: MM/DD/YYYY]

[PROGRAMMER: Some questions have conditional piping in item stems or response options that will depend on the study cohort, as captured in the COHORT variable (defined above). The conditional text appears in curly brackets “{ }” with the following rules:

Conditional text	COHORT	Display
{plaque psoriasis \ type 2 diabetes}	1 ‘Psoriasis’	plaque psoriasis
	2 ‘Diabetes’	type 2 diabetes
{four \ five}	1 ‘Psoriasis’	four
	2 ‘Diabetes’	five

Example: For the bracketed text {plaque psoriasis \ type 2 diabetes}, IF COHORT= 1 ‘Psoriasis’, then display “plaque psoriasis” in place of the bracketed text.

[PROGRAMMER: For question sections that would require more complicated piping, we instead created two distinct sets of questions designated by the suffix _P or _D. The skip logic for those questions is given in separate programming notes.]

[SCREENER]

[Age]

[NUMERICAL FIELD; INTEGER RANGE 0 – 100]

S1. What is your current age?

[Numerical Entry]  [Must be 18 or more to be Eligible]

[IF S1 < 18, set EFLAG = 0 ‘Ineligible’]

[ProviderType]

[RADIO; single punch]

S2_M. Are you a…?

1 Physician  [Must select 1 ‘Physician’ to be Eligible]

2 Any Other Type of Health Care Provider (example: nurse, physician assistant)

3 None of the above

[IF (S2_M = 2 ‘Any other…’ OR S2_M = 3 ‘None of the above’ OR S2_M = NULL), set EFLAG = 0 ‘Ineligible’ AND SKIP TO S11_M]

[Specialty]

[RADIO; Single Punch]

S3_M. What is your primary area of specialization?

1 Cardiology

2 Dermatology

3 Endocrinology

4 Gastroenterology

5 Infectious Disease/Antiviral

6 Internal and Family Medicine/General Practitioner

7 Mental and Behavioral Health

8 Nephrology

9 Neurology

10 Oncology

11 Pulmonology/Allergy

12 Rheumatology/Auto-Immune

13 Other (please specify)

S3_M_13_Open. [TEXT FIELD]

[IF S3_M = 13 ‘Other’ is selected, DISPLAY Text Field S3_M_13_Open]

[Practicing]

[RADIO; Single Punch]

S4_M. Are you currently practicing medicine?

1 Yes  [Must select 1 ‘Yes’ to be Eligible]

2 No

[IF (S4_M = 2 ‘No’ OR S4_M = NULL), set EFLAG = 0 ‘Ineligible’

AND SKIP TO S11_M]

[Percent Care]

[NUMERICAL FIELD; INTEGER RANGE 0 – 100]

S5_M. What percentage of your time do you spend providing direct patient care? Your best estimate is fine.

[Numerical Entry] %  [Must be 50% or more to be Eligible]

[IF S5_M < 50, set EFLAG = 0 ‘Ineligible’]

[Conditions]

[Checkbox; multi-punch]

S6_M. Which of the following conditions do you treat? (Select all that apply)

S6_M_1. Allergies

S6_M_2. Asthma

S6_M_3. Chronic pain

S6_M_4. High blood pressure

S6_M_5. High cholesterol

S6_M_6. Plaque psoriasis  [Must select S6_M_6 ‘Plaque psoriasis’ - Eligible]

S6_M_7. Type 2 diabetes mellitus  [Must select S6_M_7 ‘T2 diabetes’ - Eligible]

S6_M_8. None of the above

[Programmer:

• IF S6_M_8 ‘None of the above’ is selected, disable other response options

• IF S6_M_6 ‘Plaque psoriasis’ NOT selected AND S6_M_7 ‘Type 2 diabetes’ is NOT selected, set EFLAG = 0 ‘Ineligible’

• IF S6_M_6 ‘Plaque psoriasis is selected AND S6_M_7 ‘Type 2 diabetes’ is selected, GO TO S7_M (ELSE SKIP TO S10)]

[Condition_Freq]

[RADIO; single punch]

S7_M. You mentioned you treat both type 2 diabetes mellitus and plaque psoriasis. Between these two conditions, which would you say you treat more often?

1 Plaque psoriasis

2 Type 2 diabetes mellitus

[PsoriasisRx]

[NUMERICAL FIELD; INTEGER RANGE >= 0]

[ASK IF S7_M = 1 ‘Plaque psoriasis’]

S8_M. In a typical week, how many prescriptions do you write for plaque psoriasis treatments? Your best estimate is fine.

[Numerical Entry]

[DiabetesRx]

[NUMERICAL FIELD; INTEGER RANGE >= 0]

[ASK IF S7_M = 2 ‘Type 2 diabetes’]

S9_M. In a typical week, how many prescriptions do you write for type 2 diabetes mellitus treatments? Your best estimate is fine.

[Numerical Entry]

[Occupation_Orgs]

[Checkbox; multi-punch]

S10_M. Do you currently work for any of the following organizations? (Select all that apply)

S10_M_1. US Department of Health and Human Services

S10_M_2. Pharmaceutical company

S10_M_3. Market research firm

S10_M_4. RTI International

S10_M_5. None of the above  [Must select S10_M_5 to be Eligible]

[Programmer:

• IF S10_M_5 ‘None of the above’ is selected, disable other response options

• IF S10PM_5 ‘None of the above’ NOT selected, set EFLAG = 0 ‘Ineligible’]

[Gender]

[radio; single punch]

S11_M. What is your gender?

1 Male

2 Female

998 Prefer not to answer

[Screen for a mix where S11_M = 1 ‘Male’ or S11_M = 2 ‘Female’]

[Ethnicity]

[radio; single punch]

S12_M. What is your ethnicity?

1 Hispanic or Latino

2 Not Hispanic or Latino

[Screen for a mix on s12_M]

[Race]

[CHECKBOX; MULTI-PUNCH]

S13_M. What is your race? (Select all that apply)

S13_M_1. American Indian or Alaska Native

S13_M_2. Asian

S13_M_3. Black or African American

S13_M_4. Native Hawaiian or Other Pacific Islander

S13_M_5. White

[Screen for a mix on S13_M]

[IF (S2_M = 2 ‘Any other…’ OR S2_M = 3 ‘None of the above’ OR S2_M = NULL)

OR (S4_M = 2 ‘No’ OR S4_M = NULL), SKIP TO ‘Thank and Terminate’]

[State]

[DrOpdown; SINGLE PUNCH]

S14_M. In what state is the majority of your practice located?

[Drop-down menu U.S. states + District of Columbia + U.S. Territories]

[PracticeTime]

[radio; SINGLE PUNCH]

S15_M. How long have you been practicing medicine?

1 Less than 5 years

2 6 – 10 years

3 11 – 20 years

4 21 – 30 years

5 31 or more years

[Screen for a mix on s15_M]

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

[DISPLAY ‘Thank and Terminate’ IF EFLAG=0 ‘INELIGIBLE’]

[Thank and Terminate]

We’re sorry, but you are not eligible for this study. There are many possible reasons why people are not eligible for this study. These reasons were decided earlier by the researchers. However, thank you for your interest in this study and for taking the time to answer our questions today.

[IF EFLAG=0 ‘INELIGIBLE, END HERE]

B-23