Testing FDA's Drug Safety Communications with Consumers to Improve Consumer Knowledge About How FDA Communicates Risks and Benefits of Prescription Medicines

IMPROVE Study Phase 2

DSC SCREENER ONLY

Testing FDA's Drug Safety Communications with Consumers to Improve Consumer Knowledge About How FDA Communicates Risks and Benefits of Prescription Medicines

OMB: 0910-0695

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FDA Drug Safety Communications Questionnaire DRAFT




FDA DSC QUESTIONNAIRE SCREENER

[PROGRAMMER NOTE: Headings (internal use only) are in red. Programming instructions are in blue.


[GENERAL SCREENER]


[ASK ALL] [SINGLE CODE]

S1. What is your gender ?


_1  Male

_2  Female


[ASK ALL] [NUMERIC]

S2. What is your date of birth (year and month)? 


YEAR

SINGLE PUNCH DROPDOWN PREQUAL


_[ACCEPTABLE RANGE FOR YEARS: 1910

...

_2000

[IF RESPONDENT UNDER 18 YEARS TERMINATE]



[ASK ALL] [OPEN ENDED]

S3. Please enter your zip code.

[CODE OPEN ENDED RESPONSE – 5 digits only]


[ASK ALL] [MULTI CODE]

S4. Are you trained or employed as (select all that apply):


[RANDOMIZE]

[ROWS]

Health care professional [IF YES TERMINATE]

Professional scientist or researcher [IF YES TERMINATE]

Educator

Electrician

Lawyer


[COLUMNS]

Yes

No


[ASK ALL] [MULTI CODE]

S5. Do you work in any of the following industries (select all that apply):


[RANDOMIZE]

[ROWS]

Pharmaceuticals [IF YES TERMINATE]

Advertising [IF YES TERMINATE]

Market research [IF YES TERMINATE]

Publishing

Energy

Engineering


[COLUMNS]

Yes

No



[CONDITION/DRUG USE SCREENER]


[ASK ALL] [SINGLE CODE]

C1. Have you ever been told by a doctor or other health professional that you have any of the following health problems (Select one for each)?


[RANDOMIZE]

[ROWS]

Asthma

Insomnia

Depression

Constipation

Diabetes or sugar diabetes

High blood pressure


[COLUMNS]

Yes

No

Not sure



[ASK IF FEMALE (2) @S1 AND IF YES (1) FOR “DIABETES OR SUGAR DIABETES” @C1] [SINGLE CODE]

C2. Other than during pregnancy, have you ever been told by a doctor or a health professional that you have diabetes or sugar diabetes? (Select one)


Yes

No

Not sure


[ASK ALL] [SINGLE CODE]

C3. Have you had any of the following symptoms in the last 3 months (Select one for each)??


[RANDOMIZE]

[ROWS]

  • Trouble having a bowel movement (straining) during at least 25% of bowel movements

  • Lumpy or hard stools in at least 25% of bowel movements

  • A sense that everything didn’t come out for at least 25% of bowel movements

  • Sensation of blockage for at least 25% of bowel movements

  • Needing help to have at least 25% of bowel movements (e.g., use of finger to assist, using hands to support rectal or vaginal muscles)

  • Fewer than three bowel movements per week


[COLUMNS]

Yes

No

Not sure



[PROGRAMMER: ELIGIBILITY FOR SURVEY

IF C1=”DIABETES” AND S1=”MALE”, THEN DIABETES-FLAG=1

IF C1 DOES NOT =”DIABETES” AND S1=”MALE” OR “FEMALE”, THEN DIABETES-FLAG=0


IF C1=”DIABETES” AND S1=”FEMALE” AND C2=YES, THEN DIABETES-FLAG=1

IF C1=”DIABETES” AND S1=”FEMALE” AND C2=NO OR NOT SURE, THEN DIABETES-FLAG=0


IF C1=”CONSTIPATION” OR TWO ITEMS=YES @C3, THEN CONSTIPATION-FLAG=1

IF C1 DOES NOT = “CONSTIPATION” OR LESS THAN TWO ITEMS=YES @C3, THEN CONSTIPATION-FLAG=0]



[PROGRAMMER: FILTERING INTO QUOTA CONDITION

IF DIABETES-FLAG=1 AND CONSTIPATION_FLAG=0, THEN QUOTA CONDITION=DIABETES


IF DIABETES-FLAG=0 AND CONSTIPATION_FLAG=1, THEN QUOTA CONDITION=CONSTIPATION


IF DIABETES-FLAG=1 AND CONSTIPATION_FLAG=1 AND BOTH CONDITIONS ARE OPEN, RANDOMLY ASSIGN QUOTA CONDITION


IF DIABETES-FLAG=1 AND CONSTIPATION_FLAG=1 AND ONE CONDITION IS CLOSE, ASSIGN TO OPEN CONDITION]





7

CLASSIFIED INTERNAL USE

Classified - Internal use

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