Collection of Data to Support Training Decay Selection for Medical Product Usability Validation Testing (CDER)

End of Session Questionnaire

12/9/2019

OMB Control No.: 0910-0847
Expiration Date: 12/31/2022
Paperwork Reduction Act Statement: 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 0910-0847, and the expiration date is 12/31/2022. The time
required to complete this information collection is estimated to average 90 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 [email protected].
This study is being conducted on behalf of the U.S. Food and Drug Administration by UserWise,
Inc. and San Jose State University.

End of Session Questionnaire
Next, I would like to have you look at some health information and then answer a few
questions about that information. It is expected that this should take approximately 4-10
minutes.
Please note that these questions have no impact on your eligibility or compensation and are for
informational purposes, only.
*

1.

Required
Participant ID (the Moderator will enter this) *

Nutritional Facts Survey
Please note that these questions have no impact on your eligibility for compensation and
are for informational purposes, only.

The image below shows information on the back of a container of a
pint of ice cream. Using this image provided, please answer the
following questions. You may use the calculator made available to
you if needed for any of the questions.
Ice Cream Nutritional Facts:

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2.

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The image above shows information on the back of a container of a pint of ice
cream. If you eat the entire container, how many calories will you eat? *
Please enter a numerical value (no commas or decimals)

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3.

If you are allowed to eat 60 grams of carbohydrates as a snack, how many cups of
ice cream could you have? *
Please select the value in cups from the dropdown list
Mark only one oval.
None
1/4 cup
1/2 cup
3/4 cup
1 cup
1 and 1/4 cups
1 and 1/2 cups
1 and 3/4 cups
2 cups
2 and 1/4 cups
2 and 1/2 cups
2 and 3/4 cups
3 cups
3 and 1/4 cups
3 and 1/2 cups
3 and 3/4 cups
4 cups

4.

Your doctor advises you to reduce the amount of saturated fat in your diet. You
usually have 42g of saturated fat each day, which includes one serving of ice
cream. If you stop eating ice cream, how many grams of saturated fat would you
be consuming each day? *
Please enter a numerical value (no commas or decimals)

5.

If you usually eat 2,500 calories in a day, what percentage of your daily value of
calories will you be eating if you eat one serving? *
Please enter a numerical value (no commas or decimals, no percentage sign)

6.

Pretend that you are allergic to the following substances: penicillin, peanuts, latex
gloves, and bee stings. Is it safe for you to eat this ice cream? *
Mark only one oval.
Yes
No
Not sure

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7.

(if you answered no to Question 5a) What allergy would make it unsafe to eat this
ice cream? *
Mark only one oval.
Penicillin allergy
Peanut allergy
Latex glove allergy
Bee sting allergy

Additional Demographics
Please note that these questions have no impact on your eligibility for compensation and are for
informational purposes, only.
8.

What is your ethnicity? *
Note: this is an excerpt from the 2020 census program.
Mark only one oval.
American Indian or Alaska Native
Asian
Black or African American
Hispanic or Latino
Native Hawaiian or other Pacific Islander
White
I prefer not to disclose
Other:

9.

Is English your first language?
Mark only one oval.
Yes
No
Other:

10.

If English is not your first language, what language is?

11.

Which is your dominant hand? *
Mark only one oval.
Right
Left
Ambidextrous

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12.

Do you normally wear glasses or contact lenses? *
Mark only one oval.
Yes, and I had them available for the study session(s)
Yes, and I did NOT have them available for the study session(s)
No

13.

Are you color blind? *
Mark only one oval.
Yes
No
Not sure

14.

How tired are you feeling today? *
Mark only one oval.
1 - Not at all tired
2 - Slightly tired
3 - Moderately tired
4 - Very tired

15.

At the start of the study session today, what level of stress were you feeling? *
Mark only one oval.
1 - Not at all stressed
2 - Slightly stressed
3 - Moderately stressed
4 - Very stressed
5 - Extremely stressed

Note: These next questions are only applicable if you participated in two
study sessions. If you only participated in one session, please proceed to
"Next."
16.

(if you participated in two study sessions) Has your level of stress changed from
the start of the first session to the start of the second session?
Mark only one oval.
1 - Much worse
2 - Somewhat worse
3 - Stayed the same
4 - Somewhat better
5 - Much better

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17.

(if you participated in two study sessions) How tired were you feeling today,
compared to how you felt during your first session?
Mark only one oval.
1 - Much worse
2 - Somewhat worse
3 - Stayed the same
4 - Somewhat better
5 - Much better

18.

(if you participated in two study sessions with a one-hour break) What did you do,
during your break?
Check all that apply.
Checked emails or texts
Played games on my phone
Read a book or magazine
Watched a show/movie
Worked on documents on a computer
Surfed the Web
Talked on the phone
Other:

Ease of Use Ratings (as time permits)
Please rate the ease of each task performed from 1 - Very Difficult to 5 - Very Easy. If you did
not perform the task described, please choose "I did not perform this task." Please rate these
tasks, based on initial intuition, and do not think too hard about any task rating.
If you are out of time for your session, please submit the previous sections and let the
Moderator know.
19.

Set the pump date/time/year
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

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20.

Clean the vial septum with an alcohol pad
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

21.

Open the reservoir packaging
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

22.

Extend reservoir plunger rod
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

23.

Attach transfer guard/reservoir to the vial
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

24.

Press down on the plunger to pressurize the vial
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

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25.

Flip the vial over and pull the plunger to fill the reservoir
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

26.

Tap the reservoir to remove air bubbles and fill the reservoir to the desired volume
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

27.

Disconnect the reservoir from the transfer guard
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

28.

Disconnect the transfer guard from the vial and dispose of the transfer guard
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

29.

Connect the reservoir to the infusion set
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

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30.

Remove air bubbles from the reservoir
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

31.

Disconnect the plunger from the reservoir
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

32.

Insert the reservoir into the pump
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

33.

Fill the infusion set tubing
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

34.

Select the injection site
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

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35.

Wash hands
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

36.

Clean the injection site with an alcohol pad
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

37.

Place the infusion set into the insertion device
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

38.

Remove the adhesive backing from the infusion set
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

39.

Pull back handle on the insertion device to set the insertion device
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

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40.

Remove the needle guard from the infusion set
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

41.

Insert infusion set, using the insertion device
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

42.

Secure the adhesive to the skin
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

43.

Remove needle from infusion set
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

44.

Place guard on and dispose of needle hub
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

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45.

Fill the cannula
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

46.

Program basal rates
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

47.

Remove and dispose of the infusion set and reservoir
Mark only one oval.
1 - Very Difficult
2 – Difficult
3 – Neutral
4 – Easy
5 - Very Easy
I did not perform this task

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