Form 1 2021 CTG Usability Feedback instrument

OMB Control Number: 0925 -0648
Expiration Date: 05/31/2021
Public reporting burden for this collection of information is estimated to average 60 minutes per response,
including the time for reviewing instructions, searching existing data sources, gathering and maintaining the
data needed, and completing and reviewing the collection of information. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of information unless it displays a current valid
OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to NIH, Project Clearance Branch, 6705 Rockledge
Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0648). Do not return the completed form to
this address.
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NLM ClinicalTrials.gov
Usability Testing Feedback
We’d like to receive feedback on a new web design itself and your satisfaction with its general
functionality to understand how easy or difficult it is to use
A. FORMATIVE QUESTIONS
Before we have you review web prototype, we’d like to first ask you a few questions about your previous
experience with using resources around clinical trials.
A1. Why motivates you to look into clinical trials?
A2. How do you start your search?
A2a. What kind of resources have you typically looked for?
A2a-1. What did you come across?
A2b. Who did you talk to seek information from?
Have you interacted with any patient advocacy groups or FB support groups?
A2c. What other resources have you recommended to patients?
A2d. What did you like or dislike about some of these resources?
A2e. How often do your patients eventually find a trial to participate in?
A2e-1. What was helpful to them in finding that trial? What is it like caring for patients during
trials?
A3. Have you heard of or used ClinicalTrials.gov (CTG)?
[IF YES]
A3a. How did you first learn about or discover it?
A3a-1. What do you think it means if a trial is on CTG?
A3b. Have you recommended CTG to your patients?
A3b-1. Do you help your patients look up trials or do you let them do it themselves?
A3c. What was your first impression of CTG?
A3d. If used previously, how was your overall experience on the site?
A3d-1. Think of a time you visited CTG, what did you try to accomplish on the site? Were you
successful?
A3d-2. How do you determine if a trial is right for a patient? What information do you look at?
A3d-3. Did you experience any challenges when searching for a trial on CTG?
A4. What type of information or features related to clinical trials are you (or your patients) most interested in?
A5. Overall, how successful have you (or your patients) been in finding information about trials you are looking
to participate in?
A5a. What went well?
A5b. What would have made this process easier for you?
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A5c. If you had a magic wand, what information would you want most about clinical trials? How would
you want to receive it?
B. INSTRUCTIONS
Thank you for sharing your previous experience and some of your preferences with me. Now let’s move ahead
and take a look at a basic website prototype. Your responses will help us find out if we are providing the kind of
web content and experience that clinical trials patients might want. There are no right or wrong answers.
C. PARTICIPANT TASKS
C1. Now we’re on the homepage of the ClinicalTrials.gov website.
C1a. Without clicking on anything just yet, can you tell me your initial reactions to this site?
C1b. Looking at this page, what do you think the purpose of the site is?
C1c. What kind of information do you see here? What do you think you can accomplish on this site?
C1d. If you were exploring, what would you click on first?
C2. Next, I am going to ask you to complete various tasks on this site. Remember that there are no wrong
answers. If a task is difficult to complete, that just lets us know that certain areas may need to be improved.
Please remember to think aloud as much as you can. You can let me know when you feel you’ve
accomplished the task.
C2a [BASIC SEARCH]
For a patient who’s a colon cancer survivor with Type-2 Diabetes, you recommended that he/she should
look into suitable clinical trials on CTG for ways to manage his/her conditions better. He/She would like
some assistance in how exactly he/she should conduct the search. What would you show him/her?
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What type of information do you look for in a trial?
How useful is the information for completing this task? What was confusing or misleading?
What do you think should be changed? What should be included?

C2b [ELIGIBLITY AND SAFETY]
Now that you’ve helped the patient identify some trials that might be of interest, how do you advise him/her
to determine whether he/she would be eligible for them? How safe are they to you based on the
information provided?
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What was easy/difficult about this task?
How useful is the information for completing this task? What was confusing or misleading?
What do you think should be changed? What should be included?

C2c [MAKING A CHOICE]
Based on the trials that you’ve identified so far, how do you decide if there’s one that your patient should
look into further?
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If there were filters to help you narrow down your choices, what type of filters would be most helpful
to you?
How do you compare records?
a. What do you think about the functions of allowing you to customize your view of the search
results?
What do you do with the records you’ve viewed?
How useful is the information for completing this task? What was confusing or misleading?
What do you think should be changed? What should be included?

C2d [REVIEWING RECORD]
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Let’s say the top result of this list is the record you were looking for. Let’s open it. Can you tell me what this
study involves and where it takes place?
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What kind of information in a study record would be most important or useful to you?
a. What would you look at to determine if a trial is right for your patient?
How would you go about with the enrollment process?
a. Who would you like to talk to about enrolling in a trial?
How important is the study location to you?
a. If remote, how would you like to know?
b. When clicking on a location, what associated information would you like to see?
Related records – how helpful are they? Is it a way to explore other studies?

C2d [SEEKING ASSISTANCE]
You’ve found a trial that your patient would like to enroll in, but there are a few study details including
medical procedures that he/she doesn’t quite understand. How should he/she seek help on this?
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What type of information would you look for to help you better understand the study details?
a. Who would you like to talk to?
b. What would you do if the website/study did not provide contact information?
c. Would you want to ask questions live?
d. What kind of help would you expect to receive?
How useful is the information for completing this task? What was confusing or misleading?
What do you think should be changed? What should be included?

C2e [SAVING AND STAYING UPDATED]
As you’ve identified a few trials of interest that you patient might be eligible for, you’d like to save the
records for future reference so that he/she can come back to them later. How would you save these
records?
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What type of information would you seek to save?
a. What are some other ways that would allow you to save conveniently?
b. How important is this feature to you?
In the event of any record update or new trials available for you condition, would you like to be
notified?
a. If so, how would you subscribe for such update? How would you like to be notified?
b. How important is this feature to you?
How useful is the information for completing this task? What was confusing or misleading?
What do you think should be changed? What should be included?

C2f [RECORD SHARING]
Based on your search results, you’ve noticed that a few of the trials you discovered might be of interest to
some of your other patients as well and you would like to share these with them. Show me how you would
share from the website.
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What type of information would you seek to share?
a. What are some other ways that would allow you to share conveniently?
b. How important is this feature to you?
How useful is the information for completing this task? What was confusing or misleading?
What do you think should be changed? What should be included?

D. POST-TEST QUESTIONS
D1. What was your overall impression the pages we reviewed today?
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D2. What other information would you expect to see on this website?
D3. Were any of the information or links on the pages confusing to you?
D4. Anything else you wish you were able to do on this site?
D5. Do you have any last comments about all the pages we’ve reviewed today or your experiences with them?
That concludes our session today. Thank you for your time and feedback. Your input is very valuable
in helping us improve the site.

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