Pretest and Main Study

Text Analysis Study Questionnaire

OMB Control No.: 0910-0910

Expiration Date: 11/30/2025

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 time required to complete this information collection is estimated to average 20 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.

This survey is being conducted on behalf of the U.S. Food and Drug Administration.

[PROGRAMMERS: Please add a task bar to show respondents where they are in the survey.]

[PROGRAMMERS: The test link had a mobile view displayed on the right-hand side of the web page. Please disable that view for all computer respondents.]

[PROGRAMMERS: Please add a prompt for any skipped questions. If respondents still skip after one prompt, please allow them to advance in the survey.]

This survey will take about 20 minutes to complete. If possible, we ask you to complete the study in one sitting (without taking any breaks) to avoid distractions.

You will be shown several prescription drug names and asked questions about each one. Please answer the questions to the best of your ability.

[NEXT SCREEN]

Next to each drug name you will see an audio icon. Please be sure to click in the center of each audio icon so you can hear how each drug name is pronounced.

[PROGRAMMER: Randomize to 1 of 30 blocks of drug names. Within that, randomize the order of the 4 names. Show question module for 1 drug name at a time.]

A drug called [DRUG 1] [INSERT AUDIO ICON] has recently been developed to treat [MEDICAL INDICATION].

1. Please tell us what comes to mind when you see and hear [DRUG NAME]. Please provide as much detail as you can.

As you answer, please consider your general impressions and the following features of the drug:

• The drug’s benefits and how well it would work

• The drug’s risks and side effects

• How it compares to other drugs

• Any other information about the drug

[PROGRAMMER: PLEASE ENSURE THIS NEXT QUESTION APPEARS ON A SEPARATE PAGE.]

2. Please write a story or narrative about [drug name]. Please use as much detail as you can.

[PROGRAMMER: Repeat question module for all 4 drug names.]

[PROGRAMMER: After all modules have been completed, ask Q3-Q7]

Thank you for answering those questions about each of the drug names you saw. Now, we just have a few more questions about the full list of names. [PROGRAMMER—DO NOT INCLUDE THIS INSTRUCTION ON EVERY PAGE, JUST BEFORE THE FIRST INSTANCE OF THIS QUESTION.]

Please consider the drug name shown, then answer the questions about it:

A drug called [DRUG 1] [INSERT AUDIO ICON] has recently been developed to treat [MEDICAL INDICATION].

[PROVIDER VERSION; RANDOMIZE ORDER]

Q3-7. How much do you agree or disagree with each of the following statements?:

	Strongly disagree	Disagree	Neither agree nor disagree	Agree	Strongly agree
The proposed name overstates the efficacy of the drug.
The proposed name minimizes the risks associated with the drug.
The proposed name broadens the indication of the drug.
The proposed name implies the drug is superior to other drugs for this condition.
The proposed name implies unique effectiveness or composition.

[CONSUMER VERSION; RANDOMIZE ORDER]

Q3-7. How much do you agree or disagree with each of the following statements?:

	Strongly disagree	Disagree	Neither agree nor disagree	Agree	Strongly agree
The proposed name overstates the effectiveness of the drug.
The proposed name minimizes the risks associated with the drug.
The proposed name implies the drug can be used for more than just the medical indication for which it is typically prescribed.
The proposed name implies the drug is better than other drugs for this condition.
The proposed name implies the drug is unique in how well it works or its ingredients.

[REPEAT FOR ALL DRUG NAMES]

Debriefing screen

This concludes the survey. Our goal was to gather people’s reactions to information about prescription drug names. As you may have recognized, to get your true reaction to this information, some of the drug names we used in the study were not for real drugs.

[CONSUMERS ONLY]

Please see your healthcare professional for questions about your health and your medical conditions.

Thank you for taking part in this study.