#6_Justif Memo and Attach 6B 6C 6E_6F_HINTS

Date:

November 29, 2010

To:

Office of Management and Budget (OMB)

Through:

Seleda Perryman, DHHS Report Clearance Officer
Marilyn Tuttleman, NIH Project Clearance Officer, OPERA
Vivian Horovitch-Kelley, NCI OMB Project Clearance Liaison, OMAA

From:

Bradford Hesse, Project Officer
Health Information National Trends Survey (HINTS),
Division of Cancer Control and Population Sciences,
National Cancer Institute/NIH

Subject:

Health Information National Trends Survey 4 (HINTS 4) Advance Materials
Focus Groups
Generic Sub-Study under “Questionnaire Cognitive Interviewing and
Pretesting,” OMB No. 0925-0589-06, Expiration Date: 5/31/2011

The National Cancer Institute’s (NCI) Division of Cancer Control and Population Sciences
(DCCPS), Behavior Research Program (BRP) proposes conducting formative research prior to
the fourth iteration of the Health Information National Trends Survey (HINTS 4) (OMB No.
0925-0538). Specifically, NCI proposes conducting focus group research for the purpose of
obtaining feedback on alternative message content included in the survey mailing materials.
Conducting this research is critical to successful recruitment efforts and to gaining the
cooperation of thousands of household respondents for HINTS 4. Results will be used to inform
the development of the content for the following correspondence with sampled households: the
advance letter, the cover letters sent along with the HINTS 4 questionnaires, the reminder
postcard sent to households who do not initially respond to the survey request, and the Questions
and Answers (Q&A) document included with the questionnaire mailing packages.
Background, Need and Use of Information. The HINTS data collection program addresses
many critical health research and programmatic needs. The HINTS program monitors changes
in the rapidly evolving field of health communication. Survey researchers are using the data to
understand how adults 18 years and older use different communication channels, including the
Internet, to obtain vital health information for themselves and their loved ones. Program planners
are using the data to understand and address barriers to health information usage across
populations, and to create more effective communication strategies. Finally, social scientists are
using the data to refine their theories of health communication in the information age and to offer
new and better recommendations for reducing the burden of cancer throughout the population.
HINTS creates and publishes HINTS Briefs showcasing results to ensure that findings from
HINTS research can be used to develop evidence-based policies, programs, and practices
relevant to health communication at the national, state, and local level.

Office of Management and Budget (OMB) - November 29, 2010
Page 2
These important scientific and program functions require that the HINTS program engage in
efforts to develop and improve data collection protocols that will result in high data quality.
Based on experimentally controlled methods research conducted as part of the previous round of
HINTS, HINTS 4 will use an entirely mail-based data collection procedure that collects data in 4
cycles with 4 independent samples. Thus, the proposed formative research seeks to identify the
most effective messages to use with the HINTS 4 mailing materials to encourage the
participation of all sampled households, improving overall response rate and diminishing the
chances of systematic nonresponse specific to certain subpopulations.
Participants and Recruitment. Focus group participants will be recruited from the noninstitutionalized adult household population. Neither Westat nor NCI employees will be eligible
to participate in the focus groups. Two of the four focus groups will be conducted with adults
who speak primarily Spanish at home. HINTS 4 will include a Spanish-language questionnaire
and supporting materials so evaluative information about the effectiveness and clarity of those
materials for the Spanish speaking population is needed. The English-speaking focus groups will
recruit a racially diverse population. Both the English- and Spanish-speaking focus groups will
recruit participation from adults representing a variety of educational attainment levels.
Westat, along with their subcontractor EurekaFacts, will recruit participants for the focus groups.
Recruiters will place advertisements on Internet sources such as Craig’s List, and will print
advertisements in local community papers around the Washington DC metropolitan area. In
addition, local adult education programs will be contacted to seek permission to distribute flyers
at one or more classes that cater to populations with less than a college education. All
advertisements will include a toll-free phone number for those interested in finding out more
about participation.
EurekaFacts will handle recruitment of the Spanish-speaking participants. As a professional
focus group and market research firm specializing in Spanish-speaking and other hard-to-reach
populations, EurekaFacts will advertise for participants in Spanish-market papers and locations
for which they have had prior success in recruiting focus group and one-on-one interview
participants. Additionally, EurekaFacts may draw from eligible Spanish-speaking respondents
within their established recruitment database, providing individuals have not participated in a
similar focus group in the last 12 months. All advertisements will include a toll-free number
dedicated to Spanish language calls.
When interested individuals call either toll-free number, recruitment staff will explain the
purpose of the project, eligibility criteria, and what is involved in participating. Recruitment staff
will screen individuals for participation in the focus groups (see Attachment 6A). One week
before the focus group session, recruitment staff will send individuals who have agreed to
participate a reminder letter (see Attachment 6B), and directions to the Westat facility.
Recruitment staff will attempt to contact all participants by phone 1–2 days prior to the focus
group to remind them of their appointment.
Data Collection Methods. The focus groups will be conducted in the focus group facilities at
Westat in Rockville, MD. All the focus groups will be conducted by professionally trained

Office of Management and Budget (OMB) - November 29, 2010
Page 3
moderators. Two of the four total focus groups will be conducted by a bilingual
(Spanish/English) moderator and the other two conducted by an English-speaking moderator.
In addition to the moderator, each focus group will include an assistant who will take notes,
gather informed consent forms, distribute respondent payments and manage other administrative
details. Each focus group will last up-to 90 minutes, and all participants will be asked to arrive a
few minutes early to review and sign the consent form. All focus groups will be video and audio
recorded with the consent of participants. Focus group moderators will use the session notes and
recordings to summarize the sessions. The Spanish speaking moderator will do the initial
summary in Spanish, and then translate to English for NCI and other project staff. Participants
of the focus groups will receive $50.00 as a thank you for their participation. The amount of this
incentive is slightly higher than average to account for time spent in screening and reviewing the
consent form, travel time (the amount of time required by participants for a 1.5 hour focus group
is close to 2 hours when travel is counted), and travel expenses (Westat is not located on the
Metro) .
Focus Group Moderator Materials. Westat will test the following materials as part of the focus
groups (see Attachment 6C for the full set of materials):
• two versions of the cover letter mailed with the questionnaire packets, plus the version
used in the 2007 HINTS mail sample,
• two versions of a refusal conversion letter mailed to households who don’t initially
respond
• a set of Frequently Asked Questions, and
• alternative facts that could replace or add to the relevant content of the letters under
consideration.
The Spanish-language materials will reflect the same content as the English language materials,
but will be fully translated into Spanish. The moderator will follow a semi-structured moderator
guide for the focus groups (see Attachment 6D) and consent form (see Attachment 6E). The
guides address the following research objectives:
• What information about the HINTS program do participants:
ƒ find most relevant to his/her own life, if any?
ƒ consider important to them, their families or their community more
generally?
ƒ think really encourage their interest and participation in HINTS 4?
• Are there possible differences between the English and Spanish speaking groups in what
messages seem most relevant, important or encouraging?
• Do participants understand the specific language used in the proposed materials in the
intended manner? If not, what is the source and impact of the confusion?
• Do participants view any of the content in the proposed materials negatively or think the
content is likely to diminish participation in the survey? If so, why?
• Does the format or style of the letter affect the level to which participants read and attend
to the content of the letters?
Data Analysis. Westat will analyze the data using qualitative analysis methods. Consistent
themes occurring in the focus groups summaries addressing the research questions will guide the

Office of Management and Budget (OMB) - November 29, 2010
Page 4
development of the final survey letters, reminder postcard and Question & Answer information
planned for HINTS 4 data collection.
Other Considerations. The focus group activities and materials outlined in this memo have been
approved by Westat’s IRB (see Attachment 6F) and is currently under review at NCI’s IRB.
Approval or exemption from both IRBs will be provided to OMB once received and prior to the
initiation of any testing.
No personally identifying information (PII) will be retained. PII will be collected only as part of
the recruitment process. The completed recruitment questionnaires will be stored in a locked
cabinet/drawer. The keyed data from the questionnaires will replace individuals’ names with
unique ID numbers for electronic storage. The mapping between the person’s name and the
associated ID number will be stored in a separate file. Both the mapping and the electronic
version of the recruitment responses will be stored on a restricted-access drive within the Westat
firewall. Both the paper and electronic versions of the recruitment information will be destroyed
within two weeks of the completion of the final report covering the focus group research.
Respondent Burden and Costs. The table below displays the burden estimates for this data
collection effort. We anticipate screening up to 80 individuals and retaining 40 to participate
across both the English- and Spanish-language focus groups. Each focus group session will last
up to 90 minutes. The total respondent burden for this effort is estimated to be 67 hours. This
effort will account for less than 4 percent of the total burden hours (1800) granted in OMB No.
0925-0589 approved package.
Estimates of Hour Burden and Respondent Cost
Maximum
Types of
Frequency
Instrument
Number of
Respondents
of Response
Respondents
General
Public
Total

Screening Questionnaire
(Attach 6A)

80

1

Focus Group/Moderator
Guide (Attach 6C and 6D)

40

1

120

Thank you for your consideration of this proposed sub-study.
List of Attachments (Attached Below)
6B:
Reminder Letter
6C:
Test Materials - Letters, FAQs, and Alternative Facts
6E:
Consent Form
6F:
Westat IRB Approval
List of Attachments (Attached in a Separate File)
6A:
Screening Questionnaire
6D:
Moderator Guide

Estimated
Burden
(Min/Hours)
5/60
(0.083)
90/60
(1.5)

Annual Burden
Hours
7
60
67

Attachment 6B: Reminder Letter
[Date]
Dear [name],
Thank you for agreeing to participate in our study on health-related topics. Here are
details to remind you where and when to appear for the focus group session. The
session will take about an hour and a half. You will receive $50 as a token of gratitude
for your participation in the study.

DATE: XX/XX/XXXX
TIME:

XX

LOCATION: Westat
Conference Center
1600 Research Boulevard
Rockville, MD 20820

Directions and a map are enclosed.
Kindly allow enough time for travel as we would like to begin on time. There will be
parking spaces marked “(Study)” in the Conference Center Parking lot. Someone will
meet you in the lobby of the 1600 building.
If you need further information, please call me at the office (301) XXX-XXXX.
We look forward to seeing you and thank you in advance for your assistance.

Sincerely,

[Westat staff]

Attachment 6C – 1: Cover letter 1 and Frequently Asked Questions

Dear Sir or Madam:
You’ve been selected to take part in an important national survey sponsored by the U.S.
Department of Health and Human Services, the Health Information National Trends Survey (HINTS).
HINTS has interviewed over 10,000 people since 2003. From those interviews we’ve learned
that:
•

The number of Americans using email to talk with a doctor or doctor’s office doubled
between 2003 and 2007.

•

In the past several years, as health information becomes more available on-line, American’s
trust in the health information they get on-line has decreased.

•

During the same time period, public trust in doctors as a source of health information
increased.

By completing this questionnaire, you can help health professionals use HINTS to find
out how you and other Americans get health information now and what needs done to make that
information easier to find and understand.
We ask that each adult in this household complete a questionnaire and return it to us in
the postage-paid envelope within the next two weeks. We’ve enclosed $2 as a token of our
appreciation for your participation. Of course, your participation is voluntary. You can keep the
money even if you decide not to take part in the survey.
Westat, a research firm under contract with us, is administering the survey. Your answers will
be kept confidential to the extent provided by law. More information about the study is provided on
the other side of this letter. You can also go to www.HINTS.cancer.gov to find out more about
HINTS.
Thank you in advance for your cooperation. If you have any questions about the study or you
would like to request more questionnaires, please call Westat toll-free at 1–888–636-6540.

Sincerely,

Bradford W. Hesse, Ph.D.
HINTS Project Officer
Chief, Health Communication and Informatics
Research Branch
National Institutes of Health
U.S. Dept of Health and Human Services
www.HINTS.gov
Si prefiere recibir la encuesta en Español, por favor llame 1-888-636-6536.
The Health Information National Trends Survey is authorized under 42 USC, Section 285a

Some Frequently Asked Questions
about the
Health Information National Trends Survey

Q:

What is the study about? What kind of questions do you ask?
A:

Q:

Where can I find out more about HINTS?

A:

Q:

About 20 to 30 minutes.

Who is sponsoring the study? Is this study approved by the Federal Government?
A:

Q:

Yes. Your answers cannot be connected to your name or any other information that could identify
you or your household, to the extent provided by law.

How long will it take to answer the questions?
A:

Q:

Your participation is voluntary, and you may refuse to answer any questions or withdraw from the
study at any time. However, your answers are very important to the success of this study and will
represent thousands of others. Getting an answer from all the households chosen for the study is
the best way to make sure the study results reflect the thoughts and opinions of all Americans.

Will my answers to the survey be kept confidential?
A:

Q:

Your address was randomly selected from among all of the known home addresses in the nation.
It was selected using scientific sampling methods.

Why should I take part in this study? Do I have to do this?
A:

Q:

Findings will help the U.S. Department of Health and Human Services promote good health and
prevent disease by determining ways of better communicating accurate health information to
Americans.

How did you get my address?
A:

Q:

If you have any questions about the study or you would like to request more questionnaires,
please call Westat toll-free at 1–888–636-6540,or you can go to www.HINTS.gov

How will the study results be used? What will be done with my information?
A:

Q:

The study concerns health and how people receive health information. For example, we will ask
how you usually get information about how to stay healthy, the sources of information you most
trust, and how you might like to get such information in the future. We will also ask about your
beliefs on what contributes to good health, how best to prevent cancer, your participation in various
health-related activities, and related topics.

The study is sponsored by the U.S. Department of Health and Human Services. The study has
been approved by the Office of Management and Budget (OMB), the office that reviews all
federally-sponsored surveys. The OMB approval number assigned to this study is 0925-0538.

Who is Westat?
A:

Westat is a research company located in Rockville, Maryland. Westat is conducting this
survey under contract to the U.S. Department of Health and Human Services.

Attachment 6C – 2: Cover letter 2 and Frequently Asked Questions

Dear Sir or Madam:
I’m writing to ask you to take part in a national survey sponsored by the U.S. Department of
Health and Human Services. The Health Information National Trends Survey (HINTS) is how policy
makers and researchers identify the information that Americans need and want to know about health.
For example, by answering the HINTS survey you can help identify:
•

How people find out about food and drug recalls

•

The number of Americans who use the internet as their main source of health information

•

How people order and receive their prescriptions medicines

By completing this questionnaire, you can help to find ways to get you and all Americans the
health information you need, when you need it.
We ask that each adult in this household complete a questionnaire and return it to us
in the postage-paid envelope within the next two weeks. We’ve enclosed $2 as a token of our
appreciation for your participation. Of course, your participation is voluntary. You can keep the
money even if you decide not to take part in the survey.
Westat, a research firm under contract with us, is administering the survey. Your answers will
be kept confidential to the extent provided by law.
More information about the study is provided on the other side of this letter. You can also go
to www.HINTS.cancer.gov to find out more about HINTS, or call Westat toll-free at 1–888–636-6540.
Thank you in advance for your cooperation.
Sincerely,
Visit the HINTS
website:

www.HINTS.cancer.gov

Bradford W. Hesse, Ph.D.
HINTS Project Officer
Chief, Health Communication and Informatics
Research Branch
National Institutes of Health
U.S. Dept of Health and Human Services

Si prefiere recibir la encuesta en Español, por favor llame 1-888-636-6536.
The Health Information National Trends Survey is authorized under 42 USC, Section 285a

Some Frequently Asked Questions
about the
Health Information National Trends Survey

Q:

What is the study about? What kind of questions do you ask?
A:

Q:

How will the study results be used? What will be done with my information?
A:

Q:

About 20 to 30 minutes.

Who is sponsoring the study? Is this study approved by the Federal Government?
A:

Q:

Yes. Your answers cannot be connected to your name or any other information that could identify
you or your household, to the extent provided by law.

How long will it take to answer the questions?
A:

Q:

Your participation is voluntary, and you may refuse to answer any questions or withdraw from the
study at any time. However, your answers represent thousands of others and are very important to
the success of this study. Getting an answer from all the households chosen for the study is the
best way to make sure the study results reflect the thoughts and opinions of all Americans.

Will my answers to the survey be kept confidential?
A:

Q:

Your address was randomly selected from among all of the known home addresses in the nation.
It was selected using scientific sampling methods.

Why should I take part in this study? Do I have to do this?
A:

Q:

Findings will help the U.S. Department of Health and Human Services promote good health and
prevent disease by determining ways of better communicating accurate health information to
Americans.

How did you get my address?
A:

Q:

The study concerns health and how people receive health information. For example, we will ask
how you usually get information about how to stay healthy, the sources of information you most
trust, and how you might like to get such information in the future. We will also ask about your
beliefs on what contributes to good health, how best to prevent cancer, your participation in various
health-related activities, and related topics.

The study is sponsored by the U.S. Department of Health and Human Services. The study has
been approved by the Office of Management and Budget (OMB), the office that reviews all
federally-sponsored surveys. The OMB approval number assigned to this study is XXXX-XXXX.

Who is Westat?
A:

Westat is a research company located in Rockville, Maryland. Westat is conducting this
survey under contract to the U.S. Department of Health and Human Services.

Attachment 6C - 3: Refusal Conversion Letter 1

Dear Resident:
Recently, the U.S. Department of Health and Human Services mailed two
questionnaires to your household for the Health Information National Trends Survey
(HINTS). As of today we have not received any completed questionnaires from your
household.
HINTS has interviewed over 10,000 people since 2003. This year, HINTS is
asking you to participate. As health care in America continues to change, we want
you to tell us what health topics matter the most to you. Will the ways you
communicate with your doctor’s change? Can you get current information about
medical treatments for you or a family member? Do you have concerns about your
ability to take care of your own health needs? HINTS is a way for you to let the
government know what people like you do when you need health care information.
We know your time is valuable, but your participation in the study is important
to its success. To understand the health topics important to people today, HINTS
needs to collect the current views and experiences of all the people we’re trying to
contact.
Whether or not you or anyone in your family has ever had health problems,
your input and opinions are crucial to the success of this study. Your answers,
combined with those of other survey respondents, will help us understand what
health information you and other Americans want and what needs done to make that
information easier to find and understand.
In the event that your questionnaires were misplaced, replacements are
enclosed. If you have any questions, please call Westat toll free at 1-888-314-1133
or go to www.HINTS.cancer.gov.
Sincerely,

Bradford W. Hesse, Ph.D
HINTS Project Officer
Behavioral Research Program
National Cancer Institute
Si prefiere recibir la encuesta en Español, por favor llame 1-888-636-6536.
The Health Information National Trends Survey is authorized under 42 USC, Section 28

Attachment 6C – 4: Refusal Conversion Letter 2

Dear Sir or Madam:
You’ve been selected to take part in this year’s Health Information National
Trends Survey (HINTS). Policy makers and researchers use HINTS to identify the
information that Americans need and want to know about health. With your help, we
can use HINTS to keep Americans better informed on the health issues important to
them.
We recently mailed two HINTS questionnaires to your home. As of today we
have not received any back from your address. We know your time is valuable.
However, your household is part of a scientific sample representing many other
households and it cannot be replaced.
To make sure HINTS provides accurate information we need you and all the
household’s selected for this year’s HINTS to complete the survey. By taking part in
this survey, you can help us find ways to get you and all Americans the health
information you need, when you need it.
In the event that your questionnaires were misplaced, replacements are
enclosed. We ask that each adult in this household complete a
questionnaire and return it to us in the postage-paid envelope within the
next two weeks.
If you have any questions or would like to request additional
questionnaires, please call Westat toll free at 1-888-636-6540.

Sincerely, 
To find out more about
HINTS, go to:
www.HINTS.cancer.gov

Bradford W. Hesse, Ph.D. 
HINTS Project Officer 
Chief, Health Communication and Informatics  
Research  Branch 
National Institutes of Health 
U.S. Dept of Health and Human Services 

Si prefiere recibir la encuesta en Español, por favor llame 1-888-636-6536.
The Health Information National Trends Survey is authorized under 42 USC, Section 2

Attachment 6C – 5: Alternative Facts 

SET 1. 
Using HINTS data, researchers and government officials can identify what types of information 
Americans need to correctly understand health risks.    In 2005, HINTS found that: 
•
•

About 4 out of 5 adults believe that there are so many recommendations about nutrition that it 
is hard to know which ones to follow  
Similarly, more than three‐quarters (78%) of Americans think there are so many cancer 
prevention recommendations that it is hard to know which ones to follow. 

SET 2. 
HINTS data can tell us what type of health information Americans are interested in.  For example –  
•
•

Nearly 40% of all Americans have looked for cancer information at some point.   
About 50% of those people are looking for information about a specific type of cancer, but 
nearly 20% are looking for information about cancer symptoms, early detection or diagnosis.    

SET 3. 
HINTS data can help doctors and other health care professionals improve the communication they have 
with their patients. 
•
•

About 45% of English speaking households feel their doctors always explain things to them in a 
way they can understand. 
However, only a little more than 30% of Spanish‐speaking households feel their doctors explain 
things to them in an understandable way. 

Attachment 6E: CONSENT FORM
You have volunteered for a focus group discussion being conducted on behalf of the U.S. Dept.
of Health and Human Services (DHHS). The purpose of the study is to improve certain
procedures used for a survey that Westat conducts on behalf of DHHS.
•

The discussion will be videotaped and notes will be taken. Project researchers may also
observe the discussion.

•

The discussion should take up to 1½ hours.

•

Your participation is completely voluntary. You may stop at any time, and you do not
have to answer any questions you do not wish to answer.

•

This research does not involve any foreseeable risks.

•

All information obtained from this study will be kept secure and will only be seen by
people authorized to work on this project. The report summarizing the findings will not
contain any names or identifying information. We will destroy any identifying information
when the project ends.

•

There are no direct benefits to participants in this research.

•

Participants will receive $50 in cash for participating.

•

If you have questions about this research please contact Brad Hesse, the Principal
Investigator at NCI (301-594-9904; [email protected]). If you have questions about
your role as a research participant, please contact Sharon Zack, the Westat Institutional
Review Board Administrator (800-937-8285; [email protected]).

•

A copy of this consent form has also been provided for your records.

If you agree to participate in this focus group, please read the following statement and sign your
name below:
I have read the above information about this project and my rights as a participant. I
consent to participate in this research and to have this discussion videotaped.
______________________________
Researcher’s Signature

______________________________
Participant’s Signature

______________________________
Printed Name

______________________________
Printed Name

_____________________________
Date

Attachment 6F: Westat IRB approval

8

Date:

November 30, 2010

To:

Terisa Davis, Project Director

From:

Kerry Levin; Chair, Westat IRB

Subject:

Amendment Approval of OMB, Project 8861.01.04
FWA 5551

As Chair of the Westat Institutional Review Board (IRB), I reviewed the materials submitted for the following:
OMB, Project 8861.01.04. The Westat IRB reviews all studies involving research on human subjects. This project
was last approved November 11, 2010.
This request was to approve the following:
1. Focus group research to elicit feedback on alternative message content included in the survey mailing
materials.
2. Revise the informed consent form. Replace “confidential” to “secure.” As in: All information obtained
from this study will be kept secure.
3. Decrease the incentive amount from $75 to $50.
IRB regulations permit expedited review of minor changes to previously approved activities [45 CFR pt. 46.110 (b)].
This study can be considered minimal risk and is approved under expedited authority
As the Project Director you are responsible for the following:
If you received a conditional approval, project activities (e.g., recruiting, enrolling) may not begin until your
responses have been received by the IRB and final approval is granted.
You are required to submit this study for a continuing review on or before November 11, 2011.
In the interim, you are responsible for notifying the IRB Office as soon as possible if there are any injuries
to the subjects, problems with the study, or changes to the study design that relate to human subjects.
cc:

Institutional Review Board
Nancy Weinfield