Agency Information Collection Activities: Proposed Collection; Comment Request, 19667-19669 [2012-7768]
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Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Notices
their operations, conducting analysis,
and presenting that analysis to HHS
executives to inform program and policy
decisions.
3. Division of Health and Social Service
Programs (AMW2)
The Division of Health and Social
Service Programs is responsible for
establishing systems and procedures for
analyzing data on the status of HHS
health and social services programs and
their operations, conducting analysis,
and presenting that analysis to HHS
executives to inform program and policy
decisions.
Dated: March 22, 2012.
E.J. Holland, Jr.,
Assistant Secretary for Administration.
[FR Doc. 2012–7807 Filed 3–30–12; 8:45 am]
BILLING CODE 4150– 24–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
AGENCY:
ACTION:
Notice.
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘Development of a Health Information
Rating System (HIRS).’’ In accordance
with the Paperwork Reduction Act, 44
U.S.C. 3501–3521, AHRQ invites the
public to comment on this proposed
information collection.
SUMMARY:
Comments on this notice must be
received by June 1, 2012.
DATES:
Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
mstockstill on DSK4VPTVN1PROD with NOTICES
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRO.hhs.gov.
SUPPLEMENTARY INFORMATION:
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Jkt 226001
Proposed Project
Development of a Health Information
Rating System (HIRS)
Over the past several years, limited
health literacy has been identified as an
important health care quality issue.
Healthy People 2010 defined health
literacy as ’the degree to which
individuals have the capacity to obtain,
process, and understand basic health
information and services needed to
make appropriate health decisions’. In
2003, the Institute of Medicine
identified health literacy as a crosscutting area for health care quality
improvement. According to the 2003
National Assessment of Adult Literacy,
only 12 percent of adults have proficient
health literacy.
Persons with limited health literacy
face numerous health care challenges.
They often have a poor understanding of
basic medical vocabulary and health
care concepts. A study of patients in a
large public hospital showed that 26
percent did not understand when their
next appointment was scheduled and 42
percent did not understand instructions
to ‘‘take medication on an empty
stomach.’’ In addition, limited health
literacy leads to more medication errors,
more and longer hospital stays, and a
generally higher level of illness.
Health care providers can improve
their patients’ health outcomes by
delivering the right information at the
right time in the right way to help
patients prevent or manage chronic
conditions such as diabetes,
cardiovascular disease, hypertension,
and asthma. Electronic health records
(EHRs) can help providers offer patients
the right information at the right time
during office visits, by directly
connecting patients to helpful resources
on treatment and self-management.
EHRs can also facilitate clinicians’ use
of patient health education materials in
the clinical encounter. However, health
education materials delivered by EHRs,
when available, are rarely written in a
way that is understandable and
actionable for patients with basic or
below basic health literacy—an
estimated 77 million people in the
United States.
In order to fulfill the promise of EHRs
for all patients, especially for persons
with limited health literacy, clinicians
should have a method to determine how
easy a health education material is for
patients to understand and act on, have
access to a library of easy-to-understand
and actionable materials, understand
the relevant capabilities and features of
EHRs to provide effective patient
education, and be made aware of these
resources and information. Therefore,
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Sfmt 4703
19667
AHRQ developed a task order that
resulted in contract
#HHSA290200900012I to complete the
following four major tasks: (1) Develop
a valid and reliable Health Information
Rating System (HIRS), (2) create a
library of patient health education
materials, (3) review EHR’s patient
education capabilities and features, and
(4) educate EHR vendors and users. This
information collection project relates to
the first task only.
The goal of this information collection
project is to develop a valid and reliable
Health Information Rating System
(HIRS). The HIRS will offer a systematic
method to evaluate and compare the
understandability and actionability of
health education materials. Health
education materials are understandable
when consumers of diverse backgrounds
and varying degrees of health literacy
can process and explain key messages.
Health education materials are
actionable when consumers of diverse
backgrounds and varying levels of
health literacy can identify what they
can do based on the information
presented.
A Draft HIRS has been developed
through a rigorous multi-stage approach
and draws upon existing rating systems,
the evidence base in the literature, and
the real-world expertise and experience
of a Technical Expert Panel (TEP). The
final stage of developing a reliable and
valid rating system to assess the
understandability and actionability of
patient health education materials is
testing with consumers. AHRQ is
following a 5-step process to develop a
valid and reliable HIRS:
(1) Gather and synthesize evidence on
existing rating systems and literature on
consumers’ understanding of health
information. Seek TEP review of the
summary of existing health information
rating systems. Develop item pool for
each domain (i.e., understandability and
actionability).
(2) Assess the face and content
validity of the domains (i.e.,
understandability and actionability)
with the TEP.
(3) Assess the inter-rater reliability of
the HIRS on 16 different health
education materials (8 English-language
materials and 8 Spanish-language
materials) using a total of 8 raters —4
raters per material. Seek TEP review of
results and provide guidance on how to
address discrepancies.
(4) Assess the construct validity of the
HIRS by conducting testing with 48
consumers — 24 English-speaking and
24 Spanish-speaking consumers.
Consumers will review materials and be
asked questions to test whether they
E:\FR\FM\02APN1.SGM
02APN1
19668
Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Notices
understand the materials and whether
they know what actions to take.
(5) Finalize the HIRS and instructions
for users, and make them publicly
available on AHRQ’s Web site.
Steps 1, 2 and 3 do not involve data
collections requiring OMB approval and
have already been completed.
This study is being conducted by
AHRQ through its contractor, Abt
Associates, pursuant to AHRQ’s
statutory authority to conduct and
support research on health care and on
systems for the delivery of such care,
including activities with respect to the
quality, effectiveness, efficiency,
appropriateness and value of health care
services and with respect to quality
measurement and improvement. 42
U.S.C. 299a(a)(1) and (2).
Method of Collection
To complete steps 4 and 5 the
following data collections and activities
will be implemented:
(1) Demographic Questionnaire—The
demographic questionnaire will collect
basic demographic information about
each consumer participant. This data
will allow the analysis to detect
differences in health literacy by
population subgroups.
(2) Short Test of Functional Health
Literacy in Adults (S–TOFHLA)
Questionnaire—The S–TOFHLA will be
administered to all participants to
access their level of health literacy.
(3) Health Education Materials &
Interview—English, Inhaler—Each
English-speaking participant will be
randomly assigned one of a set of three
materials on using asthma inhalers,
which include: (1) A video entitled
‘‘How to Use an Inhaler,’’ by the
American College of Physicians
Foundation, (2) a material accessed via
the internet entitled ‘‘Inhaled Asthma
Medications: Tips to Remember,’’ by the
American Academy of Allergy, Asthma
& Immunology, and (3) a material
accessed via the internet entitled ‘‘How
to Use Your Metered-Dose Inhaler the
Right Way,’’ by the McKinley Health
Center. After seeing the video or reading
the randomly assigned material, a brief
interview will be conducted to assess
the participants’ understanding of how
to use an inhaler and what actions to
take based on the material.
(4) Health Education Materials &
Interview—English, Colonoscopy—Each
English-speaking participant will be
randomly assigned one of a set of three
materials about colonoscopy, which
include: (1) A video entitled
‘‘Colonoscopy,’’ by Medline Plus, (2) a
pdf material accessed via the internet
entitled ‘‘Colonoscopy,’’ by the
American College of Surgeons and (3) a
material accessed via the interne
entitled, ‘‘Colonoscopy,’’ by Jackson
Siegelbaum Gastroenterology. After
seeing the video or reading the
randomly assigned material, a brief
interview will be conducted to assess
the participants’ understanding of the
colonoscopy procedure and what
actions to take based on the material.
(5) Health Education Materials &
Interview—Spanish, High Blood
Pressure—Each Spanish-speaking
participant will be randomly assigned
one of a set of three materials about high
blood pressure, which include: (1) A
video entitled ‘‘Hipertension esencial,’’
by Medline Plus, (2) a Web site material
accessed via the internet entitled ‘‘¿Que
´
es la presion arterial alta?,’’ by the
National Heart Lung and Blood Institute
(NHLBI) and (3) a pdf material accessed
via the internet entitled, ‘‘Presion
Sanguinea Alta,’’ by the National Center
for Farmworker Health. After seeing the
video or reading the randomly assigned
material, a brief interview will be
conducted to assess the participants’
understanding of high blood pressure
and what actions to take based on the
material.
(6) Health Education Materials &
Interview—Spanish, Colonoscopy—
Each Spanish-speaking participant will
be randomly assigned one of a set of
three materials about colonoscopy,
which include: (1) A video entitled
‘‘Colonoscopia,’’ Main Line Health, (2) a
pdf material accessed via the internet
entitled ‘‘Colonoscopia: Lo Que Usted
Debe Saber,’’ by the Nebraska
Department of Health and Human
Services (DHHS) and (3) a material
accessed via the internet entitled,
´
‘‘Colonoscopıa,’’ by Centro Medicao
ABC. After seeing the video or reading
the randomly assigned material, a brief
interview will be conducted to assess
the participants’ understanding of the
colonoscopy procedure and what
actions to take based on the material.
The data collected from this project
will be used to assess the construct
validity of and inform revisions to the
HIRS. The HIRS will be the first system
that can assess the understandability
and actionability of patient health
education materials that can be
incorporated into an EHR, including
print and multimedia materials. Note
that the materials to be assessed need
not currently be incorporated into EHRs;
for now, AHRQ is focusing on materials
that have the potential to be
incorporated into EHRs.
No claim is made that the results from
this study will be generalizable in the
statistical sense. Rather, the consumer
testing will be informative and critical
to ensuring we have developed a valid
rating system by conducting consumer
testing.
Estimated Annual Respondent Burden
Exhibit 1 presents estimates of the
annualized burden hours for the
respondents’ time to participate in this
research. The Demographic and S–
TOFHLA questionnaires will be
completed by all 48 participants and
takes 5 and 7 minutes, respectively, to
complete. Each of the 48 participants
will review 2 different sets of health
education materials and then participate
in a short interview for each material
topic. English-speaking participants will
review materials related to inhaler use
and colonoscopy while Spanishspeaking participants will review
materials related to high blood pressure
and colonoscopy. To review each
material and participate in the
associated interview requires 30
minutes (15 minutes to review the
materials and 15 minutes for the
interview). The total annualized burden
is estimated to be 58 hours.
Exhibit 2 presents the estimated
annualized cost burden associated with
the respondents’ time to participate in
this research. The total cost burden is
estimated at $962.
mstockstill on DSK4VPTVN1PROD with NOTICES
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Data collection
Demographic Questionnaire ............................................................................
S-TOFHLA Questionnaire ................................................................................
Health Education Materials & Interview—English, Inhaler ..............................
Health Education Materials & Interview —English & Spanish, Colonoscopy
Health Education Materials & Interview—Spanish, High Blood Pressure ......
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17:42 Mar 30, 2012
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Number of
responses per
respondent
48
48
24
48
24
E:\FR\FM\02APN1.SGM
1
1
1
1
1
02APN1
Hours per
response
5/60
7/60
30/60
30/60
30/60
Total burden
hours
4
6
12
24
12
19669
Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Data collection
Total ..........................................................................................................
Number of
responses per
respondent
192
Hours per
response
Total burden
hours
na
na
58
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Data collection
Average
hourly
wage rate*
Total burden
hours
Total cost
burden
Demographic Questionnaire ............................................................................
S-TOFHLA Questionnaire ................................................................................
Health Education Materials & Interview—English, Inhaler ..............................
Health Education Materials & Interview —English & Spanish, Colonoscopy
Health Education Materials & Interview—Spanish, High Blood Pressure ......
48
48
24
48
24
4
6
12
24
12
$21.35
21.35
21.35
21.35
21.35
$85
128
256
512
256
Total ..........................................................................................................
192
58
na
1,237
* Based upon the mean wage for all occupations, National Compensation Survey: Occupational wages in the United States May 2010, ‘‘U.S.
Department of Labor, Bureau of Labor Statistics.’’
Estimated Annual Costs to the Federal
Government
The total cost of this contract to the
government is $524,945, and the project
extends over 3 years (July 19, 2010 to
July 18, 2013). The data collection for
which we are seeking OMB clearance
will take place from September 1, 2012
to December 31, 2012. Exhibit 3 shows
a breakdown of the total cost as well as
the annualized cost for the data
collection, processing and analysis
activity for this entire contract.
EXHIBIT 3—ESTIMATED COST
Cost Component
Total Cost
Annual Cost
Project Development .......................................................................................................................................
Data Collection Activities .................................................................................................................................
Data Processing and Analysis .........................................................................................................................
Publication of Results ......................................................................................................................................
Project Management ........................................................................................................................................
$66,447
129,547
129,548
131,571
67,832
$22,149
43,182
43,183
43,857
22,611
Total ..........................................................................................................................................................
524,945
174,982
mstockstill on DSK4VPTVN1PROD with NOTICES
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
VerDate Mar<15>2010
17:42 Mar 30, 2012
Jkt 226001
proposed information collection. All
comments will become a matter of
public record.
Dated: March 22, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012–7768 Filed 3–30–12; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
PO 00000
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the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for
Scientific Review Special Emphasis
Panel; Neurodegeneration: Mechanisms
and Therapeutic Targets.
Date: April 17, 2012.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
6701 Rockledge Drive, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Laurent Taupenot,
Ph.D, Scientific Review Officer, Center
for Scientific Review, National Institutes
of Health, 6701 Rockledge Drive, Room
4811, MSC 7850, Bethesda, MD 20892,
301–435–1203, taupenol@csr.nih.gov.
Name of Committee: Center for
Scientific Review Special Emphasis
E:\FR\FM\02APN1.SGM
02APN1
]]>Agencies
[Federal Register Volume 77, Number 63 (Monday, April 2, 2012)]
[Notices]
[Pages 19667-19669]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7768]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project: ``Development of a Health Information Rating System (HIRS).''
In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521,
AHRQ invites the public to comment on this proposed information
collection.
DATES: Comments on this notice must be received by June 1, 2012.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at
doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
doris.lefkowitz@AHRO.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Development of a Health Information Rating System (HIRS)
Over the past several years, limited health literacy has been
identified as an important health care quality issue. Healthy People
2010 defined health literacy as 'the degree to which individuals have
the capacity to obtain, process, and understand basic health
information and services needed to make appropriate health decisions'.
In 2003, the Institute of Medicine identified health literacy as a
cross-cutting area for health care quality improvement. According to
the 2003 National Assessment of Adult Literacy, only 12 percent of
adults have proficient health literacy.
Persons with limited health literacy face numerous health care
challenges. They often have a poor understanding of basic medical
vocabulary and health care concepts. A study of patients in a large
public hospital showed that 26 percent did not understand when their
next appointment was scheduled and 42 percent did not understand
instructions to ``take medication on an empty stomach.'' In addition,
limited health literacy leads to more medication errors, more and
longer hospital stays, and a generally higher level of illness.
Health care providers can improve their patients' health outcomes
by delivering the right information at the right time in the right way
to help patients prevent or manage chronic conditions such as diabetes,
cardiovascular disease, hypertension, and asthma. Electronic health
records (EHRs) can help providers offer patients the right information
at the right time during office visits, by directly connecting patients
to helpful resources on treatment and self-management. EHRs can also
facilitate clinicians' use of patient health education materials in the
clinical encounter. However, health education materials delivered by
EHRs, when available, are rarely written in a way that is
understandable and actionable for patients with basic or below basic
health literacy--an estimated 77 million people in the United States.
In order to fulfill the promise of EHRs for all patients,
especially for persons with limited health literacy, clinicians should
have a method to determine how easy a health education material is for
patients to understand and act on, have access to a library of easy-to-
understand and actionable materials, understand the relevant
capabilities and features of EHRs to provide effective patient
education, and be made aware of these resources and information.
Therefore, AHRQ developed a task order that resulted in contract
HHSA290200900012I to complete the following four major tasks:
(1) Develop a valid and reliable Health Information Rating System
(HIRS), (2) create a library of patient health education materials, (3)
review EHR's patient education capabilities and features, and (4)
educate EHR vendors and users. This information collection project
relates to the first task only.
The goal of this information collection project is to develop a
valid and reliable Health Information Rating System (HIRS). The HIRS
will offer a systematic method to evaluate and compare the
understandability and actionability of health education materials.
Health education materials are understandable when consumers of diverse
backgrounds and varying degrees of health literacy can process and
explain key messages. Health education materials are actionable when
consumers of diverse backgrounds and varying levels of health literacy
can identify what they can do based on the information presented.
A Draft HIRS has been developed through a rigorous multi-stage
approach and draws upon existing rating systems, the evidence base in
the literature, and the real-world expertise and experience of a
Technical Expert Panel (TEP). The final stage of developing a reliable
and valid rating system to assess the understandability and
actionability of patient health education materials is testing with
consumers. AHRQ is following a 5-step process to develop a valid and
reliable HIRS:
(1) Gather and synthesize evidence on existing rating systems and
literature on consumers' understanding of health information. Seek TEP
review of the summary of existing health information rating systems.
Develop item pool for each domain (i.e., understandability and
actionability).
(2) Assess the face and content validity of the domains (i.e.,
understandability and actionability) with the TEP.
(3) Assess the inter-rater reliability of the HIRS on 16 different
health education materials (8 English-language materials and 8 Spanish-
language materials) using a total of 8 raters --4 raters per material.
Seek TEP review of results and provide guidance on how to address
discrepancies.
(4) Assess the construct validity of the HIRS by conducting testing
with 48 consumers -- 24 English-speaking and 24 Spanish-speaking
consumers. Consumers will review materials and be asked questions to
test whether they
[[Page 19668]]
understand the materials and whether they know what actions to take.
(5) Finalize the HIRS and instructions for users, and make them
publicly available on AHRQ's Web site.
Steps 1, 2 and 3 do not involve data collections requiring OMB
approval and have already been completed.
This study is being conducted by AHRQ through its contractor, Abt
Associates, pursuant to AHRQ's statutory authority to conduct and
support research on health care and on systems for the delivery of such
care, including activities with respect to the quality, effectiveness,
efficiency, appropriateness and value of health care services and with
respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1)
and (2).
Method of Collection
To complete steps 4 and 5 the following data collections and
activities will be implemented:
(1) Demographic Questionnaire--The demographic questionnaire will
collect basic demographic information about each consumer participant.
This data will allow the analysis to detect differences in health
literacy by population subgroups.
(2) Short Test of Functional Health Literacy in Adults (S-TOFHLA)
Questionnaire--The S-TOFHLA will be administered to all participants to
access their level of health literacy.
(3) Health Education Materials & Interview--English, Inhaler--Each
English-speaking participant will be randomly assigned one of a set of
three materials on using asthma inhalers, which include: (1) A video
entitled ``How to Use an Inhaler,'' by the American College of
Physicians Foundation, (2) a material accessed via the internet
entitled ``Inhaled Asthma Medications: Tips to Remember,'' by the
American Academy of Allergy, Asthma & Immunology, and (3) a material
accessed via the internet entitled ``How to Use Your Metered-Dose
Inhaler the Right Way,'' by the McKinley Health Center. After seeing
the video or reading the randomly assigned material, a brief interview
will be conducted to assess the participants' understanding of how to
use an inhaler and what actions to take based on the material.
(4) Health Education Materials & Interview--English, Colonoscopy--
Each English-speaking participant will be randomly assigned one of a
set of three materials about colonoscopy, which include: (1) A video
entitled ``Colonoscopy,'' by Medline Plus, (2) a pdf material accessed
via the internet entitled ``Colonoscopy,'' by the American College of
Surgeons and (3) a material accessed via the interne entitled,
``Colonoscopy,'' by Jackson Siegelbaum Gastroenterology. After seeing
the video or reading the randomly assigned material, a brief interview
will be conducted to assess the participants' understanding of the
colonoscopy procedure and what actions to take based on the material.
(5) Health Education Materials & Interview--Spanish, High Blood
Pressure--Each Spanish-speaking participant will be randomly assigned
one of a set of three materials about high blood pressure, which
include: (1) A video entitled ``Hipertension esencial,'' by Medline
Plus, (2) a Web site material accessed via the internet entitled
``[iquest]Que es la presi[oacute]n arterial alta?,'' by the National
Heart Lung and Blood Institute (NHLBI) and (3) a pdf material accessed
via the internet entitled, ``Presion Sanguinea Alta,'' by the National
Center for Farmworker Health. After seeing the video or reading the
randomly assigned material, a brief interview will be conducted to
assess the participants' understanding of high blood pressure and what
actions to take based on the material.
(6) Health Education Materials & Interview--Spanish, Colonoscopy--
Each Spanish-speaking participant will be randomly assigned one of a
set of three materials about colonoscopy, which include: (1) A video
entitled ``Colonoscopia,'' Main Line Health, (2) a pdf material
accessed via the internet entitled ``Colonoscopia: Lo Que Usted Debe
Saber,'' by the Nebraska Department of Health and Human Services (DHHS)
and (3) a material accessed via the internet entitled,
``Colonoscop[iacute]a,'' by Centro Medicao ABC. After seeing the video
or reading the randomly assigned material, a brief interview will be
conducted to assess the participants' understanding of the colonoscopy
procedure and what actions to take based on the material.
The data collected from this project will be used to assess the
construct validity of and inform revisions to the HIRS. The HIRS will
be the first system that can assess the understandability and
actionability of patient health education materials that can be
incorporated into an EHR, including print and multimedia materials.
Note that the materials to be assessed need not currently be
incorporated into EHRs; for now, AHRQ is focusing on materials that
have the potential to be incorporated into EHRs.
No claim is made that the results from this study will be
generalizable in the statistical sense. Rather, the consumer testing
will be informative and critical to ensuring we have developed a valid
rating system by conducting consumer testing.
Estimated Annual Respondent Burden
Exhibit 1 presents estimates of the annualized burden hours for the
respondents' time to participate in this research. The Demographic and
S-TOFHLA questionnaires will be completed by all 48 participants and
takes 5 and 7 minutes, respectively, to complete. Each of the 48
participants will review 2 different sets of health education materials
and then participate in a short interview for each material topic.
English-speaking participants will review materials related to inhaler
use and colonoscopy while Spanish-speaking participants will review
materials related to high blood pressure and colonoscopy. To review
each material and participate in the associated interview requires 30
minutes (15 minutes to review the materials and 15 minutes for the
interview). The total annualized burden is estimated to be 58 hours.
Exhibit 2 presents the estimated annualized cost burden associated
with the respondents' time to participate in this research. The total
cost burden is estimated at $962.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Data collection Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Demographic Questionnaire....................... 48 1 5/60 4
S-TOFHLA Questionnaire.......................... 48 1 7/60 6
Health Education Materials & Interview--English, 24 1 30/60 12
Inhaler........................................
Health Education Materials & Interview --English 48 1 30/60 24
& Spanish, Colonoscopy.........................
Health Education Materials & Interview--Spanish, 24 1 30/60 12
High Blood Pressure............................
---------------------------------------------------------------
[[Page 19669]]
Total....................................... 192 na na 58
----------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Average
Data collection Number of Total burden hourly wage Total cost
respondents hours rate* burden
----------------------------------------------------------------------------------------------------------------
Demographic Questionnaire....................... 48 4 $21.35 $85
S-TOFHLA Questionnaire.......................... 48 6 21.35 128
Health Education Materials & Interview--English, 24 12 21.35 256
Inhaler........................................
Health Education Materials & Interview --English 48 24 21.35 512
& Spanish, Colonoscopy.........................
Health Education Materials & Interview--Spanish, 24 12 21.35 256
High Blood Pressure............................
---------------------------------------------------------------
Total....................................... 192 58 na 1,237
----------------------------------------------------------------------------------------------------------------
* Based upon the mean wage for all occupations, National Compensation Survey: Occupational wages in the United
States May 2010, ``U.S. Department of Labor, Bureau of Labor Statistics.''
Estimated Annual Costs to the Federal Government
The total cost of this contract to the government is $524,945, and
the project extends over 3 years (July 19, 2010 to July 18, 2013). The
data collection for which we are seeking OMB clearance will take place
from September 1, 2012 to December 31, 2012. Exhibit 3 shows a
breakdown of the total cost as well as the annualized cost for the data
collection, processing and analysis activity for this entire contract.
Exhibit 3--Estimated Cost
------------------------------------------------------------------------
Cost Component Total Cost Annual Cost
------------------------------------------------------------------------
Project Development................. $66,447 $22,149
Data Collection Activities.......... 129,547 43,182
Data Processing and Analysis........ 129,548 43,183
Publication of Results.............. 131,571 43,857
Project Management.................. 67,832 22,611
-----------------------------------
Total........................... 524,945 174,982
------------------------------------------------------------------------
Request for Comments
In accordance with the Paperwork Reduction Act, comments on AHRQ's
information collection are requested with regard to any of the
following: (a) Whether the proposed collection of information is
necessary for the proper performance of AHRQ health care research and
health care information dissemination functions, including whether the
information will have practical utility; (b) the accuracy of AHRQ's
estimate of burden (including hours and costs) of the proposed
collection(s) of information; (c) ways to enhance the quality, utility,
and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information upon the
respondents, including the use of automated collection techniques or
other forms of information technology.
Comments submitted in response to this notice will be summarized
and included in the Agency's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.
Dated: March 22, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012-7768 Filed 3-30-12; 8:45 am]
BILLING CODE 4160-90-M
