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[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]

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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.

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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
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                                                                     Number of
                 Data collection                     Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
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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
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                                                      Average
                 Data collection                     Number of     Total burden    hourly  wage     Total cost
                                                    respondents        hours           rate*          burden
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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
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* 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
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           Cost Component                Total Cost        Annual Cost
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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
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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
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