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[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Notices]
[Pages 60997-61000]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24454]

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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 December 4, 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@AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Proposed Project

Development of a Health Information Rating System (HIRS)

    Over the past several years, low 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, 
resulting in an estimated excess cost for the US health care system of 
$50 billion to $73 billion per year.
    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,

[[Page 60998]]

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 project that includes 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 project relates 
to the first task only.
    As a first step, AHRQ has developed a draft HIRS using the 
following rigorous multistage approach that draws upon existing rating 
systems, the evidence base in the literature, and the real-world 
expertise and experience of a Technical Expert Panel (TEP):
    (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--understandability and actionability, 
defined as follows:
     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.
    (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 English-
language health education materials. Seek TEP review of results and 
provide guidance on how to address discrepancies.
    The draft HIRS was used by AHRQ researchers to rate 2 sets of 
patient health education materials: A set of 6 education materials 
related to asthma and a set of 6 education materials related to 
colonoscopy. Each of these 12 health education materials received a 
score for their understandability and actionability. Some of the 
materials received good scores on the draft HIRS, meaning that the 
researchers considered them to be understandable or actionable, and 
some materials received poor scores on the draft HIRS, indicating that 
the materials had low understandability or low actionability.
    The final stage of developing a reliable and valid rating system to 
assess the understandability and actionability of health education 
materials is testing with consumers.
    This project has the following goals:
    (1) To assess the construct validity of AHRQ's draft HIRS. The 12 
rated health education materials will be tested with a total of 48 
English-speaking consumers. Consumers will review materials and be 
asked questions to test whether they understand the materials and 
whether they know what actions to take. The outcome of this testing 
will be an HIRS that will offer professionals (e.g., clinicians, health 
librarians, etc.) a systematic method to evaluate and compare the 
understandability and actionability of health education materials. 
Since actionability is a new domain, we are testing it distinct from 
understandability though there is a theoretical relationship between 
the domains as we have defined them; that is, a material cannot be 
actionable if it is not first understandable. So actionability may in 
fact be a sub-domain of understandability. Besides assessing the 
construct validity, consumer testing will help us determine how to 
revise and improve the HIRS.
    (2) Finalize the HIRS and instructions for users, and make them 
publicly available on AHRQ's Web site.
    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 achieve the goals of the project the following data collections 
and activities will be implemented:
    (1) Demographic Questionnaire--The demographic questionnaire will 
collect basic demographic information about each 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 once to all 
participants to assess their level of health literacy.
    (3) Health Education Materials & Questionnaire--Asthma/Inhaler--
This includes a set of educational materials related to asthma and 
proper use of inhalers. Each consumer will be randomly assigned one of 
the six following materials:
    (i) An audiovisual material (understandable and actionable), titled 
How to use an inhaler by the Utah Department Health Asthma Program.
    (ii) An audiovisual material (understandable and poorly 
actionable), titled Asthma Triggers by Children's Healthcare of 
Atlanta.
    (iii) An audiovisual material (poorly understandable), titled 
Asthma Inhaler Medication Technique--How to Take an Asthma Inhaler by 
America's Allergist.
    (iv) A printable material (understandable and actionable), titled 
Asthma: How to Use A Metered Dose Inhaler, by FamilyDoctor.org.
    (v) A printable material (understandable and poorly actionable), 
titled How to use an inhaler--no spacer, by MedlinePlus.
    (vi) A printable material (poorly understandable), titled Inhaled 
Asthma Medications: Tips to Remember, by the American Academy of 
Allergy Asthma & Immunology.
    After seeing the randomly assigned audiovisual or printable 
material the participants will be administered a brief questionnaire to 
assess their understanding of how to use an inhaler and what actions to 
take based on the material.
    (4) Health Education Materials & Questionnaire--Colonoscopy--This 
includes a set of educational materials related to colonoscopy. Each 
consumer will be randomly assigned one of the six following materials:
    (i) An audiovisual material (understandable and actionable), titled 
Colonoscopy Patient Education Video by Krames.
    (ii) An audiovisual material (understandable and poorly 
actionable), titled Colorectal Cancer Awareness by St. Vincent's 
Healthcare.
    (iii) An audiovisual material (poorly understandable), titled 
Prepare for a Colonoscopy by The University of Texas MD Anderson Cancer 
Center.
    (iv) A printable material (understandable and actionable), titled 
Getting Ready for Your Colonoscopy by West Chester Endoscopy Suite.
    (v) A printable material (understandable and poorly actionable), 
titled Colonoscopy in the National

[[Page 60999]]

Digestive Diseases Information Clearinghouse (NDDIC).
    (vi) A printable material (poorly understandable), titled 
Colonoscopy by the American College of Surgeons Division of Education.
    After viewing the randomly assigned audiovisual or printable 
material the participants will be administered a brief questionnaire to 
assess their understanding of a colonoscopy 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 instrument that can assess the understandability and 
actionability of patient health education materials that can be 
incorporated into an EHR, including printable and audiovisual 
materials. Note that the materials to be assessed need not currently be 
incorporated into EHRs; for now, we are 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 
participants' 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 health education materials and 
then answer the associated questionnaires for each material topic. 
Participants will review English-language materials related to inhaler 
use and colonoscopy. To review each material and answer the associated 
questionnaire requires 30 minutes (15 minutes to review the materials 
and 15 minutes to complete the questionnaire). 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 $1,237.

                                  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 & Questionnaire--                  48               1           30/60              24
 Inhaler........................................
Health Education Materials & Questionnaire--                  48               1           30/60              24
 Colonoscopy....................................
                                                 ---------------------------------------------------------------
    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 & Questionnaire--                  48              24           21.35             512
 Inhaler........................................
Health Education Materials & Questionnaire--                  48              24           21.35             512
 Colonoscopy....................................
                                                 ---------------------------------------------------------------
    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 February 1, 2013 to March 31, 2013. 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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[[Page 61000]]

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: September 27, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012-24454 Filed 10-4-12; 8:45 am]
BILLING CODE 4160-90-M
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