[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Notices]
[Pages 8871-8874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3309]
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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: ``Use of Deliberative Methods to Enhance Public Engagement in
the Agency for Healthcare Research and Quality's (AHRQ's) Effective
Healthcare (EHC) Program and Comparative Effectiveness Research (CER)
Enterprise.'' In accordance with the Paperwork Reduction Act, 44 U.S.C.
3501-3521, AHRQ invites the public to comment on this proposed
information collection.
This proposed information collection was previously published in
the Federal Register on December 1st, 2011 and allowed 60 days for
public comment. No comments were received. The purpose of this notice
is to allow an additional 30 days for public comment.
DATES: Comments on this notice must be received by March 16, 2012.
ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by
email at [email protected] (attention: AHRQ's desk officer).
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
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Use of Deliberative Methods To Enhance Public Engagement in the Agency
for Healthcare Research and Quality's (AHRQ's) Effective Healthcare
(EHC) Program and Comparative Effectiveness Research (CER) Enterprise
With this project, AHRQ seeks evidence on the feasibility and
usefulness of public deliberation as an approach to obtaining public
input on questions related to the conduct and use of comparative
effectiveness research (CER). Although stakeholder engagement has been
central to the Effective Healthcare (EHC) program to date, public input
has not traditionally been used to inform and guide broad strategies
related to the use of evidence to inform decisions. This study would
provide a research base to address this gap. This project closely ties
to AHRQ's efforts to improve the rigor of methods, as it will generate
methodological evidence through a randomized controlled experiment
comparing five distinct methods of public deliberation to find the most
effective approaches for involving the general public, including
members of AHRQ's priority populations, in questions related to the
research enterprise.
Public deliberation is a strategy for engaging lay people in
informing decisions when these decisions require consideration of
values and ethics in addition to scientific evidence. It includes three
core elements:
(1) Convening a group of people (either in person or via online
technologies to connect people in remote locations),
(2) Educating the participants on the relevant issue(s) through
dissemination of educational materials and/or the use of content
experts, and
(3) Having the participants engage in a reason-based discussion, or
deliberation, on all sides of the issue(s).
AHRQ wishes to study the effectiveness of public deliberation,
because it offers the opportunity to obtain public input on complex
topics in an environment that encourages participants to educate
themselves about the topic and discuss it in a thoughtful, respectful
manner. Information about the topic is intentionally neutral and
respectful of the full range of underlying values and experience with
health care issues in the population. This approach is designed to
improve upon the sometimes superficial or ``top of mind'' responses
that are often provided by public opinion surveys. AHRQ views public
deliberation as a potential source of higher quality public input on
issues fundamental to the Agency's mission, such as the best and most
effective ways to use comparative effectiveness research, than has
heretofore been available.
Several distinct deliberative methods have been developed and used
previously. They share the three core elements of public deliberation,
but differ on key features of implementation such as duration, whether
they take place in-person or online, and the use of content experts.
Although there is considerable theoretical and case study literature
endorsing the value of public deliberation, there has been little
empirical research about its effectiveness and even less about the
comparative merits of different deliberative methods (Community Forum
Deliberative Methods Literature Review, 2010).
The objectives of this study are to:
1. Obtain informed and deliberated input from lay people on
important questions underlying AHRQ's research program; and
2. Expand the evidence base for the use of public deliberation
methods for exploring issues relevant to health care research by
comparing the outcomes of five distinct deliberative methods to a
control condition and to each other.
This study is being conducted by AHRQ through its contractor, the
American Institutes of Research (AIR), pursuant to AHRQ's statutory
authority to (1) promote health care quality improvement by conducting
and supporting both research that develops and presents scientific
evidence regarding all aspects of health care and the synthesis and
dissemination of available scientific evidence for use by policymakers,
among others, and (2) conduct and support research, provide technical
assistance, and disseminate information on healthcare and on systems
for the delivery of such care. See 42 U.S.C. 299(b)(1)(A), (D), (F),
and (G); 42 U.S.C. 299(b)(2); 42 U.S.C. 299a(a)(1)-(4).
Method of Collection
To achieve the objectives of this study the following activities
and data collections will be implemented:
(1) Participant recruitment--A short screening questionnaire,
including a brief overview of the study, will be used to recruit
persons for the study.
(2) Educational Materials--Educational materials are designed to
inform participants about the topics that are being deliberated and
will be
[[Page 8872]]
provided to all 1,685 participants recruited before the implementation
of any of the methods, but after the administration of the Knowledge
and Attitudes Pre-test Survey (described below). Additional content
provided during the deliberative method sessions includes an overview
of the study and the background materials needed by participants to
competently deliberate the issues. For two methods (ODP and IDP; see
below) educational materials to be used during the sessions will be
sent to participants before the sessions (but after administration of
the pre-test).
(3) Deliberative Discussion Groups and Control Group--The purpose
of the discussion groups is to obtain informed and deliberated input
from lay people on an important set of issues underlying health care
research. Participants will be randomly assigned to one of the five
deliberative methods or a control condition. The five methods were
selected because they have been previously implemented and vary on key
features that may affect the scalability and effectiveness of the
methods, including: duration (from two hours to three days), mode of
implementation (online versus in person), role of content experts, and
time between sessions allowing participants to seek additional
information on the issues and communicate informally with other
participants. The subject of the deliberations is the use of research
evidence in healthcare decision-making. This deliberative topic
encompasses several themes or ``variations'' that will be elaborated in
the deliberations:
1. Use of evidence to encourage better healthcare: Is evidence
useful (or, what kind of evidence is useful) to a physician and a
patient who are considering a test or treatment that has been found to
be ineffective, less effective than another, riskier than another, or
for which effectiveness has not been demonstrated?
2. Use of evidence to encourage better value: Is evidence useful
(or, what kind of evidence is useful) to a physician and a patient who
are considering a test or treatment that is effective even though an
equally effective but less expensive alternative is available?.
3. Decision-making when evidence shows more complex trade-offs: Is
evidence useful (or, what kind of evidence is useful) in treatment
decisions that involve the balancing of effectiveness, risk, and value?
The issues involved in each variation will be discussed in the
context of specific comparative effectiveness research (CER) examples.
These ``vignettes'' illustrate the issues and elicit participants'
input on the issues and the values employed by participants in the
deliberations.
(4) Knowledge and Attitudes Pre-test Survey -- This survey will
measure knowledge of and attitudes about the health issues discussed in
the deliberations. It will be administered to deliberation participants
and controls before educational materials are sent or the methods are
implemented.
As described, study participants will be provided with educational
materials related to the deliberative topic. In order to assess whether
or not participants were sufficiently informed on the topics addressed
in the materials, the Knowledge and Attitudes Survey contains items
assessing knowledge of medical research and medical evidence, of
comparative effectiveness research, and of healthcare costs. The
attitudinal questions refer to the use of medical evidence in
healthcare decision making. They include attitudes about health care
decision-making when research findings can provide no support for, or
conflict with patient and doctor preferences for particular treatments.
The questionnaire will also gather demographic and other
information necessary to characterize the study sample, test the
success of the randomization, and define population subgroups for which
variation in outcomes will be examined. The demographic variables also
will be used to control for participant and group characteristics that
may influence the outcomes. Even though the design involves
randomization, and these characteristics should be balanced across
groups, including them in the statistical models guards against
inadequate results from randomization.
The variables to be measured in the Knowledge and Attitudes Pre-
test Survey include:
Sociodemographic characteristics: gender, age, marital
status, education, employment status, household income, race/ethnicity,
priority population, languages spoken (in addition to English).
General health status.
Recent experience with the healthcare system (e.g., seeing
a healthcare provider more than three times for the same condition in
the last 12 months).
Health insurance coverage.
Health information-seeking behavior (e.g., the extent to
which people seek healthcare information or rely on their doctors to
provide information).
(5) Knowledge and Attitudes Post-test Survey--This survey will
measure knowledge of and attitudes about the issues discussed in the
deliberations after the deliberations take place. It will be
administered to deliberation participants and controls within one week
following conclusion of the deliberative methods and will include the
same knowledge and attitude questions as the pre-test questionnaire.
(6) Deliberative Experience Survey--As described above, the five
deliberative methods being tested vary in terms of duration, mode, use
of educational materials, and time between deliberative sessions. A
one-time survey will be administered to participants in the
deliberative methods after implementation of the experimental
conditions to compare deliberative methods to each other. Levels of
discourse quality and implementation quality achieved will be assessed.
Using multi-item scales, the survey will measure the following:
Discourse Quality
Equal participation in the discussions
Respect for others' opinions and tolerance of differing
perspectives
Appreciation of perspectives other than their own
Reasoned justification of ideas: sharing the reasoning or
rationale for positions, opinions, beliefs, or preferences
Implementation Quality
Quality of group facilitation
Quality of the educational materials provided
Quality of the experts
Transparency of the process and use of the results
Participants' perceived value of method
Participants' view of the influence the results will have
on programs
In sum, information collection in this study will entail
qualitative transcript review and quantitative surveys. This
information will be used to describe and summarize the input obtained
from the participants in the deliberative groups concerning the use of
evidence, presenting the findings in reports for AHRQ and the public.
The information from the surveys also will be used to expand the
evidence base for public deliberation. The experiment is designed to:
(1) Compare the effectiveness of the five deliberative methods to the
control condition and to each other, (2) compare the quality of the
discourse achieved by the deliberative methods to each other, (3)
assess the quality of implementation of the five methods, and (4) test
for variation in effectiveness and discourse quality by features of the
deliberations
[[Page 8873]]
and for population subgroups defined by sociodemographic
characteristics of the participants.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden associated with the
respondents' time to participate in this research. The total annualized
burden hours are estimated to be 11,647 hours. The burden estimate
comprises the following activities:
Participant Recruitment--The screening questionnaire and
recruitment letter and materials will be sent to 1,685 participants. We
estimate that it will take 15 minutes to complete the questionnaire and
review the recruitment letter and materials.
Educational materials--Educational materials will be provided to
all 1,685 participants recruited before the implementation of any of
the methods. We estimate that it will take up to 1 hour to review the
materials.
Short Citizens' Deliberation (SCD): This method will be tested with
192 participants (12 groups). Participants will attend a single, 2-hour
in-person meeting.
Online Deliberative Polling[supreg] (ODP): This method will be
tested with 288 participants (24 groups) and will consist of 4 online
sessions over the course of 4 weeks; in total, this method will take
about 5 hours per person.
In-Person Deliberative Polling[supreg] (IDP): This method will be
tested with 288 participants (16 groups); participants will attend a
single in-person meeting, lasting a full day.
Citizens' Panel (CP): This method will be tested with 96
participants (4 groups); participants will attend a 3-day, in-person
meeting.
Interrupted Deliberation (ID): This method will be tested with 192
participants (12 groups). Participants will attend 2 in-person
meetings, lasting 3 hours each, a week apart. Between meetings,
participants will be asked to access an online platform. In total, this
method will take about 6 hours per person.
Knowledge and Attitudes Pre-test Survey: This survey will be
administered to 1,685 participants and will take an estimated 30
minutes to complete.
Knowledge and Attitudes Post-test Survey: This survey will be
administered to 1,685 participants and will take an estimated 20
minutes to complete.
Deliberative Experience Survey: This survey will be administered to
1,056 deliberative methods participants at the conclusion of the
deliberative method. It will take about 15 minutes to complete.
Exhibit 1--Estimated Annualized Burden Hours
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Number of
Form name/Deliberative method Number of responses per Hours per Total burden
respondents respondent response hours
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Recruitment and Consent Materials............... 1,685 1 15/60 421
Short Citizens' Deliberation (SCD).............. 192 1 2 384
Online Deliberative Polling[reg] (ODP).......... 288 1 5 1,440
In-Person Deliberative Polling[reg] (IDP)....... 288 1 9 2,592
Citizens' Panel................................. 96 1 24 2,304
Interrupted Deliberation (ID)................... 192 1 6 1,152
Educational Materials........................... 1,685 1 1 1,685
Knowledge and Attitudes Pretest Survey.......... 1,685 1 30/60 843
Knowledge and Attitudes Post-test Survey........ 1,685 1 20/60 562
Deliberative Experience Survey.................. 1,056 1 15/60 264
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Total....................................... 8852 N/A N/A 11,647
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Exhibit 2--Estimated Annualized Cost Burden
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Average
Form name/deliberative method Number of Total burden hourly wage Total cost
respondents hours rate burden
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Recruitment and Consent Materials............... 1,685 421 $21.35 $8,988
Short Citizens' Deliberation (SCD).............. 192 384 21.35 8,198
Online Deliberative Polling[reg] (ODP).......... 288 1,440 21.35 30,744
In-Person Deliberative Polling[reg] (IDP)....... 288 2,592 21.35 55,339
Citizens' Panel................................. 96 2,304 21.35 49,190
Interrupted Deliberation (ID)................... 192 1,152 21.35 24,595
Educational Materials........................... 1,685 1,685 21.35 35,975
Knowledge and Attitudes Pretest Survey.......... 1,685 843 21.35 17,998
Knowledge and Attitudes Post-test Survey........ 1,685 562 21.35 11,999
Deliberative Experience Survey.................. 1,056 264 21.35 5,636
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Total....................................... 8852 N/A N/A $248,662
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\*\ Based upon the mean of the wages for 00-000 All Occupations ($21.35), May 2010 National Occupational
Employment and Wage Estimates. United States, ``U.S. Department of Labor, Bureau of Labor Statistics.'' http://www.bls.gov/oes/current/oes_nat.htm#00-0000
Estimated Annual Costs to the Federal Government
Exhibit 3 below breaks down the costs related to this study. These
are the costs associated with the portion of the contract awarded to
AIR to conduct the experiment. Since the implementation and evaluation
periods will span 24 months, the costs have been annualized by taking
the total cost and dividing by 2.
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Exhibit 3--Estimated Annualized Cost to the Federal Government
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Annualized
Cost component Total cost cost
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Project Management...................... $60,106 $30,053
Technical Expert Panel.................. 117,793 58,896
Technology Tools........................ 177,580 88,790
Develop Educational Materials........... 368,624 184,312
Evaluation Plan......................... 214,566 107,283
Implement Methods....................... 1,624,169 812,085
Conceptual Framework.................... 50,195 25,098
Data Processing and Analysis............ 566,846 283,423
Reporting............................... 135,693 67,847
Overhead................................ 1,281,340 640,670
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Total............................... $4,596,914 $2,298,457
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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 healthcare research and
healthcare 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: February 3, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012-3309 Filed 2-14-12; 8:45 am]
BILLING CODE 4160-90-M