[Federal Register Volume 76, Number 231 (Thursday, December 1, 2011)]
[Notices]
[Pages 74785-74788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30795]


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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.

DATES: Comments on this notice must be received by January 30, 2012.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
[email protected].
    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) prop-am 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 
healthcare 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

[[Page 74786]]

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 healthcare 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 healthcare quality improvement by conducting 
and supporting both research that develops and presents scientific 
evidence regarding all aspects of healthcare 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 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 healthcare 
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

[[Page 74787]]

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 and for population subgroups defined by sociodemogiaphic 
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.......              1685                 1             15/60               421
Short Citizens' Deliberation (SCD)......               192                 1                 2               384
Online Deliberative Polling[reg] (ODP)..               288                 1                 5              1440
In-Person Deliberative Polling[reg]                    288                 1                 9              2592
 (IDP)..................................
Citizens' Panel.........................                96                 1                24              2304
Interrupted Deliberation (ID)...........               192                 1                 6              1152
Educational Materials...................              1685                 1                 1              1685
Knowledge and Attitudes Pretest Survey..              1685                 1             30/60               843
Knowledge and Attitudes Posttest Survey.              1685                 1             20/60               562
Deliberative Experience Survey..........              1056                 1             15/60               264
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    Total...............................              8852               N/A               N/A             11647
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                              Number of       Total burden     Average hourly      Total cost
      Form name/Deliberative method          respondents          hours           wage rate          burden
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Recruitment and Consent Materials.......              1685               421            $21.35            $8,988
Short Citizens' Deliberation (SCD)......               192               384             21.35             8,198
Online Deliberative Polling[reg] (ODP)..               288              1440             21.35            30,744
In-Person Deliberative Polling[reg]                    288              2592             21.35            55,339
 (IDP)..................................
Citizens' Panel.........................                96              2304             21.35            49,190
Interrupted Deliberation (ID)...........               192              1152             21.35            24,595

[[Page 74788]]

 
Educational Materials...................              1685              1685             21.35            35,975
Knowledge and Attitudes Pretest Survey..              1685               843            $21.35           $17,998
Knowledge and Attitudes Post-test Survey              1685               562             21.35            11,999
Deliberative Experience Survey..........              1056               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.

     Exhibit 3--Estimated Annualized Cost to the Federal Government
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           Cost component                Total cost      Annualized 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
    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: November 16, 2011.
Carolyn Clancy,
Director.
[FR Doc. 2011-30795 Filed 11-30-11; 8:45 am]
BILLING CODE 4160-90-M