Agency Information Collection Activities: Proposed Collection; Comment Request, 74785-74788 [2011-30795]

Download as PDF emcdonald on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 231 / Thursday, December 1, 2011 / Notices higher per-foot dockage fee than other vessels’’ is unlawfully discriminatory. Complainant asserted this claim in the United States District Court for the District of Alaska, which court referred the claim to the Commission upon Respondent’s motion in that court ‘‘alleging that the dispute was within the Commission’s primary jurisdiction.’’ Thus Complainant alleges that Respondent has violated the Shipping Act of 1984 ‘‘by unreasonably prejudicing and disadvantaging Minto and unreasonably preferring and advantaging others in violation of 46 U.S.C. 41106(2), and by failing to establish, observe, and enforce just and reasonable regulations and practices relating to or connected with receiving, handling, storing, or delivering property, in violation of 46 U.S.C. 41102. Complainant also presents its state law discrimination claim at the direction of the District Court. Complainant requests that Respondent be ordered ‘‘after due hearing, to answer the charges herein, to cease and desist from the aforesaid violations of the Shipping Act, to establish and put in force such practices as the Commission determines to be lawful and reasonable, and to pay Minto reparations for PARN’s violations of the Act, including the amount of the actual injury, plus interest, costs and attorneys fees, and any other damages to be determined; and that the Commission order any such other relief as it determines proper.’’ The full text of the complaint can be found in the Commission’s Electronic Reading Room at http://www.fmc.gov. This proceeding has been assigned to the Office of Administrative Law Judges. Hearing in this matter, if any is held, shall commence within the time limitations prescribed in 46 CFR 502.61, and only after consideration has been given by the parties and the presiding officer to the use of alternative forms of dispute resolution. The hearing shall include oral testimony and crossexamination in the discretion of the presiding officer only upon proper showing that there are genuine issues of material fact that cannot be resolved on the basis of sworn statements, affidavits, depositions, or other documents or that the nature of the matter in issue is such that an oral hearing and crossexamination are necessary for the development of an adequate record. Pursuant to the further terms of 46 CFR 502.61, the initial decision of the presiding officer in this proceeding shall be issued by November 23, 2012 and the VerDate Mar<15>2010 17:34 Nov 30, 2011 Jkt 226001 final decision of the Commission shall be issued by March 25, 2013. Karen V. Gregory, Secretary. [FR Doc. 2011–30895 Filed 11–30–11; 8:45 am] BILLING CODE 6730–01–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. ACTION: Notice. AGENCY: 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 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 dorislefkowitz@AHRQ.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: 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 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 74785 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 E:\FR\FM\01DEN1.SGM 01DEN1 74786 Federal Register / Vol. 76, No. 231 / Thursday, December 1, 2011 / Notices emcdonald on DSK5VPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 17:34 Nov 30, 2011 Jkt 226001 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 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 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 E:\FR\FM\01DEN1.SGM 01DEN1 74787 Federal Register / Vol. 76, No. 231 / Thursday, December 1, 2011 / Notices 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® (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® (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 Number of responses per respondent Number of respondents Form name/Deliberative method Hours per response Total burden hours Recruitment and Consent Materials ................................................ Short Citizens’ Deliberation (SCD) .................................................. Online Deliberative Polling® (ODP) ................................................ In-Person Deliberative Polling® (IDP) ............................................. Citizens’ Panel ................................................................................. Interrupted Deliberation (ID) ............................................................ Educational Materials ...................................................................... Knowledge and Attitudes Pretest Survey ........................................ Knowledge and Attitudes Posttest Survey ...................................... Deliberative Experience Survey ...................................................... 1685 192 288 288 96 192 1685 1685 1685 1056 1 1 1 1 1 1 1 1 1 1 15/60 2 5 9 24 6 1 30/60 20/60 15/60 421 384 1440 2592 2304 1152 1685 843 562 264 Total .......................................................................................... 8852 N/A N/A 11647 emcdonald on DSK5VPTVN1PROD with NOTICES EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Number of respondents Form name/Deliberative method Recruitment and Consent Materials ................................................ Short Citizens’ Deliberation (SCD) .................................................. Online Deliberative Polling® (ODP) ................................................ In-Person Deliberative Polling® (IDP) ............................................. Citizens’ Panel ................................................................................. Interrupted Deliberation (ID) ............................................................ VerDate Mar<15>2010 17:34 Nov 30, 2011 Jkt 226001 PO 00000 Frm 00017 Fmt 4703 Total burden hours 1685 192 288 288 96 192 Sfmt 4703 Average hourly wage rate 421 384 1440 2592 2304 1152 E:\FR\FM\01DEN1.SGM $21.35 21.35 21.35 21.35 21.35 21.35 01DEN1 Total cost burden $8,988 8,198 30,744 55,339 49,190 24,595 74788 Federal Register / Vol. 76, No. 231 / Thursday, December 1, 2011 / Notices EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued Number of respondents Form name/Deliberative method Total burden hours Average hourly wage rate Total cost burden Educational Materials ...................................................................... Knowledge and Attitudes Pretest Survey ........................................ Knowledge and Attitudes Post-test Survey ..................................... Deliberative Experience Survey ...................................................... 1685 1685 1685 1056 1685 843 562 264 21.35 $21.35 21.35 21.35 35,975 $17,998 11,999 5,636 Total .......................................................................................... 8852 N/A N/A 248,662 * 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 Cost component Total cost Project Management ........................................................................................................................................ Technical Expert Panel .................................................................................................................................... Technology Tools ............................................................................................................................................ Develop Educational Materials ........................................................................................................................ Evaluation Plan ................................................................................................................................................ Implement Methods ......................................................................................................................................... Conceptual Framework .................................................................................................................................... Data Processing and Analysis ......................................................................................................................... Reporting ......................................................................................................................................................... Overhead ......................................................................................................................................................... Total .......................................................................................................................................................... emcdonald on DSK5VPTVN1PROD 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 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. VerDate Mar<15>2010 17:34 Nov 30, 2011 Jkt 226001 Dated: November 16, 2011. Carolyn Clancy, Director. [FR Doc. 2011–30795 Filed 11–30–11; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Annualized cost $60,106 117,793 177,580 368,624 214,566 1,624,169 50,195 566,846 135,693 1,281,340 4,596,914 $30,053 58,896 88,790 184,312 107,283 812,085 25,098 283,423 67,847 640,670 2,298,457 Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ‘‘delisted’’ by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. Patient Safety Organizations: Voluntary Relinquishment From HealthWatch, Inc. Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of delisting. The directories for both listed and delisted PSOs are ongoing and reviewed weekly by AHRQ. The delisting was effective at 12 Midnight ET (2400) on November 1, 2011. ADDRESSES: DATES: AGENCY: AHRQ has accepted a notification of voluntary relinquishment from HealthWatch, Inc. of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109–41, 42 U.S.C. 299b–21—b–26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety SUMMARY: PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 Both directories can be accessed electronically at the following HHS Web site: http:// www.pso.AHRQ.gov/index.html. FOR FURTHER INFORMATION CONTACT: Susan Grinder, Center for Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 20850; Telephone (toll free): (866) 403–3697; Telephone (local): (301) 427–1111; TTY (toll free): (866) 438–7231; TTY (local): (301) 427–1130; Email: pso@AHRQ.hhs.gov. SUPPLEMENTARY INFORMATION: E:\FR\FM\01DEN1.SGM 01DEN1

Agencies

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


=======================================================================
-----------------------------------------------------------------------

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: ``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 
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 
dorislefkowitz@AHRQ.hhs.gov.

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
----------------------------------------------------------------------------------------------------------------
                                                                Number of
      Form name/Deliberative method           Number of       responses per       Hours per       Total burden
                                             respondents       respondent         response            hours
----------------------------------------------------------------------------------------------------------------
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
                                         -----------------------------------------------------------------------
    Total...............................              8852               N/A               N/A             11647
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                              Number of       Total burden     Average hourly      Total cost
      Form name/Deliberative method          respondents          hours           wage rate          burden
----------------------------------------------------------------------------------------------------------------
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
                                         -----------------------------------------------------------------------
    Total...............................              8852               N/A               N/A          248,662
----------------------------------------------------------------------------------------------------------------
* 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
------------------------------------------------------------------------
           Cost component                Total cost      Annualized cost
------------------------------------------------------------------------
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
------------------------------------------------------------------------

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