[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Notices]
[Pages 44929-44932]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18790]


-----------------------------------------------------------------------

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: ``Evaluation of ARRA Comparative Effectiveness Research 
Dissemination Contractor Efforts.'' 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 September 26, 2011.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by e-mail 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 e-mail at 
doris.lefkowitz@AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION:

Proposed Project

Evaluation of ARRA Comparative Effectiveness Research Dissemination 
Contractor Efforts

    Today, both patients and their health care providers have many 
options when deciding on a treatment plan. Information available to 
patients and their health care providers offers great opportunities for 
informed decision making. However, the volume of information that needs 
to be reviewed and synthesized can be daunting. To complicate matters, 
studies may offer conflicting information or have a conflict of 
interest (e.g., research sponsored by pharmaceutical companies that 
make drugs). Sorting through conflicting information requires a 
background in research that most patients do not have, and physicians 
have limited time to conduct these reviews. Having a neutral third 
party review research, draw conclusions, and disseminate findings is 
necessary to ensure effective health care delivery and consumption of 
quality care.
    AHRQ recognizes the need to fill this gap and has taken a lead role 
in developing mechanisms for reviewing and disseminating Comparative 
Effectiveness Research (CER) and findings to clinicians, health care 
decision makers, purchasers/business decision makers, and consumers 
through its Effective Healthcare Program (EHCP). CER directly compares 
the benefits, potential risks, and costs of two or more health care 
interventions. These direct comparisons allow assessments of how well a 
health care treatment or intervention works under real-world 
conditions. AHRQ has paid careful attention not only to how studies are 
conducted but also to how results are communicated to its audiences.
    To augment AHRQ's existing CER dissemination efforts performed by 
the Eisenberg Center and other initiatives, AHRQ is conducting four 
one-time projects to test other ways to disseminate CER results. These 
four related projects will test new approaches to CER dissemination and 
promote awareness of the EHCP. Collectively, dissemination efforts will 
reach AHRQ's priority audiences of: clinical decision makers, health 
care system decision makers, purchasers/business decision makers, 
public policy decision makers, and consumers/patients.
    Through these four projects AHRQ aims to: (1) Educate professional 
and consumer audiences about CER; (2) inform professional and consumer 
audiences about AHRQ's EHCP; (3) and inform a wide range of audiences 
about new EHCP research findings.
    This project will evaluate the effectiveness of these four new 
dissemination efforts. The evaluation has four main goals:
    1. Assess the effectiveness of the four dissemination strategies in 
creating awareness of CER, specific CER topics, and the EHCP.
    2. Assess the effectiveness of the four dissemination strategies in 
fostering knowledge and understanding of CER finding, specific CER 
topics, and the EHCP.
    3. Assess the effectiveness of the four dissemination strategies in 
promoting utilization, including use of the EHCP materials by consumers 
and by clinicians in patient care and if usage by clinicians is 
increasing across time.
    4. Assess the effectiveness of the four dissemination strategies in 
supporting the benefits of using CER, and specific CER topics, for both 
patients and health care providers.
    This study is being conducted by AHRQ through its contractor, IMPAQ

[[Page 44930]]

International, LLC and its subcontractor, Battelle Memorial Institute, 
pursuant to AHRQ's statutory authority to conduct and support research 
on healthcare and on systems for the delivery of such care, including 
activities with respect to the quality, effectiveness, efficiency, 
appropriateness and value of healthcare services and with respect to 
clinical practice, including primary care and practice-oriented 
research. 42 U.S.C. 299a(a)(1) and (4).

Method of Collection

    To achieve project goals the following data collections will be 
implemented, each of which apply to all of the above-stated goals:
    1. Clinician Survey--Conduct three cross-sectional mail surveys 
with clinicians to measure awareness, understanding, use of the EHCP 
materials, and benefits of CER. Collecting survey data at multiple time 
points is critical to assess trends in the outcomes of interest among 
clinicians and the impact of ongoing and increased dissemination 
contractor activities. Three data points for the survey will allow us 
to test if the proportion of clinicians aware of CER and the Effective 
Healthcare Program is changing over time and if the rate of change is 
changing. The Survey will be administered at the end of years 1, 3 and 
4; the burden for the year 4 data collection is not included in the 
estimates in Exhibits 1 and 2 since it will be included in a second OMB 
clearance package to be submitted after year 3.
    2. Consumer/Patient Survey--Conduct two cross-sectional telephone 
surveys with consumers/patients to measure awareness, understanding, 
use of the EHCP materials, and benefits of CER. Collecting survey data 
at multiple time points is critical to assess trends in the outcomes of 
interest among consumers/patients and the impact of ongoing and 
increased dissemination contractor activities. Two data points for the 
survey will allow us to test if the proportion of consumers/patients 
aware of CER and the Effective Healthcare Program is changing over 
time. The Survey will be administered at the end of years 1 and 3. A 
short screener questionnaire will be used to identify eligible 
respondents.
    3. Health System Decision Maker Survey--Conduct one cross-sectional 
telephone survey with health care system decision makers to measure 
awareness, understanding, use of the EHCP materials, and benefits of 
CER. The questionnaire and respondent materials for this data 
collection are not included in this submission since it occurs in year 
4 of the project and have not yet been developed. These materials will 
be submitted in another OMB clearance package in year 3 of this 
project. This data collection is mentioned here in order to provide an 
overview of the entire 5 years of the project; it is not included in 
the burden estimates in Exhibits 1 and 2.
    4. Clinician Focus Groups--Conduct six follow-up focus groups with 
clinicians after the first and third cross-sectional surveys of this 
audience, The focus groups will be conducted with three clinician 
segments: (1) Those who report awareness of CER and have self-reported 
use of CER in their clinical practice; (2) those who report awareness 
of CER and have self-reported non-use of CER in their clinical 
practice; and (3) those who report no awareness of CER. One moderator 
guide will be used for each focus group. By asking the same questions 
to each clinician segment, who will have been targeted by all four 
dissemination contractors, differences among answers are more likely to 
be attributed to the segmentation criteria and eliminate bias through 
different questions. Two focus groups will be conducted for each of the 
three segments. The clinician focus groups will be conducted by 
telephone. The focus groups will be administered at the end of year 2 
and during year 5; the burden for the year 5 data collection is not 
included in the estimates in Exhibits 1 and 2 since it will be included 
in a second OMB clearance package to be submitted after year 3.
    5. Consumer/Patients Focus Groups--Conduct twelve follow-up focus 
groups with consumers/patients after the first cross-sectional survey 
of this audience, at the end of year 2 of the project. The focus groups 
will be conducted with three consumer/patient segments: (1) Those who 
report awareness of CER and have self-reported use of CER in medical 
decision making; (2) those who report awareness of CER and have self-
reported non-use of CER in medical decision making; and (3) those who 
report no awareness of CER. Four focus groups will be conducted for 
each of the three segments. A single screening questionnaire will be 
used to recruit participants. The consumer/patient focus groups will be 
conducted by telephone.
    6. Health System Decision Maker Focus Groups--Conduct twelve 
follow-up focus groups with health care system decision makers, after 
the cross-sectional survey of this audience. The focus groups will be 
conducted with three decision maker segments: (1) Those who reported 
awareness of CER and have self-reported use of CER in business decision 
making; (2) those who reported awareness of CER and have self-reported 
non-use of CER in business decision making; and (3) those who report no 
awareness of CER. Four focus groups will be conducted for each of the 
three segments. The focus groups will be conducted by telephone. The 
screener, moderator guides, and respondent materials for this data 
collection are not included in this submission since it occurs in year 
5 of the project and have not yet been developed. These materials will 
be submitted in another OMB clearance package in year 3 of this 
project. This data collection is mentioned here in order to provide an 
overview of the entire 5 years of the project; it is not included in 
the burden estimates in Exhibits 1 and 2.
    7. Semi-structured Interviews--Conduct semi-structured interviews, 
in year 3 of the project, with 20 individuals in each of the following 
groups: health care system decision makers, purchasers, and 
policymakers for a total of 60 interviews. In-depth interviews will be 
used to determine how people receive and interpret CER-related 
materials and verbal information, and adopt new behaviors based on 
information they receive.
    AHRQ will use the survey, focus group, and in-depth interview data 
to assess trends and the effectiveness of the four complementary and 
different dissemination methods to inform current and future 
dissemination of the EHCP. Specific attention will be given to changes 
in audience awareness, understanding, behavior change/use, and benefits 
of CER. Collecting data at multiple times will enable AHRQ to determine 
whether increased dissemination contractors' activities over time is 
associated with any change in CER awareness, knowledge, use, or 
benefit. Finally, collecting data from five audiences (i.e., 
clinicians, consumers/patients, health system decision makers, 
purchasers, and policy makers) will enable AHRQ to assess the 
effectiveness of its CER-related dissemination efforts among its target 
populations.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondent's time to participate in this evaluation. The total burden 
hours are estimated to be 3,760.
    Clinician Surveys: The design for the clinician survey consists of 
three cross sectional waves (only 2 of which are included in the 
estimates here, as explained in section 1), each wave having 1,926 
respondents for a total of

[[Page 44931]]

3,852 across the two waves included in this information collection 
request. The survey will take no longer than 20 minutes to complete.
    Consumer/Patient Surveys: The design for the consumer/patient 
survey consists of two cross-sectional waves, each wave having 1,000 
respondents for a total of 2,000 across both waves. The screener will 
take no longer than 5 minutes to complete. The survey will take no 
longer than 20 minutes to complete.
    Clinician Focus Groups: Six follow-up focus groups with clinicians 
will be conducted by telephone twice; once after the first and again 
after the third cross-sectional surveys of this audience (only one of 
which is included in the estimates here, as explained in section 1). 
Focus group participants will have completed the survey and will have 
expressed interest in participating in a telephone focus group. For 
each of the two rounds of focus groups, twelve clinicians will be 
recruited for each of six focus groups.
    Focus groups will last one hour.
    Consumer/Patient Focus Groups: Twelve follow-up focus groups with 
consumer/patients will be conducted by telephone after the first cross-
sectional survey of this audience. Focus group participants will have 
completed the survey and will have expressed interest in participating 
in a telephone focus group. Eight people will be in each focus group. 
The screener will take no longer than 5 minutes to complete. Focus 
group will last approximately 90 minutes.
    In-Depth Interviews with Other Key Audiences: In-depth interviews 
will be conducted with up to 20 representatives in each of three key 
audiences: (1) Health care system decision makers, (2) purchasers, and 
(3) policy makers. Respondents located in the metropolitan Washington, 
DC/Baltimore area will be interviewed in person, and respondents 
located outside the local area will be interviewed by telephone. 
Participant recruitment should take no longer than five minutes. The 
interviews will last one hour.
    The estimated annualized cost burden associated with the 
respondent's time to participate in this evaluation is shown in Exhibit 
2. The total cost burden is estimated to be $144,266.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
            Data Collection Activity                 Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Clinician Survey................................           3,852               1           20/60           1,284
Consumer/Patient Survey Screener................            2560               1            5/60             214
Survey..........................................            2000               1           20/60             667
Clinician Focus Groups..........................              72               1           60/60              72
Consumer/Patient Focus Groups Screener..........             120               1            5/60              10
Focus Group.....................................              96               1           90/60             144
Semi-structured Interviews with Health System                 20               1           60/60              20
 Decision Makers................................
Semi-structured Interviews with Purchasers......              20               1           60/60              20
Semi-structured Interviews with Policymakers....              20               1           60/60              20
                                                 ---------------------------------------------------------------
    Total.......................................           8,760             n/a             n/a           2,451
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2: Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
            Data Collection Activity                 Number of     Total burden     hourly wage     Total cost
                                                    respondents        hours           rate*          burden
----------------------------------------------------------------------------------------------------------------
Clinician Survey................................           3,852           1,284          $88.46        $113,583
Consumer/Patient Survey Screener................            2560             214           20.90           4,473
Survey..........................................            2000             667           20.90          13,940
Clinician Focus Groups..........................              72              72           88.46           6,369
Consumer/Patient Focus Groups Screener..........             120              10           20.90             209
Focus Groups....................................              96             144           20.90           3,010
Semi-structured Interviews with Health System                 20              20           43.74             875
 Decision Makers................................
Semi-structured Interviews with Purchasers......              20              20           46.59             932
Semi-structured Interviews with Policymakers....              20              20           43.74             875
                                                 ---------------------------------------------------------------
    Total.......................................           8,760           2,451             n/a        144,266
----------------------------------------------------------------------------------------------------------------
* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United
  States May 2009, ``U.S. Department of Labor, Bureau of Labor Statistics.'' Hourly wage rates for clinicians
  were estimated using the mean wage for internists (occupation code 29-1063). Hourly wage rates for consumers/
  patients were estimated using the mean wage for all occupations (occupation code 00-0000) since participants
  in the consumer groups may have a wide range of jobs and occupations. Hourly wage rates for health system
  decision makers and policymakers were estimated using the mean wage for medical and health services managers
  (occupation code 11-9111). Hourly wage rates for purchasers were estimated using the mean wage for purchasing
  managers (occupation code 11-3061). These rates were obtained in January 2011 at the following Web site: http://www.bls.gov/oes/current/oes_nat.htm#b29-0000.

Estimated Annual Costs to the Federal Government

    The total cost to the Government for this information collection is 
$2,719,272 over the five years of the project. Exhibit 3 provides a 
breakdown of these costs.

[[Page 44932]]



             Exhibit 3--Estimated Total and Annualized Cost
------------------------------------------------------------------------
                                                              Annualized
                Cost Component                   Total cost      cost
------------------------------------------------------------------------
Project Development...........................     $420,055      $84,011
Data Collection Activities....................    1,452,290      290,458
Data Processing and Analysis, and Reports to        141,637       28,327
 AHRQ.........................................
Project Management............................      291,706       58,341
Overhead......................................      413,584       82,717
                                               -------------------------
    Total.....................................    2,719,272      543,854
------------------------------------------------------------------------

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: July 6, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-18790 Filed 7-26-11; 8:45 am]
BILLING CODE 4160-90-M