83 FR 4053 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 83, Issue 19 (January 29, 2018)

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 ``Outcome Measure Repository (OMR).''

[Federal Register Volume 83, Number 19 (Monday, January 29, 2018)]
[Notices]
[Pages 4053-4055]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-01515]


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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 ``Outcome Measure Repository (OMR).''

DATES: Comments on this notice must be received by March 30, 2018.

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 emails at 
[email protected].

SUPPLEMENTARY INFORMATION:

Proposed Project

Outcome Measure Repository

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, AHRQ invites public comment on this proposed information 
collection. In accordance with the agency's mission, AHRQ developed the 
Outcome Measure Repository (OMR), a web-based database with the purpose 
of providing a readily available public resource that includes 
definitions of outcome measures associated with patient registries. The 
information being collected in each OMR record will be visible to the 
public and readily available for public use.
    This effort is in alignment the AHRQ Registry of Patient Registries 
(RoPR), which provides a centralized point of collection for 
information about all patient registries in the United States. The RoPR 
furthers AHRQ's goals to enhance the description of the quality, 
appropriateness, and effectiveness of health services, and patient 
registries in particular, in a more readily available, central location 
by enhancing patient registry information, extracted from 
ClinicalTrials.gov or modeled based on the ClinicalTrials.gov data 
elements.
    The development of the OMR continues these efforts, and aims to 
achieve the following objectives:
    (1) Provide a searchable database of outcome measures used in 
patient registries in the United States to promote collaboration, 
reduce redundancy, and improve transparency;
    (2) Facilitate the use of standardized data elements and outcome 
measures; and

[[Page 4054]]

    (3) Facilitate the identification of potential areas of 
harmonization.
    The OMR system will be linked to RoPR in two key ways. First, users 
entering registry information in the RoPR system will be able to 
associate OMR measure records with the RoPR registry records. Second, 
measure stewards listing a measure record in the OMR system will be 
able to associate the measure with an existing patient registry in 
RoPR. Users will be able to access both databases with a single account 
(i.e., users with a RoPR account will be able to log in/access the OMR 
using that account, and vice versa).
    This study is being conducted by AHRQ through its contractor, L&M 
Policy Research and subcontractors Truven Health Analytics, an IBM 
Company, and OM1, pursuant to AHRQ's statutory authority to conduct and 
support research on health care and on systems for the delivery of such 
care, including activities with respect to the outcomes, cost, cost-
effectiveness, and use of health care services and access to such 
services, and with respect to health statistics and database 
development. 42 U.S.C. 299a(a)(3) and (8).

Method of Collection

    To achieve the three objectives of this project, information on 
outcome measures and related sub-elements from measure stewards who 
populate the OMR database system will be collected. Users of the OMR 
will primarily fall into two types: those stewarding a registry who 
will provide information on the data they collect in their registry, 
and those who will search for information about how a particular type 
of outcome measure is collected within patient registries. For the OMR 
to succeed, the first group of users--registry stewards--must be able 
to enter information into the system easily and efficiently. The second 
group of users--parties interested in seeking information on outcome 
measures--must be able to find sufficient information efficiently on 
outcome measures to identify items for use in their own registry or 
research. Meeting the needs of both sets of users is an important 
consideration in the design of the OMR.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondent's time to contribute to the OMR.
    Based on the number of respondents submitting RoPR records in 2016 
(65 respondents), it is expected that a similar number of stakeholders 
(approximately 70 respondents) will provide measure information in the 
OMR on an annual basis.
    All users will complete required fields on the ``Measure Profile'' 
form. Some users may also choose to complete the ``Sub-Element 
Profile'' form for one or more sub-elements associated with a given 
measure although this is not required. The number of sub-elements for a 
given measure is expected to vary widely. Many users may not provide 
sub-element information, while others may include five or more. It is 
expected that on average, measure stewards will enter information for 
two sub-elements.
    In September 2017, Truven Health Analytics consulted with several 
stakeholders and used a sample of existing measure definitions to 
estimate the time required to enter all OMR fields. The sample included 
measures representing a range of depth and complexity. For example, one 
measure record contained no sub-element information, only required 
fields, and short responses to open text fields (e.g., title and 
description). Another record contained two sub-elements, all optional 
fields, and longer responses to open text fields.
    As a result of the knowledge gained during these processes, it is 
estimated that it will take users 16 minutes, on average, to enter 
manually the additional fields added through the self-registration 
process (an average of 12 minutes to complete the Measure Profile form 
and 4 minutes to complete two Sub-Element Profile sub-forms). If 70 
respondents complete the Measure Profile form and two Sub-Element 
Profile sub-forms, the estimated annualized burden would be 18.7 hours 
total.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of    responses  per    Minutes per    Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
OMR Measure Profile/Sub-Element Profile.........              70               1           16/60            18.7
                                                 ---------------------------------------------------------------
    Total.......................................              70               1           16/60            18.7
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    Exhibit 2 shows the estimated cost burden associated with the 
respondent's time to participate in the OMR. The total cost burden to 
respondents is estimated at an average of $711.72 annually.

                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                                                  Average hourly
                    Form name                        Number of     Total burden      wage rate      Total cost
                                                    respondents        hours         [dagger]         burden
----------------------------------------------------------------------------------------------------------------
OMR Measure Profile/Sub-Element Profile.........              70            18.7          $38.06         $711.72
                                                 ---------------------------------------------------------------
    Total.......................................              70            18.7           38.06          711.72
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* Based on the mean wages for Healthcare Practitioners and Technical Occupations, 29-0000.
National Compensation Survey: Occupational Wages in the United States May 2016, ``U.S. Department of Labor,
  Bureau of Labor Statistics.'' Available at: https://www.bls.gov/oes/current/oes290000.htm.

Request for Comments

    In accordance with the Paperwork Reduction Act, comments on AHRQ's 
information collection are requested with regard to any of the 
following: (a) Whether the proposed collection of information is 
necessary for the proper performance of AHRQ health care research and 
health care information

[[Page 4055]]

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.

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2018-01515 Filed 1-26-18; 8:45 am]
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