[Federal Register Volume 84, Number 215 (Wednesday, November 6, 2019)]
[Notices]
[Pages 59811-59813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24194]


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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 Harmonization and Data Infrastructure for 
Patient Centered Outcomes Research in Depression.''
    This proposed information collection was previously published in 
the Federal Register on August 22, 2019 and allowed 60 days for public 
comment. No substantive comments were received by AHRQ during these 60 
days. The purpose of this notice is to allow an additional 30 days for 
public comment.

DATES: Comments on this notice must be received by 30 days after date 
of publication.

ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk 
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by 
email at [email protected] (attention: AHRQ's desk officer).

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email at 
[email protected].

SUPPLEMENTARY INFORMATION: 

Proposed Project

Outcome Measure Harmonization and Data Infrastructure for Patient 
Centered Outcomes Research in Depression

    The Agency for Healthcare Research and Quality's (AHRQ) mission is 
to produce evidence to make health care safer, higher quality, more 
accessible, equitable, and affordable, and to work within the U.S. 
Department of Health and Human Services and with other partners to make 
sure that the evidence is understood and used.
    In support of this mission, AHRQ funded a prior project to 
harmonize the outcome measures collected across patient registries and 
routine clinical practice, with the goals of supporting the development 
of a robust data infrastructure that can consistently and efficiently 
collect high-quality data on outcome measures that are relevant to 
patients and clinicians and supporting patient-centered outcomes 
research and quality improvement. Harmonized outcome measures would 
also form the foundation for learning healthcare systems. Of note, AHRQ 
has supported the development of the Outcome Measures Framework (OMF). 
The OMF is a conceptual model for classifying outcomes that are 
relevant to patients and providers across most conditions. AHRQ, in 
collaboration with the U.S. Food and Drug Administration and the 
National Library of Medicine, recently

[[Page 59812]]

supported an effort to use the OMF as a content model for developing 
harmonized outcome measures in specific disease areas, including 
depression.
    Major depressive disorder (MDD) is a common mental disorder that 
affects an estimated 16.2 million adults and 3.1 million adolescents in 
the United States. Characterized by changes in mood, cognitive 
function, and/or physical function that persist for two or more weeks, 
MDD can reduce quality of life substantially, impair function at home, 
work, school, and in social settings, and result in increased mortality 
due to suicide. MDD also is a major cause of disability, with an 
economic burden of approximately $210.5 billion per year in the United 
States.
    Despite the burden of MDD and the availability of treatment, the 
condition is often undiagnosed and untreated. In 2016, the U.S. 
Preventive Services Task Force recommended screening for depression in 
the general adult population, including pregnant and postpartum women, 
and in adolescents. While routine screening is intended to improve 
diagnosis and treatment of MDD, many questions remain, such as about 
the comparative effectiveness of different treatment approaches, the 
incidence of adverse events, when to add medications for patients who 
do not respond to an initial course of treatment, how and why 
depression recurs, and how to classify and treat treatment-resistant 
depression. Patient registries capture a wealth of data on depression 
treatment patterns and outcomes in the United States and could serve as 
the foundation for a national research infrastructure to address these 
and other research questions. Yet, a lack of harmonization in the 
outcome measures collected by each registry makes it challenging, if 
not impossible, to link and compare data across registries and related 
efforts. As documented in the prior project, existing registries use 
different outcome measures (e.g., remission as defined by the PHQ-9 vs. 
HAM-D) and capture data at different timepoints.
    Depression registries offer an excellent opportunity to demonstrate 
the feasibility and value of implementing the harmonized outcome 
measures. Existing registries already capture some of the harmonized 
depression measures for quality reporting, although at different 
timepoints; capture of these measures and the additional measures at 
consistent intervals will enable the registries to generate more robust 
data suitable for research purposes.
    AHRQ is now proposing to implement the harmonized depression 
outcome measures developed under the prior project in two patient 
registries (the PRIME Registry and PsychPRO) and a health system 
setting. The purpose of this project is to demonstrate that capturing 
the harmonized outcome measures in the clinical workflow and submitting 
these data to different registries can improve clinical care, reduce 
the burden of registry participation, and increase the utility of 
registry data for research purposes. The objectives of the project are 
to:

--Demonstrate that collection of the harmonized outcome measures is 
feasible, sustainable, and useful for clinicians participating in 
primary care and mental health patient registries.
--Demonstrate that collection of the harmonized outcome measures is 
feasible, sustainable, and useful for clinicians in a health system 
setting.

    Evaluate whether collection of the harmonized measures increases 
the utility of registry data for research purposes.
    The project is being conducted by AHRQ through its contractor, OM1, 
Inc., 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 the outcomes of such services. 42 U.S.C. 299a(a)(1) and (3).

Method of Collection

    To achieve the goals of this project the following data collections 
will be implemented:
    (1) Patient Health Questionnaire-9 (PHQ-9)--the PHQ-9 is a brief, 
9-item scale that is completed by patients and reviewed by clinicians 
at three points during this project. The scale is used to measure 
depression severity, to monitor changes in depression severity over 
time, and to calculate the harmonized outcome measures for depression 
remission, response, recurrence, and suicide ideation and behavior.
    (2) Frequency, Intensity, and Burden of Side Effects Ratings 
(FIBSER)--the FIBSER is a brief, 3-item scale that is completed by 
patients and reviewed by clinicians at three points during this 
project. The scale is used to measure the burden of side effects 
related to depression treatment and to calculate the harmonized outcome 
measure for adverse events.
    (3) Clinician Survey--the clinician survey is a brief, 20-question 
survey that clinicians in the health system setting will be asked to 
complete once at the conclusion of the project. The survey captures 
information on the value of the harmonized outcome measures for 
informing patient care.
    Users of the information captured in this project will fall into 
two categories: Clinicians providing care for patients with depression; 
and researchers using the de-identified data to answer a patient-
centered outcomes research question. AHRQ will receive summary findings 
from the data analysis only; no patient-level data will be shared with 
AHRQ.

Estimated Annual Respondent Burden

    A key objective of this project is to demonstrate that the 
harmonized outcome measures can be captured as part of the routine 
clinical workflow, with little to no added burden for clinicians and 
patients. The harmonized measures will be calculated primarily with 
existing data extracted from electronic medical records (EMRs). 
Extraction of these data will not represent an additional burden for 
clinicians. Patients participating in this project will be asked to 
complete up to two patient-reported outcome measures--the Patient 
Health Questionnaire-9 (PHQ-9) and the Frequency, Intensity, and Burden 
of Side Effects Ratings (FIBSER). Burden is estimated below for 
completion of these instruments by the patient respondent. Clinicians 
participating in the health system component of the project will be 
asked to complete the Clinician Survey. Burden is estimated below for 
completion of this survey by the clinician respondent.
    Exhibit 1 shows the estimated annualized burden hours for the 
patient respondent's time to complete the PHQ-9 and FIBSER at three 
time points as part of this project and for the clinician respondent to 
complete the Clinician Survey at one time point during this project. 
The PHQ-9 is a brief, 9-item scale used to measure depression severity. 
The FIBSER is a brief, 3-item scale used to measure the burden of side 
effects related to depression treatment. The Clinician Survey is a 
brief, 20-question survey designed to assess the value of the 
harmonized outcome measures for informing patient care. The PHQ-9 is 
used in routine clinical practice to screen for depression and monitor 
changes in depression severity over time, as recommended by the U.S. 
Preventive Services Task Force. For some participants in this project, 
completion of the PHQ-9 is part of their existing clinical care routine 
and does not represent an extra burden. For

[[Page 59813]]

example, the PHQ-9 is already captured routinely for participants in 
the PsychPRO registry. The estimates below do not include participants 
in the PsychPRO registry for that reason.
    Because the primary objective of this project is to determine the 
feasibility and value of extracting the relevant data and calculating 
the measures, a formal sample size has not been calculated. We estimate 
that the 20 participating sites in the two patient registries will each 
enroll 10 patients, for a total of 200 patients. We estimate that the 5 
participating sites at the health system will each enroll 10 patients, 
for a total of 50 patients. We did not include the PsychPRO enrollment 
in the PHQ-9 estimates, as the PHQ-9 is already collected in this 
registry and does not represent extra burden. We also do not anticipate 
implementing the FIBSER at the health system sites. Therefore, the 
total number of respondents for the PHQ-9 is estimated at 150, and the 
total number of respondents for the FIBSER is estimated at 200. We 
anticipate that three clinicians associated with each of the five 
health system sites will complete the Clinician Survey. Therefore, the 
total number of respondents for the Clinician Survey is estimated at 
15.
    Based on existing literature, it is estimated that completion of 
the PHQ-9 takes, on average, 3 minutes, and the FIBSER takes, on 
average, 2 minutes to complete. Participants in the patient registries 
will be asked to complete the PHQ-9 and FIBSER three times over the 
course of a year, for a total time of 15 minutes per year. Participants 
from the health system will be asked to complete the PHQ-9 three times 
over the course of a year. Clinicians from the health system sites will 
be asked to complete the Clinician Survey once, at the conclusion of 
the project; the survey is designed to be completed in 5 minutes or 
less. If 150 respondents complete the PHQ-9 three times over the course 
of one year, the estimated annualized burden would be 22.5 hours. If 
200 respondents complete the FIBSER three times over the course of one 
year, the estimated annualized burden would be 20 hours. If 15 
clinicians complete the Clinician Survey once over the course of one 
year, the estimated annualized burden would be 1.25 hours. The total 
estimated annualized burden would be 43.75 hours.

                                  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
----------------------------------------------------------------------------------------------------------------
PHQ-9...........................................             150               3               3            22.5
FIBSER..........................................             200               3               2              20
Clinician Survey................................              15               1               5            1.25
                                                 ---------------------------------------------------------------
    Total.......................................             365  ..............  ..............           43.75
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    Exhibit 2 shows the estimated cost burden associated with the 
respondent's time to complete the PHQ-9, FIBSER, and Clinician Survey 
as part of this project. The total cost burden to respondents is 
estimated at an average of $1,110.93 annually. The duration of this 
project is one year.

                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours         wage rate        burden
----------------------------------------------------------------------------------------------------------------
PHQ-9...........................................             150            22.5        * $24.98         $562.05
FIBSER..........................................             200              20         * 24.98           499.6
Clinician Survey................................              15            1.25          39.42           49.28
                                                 ---------------------------------------------------------------
    Total.......................................             365            42.5           24.98        1,110.93
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* Based on the mean wages for all occupations, 00-0000. May 2018 National Occupational Employment and Wage
  Estimates. U.S. Department of Labor, Bureau of Labor Statistics. Available at: https://www.bls.gov/oes/current/oes_nat.htm#00-0000.
 Based on the mean wages for Healthcare Practitioners and Technical Occupations, 29-0000. May 2018 National
  Occupational Employment and Wage Estimates. U.S. Department of Labor, Bureau of Labor Statistics. Available
  at: https://www.bls.gov/oes/current/oes_nat.htm#29-0000.

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's health care research and 
health care 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: October 31, 2019.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019-24194 Filed 11-5-19; 8:45 am]
 BILLING CODE 4160-90-P