[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
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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
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PHQ-9........................................... 150 3 3 22.5
FIBSER.......................................... 200 3 2 20
Clinician Survey................................ 15 1 5 1.25
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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
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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
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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