Attachment A: Depression Capstone Project Registry Protocol

Implementation of Harmonized Depression Outcome Measures to support PCOR
Version 1.0 dated 15 August 2019

OBSERVATIONAL STUDY PROTOCOL
TITLE

Implementation of Harmonized Depression Outcome
Measures in a Primary Care Registry and a Mental Health
Registry to Support Patient-Centered Outcomes Research

PROTOCOL/STUDY
NO.

N/A

VERSION

1.0
15-August-2019

SPONSOR

Agency for Healthcare Research and Quality
5600 Fishers Lane
Rockville, MD 20857

CONDUCTED BY

OM1, Inc.
800 Boylston Street, Suite 1410
Boston, MA 02199

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Table of Contents
Sponsor Signature Page ................................................................................................................. 4
List of Abbreviations ....................................................................................................................... 5
1.

Background ............................................................................................................................. 6

2.

Rationale ................................................................................................................................. 7

3.

Objectives ................................................................................................................................ 7

4.

Study Design ........................................................................................................................... 8
4.1

Study Description ....................................................................................................................... 8

4.2

Study Population ........................................................................................................................ 8

4.2.1
4.2.2
4.2.3
4.2.4

4.3

Exposure Definition and Measures........................................................................................... 9

4.4

Outcome Definitions and Measures .......................................................................................... 9

4.5

Minimization of Bias ................................................................................................................ 10

4.6

Data Collection ......................................................................................................................... 10

4.6.1
4.6.2

5.

Determination of Eligibility ................................................................................................................. 11
Data Elements....................................................................................................................................... 11

Statistical Methods ................................................................................................................ 12
5.1

Sample Size ............................................................................................................................... 12

5.2

Data Analyses ........................................................................................................................... 12

5.2.1
5.2.2

5.3
5.3.2
5.3.3

6.

Inclusion Criteria .................................................................................................................................... 8
Exclusion Criteria ................................................................................................................................... 8
Study Enrollment .................................................................................................................................... 9
Patient Withdrawal ................................................................................................................................. 9

General Considerations ........................................................................................................................ 12
Planned Analyses ................................................................................................................................. 12

Data Reporting ......................................................................................................................... 13
Annual/interim Analyses and Reporting .............................................................................................. 13
Final Analyses and Reporting .............................................................................................................. 13

Study Management ............................................................................................................... 13
6.1

Data Management .................................................................................................................... 13

6.2

Changes to the Protocol ........................................................................................................... 13

6.3

Study Governance .................................................................................................................... 13

6.4

Publication Policy ..................................................................................................................... 13

7.

Safety Reporting ................................................................................................................... 14

8.

Ethical and Regulatory Considerations ............................................................................... 14
8.1

Guiding Principles .................................................................................................................... 14

8.2

Required Documents ................................................................................................................ 14

8.3

Patient Information and Informed Consent .......................................................................... 14

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9.

8.4

Patient Confidentiality ............................................................................................................. 14

8.5

IRB ............................................................................................................................................. 15

References ............................................................................................................................. 16

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Sponsor Signature Page
Reviewed and Approved by:

Signature

Title

Date

Signature

Title

Date

Signature

Title

Date

Principal Investigator

OM1, Inc

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List of Abbreviations
ABFM

American Board of Family Medicine

AHRQ

Agency for Healthcare Research and Quality

APA

American Psychiatric Association

CFR

Code of Federal Regulations

CHRT

Concise Health Risk Tracking

EHR

Electronic health record

EMR

Electronic medical record

FDA

U.S. Food and Drug Administration

FIBSER

Frequency, Intensity, and Burden of Side Effects Ratings

GCP

Good Clinical Practice

GPP

Good Pharmacovigilance Practices

HAM-D

Hamilton Depression Score

HIPAA

Health Insurance Portability and Accountability Act of 1996

ICH

International Committee on Harmonization

ICMJE

International Committee of Medical Journal Editors

IRB

Institutional review board

ISPE

International Society for Pharmacoepidemiology

MDD

Major Depressive Disorder

MIPS

Merit-based Incentive Payment System

OMF

Outcome Measures Framework

PHQ-9

Patient Health Questionnaire – 9

PRO

Patient Reported Outcome

PsychPRO

Psychiatric Patient Registry Online

SAP

Statistical analysis plan

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1. Background
A patient registry is defined as “an organized system that uses observational study methods to
collect uniform data (clinical and other) to evaluate specified outcomes for a population defined
by a particular disease, condition, or exposure and that serves one or more pre-determined
scientific, clinical, or policy purposes.”1 Patient registries fulfill different purposes for a wide
range of stakeholders, as documented in the publication, Registries for Evaluating Patient
Outcomes: A User’s Guide.1 Given their myriad purposes, it is unsurprising that a large number
of registries exist – over 5,000 according to the ClinicalTrials.gov.
Together, these registries represent an enormous investment in research infrastructure and a
tremendous data resource that could be used to address new research questions in a timely and
efficient manner. Yet, linkage and comparisons of data across registries to address research
questions is challenging, if not impossible, because of variation in both the concepts and
definitions of the outcome measures used in registries within the same clinical area. Even when
the outcome concept is the same (e.g., remission in depression), registries may define the
measure differently (e.g., using the Hamilton Depression Rating Scale [HAM-D] vs. the Patient
Health Questionnaire-9 [PHQ-9]) because very few standardized definitions exist. This limits the
potential of registries to support new research and serve as a foundation for learning health
systems and national health data infrastructure. This also introduces inefficiency in registry data
collection. Many organizations, such as health systems, participate in multiple registries, but data
must be captured differently for each registry. Incorporation of key data elements within
electronic health record (EHR) systems would reduce the burden of registry data entry, but, for
many organizations, the cost of incorporating each registry’s unique data elements within the
EHR system is too high.
To address these issues, patient registries must implement standardized outcome measures that
can be captured consistently as part of routine clinical practice across care settings and
seamlessly transferred into different registries. The Agency for Healthcare Research and Quality
(AHRQ) has supported the development of the Outcomes Measures Framework (OMF), a
conceptual model for classifying outcomes that are relevant to patients and providers across most
conditions.2 Under this OMF project,3, 4 minimum sets of standardized outcome measures
suitable for use in registries and clinical practice were developed in five clinical areas, including
depression.
While registries and stakeholders expressed enthusiasm about standardized outcome measures,
they identified several barriers to implementation during workgroup meetings for the previous
project. First, stakeholders noted the difficulty of working with different EHRs to extract data for
patient registries. Registry sites often use EHRs from different vendors; even when sites use the
same vendor (e.g., Epic), they often have customized implementations that make extraction of
data in a standardized manner difficult. In reviewing the standardized measures, stakeholders
also expressed concerns about the burden on patients and clinicians of capturing patient-reported
outcomes (PROs) on a regular basis, particularly for long-term follow-up. Lastly, stakeholders
noted the potential for disruptions to clinical care if clinicians are asked to document additional
information in structured fields (as opposed to notes). Many stakeholders emphasized the need
for pilot testing to demonstrate the feasibility of implementing the harmonized measures and to

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show the value of the harmonized measures – both in terms of reduced burden of data entry and
the ability to generate data of sufficient quality for registry-based research.
The proposed project will implement the harmonized outcome measures in a manner that
addresses these barriers, using depression as a test case. 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.5, 6 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.7 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.7, 8 While routine screening is intended to improve diagnosis and treatment of MDD,
many questions remain, such as 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.9, 10
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, 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.

2. Rationale
Depression registries offer an excellent opportunity to demonstrate the feasibility and value of
implementing the harmonized outcome measures. Existing registries, such as the American
Psychiatric Association’s (APA) Psychiatric Patient Registry Online (PsychPRO) and the
American Board of Family Medicine’s (ABFM) PRIME Registry, already capture some of the
necessary data for the harmonized measures for quality reporting purposes, 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. A feasibility
study will show that it is technically feasible for registries to collect the data elements necessary
to calculate the harmonized outcome measures and to pool the de-identified data for research
purposes.

3. Objectives
The purpose of this pilot project is to demonstrate feasibility and value of collecting a subset of
the harmonized outcomes measures for MDD in two registries and combining the data to support
patient-centered outcomes research.

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Objectives:
● To demonstrate that it is technically feasible for two patient registries to collect the data
elements necessary to calculate six harmonized MDD outcome measures.
● To demonstrate that the harmonized de-identified data can be combined across the two
registries to address new research questions in a timely and cost-efficient manner.

4. Study Design
4.1

Study Description

The study is a longitudinal, multi-center observational feasibility study that will include data on
eligible patients with a diagnosis of MDD. Retrospective data on previous disease status and
patient characteristics will be collected and combined with longitudinal data from these data
sources on outcomes during the study timeframe (see Figure 1). All data will be collected from
institution electronic medical records (EMRs), PRO portals, and other existing data sources, as
needed.
Figure 1. Study Design
6-month
follow-up

Baseline
visit

(+/- 60 days)

Enrollment Period
(1 Month)

12-month
follow-up

(+/- 60 days)

Follow-Up Period
(14 Months)

Ongoing data collection from EMR and other existing data sources

4.2

Study Population

The study will collect data on approximately 200 patients from a total of two registries in the
United States. All eligible patients will be included.
4.2.1

Inclusion Criteria

The following criteria must be met in order to be enrolled in the study:
• ≥ 18 years of age
• Diagnosed with major depression or dysthymia
4.2.2

Exclusion Criteria

There are no exclusion criteria for this study.

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4.2.3

Study Enrollment

Two registries (PsychPRO and the PRIME Registry) will participate in this feasibility study. A
total of 20 sites participating in the registries (10 from each registry) will be recruited to
participate in this study. To participate, sites must see adult patients with major depression or
dysthymia and be willing to collect the PHQ-9 on a regular basis. Sites will have the option of
using the Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale to capture
information on adverse events, but use of the FIBSER is not required.
All eligible patients identified during the determined enrollment period at the site will be
enrolled.
4.2.4

Patient Withdrawal

Not applicable. Due to the use of routinely recorded existing data, patient informed consent is
not required for this study and therefore there is no consideration for withdrawal of eligible
patients.
4.3

Exposure Definition and Measures

This is an observational feasibility study in this patient population. This protocol does not
recommend the use of any specific treatments.
4.4

Outcome Definitions and Measures

Outcome
Measure
Death from
suicide

Improvement in
Depressive
Symptoms:
Remission

Improvement in
Depressive
Symptoms:
Response

Definition
Patient age 18 or older with a diagnosis of major depression or dysthymia who
died from suicide, reported in 12-month intervals.
This should be captured where feasible; however, this information may not be
recorded accurately or available to all providers.
Patient age 18 or older with a diagnosis of major depression or dysthymia and an
initial PHQ-9 score > 9 who demonstrates remission defined as a PHQ-9 score
less than 5.
Timeframe for measurement:
Baseline, 6 months post baseline (+/- 60 days), 12 months post baseline (+/- 60
days)
Patient age 18 or older with a diagnosis of major depression or dysthymia and an
initial PHQ-9 score > 9 who demonstrates a response to treatment defined as a
PHQ-9 score that is reduced by 50% or greater from the initial PHQ-9 score.
Timeframe for measurement:
Baseline, 6 months post baseline (+/- 60 days), 12 months post baseline (+/- 60
days)

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Worsening in
Depressive
Symptoms:
Recurrence

Adverse Events

Suicide Ideation
and Behavior

Patient age 18 or older with a diagnosis of major depression or dysthymia and an
initial PHQ-9 > 9 who demonstrates remission (defined as a PHQ-9 score < 5)
of at least two months’ duration and subsequently experiences a recurrence of a
depressive episode, defined as a PHQ-9 score > 9 OR hospitalization for
depression or suicidality.
Timeframe for measurement:
Baseline, 6 months post baseline (+/- 60 days), 12 months post baseline (+/- 60
days)
Depression treatment-related adverse events, captured using the FIBSER scale
where available and extracted from data routinely recorded in the EMR.
Timeframe for measurement:
Baseline, 6 months post baseline (+/- 60 days), 12 months post baseline (+/- 60
days)
Selection of ‘several days’, ‘more than half the days’ or ‘nearly every day’
option on PHQ-9 item 9 (“Thoughts that you would be better off dead or of
hurting yourself in some way”) and/or documentation of nonfatal suicide
attempts/suicide attempt behaviors, planning/preparatory acts, or active suicidal
ideation extracted from data routinely recorded in the EMR.
Timeframe for measurement:
Baseline, 6 months post baseline (+/- 60 days), 12 months post baseline (+/- 60
days)
Note, supplemental assessments of suicide ideation and behavior should be
completed for patients who screen positive for suicide ideation on the PHQ-9 or
when a clinician has concerns about suicidality. Supplemental assessments
should be completed using an appropriate, brief, validated instrument, such as
the Concise Health Risk Tracking (CHRT) scale.

4.5

Minimization of Bias

The study will enroll all eligible patients. The inclusion of all ‘eligible’ patients minimizes any
potential for bias in the selection of patients for participation in this registry.
4.6

Data Collection

No data will be collected solely for the purposes of this study. All data elements will be collected
from information routinely recorded in the registry or other relevant existing data sources. No
visits or examinations, laboratory tests or procedures are mandated as part of this study.
Sites participating in the patient registries use an existing process to extract data from the EHR
and send data to the registry on a regular basis. Data will continue to be sent to the registry using
the existing processes for this study. In addition, the registry data dictionaries have been
compared to the outcome measure definitions, and some additional data elements will be
extracted from participating site EHRs (if routinely documented) to support calculation of the
outcome measures. These additional data elements include death, suicide ideation and behavior,

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and adverse events related to depression treatment. The duration of ongoing prospective data
collection for the purposes of this study will be approximately 12 months.
The capture of PROs, specifically the PHQ-9, at regular intervals is critical for implementation
of the depression outcome measures. Sites participating in the registries will capture the PROs at
regular intervals (including outside of clinical visits with reminders sent to patients) using the
registry patient portal. This is done as part of routine clinical care for patients with depression,
and data captured in this manner are used to calculate quality measures for submission to the
Centers for Medicare and Medicaid Services under the Merit-based Incentive Payment System
(MIPS).11, 12 The patient portal is already available in the PsychPRO registry, and the PRIME
Registry is adding the patient portal as part of this project to facilitate capture of the MIPS
measures related to depression.
4.6.1

Determination of Eligibility

The following data will be used to determine patient eligibility for inclusion in the registry:
● Age >=18 years
● Diagnosis of major depression or dysthymia as documented in the patient’s EMR
4.6.2

Data Elements

The following data will be collected for all patients (if available in the EMR or other existing
data sources):
Patient Characteristics
• Sex
• Age
• Race/ethnicity
• Family history of depression and other major mental illnesses
• Socioeconomic status
• Pregnancy/Postpartum status
Disease
• Comorbidities
• Disease course
o Type of depressive episode
o Depressive severity at diagnosis
o Duration of symptoms
o Previous relapses/prior history of depression
o Prior treatments, including number of medications and number of failed
antidepressant treatment attempts
o Lab tests (e.g., thyroid function, metabolic indices, inflammatory markers)
• Suicidality
Treatments

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• Type
o Medications (type, dose, duration, adherence)
o Psychotherapy
o Devices (type, dose, and duration)
o Alternative
• Referral(s) for treatment
Outcomes
• Death from suicide
• Improvement in depressive symptoms (assessed via PHQ-9 scores)
o Response
o Remission
• Worsening in depressive symptoms
o Recurrence (PHQ-9 score, hospitalization data)
• Adverse events
• Suicide Ideation and Behavior (assessed via PHQ-9, diagnosis codes)

5. Statistical Methods
5.1

Sample Size

For this observational feasibility study, no sample size calculations were done, and all eligible
patients will be included. We anticipate that approximately 200 patients will be sufficient to
address the objectives of this pilot analysis.
5.2

Data Analyses

5.2.1

General Considerations

The specific nature of the analysis will be determined following selection of a research question
by a Stakeholder Panel. The study will include, at minimum, descriptive analyses to gain an
understanding of the study population (e.g., demographics, depression severity as indicated by
PHQ-9 scores) and any subgroups of interest. In general, continuous variables will be reported as
mean (and standard deviation) and median (interquartile range) where appropriate. Categorical
variables will be summarized as number and proportion of the total patients enrolled and by
subgroups of interest. All computations and generation of tables, listings, and data for figures
will be performed using SAS® version 9.4 or higher (SAS Institute, Cary, NC, USA). Analytic
methods and tools will be described in detail in the statistical analysis plan (SAP).
5.2.2

Planned Analyses

One pilot analysis is planned to demonstrate the feasibility of combining data from separate
registries for pooled analysis. The objectives for this descriptive analysis will be determined after
the initial feasibility work is completed and will be described in a separate analytic plan.

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5.3

Data Reporting

5.3.2

Annual/interim Analyses and Reporting

No interim analysis is planned for this study.
5.3.3

Final Analyses and Reporting

A final study report will be generated after all data collection is complete. The final report will
encompass all planned analyses, including a description of the complete study population and
study results, as described above.

6. Study Management
This study will be performed by OM1 in close collaboration with the APA and ABFM registry
teams, with guidance, input, review, and approval of AHRQ. The APA and ABFM teams will
lead the engagement and support activities for the participating registry sites, including
development of site recruitment materials, training materials, and data management activities,
with support from the OM1 team. To ensure the quality and integrity of research, this study will
be conducted under the Guidelines for Good Pharmacoepidemiology Practices issued by the
International Society for Pharmacoepidemiology (ISPE),13 the principles outlined in the
Declaration of Helsinki,14 and any applicable national guidelines.
6.1

Data Management

All data will be extracted from the patient’s EMR or other relevant existing data sources and sent
to the patient registries using the procedures already established and in use for the patient
registries. The patient registries have existing data management and data quality assurance plans
in place and will continue to follow those procedures for this study.
6.2

Changes to the Protocol

Changes to the protocol will be documented in written protocol amendments. Major (i.e.,
substantial, significant) amendments will usually require submission to the relevant institutional
review board (IRB) for approval or favorable opinion. In such cases, the amendment will be
implemented only after approval or favorable opinion has been obtained. Minor (nonsubstantial)
protocol amendments, including administrative changes, will be filed by at each participating site
and will be submitted to the relevant IRB.
6.3

Study Governance

OM1 will be responsible for providing appropriate oversight of all scientific, technical, financial,
and administrative matters related to this project, under the direction of Dr. Richard Gliklich as
the Project Director.
6.4
Publication Policy
Any publication of the results from this study will be guided by the Uniform Requirements for
Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication
of the International Committee of Medical Journal Editors (ICMJE), updated December 2018.15

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The rights of the participating sites and of OM1 with regard to publication of the results of this
study are described in the site contract.

7. Safety Reporting
Due to the observational nature of the study and the use of existing data sources, no adverse
event reporting is required. No specific medicinal products or devices are being evaluated as part
of the study, and there are no objectives related to safety.

8. Ethical and Regulatory Considerations
8.1

Guiding Principles

The study will be conducted in compliance with the US Food and Drug Administration (FDA)
Title 21 Code of Federal Regulations (CFR) Part 50 – Protection of Human Patients and Part 56
– Institutional Review Boards; the International Council for Harmonisation for Pharmaceuticals
for Human Use (ICH) Good Clinical Practice (GCP) guidelines E6R2 (November 09, 2016) as
they apply to post-marketing, observational studies; the Guidelines for Good
Pharmacoepidemiology Practices (GPPs) issued by the International Society for
Pharmacoepidemiology (ISPE); the Belmont Report; US Title 45 CFR Part 164 Subpart E –
Privacy of Individually Identifiable Health Information and the Health Insurance Portability and
Accountability Act of 1996 (HIPAA) Privacy Rule (2002); and any applicable national
guidelines.
8.2

Required Documents

Prior to commencement of any study procedures, the protocol signature page, site contract, and
IRB approval must be on file with OM1.
8.3

Patient Information and Informed Consent

No direct contact with patients will occur as part of this study, and all data elements will be
collected from information routinely recorded in the electronic medical record. No visits or
examinations, laboratory tests, or procedures are mandated as part of this study. A waiver of
informed consent will be obtained for this observational study as the following elements have
been met:
1. The study involves no more than minimal risk (as defined in 21 CFR 50.3(k) or
56.102(i));
2. The waiver will not adversely affect the rights and welfare of the subjects;
3. The study could not practicably be carried out without the waiver
There should be no adverse effects to patients as a result of waiver of informed consent as there
are no study related procedures.
8.4

Patient Confidentiality

Medical record number or other local reference identifiers will not be collected as part of the
study database. De-identification will be performed in a manner consistent with the Health

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Information Portability and Accountability Act (HIPAA). All study analyses performed will use
the statistically de-identified data. All parties will ensure protection of patient personal data and
will not include patient identifiable information on any study forms, reports, publications, or in
any other disclosures, except where required by law.
8.5

IRB

Consistent with local regulations and prior to commencement of any study procedures, the study
protocol will be submitted to the responsible IRB for its review. Enrollment will not start at any
site before OM1 has obtained written confirmation of a favorable opinion/approval from the
relevant central or local IRB. The IRB will be asked to provide documentation of the date of the
meeting at which the favorable opinion/approval was given that clearly identifies the study and
the protocol version.
Before implementation of any substantial changes to the protocol, protocol amendments will also
be submitted to the relevant IRB in a manner consistent with local regulations. It is the
responsibility of the investigator to have prospective approval of the study protocol, protocol
amendments, and other relevant documents, if applicable, from their local IRB and provide
documentation of approval to OM1. All correspondence with the IRB should be retained in the
Investigator File.
Should the study be terminated early for any unanticipated reason, the investigator will be
responsible for informing the IRB of the early termination.

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9. References
1. Gliklich R Dreyer N, Leavy M, eds. Registries for Evaluating Patient Outcomes: A User’s
Guide. Third edition. Two volumes. (Prepared by the Outcome DEcIDE Center [Outcome
Sciences, Inc., a Quintiles company] under Contract No. 290 2005 00351 TO7.) AHRQ
Publication No. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and
Quality. April 2014. http://www.effectivehealthcare.ahrq.gov.
2. Gliklich RE, Leavy MB, Karl J, et al. A framework for creating standardized outcome
measures for patient registries. J Comp Eff Res. 2014;3(5):473-80. PMID: 25350799. DOI:
10.2217/cer.14.38.
3. Calkins H, Gliklich RE, Leavy MB, et al. Harmonized outcome measures for use in atrial
fibrillation patient registries and clinical practice: Endorsed by the Heart Rhythm Society
Board of Trustees. Heart Rhythm. 2019;16(1):e3-e16. PMID: 30449519. DOI:
10.1016/j.hrthm.2018.09.021.
4. Gliklich RE, Castro M, Leavy MB, et al. Harmonized outcome measures for use in asthma
patient registries and clinical practice. J Allergy Clin Immunol. 2019. PMID: 30857981.
DOI: 10.1016/j.jaci.2019.02.025.
5. Depression and Other Common Mental Disorders: Global Health Estimates. Geneva: World
Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO.
6. National Institute of Mental Health. Major Depression: Prevalence of Major Depressive
Episode Among Adults. [Internet]. Bethesda, MD; [updated 2019 Feb; cited 2019 Jun 19].
Available from: https://www.nimh.nih.gov/health/statistics/major-depression.shtml.
7. Siu AL, Force USPST, Bibbins-Domingo K, et al. Screening for Depression in Adults: US
Preventive Services Task Force Recommendation Statement. JAMA. 2016;315(4):380-7.
PMID: 26813211. DOI: 10.1001/jama.2015.18392.
8. Siu AL, Force USPST. Screening for Depression in Children and Adolescents: US
Preventive Services Task Force Recommendation Statement. Pediatrics.
2016;137(3):e20154467. PMID: 26908686. DOI: 10.1542/peds.2015-4467.
9. Mojtabai R. Universal Depression Screening to Improve Depression Outcomes in Primary
Care: Sounds Good, but Where Is the Evidence? Psychiatr Serv. 2017;68(7):724-6. PMID:
28292224. DOI: 10.1176/appi.ps.201600320.
10. Gaynes BN, Asher G, Gartlehner G, et al. Definition of Treatment-Resistant Depression in
the Medicare Population. Technology Assessment Program. Project ID: PSYT0816.
(Prepared by RTI–UNC Evidence-Based Practice Center under Contract No.
HHSA290201500011I_HHSA29032006T). Rockville, MD: Agency for Healthcare Research
and Quality. February 2018. http://www.ahrq.gov/clinic/epcix.htm.

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11. Centers for Medicare and Medicaid Services. Depression Remission at Six Months. Quality
ID #411 (NQF 0711). https://qpp.cms.gov/docs/QPP_quality_measure_specifications/CQMMeasures/2019_Measure_411_MIPSCQM.pdf. Accessed July 29, 2019.
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