Attachment B: Depression Capstone Project Health System 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 Health System 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 ................................................................................................................. 3
List of Abbreviations ....................................................................................................................... 4
1.

Background ............................................................................................................................. 5

2.

Rationale ................................................................................................................................. 6

3.

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

4.

Study Design ........................................................................................................................... 7
4.1

Study Description ....................................................................................................................... 7

4.2

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

4.2.1
4.2.2
4.2.3
4.2.4

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

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

Data Elements....................................................................................................................................... 10

5.

Qualitative Assessment ......................................................................................................... 11

6.

Study Management ............................................................................................................... 12
6.1

Data Management .................................................................................................................... 12

6.2

Changes to the Protocol ........................................................................................................... 12

6.3

Study Governance .................................................................................................................... 12

6.4

Publication Policy ..................................................................................................................... 12

7.

Safety Reporting ................................................................................................................... 13

8.

Ethical and Regulatory Considerations ............................................................................... 13

9.

8.1

Guiding Principles .................................................................................................................... 13

8.2

Required Documents ................................................................................................................ 13

8.3

Patient Information and Informed Consent .......................................................................... 13

8.4

Patient Confidentiality ............................................................................................................. 13

8.5

IRB ............................................................................................................................................. 13

References ............................................................................................................................. 15

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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. These outcome measures also must be useful in
routine clinical practice for informing treatment decision and monitoring patients over time. 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, clinicians, and other stakeholders expressed enthusiasm about standardized
outcome measures, they identified several barriers to implementation in registries and in clinical
practice 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
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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 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 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.9, 10 MDD patients also may receive care from different
providers, such as primary care physicians, psychologists, and psychiatrists. Care coordination is
important for improving patient outcomes but can be difficult to achieve even within the same
health system.
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. Similarly, data are not captured consistently across practice settings
in routine clinical practice.

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.

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A pilot study is necessary to show that is possible to capture the standardized outcome measures
in the clinical workflow, without overburdening clinicians or patients; to provide the measure
information back to clinicians to help inform patient care; and to submit the data to different
patient registries.

3. Objectives
The purpose of this pilot study is to demonstrate feasibility and value of collecting a subset of the
harmonized outcomes measures for MDD in the primary care and mental health setting.
Objectives:
● Demonstrate that it is technically and operationally feasible to use an open-source app to
extract the selected outcome measures, including PHQ-9 information, from existing
clinical systems and provide the calculated measure results in the clinician’s workflow.
● Assess burden of capturing the measures from patients (PHQ-9) and clinicians and value
of providing the measure results.

4. Study Design
4.1

Study Description

The study is a longitudinal, observational pilot study that will assess the utility and value
displaying the harmonized outcomes data to clinicians in the clinical workflow using an opensource, SMART on FHIR app. The app will connect with the site EHR, aggregate EHR and PRO
data, calculate the outcome measure results, and return the results to the EHR so that they are
viewable within the clinician workflow. Baseline data on patient characteristics, treatments, and
symptoms will be combined with longitudinal data 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

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6-month
follow-up

Baseline
visit

(+/- 60 days)

Enrollment Period
(1 Month)

12-month
follow-up

(+/- 60 days)

Clinician
survey on
app

Follow-Up Period
(14 Months)

Ongoing data collection from EMR and other existing data sources
Clinician views outcome measure results in app

4.2

Study Population

The study will collect data on approximately 50 patients from a total of five practices within the
same health system.
4.2.1

Inclusion Criteria

The following criteria must be met in order to be enrolled in the study:
• Patients age 18 and older
• Diagnosis of major depression or dysthymia
• Willing and able to provide informed consent
4.2.2

Exclusion Criteria

There are no exclusion criteria for this study.
4.2.3

Study Enrollment

Both specialist (mental health) and general practice sites within the participating health system
will be targeted for recruitment. Sites with the ability to implement a SMART on FHIR app will
be prioritized. Selection criteria and basic site information (e.g., site size, site type) will be
collected via a site qualification survey.
All eligible patients identified during the determined enrollment period at the site will be
enrolled.
4.2.4

Patient Withdrawal

Patients may withdraw from the study for any reason at any time.

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4.3

Exposure Definition and Measures

This is an observational pilot study focused on technical and operational feasibility in this patient
population. This protocol does not recommend the use of any specific treatments, and all
assessments are captured as part of routine clinical care.
4.4

Outcome Definitions and Measures

Outcome
Measure
Death from suicide

Improvement in
Depressive
Symptoms:
Remission

Improvement in
Depressive
Symptoms:
Response

Worsening in
Depressive
Symptoms:
Recurrence

Adverse Events

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)
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 Frequency,
Intensity, and Burden of Side Effects Ratings (FIBSER) scale 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)

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Suicide Ideation
and Behavior

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 identified during the determined enrollment period at
each site. 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 EHR or other relevant data sources (e.g., a standalone
PRO platform). No visits or examinations, laboratory tests or procedures are mandated as part of
this study. In addition, the app will be implemented locally, meaning that no data will leave the
health system IT systems. The app will have the ability to transmit data externally (e.g., to a
patient registry), but this feature will not be activated during the pilot study.
The capture of PROs, specifically the PHQ-9, at regular intervals is critical for implementation
of the depression outcome measures. Practices participating in this pilot project will capture the
PROs at regular intervals (including outside of clinical visits with reminders sent to patients)
using a standalone PRO system implemented within the health system. 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
4.6.1

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

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•
•
•
•

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
• 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. Qualitative Assessment
No formal statistical analysis is planned for this pilot study, and no sample size calculations were
done. We anticipate that approximately 50 patients enrolled at five practices will be sufficient to
address the objectives of this pilot study.

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The purpose of this analysis is to assess the feasibility and value of the open-source app.
Clinicians and other personnel (e.g., IT staff) at participating practices will be asked to complete
a brief web-based survey at the conclusion of the data collection period to provide feedback on
the app. The survey will contain approximately 20 questions assessing three domains: usability
of the app, burden of using the app, and overall value of the app for informing patient care and
improving engagement with patients. Results of the survey will be summarized in a final study
report and in a publication. No patient data will be included in the assessment phase.

6. Study Management
This study will be performed by OM1 in close collaboration with the health system, with
guidance, input, review, and approval of AHRQ. The health system team will lead the
engagement and support activities for the participating practices, including development of site
recruitment materials and training materials, 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 remain within the health system IT systems.
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
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.

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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

All data elements will be collected from information routinely recorded in the electronic medical
record or as part of the patient’s participation in one of the registries. No visits or examinations,
laboratory tests, or procedures are mandated as part of this study. Patients will be asked to
provide consent for their data to be presented to clinicians within the context of the open-source
app.
8.4

Patient Confidentiality

No patient data will leave the health system IT systems as part of this project. Neither OM1 nor
AHRQ will have access to any patient data as part of this project. All parties will ensure
protection of patient personal data and will not include patient names 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

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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.
12. Centers for Medicare and Medicaid Services. Depression Remission at Twelve Months.
MH-1 (NQF 0710). https://qpp.cms.gov/docs/QPP_quality_measure_specifications/WebInterface-Measures/2019_Measure_MH1_CMSWebInterface_UPDATED.pdf. Accessed
July 29, 2019.
13. Ispe. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug
Saf. 2008;17(2):200-8. PMID: 17868186. DOI: 10.1002/pds.1471.
14. World Medical Association. Declaration of Helsinki - Ethical Principles for Medical
Research Involving Human Subjects. https://www.wma.net/policies-post/wma-declarationof-helsinki-ethical-principles-for-medical-research-involving-human-subjects/. Accessed
July 29, 2019.
15. International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts
Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication.
http://www.icmje.org. Accessed June 10, 2019.

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