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Center for Trans Magnetic Stimulation for the Veterans Health Administration

Cejamil S. Calderon
University of San Diego
HCIN 557: Financial Management in Health Care Systems
Dr. Brenda Boone
28 November 2021
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EXECUTIVE SUMMARY
The Center for Transcranial Magnetic Stimulation Clinic (CFTMS) provides an

innovative therapy that can help veterans who struggle with major depression disorder, chronic

neuropathic pain, acute pain, primary headache disorders, and post traumatic brain injury

headaches. Transcranial Magnetic Stimulation (TMS) is currently approved by the FDA and is a

non-invasive treatment. TMS uses a small handheld device called a “treatment coil” to deliver

energy to the brain using pulsed “magnetic fields.” These magnetic fields are like those used in

magnetic resonance imaging (MRI) machines. Veterans treated with TMS do not require

anesthesia or sedation. The patient remains awake, alert, and can return to work or their daily

routine right after treatment. Because TMS is a non-drug treatment, people do not experience

side effects like those associated with antidepressant medications.

TMS is a breakthrough in the treatment of major depression disorder, chronic neuropathic

pain, acute pain, and primary headache disorders because it offers a potential for long-term

remission of symptoms and a reduction of drug therapies. TMS relieves pain and helps veterans

cope with major depression disorder. The CFTMS Clinic has a well-established and dedicated

staff to provide excellent quality of care to our nation’s veterans. Our staff includes a Chief TMS

anesthesiologist physician that specializes in pain medicine, staff procedural physician,

psychiatrist, nurse practitioner registered nurse clinic coordinator, three TMS technician,

administrative officer and administrator/scheduler. The CFTMS Clinic uses robust and unique

staff and equipment, thus having a total anticipated budget of 1.8 million dollars. Major

depression disorder inevitably leads to suicide; suicide is a national priority, and there is no

dollar amount high enough to save a veteran’s life. The CFTMS Clinic is dedicated to the

mission of saving veterans’ lives.


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Center for Trans Magnetic Stimulation for the Veterans Health Administration
According to the World Health Organization (WHO), there are currently more than 264

million people of all ages who suffer from depression around the world (2020). There may be

other disorders or pains that can be associated with depression such as chronic neuropathic pain,

acute pain, primary headache disorders, and post traumatic brain injury headaches. There are

countless medications and therapies that can help with depression, certain disorders, and

chronic/acute pains—one alternative would be Transcranial Magnetic Stimulation (TMS). TMS

is a noninvasive treatment that works by stimulating the brain by using electromagnetic coils to

produce small focal electrical currents in the cortex (Leung et al., 2020). TMS effects the brain

cells and can depolarize cerebral neurons noninvasively (Rizvi & Khan, 2019). The TMS

treatment uses a small handheld device called a “treatment coil” to deliver energy to the brain

using pulses “magnetic fields”. These magnetic fields are like those used in magnetic resonance

imaging (MRI) machines. This magnetic field can then induce an electric field through the scalp

and skull to reach the first few centimeters of the brain without significant attenuation (Leung et

al., 2020). Currently, two TMS treatments have been approved by the U.S. Food and Drug

Administration (FDA): 1) Repetitive TMS (rTMS) are repeated trains/sequences of TMS applied

over the scalp for treating major depression and obsessive–compulsive disorder and 2) single

pulse TMS has been approved for treating migraine headaches (Leung et al., 2020).

The development of the Center for Trans Magnetic Stimulation (CFTMS) clinic for the

Veteran Health Administration (VHA) is crucial to veteran populations that suffer from

depression, chronic and acute pain, and certain disorders. Having a CFTMS clinic as part of

(VHA) would additionally help increase services to people with mental, neurological, and

substance use disorders. Furthermore, help with global reduction of opioid addiction and

dependence. The clinical efficacy of TMS as an antidepressant and alternative to pain


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management has been well established from prior evidence-based practices and research (Leung

et al., 2020). The development of a freestanding TMS clinic within the VHA is an innovative and

promising treatment that can be used as an additional alternative to the veteran patient’s overall

pain or mental health treatment, improving their overall quality of life, preventing suicidal

ideation, and most importantly sustaining veterans’ lives.

Business Description of Trans Magnetic Stimulation Treatment for the Veteran


Community
The CFTMS Clinic is an absolute necessity for veterans who suffer from major

depression, neuropathic pain (NP), acute pain, primary headache disorders, and posttraumatic

brain injury-related headaches (PTBI-HA). These conditions have been identified as having a

correlation with Veteran suicide. According to the Department of Veterans Affairs 2020 National

Veterans Suicide Prevention Annual Report, 45,510 American adults died from suicide in 2018

and amongst those adults 6,435 were U.S Veterans. Furthermore, in 2018, 66.4 per 100,000

veterans were diagnosed with depression, 67.0 per 100,000 veterans were diagnosed with

anxiety, and 56.2 per 100,000 veterans were diagnosed with other mental health or substance use

disorders (U.S. Department of Veteran Affairs, 2020).

According to the Morbidity and Mortality Weekly Report (MMWR) by Center for

Disease (CDC), chronic pain is one of the most common reasons adults seek medical care and

has been linked to anxiety, depression, and poor perceived health or reduced quality of life.

Approximately 50 million U.S. adults have chronic pain (Dahlhamer et al., 2019). The target

population that would be primarily focused on first would include the veteran population in San

Diego County. Veterans are more susceptible to mental health issues and chronic pain due to the

dangerous nature of their occupation. Veteran suicide does not only impact the victim but their

family members, friends, and acquittances as well (U.S. Department of Veteran Affairs, 2020).
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The conditions of chronic pain and depression have been separately addressed in

scholarly research, and it is clinically documented that there are significant neurobiological

correlations between chronic pain and major depressive disorder (Leung et al., 2020). For

example, one study of 300 patients referred to a pain center noted 261 (87%) of the patients met

the criteria for major depressive disorder; it has also been shown that patients with multiple pain

conditions are 3 to 5 times more likely to be depressed (Leung et al., 2020).

According to the Clinical TMS Society, there are only nine TMS clinics within a 50-mile

radius of San Diego County (2021). The CFTMS clinic will provide a central location for

veterans to gain quality access to care for the pain and mental health conditions. The CFTMS

Clinic will operate from Monday through Friday from the hours of 7 am to 4 pm. The CFTMS

clinic will have 30-minute appointment slots with an hour lunch break in between for staff. The

CFTMS clinic will include a total of ten staff members. The CFTMS clinic will include the

following: chief TMS physician, procedural physician, psychiatrist, nurse practitioner, registered

nurse clinic coordinator, 2 TMS technicians, administrative Officer, and scheduler. The estimated

value of the CFTMS clinic will be $1.5 million dollars which includes annual overhead costs of

the salaries, equipment, maintenance, and utilities. TMS should be included in the veterans’

treatment plan that would meet those mental health and pain criteria. The CFTMS clinic would

ultimately help decrease the signs and symptoms of multiple pain and mental health disorders but

more importantly decrease veteran suicide.

Market Analysis for Trans Magnetic Stimulation

Trans Magnetic Stimulation Industry

The CFTMS clinic will operate and compete in the mental health and pain management

sector of the healthcare industry within San Diego County. Mental health issues and pain have
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been steadily on the rise within the San Diego Veteran community, according to the VA San

Diego Healthcare System from the fiscal year (FY) 2010 to the fiscal year (FY) 2016, 24,872

veterans are receiving care for post-traumatic stress disorder (PTSD) in San Diego County. FY

2016, 70,633 veterans are classified as combat veterans enrolled in the VHA San Diego. Out of

the 70,633 veterans, 24.9 % of all combat veterans residing in San Diego are diagnosed with

PTSD (U.S. Department of Veterans Affairs, 2017). Furthermore, according to a 2017 report

from the National Health Institute (NIH), 65.6 % of American Veterans report having pain, with

9.1% classified as having severe pain (U.S. Department of Veterans Affairs, 2021). Lastly, The

COVID-19 pandemic has dramatically affected the global population mental status, the NIH

conducted a study that found that the prevalence of generalized anxiety disorder (GAD) positive

screens increased from pre- to peri-pandemic (7.1% to 9.4%; p < 0.001) and was driven by an

increase among veterans aged 45-64 years (8.2% to 13.5%; p < 0.001) as shown in appendix A

(Hill et al., 2021).

TMS Market Segmentation

As a TMS located within the VA healthcare facility, it will be unique and centralized for

all veterans in San Diego County. According to the Clinical TMS Society, there are only nine

privately own TMS clinics within a 50-mile radius of San Diego County (Clinical TMS Society,

2021). According to the VA 2020 annual budgetary report, the VA San Diego had spent

$124,843,016 on the community care network (Keeping Veterans Safe 2020 - VASDHS Annual

Report 2020). The CFTMS clinic will be the only governmental affiliated clinic that will

primarily focus on San Diego veterans. This will allow the VA San Diego Healthcare system to

provide continuity of care for our San Diego Veterans without them being sent to privately

own clinics. Based on the CFTMS annual financial plan this will allow the VA to decrease
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financial costs by preventing the utilization of community care under the MISSION Act. The

Mission Act enables Veterans to seek medical services that the VA does not offer (U.S.

Department of Veterans Affairs,2019). By implementing a CFTMS Clinic will provide veterans

with veteran-centric care which will allow them to have a sense of comfort, compassion,

advocacy, and familiarity.

CFTMS Clinic SWOT Analysis

One of the key strategies that will help maximize the potential and opportunities for the

CFTMS Clinic is that it provides quick, non-invasive Veteran-centric care. This can only be

achieved in a VA facility where veterans are also employed by the VA and seeing their fellow

Veterans patients, thus preserving the ideation of Veterans helping Veterans. A centralized

location and the VA physical infrastructure can be considered a weakness since Veterans may live

more than 50 miles out of San Diego County. In addition, the VA San Diego is conducting

construction and remodeling efforts till 2023 (U.S. Department of Veterans Affairs, 2021b).

Space and parking cause an issue for veterans and employees. The strengths dramatically

outweigh the weaknesses and overall can bring forth significant opportunities to expand the

CFTMS clinic amongst other VA medical facilities in California and nationality.


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STRENGTHS WEAKNESSES
 Noninvasive • Centralized Location
Treatment • VA San Diego
 Providing Veteran physical
Centric Care infrastructure may
 Non sedated result to lost of
Treatment
 Quality FDA
SWOT For placement for
CFTMS Clinic
Approved TMS
Equipment CFTMS • Overdependence of
TMS treatment
 Quick 10- 30- • Staffing retention and
minute treatments issues

OPPORTUNITIES THREATS
• Potential to • Increased of Private
lower suicide Sector TMS facilities
rates within the and competition
San Diego • Price volatility of the
Community TMS market
• Expansion to • Changing Treatment
other VA sites protocols for TMS
nation wide
• Regaining trust
of the VA
image to the
public.
• New
technological
advances for
TMS hardware
and software.
• Creating
partnerships
amongst the
Mental health
and pain
management
organizations in
San Diego
County
• Reduce Opioid
usage and
dependency.
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CFTMS FINANCIAL PLAN


The VA San Diego had spent a total of $723,473,794 on operational expenses in the

fiscal year 2020 (U.S. Department of Veterans Affairs, 2020b). The VA San Diego operational

cost included salaries, wages and benefits, services, supplies, and other expenses (U.S.

Department of Veterans Affairs, 2020b). In addition to the operational costs, the VA San Diego

had spent $124,843,016 on the community care network (U.S. Department of Veterans Affairs,

2020b). The community care network allows veterans to receive their specialty care out of town

from a private or public health facility (U.S. Department of Veterans Affairs, 2020b).

Having an internal TMS clinic within the VHA will cut expenditure costs to the

community care network. The estimated annual start-up costs for the CFTMS clinic are a total of

$1,856,400. The annual cost for the CFTMS CLINIC is broken up into five categories:

administrative/general cost, clinic infrastructure cost, marketing cost, labor expenses, and

other/miscellaneous expenses. These costs have been analyzed through extensive market

research by utilizing multiple medical supply vendors, office supply vendors, and the current

salary range based on the Office of Personnel Management (OPM).


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The CFTMS clinic will respectfully ask for grants from the Clinical TMS Society and

Disable American Veterans (DAV) to help alleviate some of the start-up costs. The CFTMS will

simultaneously volunteer for the Clinical TMS Society and DAV whole promoting the CFTMS

clinic. The CFTMS will collaborate with the DAV and Clinical TMS Society in five mental

health awareness and pain management events.

The following list depicts the estimated annual startup costs for the CFTMS:

Start Up Annual Operating Cost for CFTMS


CFTMS COST ITEMS BUDGET DETAIL
ADMINISTRATIVE/GENERAL
Visor software will include a 2-
Visor Neuronavigational Software $15,000 day in-service and 5-year
warranty
MagVenture Will include a 10-
year warranty including annual
MagVenture TMS Therapy Machines $75,000
preventative maintenance and a
3-day in-service.
Include 10 Computers and
Dell Desktops Systems $14,000
installation fees
Includes, exam tables, desks,
Furniture and fixtures $65,000 Chairs, supply cabinets etc for 6
exam/procedural rooms
Includes vital signs monitor,
Miscellaneous Medical Supply $27,000 gloves, disinfectant, masks,
hand sanitizer, etc.
Includes pen, paper, binders,
Miscellaneous Office Supplies $3600
etc.
CLINIC INFRASTRUCTURE
Utility Costs $12,000 Water and electricity
Space lease within VHA
Space Lease $36,000
property
Network, Internet, and Telephone $4700
MARKETING
Internet web Marketing $600
Networking Events $500
ANNUAL LABOR EXPENSES
Chief TMS Physician $490,000
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Start Up Annual Operating Cost for CFTMS


CFTMS COST ITEMS BUDGET DETAIL
Procedure Physician $395,000
Psychiatrist $220,000
Nurse Practitioner $125,000
Registered Nurse Clinic Coordinator $85,000
TMS technician x 3
3 TMS Technician assigned to
$165,000
the 3 procedural rooms
Administrative Officer $75,000
Scheduler/Clerk $45,000
OTHER
MISCELLANEOUS
(CONTINGENCY $3000
RESERVE/LAUNCH PARTY/ETC.)
ESTIMATED START-UP BUDGET $1,856,400

CFTMS Clinic Operation and Implementation Plan

The CFTMS clinic implementation project will be divided into three phases. It will

consist of planning, building/execution, opening clinic/continuous process improvement.

CFTMS Clinic Phase 1: Planning

Phase 1 will consist of appointing a project manager that will identify a project team.

The project team will be responsible for the organization and development of the CFTMS clinic.

The project team will determine the clinic workflow; analysis as illustrated in Appendix B,

proper equipment, supplies, personnel, allocation, funding, and training need. Furthermore, the

project team will submit all the proper documentation to the VHA executive staff to implement a

clinic within the hospital. VHA executives will determine the location of clinic and approve the

necessary funding of $1,856,400.

CFTMS Clinic Phase 2: Building/Executing CFTMS Clinic Development


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Once VHA executive staff has authorize funding and location for the CFTMS clinic, the

project team will execute the plan in Phase 1. Project team will submit hiring requests to the VA

human resources (HR), select and establish contracts with a proper TMS vendor, establish a

patient panel for the clinic as illustrated in Appendix C. Furthermore, the project team will

coordinate with the biomedical engineer department to establish TMS equipment setup, testing

and preventative maintenance schedules. In addition, the project team will coordinate with the IT

department to establish computer/network set up. The project team will coordinate with the

clinical informatics team to establish EHR templates for the clinicians. Lastly, training for

CFTMS staff will be established. Clinicians will be properly train to the specific TMS device

that will be used and clinic workflow. The administrators will also be train through the

registration and workflow of the CFTMS Clinic.

CFTMS Clinic Phase 3: Open TMS Clinic and on-going Process Improvement

The third and final phase will be the grand opening of the CFTMS clinic. There will be

continuous process improvements withing the clinic. The staff will be conducting monthly

meetings to recognize concerns with staff and having discussions regarding the productivity of

the clinic.

CFTMS Technology

The CFTMS clinic will possess state of the art pain and mental health technology. The

clinic will utilize the visor neuronavigational software to pinpoint the exact location of the brain

that correlates pain and depression. Secondly, the CFTMS clinic will utilize the MagVenture

TMS therapy machines and set up as illustrated in Appendix D. Lastly, the CFTMS clinic will

utilize Cerner Electronic Health Record (EHR) as provided by the VA as the standard HER

system.
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CFTMS Clinic Stakeholders

The CFTMS clinic stakeholders comprises off the VHA Executive Staff, leadership from

the pain and mental health services, biomedical engineer services, leadership from health

informatics department, and leadership from the IT department. Furthermore, external

stakeholders such as manufacturer companies for the TMS equipment, such as MagVenture will

endorse and initiate contractual/service agreements for the CFTMS clinic (Leung et al., 2020).

CFTMS Clinic Employees

The CFTMS Clinic will consist of one chief TMS physician, one procedure physician,

one psychiatrist, one nurse practitioner, one registered nurse clinic coordinator, three TMS

technicians, one administrative officer, one receptionist/scheduler.

Description of Work Start and End Dates


Phase One  Organize, Planning and September 2021-January
Implementation of CFTMS 2022
Clinic.
 Secure support and
permission from VHA
executive staff.
Phase Two  Execution of CFTMS Clinic January 2022- August 2022
Development:
 Establish location in a VHA
facility
 Establish Funding with
Executive Staff
 Hire Personnel
 Purchase Equipment
 Train Staff
 Schedule Patients
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 Test TMS Equipment

Phase Three Open CFTMS Clinic August/September 2022


Maintain Process Improvement for
TMS clinic

Next Steps for the CFTMS Clinic

Future developments for the CFTMS Clinic will include a yearly evaluation of the

progress of the clinic. This will allow the clinic to consider any process redesign improvement

protocols. Secondly, the CFTMS Clinic has the potential to be implemented at other VHA

facilities depending on the demand of the San Diego site. Lastly, research and clinic trials will be

conducted to improve stimulation technics and possible new developments that may include new

coils for the stimulation of new cortical and subcortical targets. (Leung et al., 2020).

Progress will be evaluated throughout the development of the CFTMS by achieving the

milestones indicated in the CFTMS goals/objectives section. Weekly meetings with Stakeholders

will be conducted to monitor and evaluate the CFTMS Clinic progression. To evaluate the

reduction of depression, anxiety, chronic/acute pain, head disorders, and suicide rates among the

veteran community the Department of Veteran Affairs-Office of Mental Health and Suicide

Prevention conducts a comprehensive annual report on veteran suicide The report is called  

National Veteran Suicide Prevention Annual Report (U.S Department of Veteran Affairs, 2019).

The CFTMS administrative staff can gather evidence on the status of suicides and mental health

information. To evaluate if the CFTMS clinic needs to expand to the other southern California

VHA medical centers; a patient productivity report can be generated. The CFTMS staff can

evaluate the patient load of the clinic within the first year and deem if it is truly necessary to

expand. The CFTMS staff can utilize the VA Vista HER and community care data to analyze if
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the patients are traveling from long distances (i.e. Orange County, Palm Springs, Los Angeles, El

Centro). The project evaluation will be carried out by the project manager (myself). The project

manager will be delegating certain tasks to the stakeholders and team. The project manager will

be forecasting the budget on a quarterly basis. The project manager will create the baseline for

the development of the CFTMS and will sustain momentum for the CFTMS Clinic to be

established by an October 2022 deadline. 


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References

Dahlhamer, J., Lucas, J., Zelaya, C., Nahin, R., Mackey, S., DeBar, L., Kerns, R., Von Korff, M.,

Porter, L., Helmick, C. (2019, September 16). Prevalence of Chronic Pain and High-

Impact Chronic Pain Among Adults - United States, 2016. Centers for Disease Control

and Prevention. https://www.cdc.gov/mmwr/volumes/67/wr/mm6736a2.htm

Find a provider. Find a Provider | Clinical TMS Society. (2021). Retrieved September 29, 2021,

from https://www.clinicaltmssociety.org/providers?display_name=&distance%5Blatitude

%5D=32.715738&distance%5Blongitude%5D=-

117.1610838&country=&state=&city=san%2Bdiego&postal-code=&distance

%5Bsearch_distance%5D=60&distance%5Bsearch_units%5D=mile.

Hill, M. L., Nichter, B., Na, P. J., Norman, S. B., Morland, L. A., Krystal, J. H., & Pietrzak, R. H.

(2021). Mental health impact of the COVID-19 pandemic in U.S. military veterans: a

population-based, prospective cohort study. Psychological medicine, 1–12. Advance

online publication. https://doi.org/10.1017/S0033291721002361

Leung, A., Shirvalkar, P., Chen, R., Kuluva, J., Vaninetti, M., Bermudes, R., Poree, L.,

Wassermann, E., Kopell, B., Levy, R. (2020). Transcranial Magnetic Stimulation for Pain,

Headache, and Comorbid Depression: INS‐NANS Expert Consensus Panel Review and

Recommendation. Neuromodulation: Technology at the Neural Interface, 23(3), 267–

290. https://doi.org/10.1111/ner.13094

Policy, Data, Oversight Pay & Leave. U.S. Office of Personnel Management. (2020).

https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2020/general-

schedule/
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Rizvi, S., & Khan, A. M. (2019, May 23). Use of Transcranial Magnetic Stimulation for

Depression. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6649915/

U.S. Department of Veterans Affairs. (2020a, September 19). 2020 National Veteran Suicide

Prevention Annual Report. U.S. Department of Veterans Affairs, Office of Mental Health

and Suicide Prevention. Retrieved September 27, 2021, from

https://www.mentalhealth.va.gov/docs/data-sheets/2020/2020-National-Veteran-Suicide-

Prevention-Annual-Report-11-2020-508.pdf

U.S. Department of Veterans Affairs. (2020b). Keeping Veterans Safe 2020 - VASDHS Annual

Report. VA san Diego Healthcare System. Retrieved October 25, 2021, from

https://www.sandiego.va.gov/docs/annual_report2020.pdf

U.S. Department of Veterans Affairs. (2019, May 31). Va.gov: Veterans Affairs. Community Care

for Veterans. Retrieved October 13, 2021, from

https://www.sandiego.va.gov/services/Community_Care_for_Veterans.asp

U.S. Department of Veterans Affairs, V. H. A. (2020c). VA.gov: Veterans Affairs. About the VA

San Diego Healthcare System. https://www.sandiego.va.gov/about/index.asp

U.S. Department of Veterans Affairs. (2017, May 20). Va.gov: Veterans Affairs. Post-Traumatic

Stress Disorder care for Veterans. Retrieved October 13, 2021, from

https://www.sandiego.va.gov/services/Post_Traumatic_Stress_Disorder.asp

U.S. Department of Veterans Affairs. (2021a, January 15). VA research on Pain Management.

Pain Management. Retrieved October 13, 2021, from

https://www.research.va.gov/topics/pain.cfm
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U.S. Department of Veterans Affairs. (2021b, June 17). VA San Diego Breaks Ground on $217M

Projects. Retrieved October 13, 2021, from

https://www.sandiego.va.gov/features/sci_clc_groundbreaking.asp.
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Appendix A

Note. COVID-19=coronavirus disease 2019; Error bars represent 95% confidence intervals. Adverse childhood

experiences (0.8% relative variance explained) and pre-pandemic alcohol use severity (2.8% relative

variance explained) were not significant predictors of increased psychiatric distress in the relative

importance analysis (both p's>0.05).


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Appendix B

CFTMS Clinic Workflow Diagram


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Appendix C

CFTMS Clinic Timetable


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Appendix D

Set-up for neuronavigation guided Transcranial Magnetic Stimulation

Note: Set-up for neuronavigation guided Transcranial Magnetic Stimulation. Adapted from :Transcranial Magnetic
Stimulation for Pain, Headache, and Comorbid Depression: INS‐NANS Expert Consensus Panel Review and
Recommendation,” Leung, A., Shirvalkar, P., Chen, R., Kuluva, J., Vaninetti, M., Bermudes, R., Poree, L.,
Wassermann, E., Kopell, B., & Levy, R. 2020,. Neuromodulation: Technology at the Neural Interface, 23(3), 267–
290. 2020. Albert Leung. Adapted with permission

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