research matters - ocr.emory.edu
TRANSCRIPT
Agenda11:30 am – 11:35 am Welcome & General Announcements
John Doan, MDResearch Services ConsultantEmory University, Office for Clinical Research – Education & QI
11:35 am – 12:05 pm Men’s Health: General ConcernsIncludes Q&A Brendan Michael Browne, MD
Assistant Professor Emory University, SOM: Urology
12:05 pm – 12:30 pm Men’s Health: Mental ConcernsIncludes Q&A DeJuan White, MD
Assistant ProfessorEmory University, SOM: Psychiatry
12:30 pm – 12:55 pm OCR: Invoicing & ERMSIncludes Q&A Veronique King, CHRC
Assistant Director Clinical Research AccountsEmory University: Office for Clinical Research
1:00 pm Closing RemarksJohn Doan, MDResearch Services ConsultantEmory University, Office for Clinical Research – Education & QI
Objectives• Updates and news from Urology Research
• Evaluating mental health in men
• Other research needs to be done for men
• Review Invoicing and ERMS guidelines
• OnCore enterprise-wide CTMS – August 2022
• Epic implementation – October 2022
• External monitors and auditors• Human Subjects Research Related | Emory University | Atlanta
GA• https://www.emory.edu/forward/resources/policies-
guidelines-protocols/visitor-policy/human-subjects-research-related.html
OCR NewsJob Openings at OCR
⁻ Invoicing: CRFM (2)⁻ CRSS: Clinical Research Navigator⁻ Pre-Award: Supervisor CRFM & Lead
CRFM⁻ Education & QI: Research Service
Consultant
• https://www.hr.emory.edu/careers/
Continuing Education Credits
Continuing education credits will be provided when requested for all Research Matters educational
seminars.
Men’s Health:General Concerns
Brendan Browne, MDAssistant Professor of Urology
Emory University
My research
• Urethral stricture disease• Benign prostate hyperplasia• Biomarkers for urologic malignancy• Medical device development
• Microbiome and Metabolome• Bladder electrophysiology
Bladder Electrophysiology
Chief complaint: “My wife told me to come”
Urologic Issues• Urinary obstruction• Prostate/GU cancer• Erectile dysfunction• Low testosterone• Fertility
Other Concerns• Cardiac disease• Mobility/orthopedic• Obesity• Cognitive preservation
Prostate Cancer Active Surveillance
ProtecT trial
Neal, 2020
Active Monitoring Radical Prostatectomy Radiation
Death from Pca 1.9% 0.7% 0.7%
Metastasis 5.6% 2.4% 2.7%
Disease Progression 20.35% 5.9% 6.6%
Sexual dysfunction -- 95% 88%
Urinary incontinence -- 55%
Bowel dysfunction -- 5%
Active Surveillance Outcomes
Tosoian 2020
Adoption of Active Surveillance
Liu, 2020
Anxiety and Active Surveillance
Tan, 2016Marzouk, 2018
• General anxiety in 1 in 8 men
• Prostate cancer specific anxiety linked to moderate-to-severe urinary symptoms
• Anxiety on AS peaks at 1 year
Rebranding Prostate Cancer
Hudnall, 2021
Male compliance
• Decreased follow-up for routine conditions in COVID era• BPH• Prostate cancer screening• Diabetes• Hypertension
• Considerable morbidity and mortality when unattended
• Insidious conditions with slow progression and “point of no return”
• PVSA compliance traditionally ~50% across multiple studies• Laboratory test = 66%• Home test = 77%
Even with convenience of home testing still well less than full compliance
Trussler, 2020
Technology and health
Treatment Durability
TreatmentRetreatment Rate
2 year 5 year 10 year
TURP 10%
Rezum® 7.5% 4.4%
UroLift® 4% 13.6%
Aquablation 4%
HoLEP/Simple Prostatectomy <1%
Ulchaker, 2018
Cost Effectiveness Analysis
Ulchaker, 2018
Surgery for everyone?
• Frailty = multifactorial phenotype
• Frailty and geriatric assessments – age, chronic disease, social factors
• Increased mortality, complication and readmission rates
Li, 2016
Testosterone Supplementation Therapy
• Non-Testosterone options are efficacious for improving total T
• Improves metabolic and lipid parameters• HbgA1c, insulin [not FPG]• TC, HDL [not TG or LDL]• Waist circumference [not BMI or body weight]
Medication Baseline On Treatment
SERMs 167 ± 202 366 ± 32
hCG 284 ± 13 566 ± 40
Raheem, 2020Kim, 2021
• Testosterone in addition to exercise program improves Oral Glucose Tolerance Test
• Testosterone – 12%• Placebo – 21%
• Polycythemia• Testosterone – 22%• Placebo – 1%
Wittert 2021
Testosterone and Prostate Cancer (AUA)
• Check PSA in men >40yo prior to starting testosterone• May increase ~0.5 ng/mL in first year of TST
• “absence of evidence linking testosterone therapy to the development of prostate cancer”
• “inadequate evidence to quantify risk-benefit ratio of testosterone therapy” in patients with testosterone deficiency and history of prostate cancer
Mulhall, 2018
Men's Health: Mental ConcernsDeJuan White, MD, FAPA
Assistant Professor
Department Psychiatry and Behavioral Sciences
Emory University School of Medicine
Men and Mental Health
• About 1 in 5 Americans experience a mental condition annually
• In 2019, 16.3% of all adult males in the U.S. had a mental illness
• Of all men with a mental illness, 36.8% of men with a mental illness were noted to have received mental health services
Leading Causes of Death of Males - 2017
All races and origins, Male, All ages Percent
1) Heart Disease 24.2%
2) Cancer 21.9%
3) Unintentional Injuries 7.6%
4) Chronic Lower Respiratory Diseases 5.2%
5) Stroke 4.3%
6) Diabetes 3.2%
7) Alzheimer's Disease 2.6%
8) Suicide 2.6%
9) Influenza and Pneumonia 1.8%
10) Chronic Liver Disease 1.8%
Mental Health and Chronic Disease• Presence of a chronic disease increases the likelihood of
developing a mental health condition• Those who have a mental health condition will likely develop
a chronic disease at some time in their lives
Men and Depression
• Six million men are affected by depression annually
• Increased risk of depression in men following significant life changes including divorce and retirement
• Men are less likely to seek mental health for depressive symptoms than women
• Men with depression may present with more irritability or aggression instead of sadness
Men and Anxiety Disorders
• Anxiety disorders are the most common mental health conditions for adults in the United States
• About 3 million men have panic disorders or phobias• Obsessive compulsive disorder and social anxiety disorder
equally impact men and women
Men And PTSD• About 8 million adults in the United
States have been diagnosed with PTSD within a year
• Approximately 5-6% of men have had PTSD in their lifetime with 1.8% of men living with PTSD in the past year
• Increased risk of PTSD in men who have been in combat or the victim of an assault
Men and Schizophrenia• About 3.2 million Americans have been diagnosed with
schizophrenia• Men and women have an overall similar prevalence of
schizophrenia• Men are 90% of those diagnosed with schizophrenia by the
age of 30 years• More severe forms and negative symptoms noted in men
with schizophrenia
Men and Substance Use Disorder• About 1 in 5 men will have alcohol use disorder in their
lifetime• Men are two to three times as likely to misuse drugs than
women• More than half of those dually diagnosed with a mental
health and substance use disorder are men• Misuse of substances can worsen mental health issues
Men and Suicide• Men have lower rates of suicide attempts when compared to
women• Men die of completed suicide about 3.7x higher than women• White men over the age of 85 are at highest risk of suicide• Suicide rates of men have been on the rise for the past two
decades
Barriers to Mental Health Care in Men• Social norms• Limited or lack of understanding of mental health issues• Hesitancy to speak about mental health concerns• Minimizing symptoms of mental health disorders
Addressing Barriers to Care for Men with Mental Concerns• Education on identifying and providing assistance to men with
mental health conditions• Offer support to those with or at risk of developing mental illness• Avoid ignoring warning signs or symptoms of mental health
conditions• Research to address major mental health issues including suicide
prevention
References
• Heart Disease and Mental Health Disorders | cdc.gov. (2021, May 5). Centers for Disease Control and Prevention. https://www.cdc.gov/heartdisease/mentalhealth.htm
• Li, R., Ma, X., Wang, G., Yang, J., & Wang, C. (2016). Why sex differences in schizophrenia?. Journal of translational neuroscience, 1(1), 37–42.
• National Vital Statistics Reports - CDC. (n.d.). https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_06-508.pdf.
• Oliffe, J. L., Rossnagel, E., Seidler, Z. E., Kealy, D., Ogrodniczuk, J. S., & Rice, S. M. (2019). Men's Depression and Suicide. Current psychiatry reports, 21(10), 103. https://doi.org/10.1007/s11920-019-1088-y
• Porsche, D., & Giorgianni, S. J., Jr (2020). The Crisis in Male Mental Health: A Call to Action. American journal of men's health, 14(4), 1557988320936504. https://doi.org/10.1177/1557988320936504.
• Seidler, Z. E., Dawes, A. J., Rice, S. M., Oliffe, J. L., & Dhillon, H. M. (2016). The role of masculinity in men's help-seeking for depression: A systematic review. Clinical psychology review, 49, 106–118. https://doi.org/10.1016/j.cpr.2016.09.002
• U.S. Department of Health and Human Services. (n.d.). Mental Illness. National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/mental-illness.
OCR – Invoicing & ERMS
Veronique King, CHRCOffice for Clinical Research
June 2021
Office for Clinical Research Transforming Research … Together!
Objectives
• Review the Functions of OCR Invoicing• Review OCR Financial Management Attributes• Review OCR Invoicing Notifications• Review ERMS Non-Subject Activity Tracking
Office for Clinical Research Transforming Research … Together!
What is the Function of OCR Invoicing?
•Generate invoices to industry sponsors for start-up-costs, visit level, pass-through and milestones items•Receive payments directly from industry sponsors for invoiceable and/or non-invoiceable items and services•Process patient stipends and travel reimbursements•Process payments to external vendors•Generate and distribute monthly reports to investigators, departments and RAS
Office for Clinical Research Transforming Research … Together!
OCR Invoicing Management Attributes
Office for Clinical Research Transforming Research … Together!
IndustrySponsored/Funded
CLINICAL TRIAL
•Must meet NIH/FDA definition of a clinical trial
•OCR manages ALL of the above•with/without PRA•Non-Invoiceables payments•Milestones payments
•OCR does NOT generate/pay invoices for subawards
IndustrySponsored/FundedCLINICAL RESEARCH
•Human subjects research in which people, data or samples of tissue are studied to understand health and disease
•OCR manages ALL of the above•with/without PRA•Non-Invoiceables payments•Milestones payments
•OCR does NOT generate/pay invoices for subawards
Hybrid/Double Award
•Includes studies with two funding sources
•Federal/Non-Federal
•Evaluate case-by-case•OCR to contact RAS
•Who will manage?•Preference:
•One dept to manage acct vs. across depts
•OCR does NOT generate/pay invoices for
subawards
Non-IndustrySponsored/Funded
CLINICAL TRIAL
•Managed ONLY if:•Invoice required by sponsor for CPT coded items/services
•Includes:•PI Initiated•Foundation•Federal
•OCR does NOT generate/pay invoices for subawards
Non-IndustrySponsored/FundedCLINICAL RESEARCH
•Managed ONLY if:•Invoice required by sponsor for CPT coded items/services
•Includes:•PI Initiated•Foundation•Federal
•OCR does NOT generate/pay invoices for subawards
OCR Invoicing Management
• The OCR Budget team reviews PRA, budget terms and final sponsor budget to assign attributes
• Select “Yes” in ERMS study settings • ERMS reports to Compass all studies selected with
“Yes”– All studies managed by OCR Invoicing denoted on the
eNOA
Office for Clinical Research Transforming Research … Together!
ERMS: Partial and Full Budget Build- out
• Budget Team establish attributes• Partial Budget Build-out• FSFV• Full Budget Build-out
Office for Clinical Research Transforming Research … Together!
ERMS: Partial and Full Budget Build- out
Office for Clinical Research Transforming Research … Together!
When the FSFV is tracked in ERMS:• Triggers an automatic e-mail notification to the
Invoicing/Budget team mailbox• Triggers completion of budget build-out in ERMS• Triggers assignment of study to a CRFM and
introductory email to study team
Office for Clinical Research Transforming Research … Together!
First Subject First Visit Notification (FSFV): What does this mean?
First Subject First Visit Notification (FSFV): What does this mean?
Office for Clinical Research Transforming Research … Together!
First Subject First Visit Notification (FSFV): What does this mean?
Office for Clinical Research Transforming Research … Together!
Budget Revisions
• Budget Team Completes Budget Entry• Amendment/Revision Notification to Study Team• Amendment Placement Group Naming
Convention
Office for Clinical Research Transforming Research … Together!
Tracking Non-Subject Activity
Office for Clinical Research Transforming Research … Together!
• Non-Subject Activity– Research item/activity that does not have a procedure
code– Not associated with patient care (i.e. monitoring fees, dry
ice, FDA audits)– Track under study tab in ERMS– Add relevant comments to be included on invoices
• Tracking Errors (i.e. wrong date or wrong item )– Notify your CRFM immediately via email
Tracking Non-Subject Activity
Office for Clinical Research Transforming Research … Together!
OCR Invoicing Contact Information:
• General [email protected]
• Sherry ColemanAssociate Executive Director, Clinical [email protected](404) 727-4371
• Veronique Horne-KingAssistant Director, Clinical [email protected]
• Shan ColbertSupervisor, Clinical Research [email protected]
• Vanessa SmithSupervisor, Clinical Research [email protected]
Office for Clinical Research Transforming Research … Together!
Closing RemarksPowerPoint Presentations and this event
recording will be available on OCR’s website athttp://www.ocr.emory.edu/training/research%20
matters.html
Our next Research Matters educational seminar will be October 21, 2021.
See you next time!