Research Matters - ocr.emory.edu

Research Matters Office for Clinical Research

June 17, 2021

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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

Announcements

General Announcements

June 2021

OCR News

• 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

https://www.emory.edu/forward/resources/policies-guidelines-protocols/visitor-policy/human-subjects-research-related.html

https://www.emory.edu/forward/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/

https://www.hr.emory.edu/careers/

Continuing Education Credits

Continuing education credits will be provided when requested for all Research Matters educational

seminars.

Remember!!!

Men’s Health:General Concerns

Brendan Browne, MDAssistant Professor of Urology

Emory University

Presenter

Presentation Notes

I am more interested in non-cancer topics

Disclosures

• Advanced Dilation Strategies• aGUaRx

My research

• Urethral stricture disease• Benign prostate hyperplasia• Biomarkers for urologic malignancy• Medical device development

• Microbiome and Metabolome• Bladder electrophysiology

CAUTI and recurrent UTI

Bladder Electrophysiology

Presenter

Presentation Notes

Still waiting for the bulb to turn on (actually waiting for time and financing) People have been working on it for ~70 years and still getting through the basics Huge men’s (and women’s) general health opportunity

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

Presenter

Presentation Notes

Describe process of active surveillance Aggressive treatment for low risk disease definitely contributed to D recommendation for PSA screening Rethinking and retooling Pca treatment since 1995

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%

Presenter

Presentation Notes

Describe process of active surveill Neal DE, Metcalfe C, Donovan JL, Lane JA, Davis M, Young GJ, Dutton SJ, Walsh EI, Martin RM, Peters TJ, Turner EL, Mason M, Bryant R, Bollina P, Catto J, Doherty A, Gillatt D, Gnanapragasam V, Holding P, Hughes O, Kockelbergh R, Kynaston H, Oxley J, Paul A, Paez E, Rosario DJ, Rowe E, Staffurth J, Altman DG, Hamdy FC; ProtecT Study Group. Ten-year Mortality, Disease Progression, and Treatment-related Side Effects in Men with Localised Prostate Cancer from the ProtecT Randomised Controlled Trial According to Treatment Received. Eur Urol. 2020 Mar;77(3):320-330. doi: 10.1016/j.eururo.2019.10.030. Epub 2019 Nov 24. Erratum in: Eur Urol. 2020 Sep;78(3):e139-e143. PMID: 31771797.ance

Active Surveillance Outcomes

Tosoian 2020

Presenter

Presentation Notes

Contemporary series (Hopkins) Tosoian JJ, Mamawala M, Epstein JI, Landis P, Macura KJ, Simopoulos DN, Carter HB, Gorin MA. Active Surveillance of Grade Group 1 Prostate Cancer: Long-term Outcomes from a Large Prospective Cohort. Eur Urol. 2020 Jun;77(6):675-682. doi: 10.1016/j.eururo.2019.12.017. Epub 2020 Jan 7. PMID: 31918957.

Adoption of Active Surveillance

Liu, 2020

Presenter

Presentation Notes

Liu Y, Hall IJ, Filson C, Howard DH. Trends in the use of active surveillance and treatments in Medicare beneficiaries diagnosed with localized prostate cancer. Urol Oncol. 2020 Dec 8:S1078-1439(20)30609-8. doi: 10.1016/j.urolonc.2020.11.024. Epub ahead of print. PMID: 33308973.

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

Presenter

Presentation Notes

Tan HJ, Marks LS, Hoyt MA, Kwan L, Filson CP, Macairan M, Lieu P, Litwin MS, Stanton AL. The Relationship between Intolerance of Uncertainty and Anxiety in Men on Active Surveillance for Prostate Cancer. J Urol. 2016 Jun;195(6):1724-30. doi: 10.1016/j.juro.2016.01.108. Epub 2016 Feb 9. PMID: 26872841; PMCID: PMC4871722. Marzouk K, Assel M, Ehdaie B, Vickers A. Long-Term Cancer Specific Anxiety in Men Undergoing Active Surveillance of Prostate Cancer: Findings from a Large Prospective Cohort. J Urol. 2018 Dec;200(6):1250-1255. doi: 10.1016/j.juro.2018.06.013. Epub 2018 Jun 7. PMID: 29886089; PMCID: PMC6705118.

Rebranding Prostate Cancer

Hudnall, 2021

Presenter

Presentation Notes

Hudnall MT, Desai AS, Tsai KP, Weiner AB, Vo AX, Ko OS, Jan S, Schaeffer EM, Kundu SD. It's all in the name: Does nomenclature for indolent prostate cancer impact management and anxiety? Cancer. 2021 Jun 3. doi: 10.1002/cncr.33621. Epub ahead of print. PMID: 34081322.

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

Presenter

Presentation Notes

Improved technology allows granular data (Low) In the hospital predicting readmissions (Jonker) As an outpatient opportunities for intervention Lu Online interaction improved patient confidence in physician recommendation Immediate release of medical results National Law Low CA, Bovbjerg DH, Ahrendt S, et al. Fitbit step counts during inpatient recovery from cancer surgery as a predictor of readmission. Ann Behav Med 2018; 52: 88. Jonker LT, Lahr MMH, Oonk MHM, de Bock GH, van Leeuwen BL. Post-discharge Telemonitoring of Physical Activity, Vital Signs, and Patient-Reported Symptoms in Older Patients Undergoing Cancer Surgery. Ann Surg Oncol. 2021 Feb 27:1–11. doi: 10.1245/s10434-021-09707-3. Epub ahead of print. PMID: 33641013; PMCID: PMC7914037. Lu X, Zhang R. Impact of Physician-Patient Communication in Online Health Communities on Patient Compliance: Cross-Sectional Questionnaire Study. J Med Internet Res. 2019 May 13;21(5):e12891. doi: 10.2196/12891. PMID: 31094342; PMCID: PMC6535977.

“Prostate troubles”

BPH occurs in ~70% of 60 year olds and 80% of 80 year olds

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

Presenter

Presentation Notes

Not all treatments are created equal Ulchaker JC, Martinson MS. Cost-effectiveness analysis of six therapies for the treatment of lower urinary tract symptoms due to benign prostatic disease. Clinicoecon Outcomes Res. 2018:20:29-43.

Cost Effectiveness Analysis

Ulchaker, 2018

Presenter

Presentation Notes

Cost to health care payer (Medicare or insurance) Ulchaker JC, Martinson MS. Cost-effectiveness analysis of six therapies for the treatment of lower urinary tract symptoms due to benign prostatic disease. Clinicoecon Outcomes Res. 2018:20:29-43.

Surgery for everyone?

• Frailty = multifactorial phenotype

• Frailty and geriatric assessments – age, chronic disease, social factors

• Increased mortality, complication and readmission rates

Li, 2016

Presenter

Presentation Notes

Screen patients >70 or with >50% weight loss for frailty Get-up-and-go test, 5 meter walking time, cognitive Li JL, Henderson MA, Revenig LM, Sweeney JF, Kooby DA, Maithel SK, Master VA, Ogan K. Frailty and one-year mortality in major intra-abdominal operations. J Surg Res. 2016 Jun 15;203(2):507-512.e1. doi: 10.1016/j.jss.2016.03.007. Epub 2016 Mar 22. PMID: 27087115. Makhani SS, Kim FY, Liu Y, Ye Z, Li JL, Revenig LM, Vaughan CP, Johnson TM 2nd, García PS, Ogan K, Master VA. Cognitive Impairment and Overall Survival in Frail Surgical Patients. J Am Coll Surg. 2017 Nov;225(5):590-600.e1. doi: 10.1016/j.jamcollsurg.2017.07.1066. Epub 2017 Aug 4. PMID: 28826805; PMCID: PMC5995330.

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

Presenter

Presentation Notes

Raheem OA, Chen TT, Akula KP, Greenberg J, Le TV, Chernobylsky D, Sikka SC, Walsh TJ. Efficacy of Non-Testosterone-Based Treatment in Hypogonadal Men: A Review. Sex Med Rev. 2021 Apr 28:S2050-0521(20)30080-9. doi: 10.1016/j.sxmr.2020.08.003. Epub ahead of print. PMID: 33933392. Kim SH, Park JJ, Kim KH, Yang HJ, Kim DS, Lee CH, Jeon YS, Shim SR, Kim JH. Efficacy of testosterone replacement therapy for treating metabolic disturbances in late-onset hypogonadism: a systematic review and meta-analysis. Int Urol Nephrol. 2021 Jun 5. doi: 10.1007/s11255-021-02876-w. Epub ahead of print. PMID: 34089171.

• Testosterone in addition to exercise program improves Oral Glucose Tolerance Test

• Testosterone – 12%• Placebo – 21%

• Polycythemia• Testosterone – 22%• Placebo – 1%

Wittert 2021

Presenter

Presentation Notes

Wittert G, Bracken K, Robledo KP, Grossmann M, Yeap BB, Handelsman DJ, Stuckey B, Conway A, Inder W, McLachlan R, Allan C, Jesudason D, Fui MNT, Hague W, Jenkins A, Daniel M, Gebski V, Keech A. Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM): a randomised, double-blind, placebo-controlled, 2-year, phase 3b trial. Lancet Diabetes Endocrinol. 2021 Jan;9(1):32-45. doi: 10.1016/S2213-8587(20)30367-3. PMID: 33338415.

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

Presenter

Presentation Notes

Mulhall JP, Trost LW, Brannigan RE et al: Evaluation and management of testosterone deficiency: AUA guideline. J Urol 2018; 200: 423.

Presenter

Presentation Notes

One of the reasons that I came to Emory was that I was at a place with minimal research support and it was extremely challenging. Coordinators should be active rather than roadblocks, finding pathways to success in a remarkably complex interplay between science, ethics, and logistics that allow research to occur and flourish. Feel free to bring your own thoughts on the science too, it’s No bad ideas in brain storming

Men's Health: Mental ConcernsDeJuan White, MD, FAPA

Assistant Professor

Department Psychiatry and Behavioral Sciences

Emory University School of Medicine

DeJuan White, MDPersonal/Professional

Financial Relationship with Industry

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

Presenter

Presentation Notes

Has been noted that there is a silent crisis in men's health 49.7% of women with mental illness received mental health services; this is seen in my clinical setting Minimizing symptoms that they have been experiencing until receive collateral/additional information from a loved one who gives more insight into men's behaviors and mental health concerns

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%

Presenter

Presentation Notes

Impact of mental health on conditions noted in the leading causes of death can be seen in many if not all Rates of obesity also increasing; self care

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

Presenter

Presentation Notes

- include impact of mental health on lifestyle modifications

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

Presenter

Presentation Notes

NIMH Statistics Consideration about testosterone levels for late onset hypogonadism: Low levels of testosterone can lead to various mental health symptoms including fatigue, anxiety, depression, irritability, difficulty concentrating, memory difficulty, insomnia, and low libido

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

Presenter

Presentation Notes

PTSD mostly impacts women Of those experiencing a traumatic event, about 20% develop PTSD Combat veteras particiularly affeced, about 30% of Vietnam War vets, 10% Gulf War, and 14% of those who served in Iraq Stress, symptoms, overlap with depression

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

Presenter

Presentation Notes

Men age of onset of schizophrenia peaks between 21 and 25; while women peak between 25 and 30, then again after 45 year old Women typically have a better treatment response

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

Presenter

Presentation Notes

Center for Behavioral Health Statistics and Quality, 2017

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

Presenter

Presentation Notes

2018 data

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

Presenter

Presentation Notes

Toxic masculinity plays a part in creating the barrier Admission could lead to one thinking that a man may not be able to care for himself appropriately Addressed by APA Guidelines for Psychological Practice with Boys and Men

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

Presenter

Presentation Notes

Specifically, to reduce mortality research can contribute to guide practice. For example, study in 2019 showed offering support to men from a respected at risk of suicide

Questions?

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.

https://www.cdc.gov/heartdisease/mentalhealth.htm

https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_06-508.pdf

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


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


OCR Invoicing Management Attributes


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


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


Non-IndustrySponsored/FundedCLINICAL RESEARCH

•Managed ONLY if:•Invoice required by sponsor for CPT coded items/services

•Includes:•PI Initiated•Foundation•Federal


Presenter

Presentation Notes

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


OCR Financial Management


ERMS: Partial and Full Budget Build- out

• Budget Team establish attributes• Partial Budget Build-out• FSFV• Full Budget Build-out


ERMS: Partial and Full Budget Build- out


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


First Subject First Visit Notification (FSFV): What does this mean?





Presenter

Presentation Notes

Here is an example of the OCR Invoicing contact on the study main page

Budget Revisions

• Budget Team Completes Budget Entry• Amendment/Revision Notification to Study Team• Amendment Placement Group Naming

Convention


Budget Revisions


Tracking Non-Subject Activity


• 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





Presenter

Presentation Notes

Here is an example of where to enter the date of service of the Non-Subject Activity and any relevant information in the comments field.

Questions


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]


mailto:[email protected]





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!

http://www.ocr.emory.edu/training/research%20matters.html

Research Matters - ocr.emory.edu

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