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EHRs and Family Cancer
History Ascertainment.
The Path Forward?
W. Gregory Feero, M.D., Ph.D.
Maine-Dartmouth Family Medic...
Disclaimers
• I have no known conflicts of interest related
to the educational materials presented.
• I speak for myself a...
Outline
• A history of FHH integration
• Current status
• Path forward?
Launch of the U.S. Surgeon General’s
Family History Initiative in 2004
HISTORICAL USE ONLY
57
American Health Information
Community (AHIC)
AHIC is the public-private collaborative that sets priorities and oversees...
58
AHIC Working Group on PHC
Evaluate needs and opportunities to utilize health information technology to
advance personal...
Recommendation Approved by AHIC
July 31, 2007
Recommendation 1.0:
The Community should advance the area of Personalized He...
Recommendations Cont:
Recommendation 3.1:
Additionally, studies should be performed as part of this collaboration as an ev...
Arriving at a core data set for FHH:
• Achieved in 2008 by a public/private task force convened by the
AHIC Personalized H...
#1
August 24-26, 2009
HISTORICAL USE ONLY
17. How might family history, including
environmental and behavioral risk factors, be
improved by a systematic, technology...
MFHP in Three Eras
• 2004-2009 V.1 Basic functionality
• 2009-2014 V.2 Interoperability and sharing
• 2014- Current V.3 In...
HISTORICAL USE ONLY
Family Health History Interoperability/Portability
67
FHH
HL7 Standard
FHH User
EHRs (IHS,
Intermountain, and
Harvard Part...
www.hhs.gov/ocr/privacy/familyhealthhistoryfaqs.pdf
#2
HISTORICAL USE ONLY
HISTORICAL USE ONLY
70Surgeon General's My Family Health Portrait
Family Health History
Standards-based
• XML-based
• HL7 family history model...
My Family Health Portrait
Structured Data + Connectivity = Interoperability
HealthVault Affiliates
Structured Data
Partner...
HISTORICAL USE ONLY
HISTORICAL USE ONLY
#3
HISTORICAL USE ONLY
HISTORICAL USE ONLY
#4
HISTORICAL USE ONLY
Drivers for EHR Integration
#1Core minimum data set for FHH in EHRs
#2Privacy concerns addressed (also GINA
2008)
#3“Agree...
Challenges of developing & deploying an automated
FHH tool-the path of Health Heritage
Health Heritage development
• 2001 ...
Opportunity: Deploy and maintain Health Heritage
nationwide with new sponsors
Existing features
• Best practice designed p...
Controversial statement:
There are no compelling incentives
(disincentives) for EHR systems to develop
and deploy interope...
Conclusions
• Multiple efforts have been made to
improve utility of FHH in health care
in the United States.
• Approaches ...
• What- A national coalition of > 130 organizations
• Co-Founded by ACS and CDCP in 1997
• Goal- To increase the use of pr...
Family History/Early Onset CRC Task Group
Paul Schroy, MD, MPH,
Boston University School of Medicine, Emeritus Professor o...
Family History/Early Onset CRC Task Group
NCCRT 2017 Early Age Onset Colorectal Cancer Summit:
What we know, what we don’t...
Family History/Early Onset CRC Task Group
NCCRT 2017 Early Age Onset Colorectal Cancer Summit:
What we know, what we don’t...
FH/EO CRC Task Group- Active Projects
• EO CRC Causation Workshop- Heather Hampel, Steve Itzkowitz
• Advanced Adenoma Work...
Objectives
Develop a system that helps primary care
practices:
• Identify patients at increased/high risk based
on persona...
Implementation- Promotion
Launch June 2018
Download options: Full Guide / Quick Start / Individual Sections
Digital and Pr...
Use Metrics
NCCRT Downloads: 812 (Full Report and Quick Guide)
865 (Risk Assessment Screening Algorithm)
Pageviews: 2,394 ...
Improve EHR Collection of Cancer Family History
Delphi Survey
• Arose from NCCRT Survey of FQHCs
• All EHRs had FH section...
Delphi Survey
1. The essential goals of obtaining a cancer family history in the electronic health record include:
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Identifying patients who meet clinical criteria for Lynch syndrome and Heredit...
Delphi Survey- Results
• High Retention of participants
• 10 Questions; 76 items
• Consensus on 36
Goals Agree Strong Agre...
Should Be
Updated whenever there is new cancer family history 100%
No requirement for routine updates 0%
Capacity To Total...
FH/EO CRC Task Group
• Expertise
• Energy
• Enthusiastic
• Collaborative
• Very Productive
• In Good Hands
Great Fun
Thank...
ACS Colorectal Cancer Screening Guideline
for Average Risk Adults, 2018
100
Robert A. Smith, PhD
American Cancer Society
F...
I HAVE NO CONFLICTS OF INTEREST
TO DECLARE
101
The 2018 ACS CRC guideline update relied on two reports
commissioned for the 2016 USPSTF CRC recommendation update
102
The...
Two CISNET Microsimulation Models (MISCAN & SimCRC) Were Used to
Examine Outcomes by Age, Race/Ethnicity, and Sex Under As...
CRC Screening Guidelines for Average Risk Adults: ACS
(2018); USPSTF (2016)
Recommendations ACS, 2018 USPSTF, 2016
Age to ...
• Quality of evidence
- NEW Evidence on the burden of disease by age and race
- High-quality studies of test performance a...
Trends in Colorectal Cancer Incidence Rates by Age and Sex, 1975-2014
Rising Burden of Disease in Younger Adults
0
2
4
6
8...
Rising Burden of Disease in Younger Adults
0
2
4
6
8
10
12
14
16
Colorectalcancercasesper100,000persons
<50years
Year or d...
Trends in CRC
Incidence by
Age and Year
of Birth
Source: Siegel RL, Fedewa SA, Anderson WF, et al. Colorectal cancer incid...
Some Observations about CRC in Adults aged
45-49
109
Change in the Proportion of
CRC in Adults Under Age 50,
1990 - 2015
C...
• More noteworthy, is that the increase in the annual
percentage change in the incidence rate for adults
aged 40 to 49 yea...
Percentage of Years of Potential Life Lost Due to Death
from Colorectal Cancer by Age at Diagnosis (incidence-based
mortal...
CRC Incidence Among U.S. Adults Aged 45 & 50
Years, SEER, 1975-2015
Age 50
Age 45
Age specific incidence
is about the same...
Lifetime number of colonoscopies and life-years gained (LYG) for colonoscopy
screening strategies under 2 scenarios for CR...
Model-estimated Benefit CRC Screening by Starting Age
0
50
100
150
200
250
300
350
400
450
500
CSY CTC FS FIT HSgFOBT mt-s...
Overall, the Media Reports Were Favorable
The GI Literature Has Been Less Favorable
• CRC is a different disease in adults under 50
- We found no evidence to indicate that CRC is “different” in the 5 years ...
• Important that we concentrate further on adults 50+
- Agree, but this is an empty critique.
• The new guideline will wor...
• The new guideline will strain existing capacity
- In some areas this is a real possibility
- Further, there is a greater...
Is there Sufficient Capacity for Additional
Screening Tests for Adults Aged 45-49?
• “According to the Survey of Endoscopy...
Strategies for Addressing Early
Onset CRC: An NCCRT Report
Jan Lowery, PhD, MPH
Colorado Center for Personalized Medicine
...
Objectives:
 Review state of science and
clinical practice
 Identify gaps and missed
opportunities
 Define what we need...
The cause of the increase in EOCRC is
largely unknown
8%
8%
14%
15%
55%
% Contribution to EOCRC Lynch syndrome
Other hered...
Has prevalence of risk factors changed
over time among younger adults?
• Inherited susceptibility
• Physical inactivity
• ...
What do we know about molecular
pathway for EOCRC?
• Pathway for hereditary causes of EOCRC is
known
• Pathway for sporadi...
New hypotheses are needed
Table 2. Potential novel risk factors and new hypotheses for early-onset CRC
Exposure /Risk fact...
What are current challenges to preventing
and managing early-onset CRC?
• Identification of younger adults at risk for
her...
Screening adherence in at risk <50 is low
FDRs ≥50
Non-FDRs ≥50
FDRs 40-49
Percent
Tsai et al. Prev Chronic Dis 2015;12:14...
What are current challenges to preventing and
managing young-onset CRC?
• Adoption of universal tumor screening for Lynch
...
Strategic Plan Objectives
1) accelerate research to address unanswered
questions about the causes of increase in EOCRC
1) ...
 Table 3. Objective 1: Accelerate research to address unanswered questions about early-onset CRC (EOCRC)
 Priorities: Wh...
Priorities: What do we need to know/do? Strategies: How can we do this?
What is cause of the rising incidence of EOCRC?
 ...
What resources are available or needed? Who needs to be engaged?
Available:
 Existing cohorts (CCFRC, CPS-3, ARIC-Ca,
Mil...
Table 4. Objective 2: Increase adoption of evidenced-based practices to identify and manage persons at risk for EOCRC
Prio...
SYSTEMS LEVEL
Improve collection and use of family
history (CRC and polyps) in primary care in
younger adults to inform sc...
Table 5. Objective 3: Solidify commitment from engaged and new partners to move plan into action
Priorities: What do we ne...
Who needs to be engaged?
All of Us
• Providers’ professional
organizations
• PCPs and specialty
providers
• Genetic counse...
Short Term Action Items
• Research
o Conduct landscape of on-going research
o Convene group of investigators to identify k...
Short Term Action Items
• Partner Engagement
o Publish and disseminate paper
o Use plan to encourage engagement and
commit...
Advanced Polyp Prevalence Among First
Degree Relatives of Early Onset Colorectal
Cancer Patients
Christine Molmenti, PhD, ...
Adenoma to carcinoma sequence
Fearon and Vogelstein, Cell, 61, 759-767, 1990
Terzic et al, Gastroenterology 138(6), 2101-2...
142
31 years old
Stage IV Colorectal Cancer Survivor (left)
 Colorectal Polyps
Serrated lesions
o Hyperplastic polyps (frequent, benign)
o Sessile serrated polyps (<10%)
o Tradition...
Advanced polyps
1. Tubular adenomas ≥1 cm in size, or any adenoma with
villous elements or with high grade dysplasia
2. S...
SURVEILLANCE GUIDELINES
FOR PATIENTS WITH COLORECTAL POLYPS
Finding on colonoscopy Colonoscopy Interval
Normal findings
Sm...
Increased CRC risk among relatives
of patients with advanced polyps
 FDRs of patients with ≥1 advanced polyp carry:
 4-6...
FDR Guidelines
1. United States Multi-
Society Task Force
(USMSTF)
Advanced adenoma in 2
FDRs (any age) or AA in 1
FDR < 6...
Objectives
1. Remind providers patients with advanced polyps - patients and
family members are at increased risk for CRC a...
SECTION 1
If your patient is diagnosed with an advanced
colorectal polyp, both the patient and their family
members are at...
Adaptable
Educational
Sharable
GI Brief (Template) Letters
Knowledge gap
 What percentage of young onset
colorectal cancer is due to family history
of advanced polyps?
Dennis Ahnen, MD
Advisor
Priority area in young onset research
Understand advanced polyp prevalence among young CRC is a priority area and a
critic...
• Patients enrolled Ohio Colorectal Cancer Prevention Initiative
(OCCPI) – PI. Hampel
• Recruited between 2013 and 2016
 ...
Research Question
What percentage of young
onset CRC is due to family
history of advanced polyps?
n=492
Young onset CRC
56...
Young onset CRC
50%
Sporadic
16%
Hereditary
14%
Family history
CRC
20%
Family
History of
AP
Research Question
What percent...
56%
Sporadic
14%
Family history
of CRC
XX%
Family
History of
AA
40%
Sporadic
16%
Hereditary
14%
Family history
CRC
30%
Fam...
Step 1.
Contact probands (OSU)
(or next of kin) and collect
FDR contact
Step 2.
Contact FDRs to obtain
colonoscopy facilit...
Step 1. Contact EOCRC
probands (random selection)
Eligibility
• <50 years of age (N=492)
• No known CRC susceptibility
gen...
Feasibility outcomes
Primary
1. Recruitment rate of probands: The number enrolled (numerator)
divided by the number of pro...
Feinstein Institute for
Medical Research
and The Ohio State
University
Study Collaboration
Samantha Schneider
Research Associate
Grants Manager
sschneide5@northwell.edu
Action Plan
If recruitment of 50 probands is feasible, conduct full
study among 185 probands
Conduct investigation into o...
Summary
• Diagnosis of advanced colorectal polyps have implications for
patients and their first degree relatives (FDRs).
...
Acknowledgements
Dave Alberts
Anne Carlson
Cindy Borassi
Dorado Brooks
Maurice Cerulli
Heather Hampel
Caleb Levell
Beth Mc...
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
5th annual early age onset colorectal cancer summit session ii
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5th Annual Early Age Onset Colorectal Cancer Summit - Session II: Family History Ascertainment in the US - What Steps are Needed to Improve the Well Documented Less Than Optimal Status of this Situation?

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5th annual early age onset colorectal cancer summit session ii

  1. 1. EHRs and Family Cancer History Ascertainment. The Path Forward? W. Gregory Feero, M.D., Ph.D. Maine-Dartmouth Family Medicine Residency, Augusta, ME Associate professor, Geisel School of Medicine at Dartmouth Associate Editor, Journal of the American Medical Association
  2. 2. Disclaimers • I have no known conflicts of interest related to the educational materials presented. • I speak for myself and not any of the organizations mentioned in this presentation. • Very little of the work presented is mine. • This introduction is by no means comprehensive and is U.S.- centric.
  3. 3. Outline • A history of FHH integration • Current status • Path forward?
  4. 4. Launch of the U.S. Surgeon General’s Family History Initiative in 2004 HISTORICAL USE ONLY
  5. 5. 57 American Health Information Community (AHIC) AHIC is the public-private collaborative that sets priorities and oversees and/or endorses HIT standards, certification, the National Health Information Network, and policies on a national level.  Supported through the Office of the National Coordinator for Health Information Technology  Chaired by Secretary Leavitt and Dr. David Brailer  Seven work groups are now established involving over 100 experts and stakeholders – Biosurveillance, Electronic Health Records, Chronic Care, Consumer Empowerment, Confidentiality, Privacy and Security, Quality, and Personalized Health Care  Work groups develop recommendations to the AHIC and subsequently to the Secretary for action  Example: Executive Order requiring adoption of certification standards for electronic health records HISTORICAL USE ONLY
  6. 6. 58 AHIC Working Group on PHC Evaluate needs and opportunities to utilize health information technology to advance personalized health care.  Chaired by:  Douglas Henley, American Association of Family Physicians (AHIC member)  John Glaser, Harvard Partners  Representation from  Federal agencies : AHRQ, FDA, VA, DoD, NHGRI, NLM  Industry : Pfizer, Merck, Affymetrix, 23andME  Health plans : Permanente Federation, Intermountain Health, Wellpoint  Laboratories : Quest, Virginia Commonwealth University Department of Pathology  Consumer organizations : National Partnership for Women and Families, Patient Advocate  ELSI representatives : Genetics and Public Policy Center, Baylor College of Medicine Center for Medical Ethics, University of Louisville Institute of Bioethics HISTORICAL USE ONLY
  7. 7. Recommendation Approved by AHIC July 31, 2007 Recommendation 1.0: The Community should advance the area of Personalized Health Care as a Priority for Use Case Development. Recommendation 2.0: An extension to the Harmonized Use Case for EHRs (Laboratory Results Reporting) should be developed to address the specific information needs in the pre- analytic, analytic, and post-analytic phases of genetic/genomic tests. This extension to the use case should additionally address the need for integrated data flow across the pre-analytic, analytic, and post-analytic phases of genetic/genomic testing and address both the EHR and Laboratory Information Systems. Recommendation 3.0: A multi-stakeholder workgroup, including the private sector, federal health care providers, and federal Public Health Service agencies, should be formed to develop a core minimum data set and common data definition available for primary care collection of family health history information. HISTORICAL USE ONLY
  8. 8. Recommendations Cont: Recommendation 3.1: Additionally, studies should be performed as part of this collaboration as an evidence-base to determine the validity and utility of family health history risk assessment and management tools, clinical decision support tools, and how clinicians view this information as helpful for informing their medical decisions. Recommendation 3.2: Federal agencies in conjunction with private health care organizations with similar interests and expertise sponsoring pilots in the area of family health history should be used to evaluate the core minimum data set and evidence-base developed through Recommendations 3.0 and 3.1. Health care providers involved in these pilots should also examine the feasibility of consumer-clinician exchange of family health history information between PHR and EHR systems. When possible, the pilots should test and implement the standards and architecture identified in the HITSP developed use case. HISTORICAL USE ONLY
  9. 9. Arriving at a core data set for FHH: • Achieved in 2008 by a public/private task force convened by the AHIC Personalized Health Care workgroup – About 40 participants representing a diverse group of 18 stakeholders • Defined the minimum FHH data elements that every EHR and PHR should be able to capture • Did not specify data structures/terminologies for these elements
  10. 10. #1
  11. 11. August 24-26, 2009 HISTORICAL USE ONLY
  12. 12. 17. How might family history, including environmental and behavioral risk factors, be improved by a systematic, technology supported approach (e.g., electronic health records, record linkage, enhancing communication between family members)?
  13. 13. MFHP in Three Eras • 2004-2009 V.1 Basic functionality • 2009-2014 V.2 Interoperability and sharing • 2014- Current V.3 Interpretation of FHH
  14. 14. HISTORICAL USE ONLY
  15. 15. Family Health History Interoperability/Portability 67 FHH HL7 Standard FHH User EHRs (IHS, Intermountain, and Harvard Partners) Risk Tools (Harvard Partners) PHRs HISTORICAL USE ONLY
  16. 16. www.hhs.gov/ocr/privacy/familyhealthhistoryfaqs.pdf #2 HISTORICAL USE ONLY
  17. 17. HISTORICAL USE ONLY
  18. 18. 70Surgeon General's My Family Health Portrait Family Health History Standards-based • XML-based • HL7 family history model • LOINC • SNOMED-CT • HL7 Vocabulary • Minimum core data set (AHIC/ HITSP) HISTORICAL USE ONLY
  19. 19. My Family Health Portrait Structured Data + Connectivity = Interoperability HealthVault Affiliates Structured Data Partners My Family Health Portrait Family Members Care Providers Save to… HISTORICAL USE ONLY
  20. 20. HISTORICAL USE ONLY
  21. 21. HISTORICAL USE ONLY
  22. 22. #3 HISTORICAL USE ONLY
  23. 23. HISTORICAL USE ONLY
  24. 24. #4 HISTORICAL USE ONLY
  25. 25. Drivers for EHR Integration #1Core minimum data set for FHH in EHRs #2Privacy concerns addressed (also GINA 2008) #3“Agreed upon” data standards #4Financial incentive for family health use and integration
  26. 26. Challenges of developing & deploying an automated FHH tool-the path of Health Heritage Health Heritage development • 2001 Pilot RWJF Award to University of Virginia for feasibility to collect FHx directly from people and provide automated assessment of risk for cancer, cardiovascular, neurologic conditions • 2009 NCI grant to University of Virginia for streamlining FHx and risk factor collection for Cancer & Syndromes by connecting to EHR; add evidence based risk calculation tools • 2011 Health Heritage prototype developed and alpha tested Health Heritage deployment • 2012 Relocate project to NorthShore UniversityHealthSystems to interface with EHR (Epic) • 2014 HH successfully deployed across NorthShore’s four hospitals and all physician locations across Chicago’s North Shore within NorthShore’s patient portal • 2015 & 2017 HH licensed to a start up (NantHealth) and then to Allscripts but never hosted Health Heritage now • 2019 HH Intellectual Property Rights returned to original development team at University of Virginia with NorthShore partnership • Currently developing Dissemination & Implementation proposals to deploy HH nationwide Courtesy of William Knaus, MD
  27. 27. Opportunity: Deploy and maintain Health Heritage nationwide with new sponsors Existing features • Best practice designed patient centric GUI1 • Interface to Epic and established framework to connect to other EMR API’s • Automated extraction all cancers, risk factors aided by Natural Language Processing • Facilitated Family member sharing • Robust rules engine for risk assessment and personalized recommendations • Analytic and clinical validity established2,3 • Developing Dissemination & Implementation proposals to deploy HH nationwide Need a sponsor to assume responsibility for cloud deployment; expansion to other major diseases, annual updating to provide Health Heritage at low or no cost to all Americans 1Kinzie, et. Al.: A User Centered for Web Design: Needs Assessment, User Interface Design & Rapid Prototyping. J Am Med Inform Assoc. 2002 Jul- Aug; 9(4): 320–330. 2Cohn, WF et. al Health Heritage, a Web-Based Tool for the Collection and Assessment of Family Health History: Initial User Experience and Analytic Validity 2010 Apr 29. 3Baumgart LA, et.al. Initial clinical validation of Health Heritage a patient facing tool for personal family history collection and cancer risk assessment. Familial Cancer (2016) 15:331–339 Courtesy of William Knaus, MD
  28. 28. Controversial statement: There are no compelling incentives (disincentives) for EHR systems to develop and deploy interoperable * . * Your topic goes here.
  29. 29. Conclusions • Multiple efforts have been made to improve utility of FHH in health care in the United States. • Approaches to remove barriers to EHR integration at a national scale have been insufficient. • New technology and consumer- oriented approaches may offer new opportunities.
  30. 30. • What- A national coalition of > 130 organizations • Co-Founded by ACS and CDCP in 1997 • Goal- To increase the use of proven colorectal cancer screening tests among the entire population for whom screening is appropriate. • Strategy- Coordinated leadership, strategic planning, and advocacy • Process- Steering Committee- Task Groups (7); Annual Meeting and Special Topic Meetings National Colorectal Cancer Roundtable Convene Identify Collaborate
  31. 31. Family History/Early Onset CRC Task Group Paul Schroy, MD, MPH, Boston University School of Medicine, Emeritus Professor of Medicine Steve Itzkowitz, MD Icahn School of Medicine Mount Sinai, Professor of Medicine Heather Hampel, MS, LGC The Ohio State University Comprehensive Cancer Center Dennis Ahnen, MD, FOTW University of Colorado School of Medicine, Professor Emeritus Conflicts of Interest Speakers Bureau- Ambry Genetics Scientific Advisor- Cancer Prevention Pharmaceuticals • Established in 2012 • Expanded to include Early Onset CRC in 2016 • The charge is to identify key issues and areas of need around familial, inherited and early onset colorectal cancer for the purpose of identifying opportunities for the Roundtable to be a catalyst for change.
  32. 32. Family History/Early Onset CRC Task Group NCCRT 2017 Early Age Onset Colorectal Cancer Summit: What we know, what we don’t know, and what we need to know A strategic plan to address the rising burden of colorectal cancer in younger adults- submitted Major Kudos to Tom Weber and Jan Lowery Many should have started screening at age 40 or earlier and their CRCs might have been prevented or detected earlier • 450 Patients with CRC under age 50 • Germline testing with 25 cancer gene panel • FH of CRC in FDR by self-report Pearlman R, et al. JAMA Onc. 2017;3(4):464-71. *Estimated based on relative prevalence of CRC and AAs
  33. 33. Family History/Early Onset CRC Task Group NCCRT 2017 Early Age Onset Colorectal Cancer Summit: What we know, what we don’t know, and what we need to know A strategic plan to address the rising burden of colorectal cancer in younger adults- submitted Major Kudos to Tom Weber and Jan Lowery • Accelerate new research • Causation • Adenoma Prevalence in the Young • Enhance adoption of evidenced-based practices • Implementation Science • Promote ACS Guidelines • Improve EHR Collection of Family History • Solidify commitment from key partners- • Dissemination of Risk Assessment and Screening Toolkit
  34. 34. FH/EO CRC Task Group- Active Projects • EO CRC Causation Workshop- Heather Hampel, Steve Itzkowitz • Advanced Adenoma Working Group- 2017; Christine Molmente, Jordan Korlitz • AA Brief- AA contribution to EO CRC • Feasibility Study- Heather Hampel • On Time Screening- Whitney Jones • 50-54 yo <50% screening rates • 40-49 yo with FH of CRC <40% screening rates • Lead time messaging • ACS Guidelines- Robert Smith • Risk Assessment and Screening Toolkit- Update on implementation and request for help • Delphi Survey- Essential elements of cancer FH in any high quality EHR
  35. 35. Objectives Develop a system that helps primary care practices: • Identify patients at increased/high risk based on personal and family history • Apply screening guidelines based on risk • Refer high risk patients to genetics • Recognize and rapidly diagnose patients with a presenting CRC Emily Edelman, MS, CGC Associate Director, Clinical & Continuing Education The Jackson Laboratory
  36. 36. Implementation- Promotion Launch June 2018 Download options: Full Guide / Quick Start / Individual Sections Digital and Print ready versions Webinar introduction for resource Dissemination and Promotion by NCCRT and The Jackson Laboratories NCCRT Posted to NCCRT Resource Center nccrt.org CRC Newsletter (~3,000 recipients) NCCRT Social Media Channels (1300+ Twitter Followers) Select partners asked to promote ACS Health and Hospital Systems Staff Jackson Laboratory Posted to Jackson Lab website; www.jax.org Share tool via social media (200+ Followers) Email Campaign Blog during National Family Health History Month Presentations/Workshops Seems Daunting (77p) - Quick Start Guide (18p) More? Too CRC Focused- Many issues cut across cancer sites- Cancer Toolkit?
  37. 37. Use Metrics NCCRT Downloads: 812 (Full Report and Quick Guide) 865 (Risk Assessment Screening Algorithm) Pageviews: 2,394 (Main Page) 4,056 (Any) Average Time on Page: NCCRT – 2 mins 16 seconds (about average) Jackson Lab – 4 mins 11 seconds 3rd most popular resource in the NCCRT Resource Center Launched “Opt In” option to contact folks who have downloaded toolkit Implementation/Validation Xavier Llor- NCI grant application- not funded- needed implementation scientist NIH-funded Yale Center for Implementation Science- Steve Burnstein- submitted p50 Funding received for implementation in clinic pending funding for validation research NEED YOUR HELP
  38. 38. Improve EHR Collection of Cancer Family History Delphi Survey • Arose from NCCRT Survey of FQHCs • All EHRs had FH sections that included cancer FH • Highly variable content • Not linked to decision making • Needed agreement on optimal content of cancer FH for high quality EHR • Modified Delphi Survey; Dennis Ahnen, Jan Lowery and Heather Hampel • Questions developed and vetted • Hoped to survey large group of providers- couldn’t reach enough PCPs • Modified questions • Recuited a group of 36 experts; 12 PCPs, 12 GCs, 12 Gis • Iterative process • Consensus defined as ≥80% agree or strongly agree
  39. 39. Delphi Survey 1. The essential goals of obtaining a cancer family history in the electronic health record include:
  40. 40. 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Identifying patients who meet clinical criteria for Lynch syndrome and Hereditary Breast and Ovarian Cancer syndrome Identifying patients who meet clinical criteria for any hereditary cancer syndrome Identifying patients who should be referred for genetic counseling Identifying patients who should have a more detailed family history obtained Identifying patients who are at higher than average risk for colon breast or ovarian cancer and who, as a result, should have more intense screening and/or cancer prevention strategies Identifying patients who are at higher than average risk for any cancer due to family history and, as a result should have more intensive screening and/or cancer prevention strategies Creating a family cancer pedigree Gathering sufficient data to allow for clinical decision support when changes in cancer screening, recommendations occur The essential goals of obtaining a cancer family history in the electronic health record include:
  41. 41. Delphi Survey- Results • High Retention of participants • 10 Questions; 76 items • Consensus on 36 Goals Agree Strong Agree Total Identifying patients who should be referred for genetic 37.1 62.9 100% counseling Identifying patients who meet clinical guidelines for more 20 80 100% intensive screening than average risk individuals Content All first-degree relatives affected with cancer 5.7 94.3 100% PCP GC GI All second-degree relatives affected with cancer 37.1 42.9 80% 69% 100% 91% Age at cancer diagnosis for listed affected relatives 37.1 57.1 94%
  42. 42. Should Be Updated whenever there is new cancer family history 100% No requirement for routine updates 0% Capacity To Total Alert the providers if there is a potentially elevated cancer risk 100% Alert provider that the patient may require different screening 100% PCP GC GI Generate best practice alerts about colorectal screening 89% 75% 100% 100% recommendations for high-risk patients Completing FH should be Expected as part of high-quality care 97% A shared responsibility with patients 83% Followed by the practice/institution as a quality metric 74% 50% 100% 91% Part of Common Clinical Data Set in Meaningful 57% 50% 86% 46% PCP GC GI
  43. 43. FH/EO CRC Task Group • Expertise • Energy • Enthusiastic • Collaborative • Very Productive • In Good Hands Great Fun Thanks to them Thanks to you
  44. 44. ACS Colorectal Cancer Screening Guideline for Average Risk Adults, 2018 100 Robert A. Smith, PhD American Cancer Society Fifth Annual EAO—CRC Summit New York City, May 2-3, 2019
  45. 45. I HAVE NO CONFLICTS OF INTEREST TO DECLARE 101
  46. 46. The 2018 ACS CRC guideline update relied on two reports commissioned for the 2016 USPSTF CRC recommendation update 102 The ACS also: • Examined disease burden data & trends in incidence, • Conducted supplemental literature reviews to identify:  New literature since the publication of the USPSTF systematic review  Literature on risk associated with age, gender, and racial and ethnic subgroups
  47. 47. Two CISNET Microsimulation Models (MISCAN & SimCRC) Were Used to Examine Outcomes by Age, Race/Ethnicity, and Sex Under Assumptions of Stable and Increasing Incidence 103
  48. 48. CRC Screening Guidelines for Average Risk Adults: ACS (2018); USPSTF (2016) Recommendations ACS, 2018 USPSTF, 2016 Age to start screening  Age 45y Aged 50y Choice of test  High-sensitivity stool-based test or a structural exam. Different methods can accurately detect early stage CRC and adenomatous polyps. Acceptable Test options  • FIT annually, • HSgFOBT annually • mt-sDNA every 3y • Colonoscopy every 10y • CTC every 5y • FS every 5y All positive non-colonoscopy tests should be followed up with colonoscopy. •FIT annually •HSgFOBT annually • sDNA every 1 or 3 y • Colonoscopy every 10y • CTC every 5y • FS every 5y • FS every 10y plus FIT every year Age to stop screening  Continue to 75y as long as health is good and life expectancy 10+y 76-85y individual decision making >85y discouraged from screening 76-85 y individual decision making
  49. 49. • Quality of evidence - NEW Evidence on the burden of disease by age and race - High-quality studies of test performance and effectiveness of screening - Modeling studies (Same models used by USPSTF) • Balance between desirable and undesirable effects – for each of the included screening modalities, benefits significantly exceed harms. • Values and preferences –Since there is no single test that is consistently preferred by adults in the U.S., the GDG emphasized the importance of offering choice, rather than ranking tests based solely on quality of evidence for individual tests. What Data Informed the ACS Update?
  50. 50. Trends in Colorectal Cancer Incidence Rates by Age and Sex, 1975-2014 Rising Burden of Disease in Younger Adults 0 2 4 6 8 10 12 14 Colorectalcancercasesper100,000personsaged20-49 years Year of diagnosis Aged 20-49 years Women 0 50 100 150 200 250 300 1975-76 1977-78 1979-80 1981-82 1983-84 1985-86 1987-88 1989-90 1991-92 1993-94 1995-96 1997-98 1999-00 2001-02 2003-04 2005-06 2007-08 2009-10 2011-12 2013-14 Colorectalcancercasesper100,000personsaged50+ years Year of diagnosis Aged 50+ years Men Men Source: Wolf AMD, Fontham ETH, Church TR, et al. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018; 68: 000-000 [epub ahead of print]. URL to be: https://onlinelibrary.wiley.com/doi/full/10.3322/caac.21457 Women
  51. 51. Rising Burden of Disease in Younger Adults 0 2 4 6 8 10 12 14 16 Colorectalcancercasesper100,000persons <50years Year or diagnosis Trends in Colorectal Cancer Incidence Rates in Adults Younger than Aged 50 years by Race, 1975-2014 White Black Source: Wolf AMD, Fontham ETH, Church TR, et al. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018; 68: 000-000 [epub ahead of print]. URL to be: https://onlinelibrary.wiley.com/doi/full/10.3322/caac.21457 Whites Blacks
  52. 52. Trends in CRC Incidence by Age and Year of Birth Source: Siegel RL, Fedewa SA, Anderson WF, et al. Colorectal cancer incidence patterns in the United States, 1974-2013. JNCI 2017;109;djw322. Among adults younger than 55 years, there was a 51% increase in the incidence of CRC from 1994 to 2014 and an 11% increase in mortality from 2005 to 2015.
  53. 53. Some Observations about CRC in Adults aged 45-49 109 Change in the Proportion of CRC in Adults Under Age 50, 1990 - 2015 CRC Colon Rectu m 1990 6.4% 5.8% 8.0% 2000 7.9% 6.5% 11.6% 2010 10.7% 9.2% 14.3% 2015 12.4% 11.1% 15.4% • In 2018, an estimated 16,450 new CRC cases were diagnosed in adults younger than 50 • In 2014, approximately 43% of CRC cases under age 50 were in ages 45- 49 Source: Based on ACS estimated total cases in 2018 (140,250) and the proportion of cases < 50 in SEER 9 registries during 2014 (0.117253).
  54. 54. • More noteworthy, is that the increase in the annual percentage change in the incidence rate for adults aged 40 to 49 years (1.3%) is more than twice that of adults aged 50 to 54 years (0.5%) • This suggests that the risk for the younger cohort will continue to carry forward into the group aged 50 to 54 years. Annual % Change in CRC Incidence in Adults Aged 45-49 vs. 50-54
  55. 55. Percentage of Years of Potential Life Lost Due to Death from Colorectal Cancer by Age at Diagnosis (incidence-based mortality 2010-14 with follow-up 20 years after diagnosis) 0 0.02 0.04 0.06 0.08 0.1 0.12 0.14 0.16 0.18 0.2 30-34 years 35-39 years 40-44 years 45-49 years 50-54 years 55-59 years 60-64 years 65-69 years 70-74 years 75-79 years 80-84 years 85+ years Both sexes ~ 10 % of all LYL is due to a diagnosis of CRC between ages 45-49 vs. 13% for ages 50-54
  56. 56. CRC Incidence Among U.S. Adults Aged 45 & 50 Years, SEER, 1975-2015 Age 50 Age 45 Age specific incidence is about the same for a 45 year old in 2015 as it was for a 50 year old in 1993, about 30 per 100,000 Screening effect
  57. 57. Lifetime number of colonoscopies and life-years gained (LYG) for colonoscopy screening strategies under 2 scenarios for CRC risk for White and Black Females Meester R, et al. Cancer, Published ahead of print, May 30, 2018 White Females Black Females In the increased-risk scenario, CRC risk was increased proportionally to observed trends in CRC incidence among adults younger than 40 years
  58. 58. Model-estimated Benefit CRC Screening by Starting Age 0 50 100 150 200 250 300 350 400 450 500 CSY CTC FS FIT HSgFOBT mt-sDNA Model-estimatedLYG Screening test Model-estimated Life Years Gained from CRC Screening Starting at Aged 45y vs 50y, per 1000 Screened Over a Lifetime LYG 45y-75y LYG 50y-75 y 404 Source: Wolf AMD, Fontham ETH, Church TR, et al. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018; 68: 000-000 [epub ahead of print]. URL to be: https://onlinelibrary.wiley.com/doi/full/10.3322/caac.21457 429
  59. 59. Overall, the Media Reports Were Favorable
  60. 60. The GI Literature Has Been Less Favorable
  61. 61. • CRC is a different disease in adults under 50 - We found no evidence to indicate that CRC is “different” in the 5 years from 45- 49 • Burden of disease is very small in this age group; high costs and many harms for a small benefit - The burden of disease is not very small; (1) 45 is the new 50; (2) Diagnosis between 45-49 accounts for 1 in 10 life years lost each year from CRC death • No empirical evidence; recommendations based on modeling - We applied the same models that contribute to the USPSTF recommendations; Screening beginning at age 45 is more efficient than beginning at age 50. - We also found no evidence that stool testing or structural exams perform less effectively in adults aged 45-49 than adults in their 50s. What concerns have been raised about the new guideline?
  62. 62. • Important that we concentrate further on adults 50+ - Agree, but this is an empty critique. • The new guideline will worsen existing disparities - A real possibility in some geographic areas, and settings where existing services are stressed. We must have a mission oriented approach to increase access What concerns have been raised about the new guideline?
  63. 63. • The new guideline will strain existing capacity - In some areas this is a real possibility - Further, there is a greater emphasis on high sensitivity stool testing, which will exert less pressure on colonoscopy capacity - Since most adults do not begin screening at age 50 today, it is unlikely that most will begin screening at age 45. This means starting at 45 vs. 50 still results in 3 lifetime colonoscopies. - Finally, the argument was advanced without any data on capacity What concerns have been raised about the new guideline?
  64. 64. Is there Sufficient Capacity for Additional Screening Tests for Adults Aged 45-49? • “According to the Survey of Endoscopy Capacity, an estimated 15 million colonoscopies were performed in 2012, and an additional 10.5 million colonoscopies could be performed.” This doesn’t factor in colonoscopies that represent overscreening 120Cancer 2016;122:2479-86
  65. 65. Strategies for Addressing Early Onset CRC: An NCCRT Report Jan Lowery, PhD, MPH Colorado Center for Personalized Medicine University of Colorado
  66. 66. Objectives:  Review state of science and clinical practice  Identify gaps and missed opportunities  Define what we need to know and what we need to do  Develop a strategic plan for research and practice change 2017 EAO CRC Strategy Session (December 6, 2017)  What: NCCRT convened a meeting to focus on the concerning trend of early-onset colorectal cancer.  Participants: • 30+ experts/stakeholders • Funding from ACS, Colon Cancer Challenge Foundation, National Colorectal Cancer Research Alliance, the Entertainment Industry Foundation  Purpose: Assess how NCCRT and its member organizations can align to address this issue
  67. 67. The cause of the increase in EOCRC is largely unknown 8% 8% 14% 15% 55% % Contribution to EOCRC Lynch syndrome Other hereditary CA mutations Family Hx CRC Family HX Adv. Polyp Other Usual suspects: - Smoking - Alcohol - Obesity / Y2D - Processed foods - Physical inactivity - UC/Crohn’s DX Pearlman et al, 2017; Stoffel et al 2018; Yurgelun et al 2015; Mork et al 2015
  68. 68. Has prevalence of risk factors changed over time among younger adults? • Inherited susceptibility • Physical inactivity • Alcohol – binge drinking • UC/Crohn’s DX • Smoking • Aspirin use • Obesity • T2D and pre-diabetes • CRC screening – some for ages 40-49 • Processed meat consumption Menke et al 2015; Wang et al 2018; Grucza et al 2018; Daniel et al 2011
  69. 69. What do we know about molecular pathway for EOCRC? • Pathway for hereditary causes of EOCRC is known • Pathway for sporadic CRC in younger adults is not well understood • Possibilities: o Gene-environment interactions o Epigenetics
  70. 70. New hypotheses are needed Table 2. Potential novel risk factors and new hypotheses for early-onset CRC Exposure /Risk factor Genetics Timing of Exposure Cancer Site • Gut microbiome • Antibiotic use • Birthweight • Pesticides • Food additives • Vaccines • Insulin resistance • HPV • Helicobacter-pylori • Sleep patterns • Recreational drug use • New smoking products • Decreased exposure to aspirin Lower penetrant mutations Epigenetic alterations Gene-environment interactions In-utero Early childhood Adolescence Teens Early adult Colon - Distal vs. proximal Rectum
  71. 71. What are current challenges to preventing and managing early-onset CRC? • Identification of younger adults at risk for hereditary and familial CRC is poor o nearly 20% of persons diagnosed with CRC <50 years report a family history* o ~40% of patients have family history documented in medical chart ** Some of these persons have hereditary syndromes Pearlman et al, 2017; Stoffel et al 2018; Yurgelun et al 2015; Mork et al 2015
  72. 72. Screening adherence in at risk <50 is low FDRs ≥50 Non-FDRs ≥50 FDRs 40-49 Percent Tsai et al. Prev Chronic Dis 2015;12:140533 Colonoscopy within 10 years
  73. 73. What are current challenges to preventing and managing young-onset CRC? • Adoption of universal tumor screening for Lynch syndrome is slow – ~71% of cancer centers; 36% of CoC accredited and 15% of non-CoC accredited hospitals – Analysis of National Cancer Data = 43% tumors tested • Time to diagnosis is much longer for young adults – Symptoms not recognized or misdiagnosed (rectal bleeding = hemorrhoids) – Patient and provider factors contribute to delays
  74. 74. Strategic Plan Objectives 1) accelerate research to address unanswered questions about the causes of increase in EOCRC 1) increase adoption of evidenced-based practices to identify and manage younger adults at risk for CRC and facilitate early diagnosis 1) solidify commitment from engaged partners that is essential for moving this plan into action
  75. 75.  Table 3. Objective 1: Accelerate research to address unanswered questions about early-onset CRC (EOCRC)  Priorities: What do we need to know/do?  Strategies: How can we do this?  What resources are available or needed?  Who needs to be engaged? What is cause of the rising incidence of EOCRC?  What is role of known risk factors (RF)?  What is role of novel /proposed RF?  Do RF differ by site, i.e. colon vs. rectum?  Are there vulnerable times of exposure related to risk for YOCRC?  How has prevalence of RFs changed?  What if any is the impact of changes in clinical practice on EOCRC  Is EOCRC molecularly different than CRC in older adults? If so, what does it tell us about causation?  What is role of epigenetics?  Conduct prospective case-control studies nested within existing cohort or large health system with EMR  Conduct retrospective case-control studies  Convene group of top epidemiologists to design study and write proposal Available:  Existing cohorts (CCFRC, CPS-3, ARIC-Ca, Millennium Cohort Study)  Other cohorts; Nurses’ Health Study, Physicians Study  Childhood cohorts linked with cancer registries (Natl longitudinal survey of youth, 1970 British Cohort Study, Greater Boston Otitis Media Study) Needed:  New funding  Access to EHR data from health systems  Academic partners  Integrated healthcare systems like Kaiser or VA or large hospital groups with EMRs  Center for Microbiome Research  Funding agencies: NCI, ACS What is the natural history of EOCRC?  What is the prevalence of adenomas in younger adults?  What is rate of progression from adenoma to carcinoma in younger adults?  What is the screening regimen that will optimize reduction in incidence and mortality of EOCRC?  Collect colonoscopy data from screened individuals of all ages and indications for screening  Data modeling  Review existing colonoscopy databases  Compare average age of adenoma, adv adenomas and CRC in cohort of first colonoscopy in 45-49 yo Available:  GI QuIC, the New Hampshire Colonoscopy Registry and other endoscopic databases  The German colonoscopy screening database Needed:  45-49 yo screening registry  GI groups  CISNET  Other modeling groups What are best practices for implementing current recommendations for identifying and managing EOCRC?  RCTs or pragmatic trials within clinic or healthcare systems  Learn from on-going studies Available:  Moonshot RFA  CDC Public health genomics states  Tumor registries Needed:  Common evaluation metrics  Health care systems  Providers: oncology, PCP, genetic counselors  Public health  Tumor registry What research is on-going that may answer some of these questions?  Search NCI, NIH, ACS funded grants  Survey national and international experts/groups involved in this work Available:  Search databases for NCI, NIH, ACS Needed:  Intern/fellows/staff to reach out to investigators and collate information  NCI, ACS, NCCRT  Patient advocacy groups  Insight investigators  On-going cohort investigators
  76. 76. Priorities: What do we need to know/do? Strategies: How can we do this? What is cause of the rising incidence of EOCRC?  What is role of known risk factors (RF)?  What is role of novel /proposed RF?  Do RF differ by site, i.e. colon vs. rectum?  Are there vulnerable times of exposure related to risk for YOCRC?  How has prevalence of RFs changed?  What if any is the impact of changes in clinical practice on EOCRC (e.g. medications, screening, colonoscopy use)  Is EOCRC molecularly different than CRC in older adults? If so, what does it tell us about causation?  What is role of epigenetics?  Conduct prospective case-control studies nested within existing cohort or large health system with EMR  Conduct retrospective case- control studies  Convene group of top epidemiologists to design study and write proposal
  77. 77. What resources are available or needed? Who needs to be engaged? Available:  Existing cohorts (CCFRC, CPS-3, ARIC-Ca, Millenium Cohort Study, Nurses Health Study, Physicians Study  Childhood cohorts linked with cancer registries; Natl longitudinal survey of youth, 1970 British Cohort Study, Greater Boston Otitis Media Study Needed:  New funding  Access to EHR data from healthcare systems  Academic partners  Integrated healthcare systems like Kaiser or VA or large hospital groups with EMRs and tumor registry  Center for Microbiome Research  Funding agencies: NCI, ACS
  78. 78. Table 4. Objective 2: Increase adoption of evidenced-based practices to identify and manage persons at risk for EOCRC Priorities: What do we need to know/do? Strategies: How can we do this? What resources are available or needed? Who needs to be engaged? PROVIDER LEVEL Improve provider education about:  Rising incidence of EOCRC  Signs and symptoms of EOCRC  Separate screening vs diagnostic recommendations for colonoscopy  Disseminate Family Hx and EOCRC Provider Toolkit  Develop/disseminate CMEs  Engage provider groups  Engage payers in developing quality measures  Create educational campaigns directed to providers Available:  Family Hx and EOCRC Provider Toolkit  NCCRT and ACS education resources  Existing CMEs Needed:  New messages to alert providers  Provider professional societies  PCPs and clinic staff  COPIC  Payers  NCCRT/Jackson Labs  Advocacy groups  Other guideline groups Improve screening adherence in young adults:  LS: age 25 or younger, annually  Moderate risk due to family history: age 40 or younger; every 3-5 years  Population: age 45, every 10 years  Integrate risk-based screening messages into EMR  Develop new messages to alert patients and providers Available:  Family Hx and EOCRC Provider Tool Kit  NCCRT and ACS educational resources Needed:  Evaluation of Toolkit  ACS, CDC  PCP groups  Screening Providers  Public health  Advocacy groups PATIENT LEVEL Improve population awareness of  The importance of family history as a risk factor for CRC  The recommendations for earlier screening based on family history of CRC or advanced adenomas  The risk and symptoms of EOCRC  Media campaigns  Social media  New apps for phone/tablets Available:  Existing campaigns Needed:  New messages with marketing plan  Public Health  Patient advocacy groups; Fight CRC, Colon Cancer Alliance; Colon CA Challenge Foundation Improve uptake on referrals for risk assessment  Utilize patient navigators  Remove barriers: insurance, discrimination, cost, fear  Expand use of tele-counseling services Available:  Tele-counseling services  Counseling via laboratories Needed:  Streamlined referral systems  Better communication between providers, patients, counselors  Coordinated care for high risk  Genetic counselors  Physicians  Healthcare systems  Payers
  79. 79. SYSTEMS LEVEL Improve collection and use of family history (CRC and polyps) in primary care in younger adults to inform screening and referral for risk assessment  Enhance EMRs; collect fam hx of CRC and adenomas and integrate provider alerts  Integrate risk assessment tools into practice  Promote use of patient portals  Develop clinical guidelines and quality measures for workup of common symptoms for EOCRC Available:  Jackson Labs, NCCRT, CMEs  EMR vendors willing to collaborate  Needed:  Easy-to-use, validated risk assessment tools  Primary care providers and professional organizations  EMR vendors  NCCRT  ACS-CAN WG on EMR and family history Increase adoption of universal tumor testing for LS and cascade screening  Educate health systems  Include in COC accreditation Available  EGAPP recommendations  Implementation guides Needed:  New incentives to adopt ULS  Institutional commitment  Health care systems  Pathology departments  COC  Cancer centers  ACS, CDC PH Genomics
  80. 80. Table 5. Objective 3: Solidify commitment from engaged and new partners to move plan into action Priorities: What do we need to know/do? Strategies: How can we do this? What resources are available or needed? Who needs to be engaged? Provide forum for on-going discussion of issues related to EOCRC  Support annual Summit of key stakeholders  Support advocacy group efforts to address EOCRC Available:  NCCRT infrastructure and staff  Advocacy groups and staff Needed:  Coordination and communication  Goodwill NCCRT, ACS Advocacy groups Publish a collaborative paper or white paper with NCI, ACS, CDC with unified statement  Get support from entire group  Recruit writing committee Available:  NCCRT member expertise  Links with NCI, ACS, and CDC Needed:  Resources, enthusiasm, leadership NCI, ACS, CDC Lead author(s) NCCRT content experts  Engage healthcare systems in setting national research agenda around EOCRC  Identify champions within several systems  Promote implementation research; identify specific opportunities Available:  Outline of research priorities (from Plan) Needed:  Implementation Scientists  Leadership/commitment from healthcare systems Healthcare systems leadership Experts in EOCRC research Implementation scientists Convene the leadership of professional societies (internal medicine, family practice, GI, GYN, general surgery, etc.) to formulate strategies to work on the problem. Facilitate national meeting of key stakeholders Identify champions to move work forward Available:  Society membership charters and rosters Needed:  Interest, enthusiasm, champions Professional societies NCCRT Experts in quality metrics Payers
  81. 81. Who needs to be engaged? All of Us • Providers’ professional organizations • PCPs and specialty providers • Genetic counselors • Clinical teams • Healthcare systems • Academia • Insurers • Funders • Public health • EMR vendors • Commission on Cancer • Cancer Registries; NAACCR • Cancer Centers • NCCRT, ACS, CDC, Public Health Genomics Programs • Patient advocacy groups: Fight CRC, Colon Cancer Alliance, Colon Cancer Challenge Foundation
  82. 82. Short Term Action Items • Research o Conduct landscape of on-going research o Convene group of investigators to identify key study components; study design; data sources and funding • Adoption of evidenced-based practices o Promote adoption of new ACS guidelines (@45) o Disseminate and evaluate tool kit from Jackson Labs o Create new messages for providers and patients to emphasize reality of CRC in young adults and recent increase o Identify champions within professional orgs
  83. 83. Short Term Action Items • Partner Engagement o Publish and disseminate paper o Use plan to encourage engagement and commitment from diverse partners o Support on-going efforts of advocacy groups Keep the dialogue going!
  84. 84. Advanced Polyp Prevalence Among First Degree Relatives of Early Onset Colorectal Cancer Patients Christine Molmenti, PhD, MPH Assistant Professor Feinstein Institute for Medical Research Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Department of Occupational Medicine, Epidemiology, and Prevention Center for Health Innovations and Outcomes Research Northwell Health May 2, 2019
  85. 85. Adenoma to carcinoma sequence Fearon and Vogelstein, Cell, 61, 759-767, 1990 Terzic et al, Gastroenterology 138(6), 2101-2114 2010 Normal Epithelium Metastatic Cancer Dysplastic lesion Early Adenoma Late Adenoma Cancer Cytokines, DNA repair genes, K-ras, P53, COX-2 overexpression
  86. 86. 142 31 years old Stage IV Colorectal Cancer Survivor (left)
  87. 87.  Colorectal Polyps Serrated lesions o Hyperplastic polyps (frequent, benign) o Sessile serrated polyps (<10%) o Traditional serrated adenoma (rare) Conventional adenomas o 30-40% of the population will develop an adenoma by age 60 o 20%-50% of adenomas recur within 3-5 years o Histological characteristics  Dysplasia (high / low grade)  Villousity (tublar, tubulovillous, villous)  Size, Number, Histology Rex DK et al, Am J Gastroenterol 2017; 112:1016–1030
  88. 88. Advanced polyps 1. Tubular adenomas ≥1 cm in size, or any adenoma with villous elements or with high grade dysplasia 2. Sessile serrated polyps ≥1 cm in size, or any serrated lesion with cytologic dysplasia 3. Traditional sessile adenomas, regardless of size *Many of the risk factors of advanced adenomas are the same as the risk factors for colorectal cancer **Risk factor less well-defined, however increasing age, being female, smoking, obesity, diabetes, and possibly diets high in fat, cho, and calories appear to be important.
  89. 89. SURVEILLANCE GUIDELINES FOR PATIENTS WITH COLORECTAL POLYPS Finding on colonoscopy Colonoscopy Interval Normal findings Small (<10mm) hyperplastic polyps in rectum or sigmoid 10 years 10 years 1-2 nonadvanced polyps 5-10 years 3 -10 nonadvanced adenomas >10 nonadvanced adenomas 3 years <3 years Any advanced polyp 3 years
  90. 90. Increased CRC risk among relatives of patients with advanced polyps  FDRs of patients with ≥1 advanced polyp carry:  4-6-fold increased risk of being diagnosed with an advanced polyp  2-4 fold increased risk of developing CRC Regardless of the age at diagnosis of the affected relatives. FDR = First Degree Relative (Parent, Sibling, Child)
  91. 91. FDR Guidelines 1. United States Multi- Society Task Force (USMSTF) Advanced adenoma in 2 FDRs (any age) or AA in 1 FDR < 60 y Colonoscopy every 5 years beginning 10 years before the age at diagnosis or age 40 y, whichever is earlier. Advanced adenoma in 1 FDR at age ≥60 y Begin screening at 40. Options for screening are the same as those for average-risk persons. 2. National Comprehensive Cancer Network (NCCN) Advanced adenoma(s) in an FDR regardless of age Colonoscopy beginning at age 40 y or at age of onset of adenoma in relative, whichever is first
  92. 92. Objectives 1. Remind providers patients with advanced polyps - patients and family members are at increased risk for CRC and advanced polyps 2. Keep providers update with current guidelines 3. Provide template letters to communicate colonoscopy and pathology results, risk status and follow up recommendations
  93. 93. SECTION 1 If your patient is diagnosed with an advanced colorectal polyp, both the patient and their family members are at increased risk for colorectal cancer and advanced colorectal polyps. SECTION 2 Finding advanced polyps has implications for both the patient and their first degree relatives. SECTION 3 Develop and use a simple letter to communicate reliable information regarding advanced polyps to patients and through them to their FDRs
  94. 94. Adaptable Educational Sharable GI Brief (Template) Letters
  95. 95. Knowledge gap  What percentage of young onset colorectal cancer is due to family history of advanced polyps?
  96. 96. Dennis Ahnen, MD Advisor
  97. 97. Priority area in young onset research Understand advanced polyp prevalence among young CRC is a priority area and a critical step in decreasing incidence and mortality of young CRC Innovation: • Determine the contribution of component of familial risk that has not been measured • The first study (to our knowledge) to investigate the prevalence of advanced polyps among a cohort of pathologically confirmed young onset CRC patients 154
  98. 98. • Patients enrolled Ohio Colorectal Cancer Prevention Initiative (OCCPI) – PI. Hampel • Recruited between 2013 and 2016  Diagnosed with a primary invasive colorectal adenocarcinoma (all stages) <50 years of age  492 did not have a cancer susceptibility gene or family history of colorectal cancer Unique cohort of young onset cases N=492
  99. 99. Research Question What percentage of young onset CRC is due to family history of advanced polyps? n=492 Young onset CRC 56% Sporadic 16% Hereditary 14% Family history CRC ≥14%?? Family History of AP
  100. 100. Young onset CRC 50% Sporadic 16% Hereditary 14% Family history CRC 20% Family History of AP Research Question What percentage of young onset CRC is due to family history of advanced polyps? n=492
  101. 101. 56% Sporadic 14% Family history of CRC XX% Family History of AA 40% Sporadic 16% Hereditary 14% Family history CRC 30% Family History of AP Research Question What percentage of young onset CRC is due to family history of advanced polyps? n=492
  102. 102. Step 1. Contact probands (OSU) (or next of kin) and collect FDR contact Step 2. Contact FDRs to obtain colonoscopy facility information N=~200 Step 3. • Medical release forms • Obtain medical records • Record colorectal polyp findings FDR FDR FDR FDR Proband (YOCRC case) Feasibility Study (n=50) Study design
  103. 103. Step 1. Contact EOCRC probands (random selection) Eligibility • <50 years of age (N=492) • No known CRC susceptibility gene • No known FDR with CRC • Considered “sporadic” cases Recruitment methods • Email and/or mailed letter • Follow up phone call Data collection • Collect FDR contact information Step 2. Contact FDRs Eligibility • > 18 years of age • Colonoscopy prior to EOCRC diagnosis Recruitment methods • Email and/or mailed letter • Follow up phone call Data collection • Collect colonoscopy location/physician name to obtain records Step 3. Collect and verify colonoscopy records Eligibility • Colonoscopy records performed prior to EOCRC diagnosis will be collected Recruitment methods • Send signed medical release forms to endoscopy practice • Follow up with phone call Data collection • Verified advanced adenoma cases Feasibility Study (n=50) Study design OSU NORTHWELL/FEINSTEIN NORTHWELL CRC SURGERY/GI
  104. 104. Feasibility outcomes Primary 1. Recruitment rate of probands: The number enrolled (numerator) divided by the number of probands approached for the study (denominator) 2. Recruitment rate of FDRs: The number of FDRs enrolled in the study (numerator) divided by the number of FDRs approached for the study (denominator) 3. Rate of medical record verification: The number of colonoscopy records ascertained (numerator) divided by the number of endoscopy clinics provided by the FDRs (denominator) Secondary 1. Average length of time to obtain EMR records 2. Accuracy of self-reported colonoscopy results 3. Reasons probands and FDRs refuse participation
  105. 105. Feinstein Institute for Medical Research and The Ohio State University Study Collaboration
  106. 106. Samantha Schneider Research Associate Grants Manager sschneide5@northwell.edu
  107. 107. Action Plan If recruitment of 50 probands is feasible, conduct full study among 185 probands Conduct investigation into optimal communication methods between provider, patient, and relatives Disseminate NCCRT GI Brief  Suggestions for dissemination channels are encouraged
  108. 108. Summary • Diagnosis of advanced colorectal polyps have implications for patients and their first degree relatives (FDRs). • Prevalence of advanced colorectal polyps in FDRs of young onset colorectal cancer patients is under investigation. • NCCRT GI Brief provides an information resource for GIs and Primary Care to improve risk communication and screening/surveillance among patients and their relatives.
  109. 109. Acknowledgements Dave Alberts Anne Carlson Cindy Borassi Dorado Brooks Maurice Cerulli Heather Hampel Caleb Levell Beth McFarland Caitlin Murphy Electra Paskett Swati Patel Susan Peterson Martha Raymond Robert Smith Tom Weber Robert Wildin Andrea Zimmern Co-Chair: Jordan Karlitz Secretary: Jennifer Kolb Advisors: Dennis Ahnen, Paul Schroy Samantha Schneider Vincenza Caruso Gina Arena Gloria Ho Francine Smith

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