The Crohn’s and Colitis Foundation of
America Patient Powered Research
Network Kick-off Meeting
Michael D. Kappelman
University of North Carolina
February 3, 2014
Objectives
• Celebrate the success of our proposal!
• Get to know one another
• Review and refine scope of our project
– Leave with a shared vision
• Understand the role that each collaborator/team will play
in the development of our network
• Understand how our network fits to PCORI’s larger
National Patient-Centered Clinical Research Network
Program
An Amazing Team!
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CCFA
CCFA Partners
Crohnology
Patients Know Best
Validic
Data architecture and integration team
UNC Qualitative Research and Intervention Core
Industry stakeholder
PCORI
Most importantly, our patients!
CCFA
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Balfour Sartor
Tania Kamphaus
Project management staff (Amanda Singer/Douglas)
Other CCFA staff in attendance:
– Marie Granieri
– Marjorie Merrick
• CCFA consultants
– Kelly Myers
– Seth Myers
• Jennifer Feikin
CCFA Partners
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Bob Sandler
Myself
Millie Long
Chris Martin
Wenli Chen
Lucy Goble
Beth Jaeger
Tom Caruso
Crohnology
• Sean Ahrens
Patients Know Best
• Mohammad Al-Ubaydli
• Emily Zhao
Validic
• Ryan Beckland
• Brent Fagg
Data architecture and integration
• Kristen Anton
• Dan Crichton
UNC Qualitative Research and Intervention
Team
• Maihan Vu
• Darren DeWalt
Industry Stakeholder
• Suzanne Cook
PCORI staff
• Sarah Daugherty
• Jaye Bea Smalley
Patient Governance and Engagement
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Sue Johnson
Andy Garb
Nick Uzl
Jessica Burris
Brian Price
Ambitious Goals
Radically transform the CCFA Partners Internet Cohort!
1) Enhance network growth, diversity, and retention;
2) Build a robust network community, including patient governance
structures that allow greater involvement of patients in research
3) Expand network data to include electronic health records, data
from mHealth apps and devices, and biological samples
4) Develop a customized, yet scalable and adaptable, distributed
data network (i.e. virtual database) by repurposing NASA
technology
5) Develop and test patient and provider-focused tools that utilize
individual patient data to improve health behaviors, healthcare
decisions, and, ultimately, outcomes
6) Further engage the scientific community through open
collaboration and data sharing
7) Rapidly disseminate new knowledge to patients, enabling them
to improve their health
Logistics for Today
• Brief presentations from each of our network
partners/teams
– Skills, technology, assets, role in the project
• Presentations meant to facilitate conversation!
– Please react, respond, ask questions, make
suggestions, brainstorm
– I’m more concerned with having productive
discussion than staying on schedule
• Breaks, bathrooms, lunch
• Breakout sessions
• Some may need to leave early for flights
– Cars at Carolina Inn
– Be in car 90 minutes before flight
CCFA Introductions
High level project goals
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Integrate communities
Expand capacity
Grow membership
Become part the U.S. National Patient Centered
Research Infrastructure
High level project goals
• Integrate communities
– Membership
– Data
– Functionality
• Expand capacity
• Grow membership
• Become part the U.S. National Patient Centered
Research Infrastructure
Integration of communities
• “Whole is greater than the sum of its parts”
• Today CCFA Partners and Crohnology are quite distinct
– Comprised of largely different populations
• Survey of 2,000 CCFA Partners participants estimated that only
2% were Crohnology members
– Serve different functions
• CCFA Partners: primarily a research network; patient support,
engagement and education secondary focus
• Crohnology: Greater focus on community (interactive, facilitates
sharing) and patient self-management/tracking (tools, etc.);
secondary focus on research
– Collect different types of data
• CCFA Partners: Detailed (but infrequent) surveys to collect
research data (i.e. validated instruments)
• Crohnology: More frequent, less detailed data; focus is more
practical
Integration
• Therefore, integration will:
– Grow membership
– Enhance data assets
– Improve user experience
– Add value for both networks
– With incremental costs
• Details of this are beyond the scope of today’s meeting!
Integration
• Therefore, integration will:
– Grow membership
– Enhance data assets
– Improve user experience
– Add value for both networks
– With incremental costs
• Details of this are beyond the scope of today’s meeting!
– Technical
– Practical
– Legal
– IP
High level project goals
• Integrate communities
• Expand capacity
– New types of data
– New functionality/tools
– Enhanced patient engagement and governance
• Grow membership
• Become part the U.S. National Patient Centered
Research Infrastructure
New types of data
• mHealth apps and devices
• personal health records (PHRs)
• biosamples
mHealth apps and devices
• Quantified Self: a movement to incorporate technology
into data acquisition on aspects of a person's daily life in
terms of inputs (e.g. food consumed, quality of
surrounding air), states (e.g. mood, arousal, blood
oxygen levels), and performance (mental and physical).
Such self-monitoring and self-sensing combines
wearable sensors (EEG, ECG, video, etc.) and wearable
computing
– Wikipedia
mHealth apps and devices
• Hundreds of products for use in general population
– Activity monitors, sleep monitors, temp/HR monitors,
diet trackers, etc.
• IBD specific apps as well
– Crohnology
– CCFA GI Buddy
• A treasure chest of data for learning!
Personal Health Records
• Stay Tuned!
Biosamples
• Saliva, blood, stool, etc.
• Combined with patient-reported data and medical
records can facilitate studies of:
– Prognosis and risk stratification
– Effects of environment/lifestyle factors
– Response to treatment (med, surgery, diet)
– Side effects of treatment
• How will we obtain biosamples:
– New sample collection: recruiting from our engaged
patient network
– Using existing samples: linking with other studies
New Patient-inspired functionality
• Data as a two way street
• Moving beyond the conventional research study:
New Patient-inspired functionality
• Use data to motivate, engage, and empower our network
participants
– Design a dashboard where patients can
view/understand current health status
– Compare with others
– View trends over time and observe correlations
– Communicate better with their HCPs
– Predict future outcomes based on today’s behaviors
Enhancing Patient Governance and
Engagement
• Stay tuned
High level project goals
• Integrate communities
• Expand capacity
• Grow membership
– 6 Key strategies
• Become part the U.S. National Patient Centered
Research Infrastructure
Membership growth
• Make membership irresistible!
• Engage physicians and other HCPs
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– CCFA Clinical Research Alliance as a place to start
Partnering with other IBD cohorts
Collaboration with PCORnet
– Stay tuned
Search Engine Optimization
Qualitative research to learn more about potential
barriers/solutions
High level project goals
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Integrate communities
Expand capacity
Grow membership
Become part the U.S. National Patient Centered
Research Infrastructure
– PCORnet
• 17 other PPRNs
• 11 CDRNs
PCORnet
The most disruptive change of all
• Has nothing to do with technology!
The most disruptive change of all
• Has nothing to do with technology!
• And everything to do with patients!
Its not clinical research anymore!
• In clinical research, patients are subjects in studies
planned by clinicians/scientists, intended to answer
questions of paramount importance to the clinical or
research community
– How the CCFA, NIH, have traditionally operated
– How myself, and others in this room have previously
conceptualized research
– Involves patients, may even involve patient reported
outcomes. . .
– “Patient scented” versus “Patient Centered”
Patient-Centered Outcomes Research
Helps people and their caregivers communicate and make
informed healthcare decisions, allowing their voices to be
heard in assessing the value of healthcare options. This
research answers patient-centered questions such as:
•“Given my personal characteristics, conditions and
preferences, what should I expect will happen to me?”
•“What are my options and what are the potential benefits
and harms of those options?”
•“What can I do to improve the outcomes that are most
important to me?”
• “How can clinicians and the care delivery systems they
work in help me make the best decisions about my health
and healthcare?”
Patient Powered Research Networks
“Comprised of patients and/or caregivers who are
motivated to build an ideal network and play an active role
in patient-centered comparative effectiveness research”
“Control of the research process is held by the patients.
The active involvement of patients . . . ensures a central
role for patient participation in governing the network and
its uses, identifying and selecting research questions to be
studied, identifying and recruiting patients to participate in
the research, and in conducting the research itself”
3 Levels of Patient Governance
• Scientific leadership
• Patient leadership
• Community responsiveness
Scientific Leadership
• Dr. Balfour Sartor (Network PI)
– Adult gastroenterologist and microbiome expert
– Chief Medical Advisor to the CCFA
– Diagnosed with Crohn’s disease at age 21 (~40 years ago)
• Sean Ahrens
– Founder of Crohnology
– Computer programmer
– Diagnosed with Crohn’s disease during childhood
• Both will serve on the network executive committee
– Dual perspectives critical to informing policies related to
data sharing and return of research findings
• Should patients be informed of genetic results?
• Might there be unintended consequences?
Patient Governance Committee (PGC)
• Key responsibilities:
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1) Define network’s mission,
2) Assist in prioritizing patient-driven research agenda
3) Assist in the review of proposed network studies/partners
4) Develop policies regarding use and sharing of data
5) Assist in developing plans to facilitate communications
among network participants
– 6) Receive and act upon input from broader network
community
• PGC will report directly to the Executive committee
– 2 members of the PGC will hold seats on the Executive
Committee (total of 4 patients)
– PGC must independently approve all substantial changes in
the direction of the network
PGC Member Selection and Training
• 5 lay patients
– 2 with prior experience serving on CCFA grant review
committees
– Former Chair of the CCFA National Council of College
Leaders program
– 2 selected by popular election by Crohnology
community
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Information about the PPRN posted on Crohnology
Self-nominations were invited.
Candidates posted description of interests and qualifications
On-line election
– All will complete CCFA stakeholder training course
Crowdsourcing to broaden responsiveness
• Draft policies to be posted online
• All network members will be able to comment, suggest
changes, or contribute more substantially through the
use of “wiki-style” editing.
• The PGC will incorporate member feedback into the final
version of all policies.
Communication and dissemination of
research findings
• Network updates will be posted on discussion pages
(also distributed by emails)
– Member comments and “hearts” will be periodically
reviewed by the PGC and the network’s scientific
leadership
• Research findings will be communicated using lay
summaries and infographics
Infographics
Infographics
• In 4 weeks:
– 528 shares/views
– 116 likes
– 67 comments
• 92% indicated that the
infographic “effectively
summarized the research
findings”
Identifying and Prioritizing Research
• Crowd sourcing
• Approach Crohnology already uses to prioritize new
feature development
• Pre-work
– Candidate research topics collected from PGC, review of
>2,000 questions posted on Crohnology, input from PPRN
scientific team, and review of CCFA research priorities
– Online voting through “User Voices” functionality of
Crohnology
Results
PGC Introductions