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HERON, Frontiers, and Pioneers: Database and Recruitment Resources to Advance Your Research. Russ Waitman, PhD Associate Professor, Department of Internal Medicine Associate Vice Chancellor for Enterprise Analytics Director of Medical Informatics . Jeffrey M. Burns, MD, MS

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heron frontiers and pioneers database and recruitment resources to advance your research

HERON, Frontiers, and Pioneers: Database and Recruitment Resources to Advance Your Research

Russ Waitman, PhD

Associate Professor, Department of Internal Medicine

Associate Vice Chancellor for Enterprise Analytics

Director of Medical Informatics

Jeffrey M. Burns, MD, MS

Edward H. HashingerProfessor of Neurology

Director, Clinical and Translational Science Unit

Associate Director, KU Alzheimer’s Disease Center

Patricia Kluding, PT PhD

Associate Professor, Dept of Physical Therap & Rehab Sciences

Director, Georgia Holland Health Exercise and Aging Lab

Associate Director, Clinical and Translational Science Unit

what is the ctsu
What is the CTSU?
  • Supports research activity
      • NIH-Funded
        • A program of Frontiers: Heartland Institute of Clinical and Translational Research
    • Physical Infrastructure
      • Clinic rooms
      • Infusion center
      • Exercise physiology
      • Sleep lab and beds for extended stays
      • Metabolic kitchen
    • Nursing
    • Coordinators
    • Recruitment Program
      • Registry
      • Pioneers Community Registry
    • CTSU Satellite / CTSU Without Walls program
ku clinical research center
KU Clinical Research Center


clinical space
Clinical Space

Clinical Area

  • 9exam rooms for multi-purpose outpatient research evaluations
  • 2 cognitive testing rooms
  • 2 Isolation exam rooms, designed for smoking cessation or ID studies
  • Workspace for up to 8 study coordinators

Infusion Center

  • 11 infusion suites for drug administration and pharmacokinetic studies
  • Investigational pharmacy
extended observation unit sleep lab
Extended Observation Unit / Sleep Lab
  • Extended Observation Unit (EOU) to allow evening stays
  • 3 hospital-style suites
  • Study drug administration, observation & PK lab draws
  • Sleep Program opened in October 2012 (Suzanne Stevens)
exercise physiology laboratory
Exercise Physiology Laboratory
  • Exercise Physiologist, ACSM Certified
  • Two Parvo Medics Metabolic Carts
    • Maximal Graded Exercise Testing with Medical Monitoring
  • Multiple Modalities and Protocols
    • Treadmill
    • Cycle
    • Recumbent Stepper
    • Upper Body Ergometer

Metabolic and Demonstration Kitchens

  • Assessment of dietary intake
      • Direct or digital photograph observation
      • 24-hour recalls
      • Food records
      • Food frequency questionnaires
      • Screeners
  • Nutrition interventions
      • Recipe Development and Testing
      • Research diets / Controlled feeding protocols
      • Standardized meals
ctsu satellite space
CTSU Satellite Space
  • Meet basic needs of investigators on campus
  • Rooms and basic supplies
    • Delp – shared space with Dr. Moriarty, overflow room.
    • Hoglund Brain Imaging Center
    • Swope Health Services

Research Coordinator Pool Service

  • % FTE or $60 per hour
  • Coordinator may provide services including
    • Regulatory processing for the trial
    • Coordinating and conducting study visits
    • Performing study-required procedures
    • Documentation
    • Assisting with monitor visits
    • Many other tasks and duties
participant recruitment
Participant Recruitment
  • Frontiers Registry
  • Pioneers program
research participant registry program
Research Participant Registry Program
  • Comprehensive registry of KUMC patients willing to be contacted for participation in research studies
  • 4 clinics started in 2009, now active 17 clinics
  • 15,000+ enrolled in registry by September 2012
    • 17 researchers have received participant information for 25 protocols (7 PhDs, 8 MDs, 1 PharmD and 1 MSPT)
    • 148 participants identified from the registry have been enrolled in protocols
summary of ctsu
Summary of CTSU
  • The purpose of the CTSU is to support research by providing
    • Space
    • Nursing / coordinators
    • Access to important resources
      • Exercise physiology
      • Overnight stay and sleep lab capabilities
      • Metabolic kitchen
    • Recruitment tools
      • Frontiers Registry, Pioneers Program
kumc biomedical informatics resources for your research a focus on heron
KUMC Biomedical Informatics Resources for your Research: a focus on HERON

This project is supported in part by NIH grant UL1TR000001 and NSF Award CNS-1258315



  • “Hooking” People on Informatics
  • How We Work: the technology and the team
  • What’s on the Horizon
    • Enhanced Registry Integration and data delivery with REDCap
    • Collaboration via CTSAs and PCORI opportunity to generalize your research findings

Biomedical Informatics Can Help Your Research

  • We have tools and expertise to manage data and convert it into information
  • REDCap and CRIS – enter and manage data
  • HERON – fish for data from the hospital/clinic
  • Biweekly Frontiers Clinical Informatics Clinics
    • Tuesday 4-5 pm in 1028 Dykes Library.
    • Next session September 17, 2013.

You’re that fisherman: wanting to land data to answer your research hypothesis

Bennett Spring Trout Park, Lebanon Missouri



Second Goal: If you need help fishing, get a guide

Photo Credit: HuntFishGuide.com



Prepare and Analyze Data

Photo Credit: S. Klathill



Our shared goal: a tasty publication

Photo Credit: Steve Velo



Nightmare: looks like a nice river, but can’t catch fish

  • I’ll just enter everything in Excel….
  • What if I lose or accidentally sort my spreadsheet?
  • How to I let students only review de-identified data?
  • Hospital/Clinic is making me use this Electronic Medical Record and I get nothing in return...

Little White Salmon River, Washington State, last Summer in July


Sometimes, You’re willing to enter data/buy fish: REDCap: ResearchElectronicDataCapture

  • https://redcap.kumc.edu
    • It uses the same username and password as your KUMC email.
    • Non-KUMC researchers can request an affiliate account through Frontiers CTSA office
    • Check out the training materials under videos
  • Case Report Forms
    • (see left) registries, trials
  • Conduct Surveys
    • Similar to “SurveyMonkey”

REDCap: think Fish Tank you manage



I want to go fishing, not fill a fish tank (REDCap)

Use HERON: a managed fishery

Bonneville Hatchery: Trout, Salmon, Sturgeon, Columbia River, Oregon


Central CTSA Informatics Aim: Create a data “fishing” platform: HERON, https://heron.kumc.edu

  • Get a License: Develop business agreements, policies, data use agreements and oversight.
  • Get a Fishing Rod and Bass Boat: Implement open source NIH funded (i.e. i2b2 https://www.i2b2.org/) initiatives for accessing data.
  • Know what your catching: Transform data into information using the NLM UMLS Metathesaurus as our vocabulary source.
  • Stock Different Tasty Fish: link clinical data sources to enhance their research utility.

HERON: Getting a Fishing License

Single sign-on using your email username

Real-time check for current human subjects training

  • Fill out System Access Agreements to sponsor students/staff
  • Fill out Data Use Agreement to request data export
  • No Limit!!! IRB Protocol Not Required to view or pull de-identified data
  • Must be on campus or use VPN or https://access.kumed.com
  • Check http://frontiersresearch.org/frontiers/HERON-Introduction for more information, status, and training videos

The i2b2 “Fishing Rod”: build Diabetes cohort

Types of “fish” in folders

Drag concepts from upper left

into panels on the right


i2b2 : ANDin Frontiers Research Registry

Dragging over the second condition


i2b2: ANDa high Hemoglobin A1C

When you add a numeric concept,

i2b2 asks if you want to set a constraint


i2b2 Result: 497patients in Cohort

Run the Query

Query took 4 seconds

497 patient in cohort


The dream: landing the big one

Catch the data





“Signals” of Health: Think of each source electronic system as an EKG, blood pressure cuff, arterial line

Hypothesis #2: Computer + Clinical Process-> Better Health?

Hypothesis #1:

Admin + Clinical

-> Better Knowledge?


How the Team Works: HERON Evolves Every Month

  • Goal: stable monthly process, minimal downtime
    • Complete rebuild of the repository, not HL7 messaging update based.
    • Two databases: create new DB while old DB is in use.
    • When the new DB is ready, switch over i2b2 to serve customers fresh data.
  • Initial Files from Clinical Organizations
    • Export KUH Epic Clarity relational database instead of Cache/MUMPS.
    • Monthly file from clinic billing system (GE IDX).
      • Demographics, services, diagnoses, procedures, and Frontiers research participant flag.
    • UHC CDB hospital quality , Tumor Registry, Biospecimens
  • Extract Transform Load (ELT) processes largely SQL (Oracle)
    • Wrapped in python scripts.
  • Goals for a monthly release (21 months in a row so far):
    • Fresh data. Example: another month of visits = millions of facts
    • New types of data. Example: microbiology
    • New functionality: Example: link data by encounter across clinical and financial sources; distinguish medication administration from prescription

Monthly Release

  • Blog highlights:
  • Features
  • Size
  • Dates of sources

https://informatics.kumc.edu/work/blog - world view

https://bmi-work.kumc.edu/work/blog - internal KUMC view: latest breaking developments


HERON’s Data Sources, Types of Data


- contains current plan for next several monthly releases


“Who’s Using HERON” and collaboration approaches

  • Find a colleague
  • Talk with hospital, clinic to understand workflow
  • Attend bi-weekly clinics
  • Watch the videos:


  • Request a consult http://frontiersresearch.org/frontiers/biomedical-informatics

If you don’t see what you want, or you really like things, let us know:



HERON De-identification: Remove HIPAA 18 identifiers -> non human subjects research

  • HIPAA Safe Harbor De-identification
    • Remove 18 identifiers and randomly date shifting by up to 365 days back in time
      • Downside: can’t do seasonal studies without IRB approval to go back and get actual dates
      • In general, tack on 7 months when wanting volume for the last year.
    • Resulting in non-human subjects research data but treated as a limited data set from a system access perspective. System users and data recipients agree to treat as a limited data set (acknowledging re-identification risk)
  • To be addressed:
    • For now, we won’t add free text such as progress notes with text scrubbers (DeID, MITRE Identification Scrubber toolkit)
  • Date Shift example:
    • Patient was bornAugust 13, 1968, had their blood pressure measured on November 28, 2012.
    • Each month dates shifted, ex: to -15 for January release: Newbirthday is July 29, 1968 and the blood pressure measurement occurred on November 13, 2012.
      • For another patient, their offset might be -278. Next month the Aug 13th patient’s offset might be -192.

Repurposing i2b2 Clinical Research Infrastructure for Inpatient Quality Improvement

  • i2b2 “largely” ambulatory or population/genomics focused
  • Is i2b2 version 1.6 with same financial encounter and modifiers now useful for inpatient research?
  • Goal: understand medication

timing and antibiotic selection

  • Suspect vancomycin preferred
  • Validate HERON medications
    • Especially administration timing

Aligning Clinical Research Informatics for Quality: Registry Abstraction and Data Delivery

  • REDCap registries into i2b2 allows intuitive exploration
    • Researchers may need less abstraction as data is extracted from the EMR.
  • i2b2 into REDCap: inherit security model, graphical/export tools

Next Steps: A Learning Healthcare System

  • Evidence Generation: Trials post Electronic Health Records (EHR)
    • Learning Healthcare System Institute of Medicine Reports: 2006 onward.
    • 2011 Report: Digital Infrastructure for the Learning Health System: The Foundation for Continuous Improvement in Health and Health Care
      • “Information Technology (IT) serves as the functional engine for the continuous learning system”
  • Effective Biomedical Research Organizations will integrate Medical Informatics and Clinical Research Informatics capabilities with Operational Clinical Systems of the Healthcare Systems
    • EHR Standardization and collection of data becomes critical to the cost effective research capacity of the University.
    • EHRs (Cerner/Epic), clinical research systems like (REDCap/Oncore/Velos), and ultimately translational bioinformatics systems will need to be managed holistically as opposed to siloed.

Patient-Centered Outcomes Research Institute

Clinical Data Research Network Announcement

Scientific Advisory Board


Steering Committee

  • April 23, 2013
  • Two types of component networks: systems-generated and patient driven networks
  • Active involvement of health care systems, of clinicians and of patients
  • A commitment to establishing inter-operability and data sharing across networks and ready collaboration with the larger research community

Special Expert Group



















  • Selby JV, Krumholz HM, Kuntz RE, Collins FS. Network news: powering clinical research.
  • SciTransl Med. 2013 Apr 24;5(182):182fs13. doi: 10.1126/scitranslmed.3006298. Epub 2013 Apr 23.

What Do They Want the Network to Do?




  • Rich clinical data from electronic health records and other data sources stored in standardized, interoperable formats.
  • Capacity to conduct both observational studies and randomized trials embedded in clinical settings
  • Rigorous practices for data security and confidentiality
  • Appropriate IRB and human subjects oversight
  • Utility for CER, safety studies, surveillance, etiologic research, and potentially for pre-approval trials
  • > 1,000,000 patients enrolled
  • Data standardized within network and with other awardee networks
  • Patients, system, and clinicians engaged in governance & use
  • Capable of implementing clinical trials
  • At least two health care systems engaged
  • Willingness and capacity to work toward data standardization with other awardees
  • Willingness to participate in collaborative studies with data sharing as part of a national research infrastructure

Joe V. Selby, MD, MPH, Executive Director ONC HITCP June 5, 2013


The “Greater Plains Collaborative”

Letter of Intent Submitted Tuesday

  • KS, the University of Kansas Medical Center (KUMC)
  • MO, Children’s Mercy Hospital
  • IA, University of Iowa Healthcare
  • WI, the University of Wisconsin-Madison, the Medical College of Wisconsin, and Marshfield Clinic
  • MN, the University of Minnesota Medical Center
  • NE, the University of Nebraska Medical Center
  • TX, the University of Texas Health Sciences Center at San Antonio and the University of Texas Southwestern Medical Center.
  • Will learn in July if we can apply in September, award in December
    • $7 million total costs over 18 months
pioneers development
Pioneers Development
  • Frontiers / CTSU team
    • Communications
    • Frontiers Registry
  • Bioinformatics team
    • REDcap survey
    • HERON search
    • Active studies list
  • Information technology
  • Website development
  • Regulatory / legal
  • Ethics
  • Community Partnership for Health
    • POW! paPOW! papaPOW!
  • Outreach plan for public and researchers
    • KU entities
    • All Frontiers organizations
become a pioneer
Become a Pioneer!
  • Potential research participants = Entire community
    • KUH patients
    • Non-KUH patients
    • Healthy individuals
  • Online enrollment & informed consent
    • Enroll self, children, family member/surrogate
become a pioneer1
Become a Pioneer!
  • Email verification
  • Brief survey(redcap)
    • Demographic and contact info
    • Medical history info (self report)
    • Option to link to EMR if KUH patient
pioneers universal research portal
Pioneers: Universal Research Portal
  • Currently, multiple individual databases
  • Pioneers offers:
    • Single sign up process for participants
    • Powerful search options with EMR access
    • No cost to investigators to manage database, to search for participants, to advertise study
    • Able to screen by email with study – specific questions
investigator access
Investigator Access
  • Open to all Frontiers investigators
    • KUH EMR access only available to KUMC investigators
  • Data Request Committee (DRC) approval
    • Community Partnership for Health
    • Ethics/ Regulatory representative
    • KU Hospital
current status
Current Status


  • HSC approval
  • Website / database fully developed
  • Multiple rounds of user testingwith community group
  • “Live” early next week?


  • Searchable list of all active trials
  • Integrated study-specific surveys
future plans
Future Plans
  • Spanish language consent
  • Option to search EMR of other health care organizations
  • Link with biospecimen repository
  • Merge with existing Frontiers participant registry (enrollment via checkbox in EMR)