The Radiation Oncology EHR
of the Future
Joel W. Goldwein, MD
Senior Vice President and Director
Medical Affairs
Elekta, Inc.
August 6, 2010
Future Radiation Oncology EHR:
Agenda
• What’s the current state of the art?
• What’s driving progress?
• Where are we going?
State of the Art:
Radiation Oncology EHR
• RT used in approx 50% of 1.4M US cancer patients
• ~ 2,100 RT facilities in US
– > 70% utilize dedicated information systems
– Represents ~ 500,000 new RT patients/yr managed using RO EHR
• RO highly EHR-dependent clinical specialty (V&R…)
– Degree of EHR use highly variable
• Two major EHR vendors (Elekta MOSAIQ, Varian Aria)
– Well established / managed
– Regulated QA systems support software development
– Numerous interfaces to devices/machines, TPS, HIS, PACS, lab…
– Largely standards-based (DICOM-RT, HL7, AJCC, CTC(AE)…)
– IHE-RO participants (committed to interoperability)
RO EHR Features (Elekta MOSAIQ®)
• Clinical
–
–
–
–
–
–
–
V&R
CPOE
Comprehensive noting/charting
TPS interface/integration
Medical oncology support
Rule-based workflow management
Numerous interfaces (lab, HIS,
treatment machines…)
• Image Management (2D, 3D, 4D)
– Import/export/manipulate
– Treatment related image (IGRT)
management
– Oncology PACS Integration
RO EHR Features (Elekta MOSAIQ®)
• Practice Management/Administrative
–
–
–
–
Patient and Resource Scheduling
Charge Capture/Billing
Kiosk patient check in
Inter/intra-product communications
• Research
–
–
–
–
–
–
Data collection and reporting
Data trending
Outcome analyses support
Graphical data exploration
Clinical Trial management
Interfaces out to Cancer Registry
and RO data aggregation products
Graphical Data Exploration Module
RO EHR Environment
• Architecture
– PC Based
• Desktop workstations, laptop
carts, limited mobile devices
– Client/Server (MS-SQL)
• Workstations - five to hundreds
• LAN or WAN (Citrix)
• Device and imaging environment highly variable
– Cadre or product mix innumerable (linacs, protons,
orthovoltage, TomoTherapy, TPS, HIS…)
– Workflow associated with evolving clinical trends
• Some FDA regulated EHR components
– MLC control systems, Image management components
EHR Clinical Trial Support Features
• TrialCheck® (Coalition of Cancer Cooperative Groups)
– Determine patient eligibility for clinical trials active at your facility
– Based on clinical criteria (age, disease, stage, performance status…)
available in EHR
• Trial data collection support
– import/export
assessment templates
• DICOM-RT image
export to cooperative
groups (RTOG…)
• Integrated National
Comprehensive Cancer
Network (NCCN)
guidelines
Clinical Trial Eligibility Determination Screen
Web-centered Collaboration:
Established Community of EHR Users
• Shareable Reports
• Sharable Document
Templates
• Sharable Care Plans
• Listserver
(independent)
• Infrastructure for
future expansion
EHR Snapshots
Patient Face Sheet (Chart Cover)
EHR Snapshots
Patient Assessments (Labs, Vital Signs…)
EHR Snapshots
Treatment setup image verification (2D)
EHR Snapshots
X-ray Volumetric Image Guided RT
RO EHR: Current Status Summary
• Widely deployed systems across entire specialty
• Largely standards based
• Device, HIS, TPS interconnectivity and
interoperability comprehensive
• Modern UI, RO image-enabled
• Support clinical, research and administrative
aspects of RO practice robust
• Mature, established vendors with regulated &
structured development control systems
Seems like it’s all there!
What’s next?
How can we leverage
today’s products to build
the system of the
future?
Some Rad Onc EHR Drivers
• Health Information Technology for Economic and Clinical Health Act
(HITECH)
• Meaningful use and ARRA certification ► $$$
• Rapidly emerging technologies (device, imaging, techniques,
software…)
– All expensive; proof of utility often limited
– Associated workflows will require EHR support
– Associated high costs implicate Comparative Effectiveness Research
(CER)
• Recent safety-related incidents
– Incent development of “safer” EHR systems
• Rising costs with potential diminishing reimbursement
– Incents increased efficiency by improving workflow and
the Human-Computer Interface
Meaningful Use (HITECH)
Ambulatory Provisions
• Qualified Eligible Provider Requirements
– Meet ~ 20 MU criteria AND use certified EHR system
• e.g. - CPOE medications (e-prescribing), clinical rules engine (decision
support), capture vital signs, provide patient EHR access, supply
summary of care record…
• Payout to qualified/eligible providers begin 2011
MEDICARE PAYMENT SCHEDULE
Initial Qualifying Year
Calendar Yr
2011
2011
2012
2013
2014
2015
2016
TOTAL
$18,000
$12,000
$8,000
$4,000
$2,000
$44,000
2012
2013
2014
> 2015
$18,000
$12,000
$8,000
$4,000
$2,000
$44,000
$15,000
$12,000
$8,000
$4,000
$39,000
$12,000
$8,000
$4,000
$24,000
$0
$0
$0
Meaningful Use (HITECH)
Effect on Future of RO EHR
• Certification is current major Vendor focus
• Expected
Results
Core
Import/Export
Immunization
registry
Public registry
export
Administrative
import/export
Administrative
Appt Reminders
– Acceleration of EHR system enhancements
Demographics
Vital Signs
Lab
e-prescribe
CPOE
Problem lists
Discharge
Pt. summary
Follow-up & scheduling
– Improvements
in scope
of (meaningful)
use
Drug interactions &
Import export
Smoking
Care migration and transfer
Allergies/Alerts
Med reconciliation
standards
–Privacy
Overall:
Limited (but important)
on ROSupport
EHR
and Security
Vocabularyeffect
Decision
Authentication
Encryption
ICD-9/10;
CPT
Guidelines
features, development,
and
end-user
adoption
Disclosure Compliance
Audit
SNOMED
Already available or in progress
Interlocks and Alerts
Emerging technologies as RO EHR
drivers:
• Are we moving too quickly?
• Will there ever be sufficient supportive
evidence?
• Can EHR systems help
us obtain it?
• Will EHR’s be able to
accommodate ever
changing workflow?
RO: Fodder for Comparative
Effectiveness Research
Economic Scene
In Health Reform, a Cancer Offers an Acid Test
By DAVID LEONHARDT
Published: July 7, 2009
“The prostate cancer test will determine
whether President Obama and
Congress put together a bill that begins
to fix the fundamental problem with our
medical system: the combination of
soaring costs and mediocre results. If
they don’t, the medical system will
remain deeply troubled, no matter what
other improvements they make.”
[Radiation] Oncology:
A CER Priority?
• Cancer focus of 6 primary
IOM CER topics
• Direct US cancer costs
$80 Billion
• RO consumes approx.
10%; growing fast!
– Burden likely to fall on us to
provide evidence basis
• A real-time registry
capturing patterns-of-care
data may represent part of
the solution
Distribution of the IOM's Recommended CER Priorities
Iglehart J. N Engl J Med 2009;361:325-328
Radiation Oncology Data Registry
• Pilot Program Background
– Est. 10/2008 as derivative of more
mature Med Onc data program
• Aim
– Demonstrate proof of concept for
establishment of central RO data
warehouse derived from live EHRs
– Establish basis for CER….
– Reduce costs of data collection
• Method
– Leverage widely deployed RO EHRs
– Aggregate de-identified data collected
in EHRs in routine course of care
– Extensible/scalable design
Registry Architecture
•
Small program installed on
local EHR PC
•
Scheduled service runs
program at some regular
interval
•
Program runs => De-identified
dataset created
•
Dataset uploaded to central
data warehouse
•
Dataset
aggregated
Registry
RODA
EHR
Facility 1
EHR
Facility 3
EHR
Facility 5
EHR
Facility 4
EHR
Facility n
EHR
Facility 2
RO Registry Pilot Results
ASTRO 2009 Analysis
18 RO participants
121,000 patient records, 108,000 patient treatments
Data completeness (quality)
Date of Diagnosis: 29% complete
Overall Stage: 21% complete
Assessment
Successful, but quality issues need to be addressed
HITECH/MU may incent quality improvements
If scaled, could represent real-time model dataset for CER,
advocacy, administrative and clinical research…
Could serve as feed for higher-level multi-purpose registries and
complement US Cancer Registry program
RO Registry Multi-Purpose Model
• Opportunities
– Specialized
emerging
technologies
registries (SBRT,
Protons…)
– CER registry
– Safety (near-hit)
database
– caBIG Grid
RO EHRs and Safety
• RO info systems have incorporated safety features such
as V&R for decades
• Evidence suggests these features do indeed enhance
safety*
• Contemporary systems designed top-down to minimize
hazards
• This has not always been the case
*Frass et al – IJROBP - 1998
RO Control Systems:
Vehicles of “Safety” ?
WIRED
Nov ‘05
• 2 of 10 (and the only “deaths by software”) were RO-related
– 1985 – Therac 25 Linear Accelerator
• 5 deaths
• Significant changes in way RO software developed
– 2000 – Multidata TPS (Panama)
• 8 deaths
RO EHR Systems and Safety
The Radiation Boom
Radiation Therapy Offers New Cures, and Ways to do Harm
By WALT BOGDANICH
Published: January 24, 2010
NY State Records 2001-2008
– 621 events, 1,264 causes, 2 notable deaths
• 46% - missed target
• 41% - wrong dose
• 8% - wrong patient
#
352
252
174
133
60
24
19
Cause
Flawed Q/A plan
Human data entry/calculation error
Wrong patient, wrong site
Wedge or collimator misused
Hardware malfunction
Software bug
Erroneous software override
RO Safety Record
Event Type
Events per million RT courses*
Any ~ 10,000 - 20,000
Errors w/ significant clinical consequences ~ 1,000 – 10,000
Errors w/ serious clinical consequences ~ 5 - 10
Lots of caveats (e.g. – under-dosing, under-reporting)
• Most events ≠ serious injury
• RT safe, but could/should always be safer
[~ 1M RT courses yearly in US (IMV Report – 2007)]
* Munro – BJR 2007
Why, in era of sophisticated EHRs,
does this still happen?
• RO Highly Complex!
– Diseases varied
– Processes fluid
– Humans involved
(both sides of table)
– EHRs can’t anticipate it all
• Failure Mode and Effect
Analysis (FMEA)
– 269 course process nodes
– 127 high risk failure modes
EVALUATION OF SAFETY IN A RADIATION ONCOLOGY SETTING
USING FAILURE MODE AND EFFECTS ANALYSIS
Simplified RO Workflow Illustrating the
multitude of opportunities to manage
IJROBP,
the 2008
RO process
ERIC C. FORD, PH.D.,* RAY GAUDETTE, M.S.,* LEE MYERS, PH.D.,* BRUCE VANDERVER, M.D., LILLY
ENGINEER, DR.P.H., M.D., M.H.A., RICHARD ZELLARS, M.D.,* DANNY Y. SONG, M.D.,* JOHN WONG, PH.D.,*
AND THEODORE L. DEWEESE, M.D.*
Hazard Mitigation
Training &
Guess?
Education
• Hierarchy of effectiveness
Rules
& Policies
Reminders
& Checklists
Simplification
& standardization
Automation
& Computerization
Forcing functions
& Constraints (Interlocks)
Mitigation Strategies
The EHR Solution?
Leverage Hazard
Mitigation Strategies to
Reinforce EHR Safety
Increase
dependence on
most reliable
hazard
mitigation
strategies
Iterate!
Less Automation
Where human
intervention is
required…Reduce
dependence
Training &
Education
Rules
& Policies
Reminders
& Checklists
Simplification
& standardization
Human
Intervention
Automation
& Computerization
Forcing functions
& Constraints (Interlocks)
Safer System =>
Forcing Functions in Medicine:
Interlocks, Timeouts and Checklists



They work!
Supplied throughout
EHR, devices and
applications
Next generation
EHR

Roll your own!
Graphical
Workflow Design Toolkit
Gamma Knife Treatment Console Checklist
MOSAIQ Universal Timeout
MOSAIQ Workflow Manager



Incorporate customized
checkpoints w/ optional
interlocks and alerts at
any point
Special attention to
any/all high risk hazard
nodes in work flow
Requires iteration via
ongoing FMEA
EVALUATION OF SAFETY IN A RADIATION ONCOLOGY SETTING
USING FAILURE MODE AND EFFECTS ANALYSIS
ERIC C. FORD, PH.D.,* RAY GAUDETTE, M.S.,* LEE MYERS, PH.D.,* BRUCE VANDERVER, M.D., LILLY
ENGINEER, DR.P.H., M.D., M.H.A., RICHARD ZELLARS, M.D.,* DANNY Y. SONG, M.D.,* JOHN WONG, PH.D.,*
AND THEODORE L. DEWEESE, M.D.*
IJROBP, 2008
MOSAIQ Workflow Manager Process
Change
Prescription
Check Modality
Automatic Script
Customer Defined
Task
Ask for More Data with
User-Defined Form
Create QCL Item
To Verify Info, etc.
The Human-EHR Interface: A few words
• Pen/paper – hard to compete, but also hard to
“computerize”
• PC / keyboard / structured data entry
– slow, awkward, interferes with MD-patient relationship
– BUT, structured data necessary for true benefits of
EHR
• Dictation / voice recognition
– Faster, easier, more natural
– BUT, natural language processing that would provide
for creation of structured data far off
• A number of solutions are on the horizon
The Human-EHR Interface: Teamwork!
Software usability Improvements
Mobile
devices
MOSAIQ
EHR
Hardware usability improvements
Kiosks and
PRO Interfaces
Interfaces
(Lab, HIS,
Vitals…)
Interfaces galore
Digital pen & paper
Dictation + Natural
Language Processing
What’s the Long Term Vision?
EHRs as the Cornerstone
• Remote Care Monitoring and Delivery
– Driven by efficiency, cost containment, and Rx
consistency requirements
– Facilitated via EHR
• Radiation Oncology “Medical Home”*
– Our “processes” are far to diverse,
uncontrolled and unstructured
– Demands on our time will only increase
– Patients will demand more control of their care
*An approach to providing comprehensive evidence-based, guideline-directed care... that facilitates
partnerships between patients and providers
RO EHR Systems of the Future
RO EHR systems are
already (arguably) most
sophisticated in medicine
Managing complex tasks
in an increasingly
complicated environment
The unique mix of
technical and clinical
specialists immersed in
the explosion of
advanced technologies
will continue driving this
trend….
Which will be great for
our patients!
The Radiation Oncology EHR
of the Future
Joel W. Goldwein, MD
Senior Vice President and Director
Medical Affairs
Elekta, Inc.
August 6, 2010