Sat 31st Aug 2013
Session 2 / Talk 3
11:15 – 12:00
BROOKLYN 2
RADIOTHERAPY
Carl ROWBOTTOM
ABSTRACT
Radiotherapy is part of the care package for 40% of patients cured of their cancer;
it is a cost effective and safe form of treatment. This is in large part due to the
safety conscious culture embedded within radiotherapy services. When considering
innovation the radiotherapy environment can often be negatively seen as a riskaverse culture with clear barriers to progress. The Demings approach to statistical
and quality control can be used to ensure quality, improve productivity and
introduce innovation safely within a radiotherapy environment. The approach was
applied to increasing IMRT provision for patients treated at The Christie, the largest
radiotherapy centre in the UK, where levels of IMRT were increased from <5% in
2007 to >35% in 2012. Examples will be given of the use of clear objectives,
decision rules, feedback and statistical measurements during the project and
continuing in routine practice. It is hoped that repeated application of the principles
of the Demings approach will improve the timely uptake of innovations within
radiotherapy in the future.
NZIMRT: Hamilton Sep 2013
Innovation in a safety conscious
culture
Dr Carl Rowbottom
Radiotherapy Physics Group Leader
The Christie NHS Foundation Trust, Manchester
NZIMRT: Hamilton 31st Aug 2013
The Christie NHS Foundation Trust
The Christie
• One of only 3 specialist cancer hospitals in
England
• One of the largest radiotherapy services in
Europe
• Serves population of 3.2 million people
• 16 linacs on 3 sites (12:2:2)
NZIMRT: Hamilton Sep 2013
Innovation and a safety conscious
culture?
• How do we introduce innovation within the
radiotherapy environment?
• Resistance to change
• Ensuring safety of innovation
• Diffusion of innovation theory
• Standardization – Edwards Deming systems
thinking
• Increasing IMRT provision at The Christie as a
case study........
NZIMRT: Hamilton Sep 2013
How can we apply diffusion of
innovation theory & systems
thinking to improve IMRT provision?
NZIMRT: Hamilton Sep 2013
Diffusion of Innovations
• Everett Rogers describes theory to describe how,
why and at what rate new ideas/technology spread
through cultures.....
NZIMRT: Hamilton Sep 2013
Diffusion of Innovations
• There are 5 stages in the decision innovation
process
• Knowledge – individual exposed to an innovation,
lacks information about innovation
• Persuasion – individual interested in the innovation
and seeks information
• Decision – Individual weighs
advantages/disadvantages of using the innovation
• Implementation – Individual employs the innovation to
a varying degree
• Confirmation – individual finalizes decision to
continue using innovation.
NZIMRT: Hamilton Sep 2013
Diffusion of Innovations
• There are strategies to help diffusion......
• Innovation adopted by a highly respected individual
within a social network
• Create desire for a specific innovation
• Find early adopters to use innovation
• Provide positive reactions and benefits for early
adopters on innovation
• Benefits to patients
• Benefits to staff
NZIMRT: Hamilton Sep 2013
Edwards Deming – Systems
Thinking
• ‘If you can’t describe what you are doing as a
process, you don’t know what you are doing.’
• Key ideas
• Understand sources of variation, work on consistency
• Use statistical process control to distinguish between
different types of variability
• Perpetuate a cycle of continuous quality improvement
NZIMRT: Hamilton Sep 2013
Edwards Deming – Systems
Thinking
NZIMRT: Hamilton Sep 2013
Edwards Deming
• ‘To discuss bringing in to a more desirable state
an organization whose objectives, and the
necessary and appropriate limitations and
constraints, are really not stated is to take on an
impossible task.’
• ‘The aim of leadership is not merely to find and
record failures of men, but to remove the causes
of failure: to help people to do a better job with
less effort.’
NZIMRT: Hamilton Sep 2013
IMRT expansion as an example of
Innovation in a Safety Critical
Environment
NZIMRT: Hamilton Sep 2013
The Vision
• Establish a comprehensive intensity modulated
radiotherapy service at The Christie
• With the capacity to offer the treatment to all patients
who would benefit from this advanced form of
radiotherapy
NZIMRT: Hamilton Sep 2013
Motivation for the Vision
• Position at The Christie in 2008:
• Quota for small number of intensity modulated
radiotherapy treatments established in 2006
• Quotas set to provide a limited service amounting to
~3% of radical treatments (~20-25% would benefit)
• 100 patients received intensity modulated
radiotherapy compared to ~1000 who would benefit.
• National picture in 2008:
• 2% of radical patients treated with Intensity
Modulated Radiotherapy1
1. Williams MV, Cooper T, Mackay R, Staffurth J, Routsis D, Burnet N. ‘The implementation of intensity-modulated
radiotherapy in the UK’, Clinical Oncology, 22;623-628 (2010)
NZIMRT: Hamilton Sep 2013
IMRT position @ The Christie in 2008
• Local barriers to increased provision
• Small numbers each month make it difficult to gain
sufficient familiarity in the process
• Background knowledge of staff (IMRT not included
in any major training scheme).
• Other perceived barriers to IMRT
•
•
•
•
Linac time & resources for patient QA
Patient throughput (cf conformal treatments?)
Oncologist time for outlining
Familiarity with the process/ Lack of confidence
NZIMRT: Hamilton Sep 2013
Adoption of Innovation Phase
• Focus on training initial core team of physicists
and planning radiographers to meet future
demand (Early adopters)
• Concentrated training & development (theoretical
& practical)
• (Knowledge / Persuasion)
• Focus on improved quality of treatment for the
patient
• (Persuasion / Decision)
• Regular feedback to staff regarding progress
• (Implementation / Confirmation)
NZIMRT: Hamilton Sep 2013
Moving forwards
• New IMRT planning room established in Jan
2009
• 2 planning radiographers + 2 physicists
• Co-ordinating outlining, planning, verification,
treatment of IMRT patients only
• (early adopters / implementation phase of
adoption)
• Increasing targets for number of patients per
month
• Protocols & SOPs for majority of IMRT
treatments
• (Standardization / Consistency)
NZIMRT: Hamilton Sep 2013
Moving forwards
• Comprehensive training programme for staff
(early majority / late majority)
• Background teaching
• Practice case studies
• Supervised learning
• (Persuasion stage of adoption for early/late
majority)
• Quality Management System (QMS) sign-off
• (Standardization / Consistency)
NZIMRT: Hamilton Sep 2013
Early Adopters - IMRT Central
The Christie in 2009
Perceived barriers to IMRT
• Local barriers to increased provision
• Small numbers each month make it difficult to gain
sufficient familiarity in the process
• Background knowledge of staff (IMRT not included
in any major training scheme).
• Other perceived barriers to IMRT
•
•
•
•
Linac time & resources for patient QA
Patient throughput (cf conformal treatments?)
Oncologist time for outlining
Familiarity with the process/ Lack of confidence
NZIMRT: Hamilton Sep 2013
Will patient specific IMRT/VMAT QA
limit capacity?
NZIMRT: Hamilton Sep 2013
Verification will limit IMRT/VMAT
Capacity
100
90
80
70
60
50
40
30
20
10
0
Oct-12
Jul-12
Apr-12
Jan-12
Oct-11
Jul-11
Apr-11
Jan-11
Oct-10
NZIMRT: Hamilton Sep 2013
Jul-10
Apr-10
Jan-10
Oct-09
Jul-09
Apr-09
Target
Jan-09
Total no. of plans
• Eventually >95 verifications per month needed.
• >100 in 2013 (120 inverse planned IMRT/VMAT
treatment plans in July 2013)
Options for verification?
• Scale up resources to achieve verification for all
inverse planned treatments
• Will resources be available?
• Could resource be better utilised?
• Batch verifications and perform within first 3 days of
treatment
• What if days 1-3 are incorrect?
• Don’t verify all treatment plans
• How do we decide what not to verify?
• What other measures do we put in place?
NZIMRT: Hamilton Sep 2013
Edwards Deming
• ‘Routine inspection becomes unreliable through
boredom and fatigue’
120
100
80
Total Verifs
60
Total Plans
40
20
Ja
n09
Ap
r- 0
9
Ju
l-0
9
O
ct
-0
9
Ja
n10
Ap
r- 1
0
Ju
l-1
0
O
ct
-1
0
Ja
n11
Ap
r- 1
1
Ju
l-1
1
O
ct
-1
1
Ja
n12
Ap
r- 1
2
Ju
l-1
2
O
ct
-1
2
0
NZIMRT: Hamilton 31st Aug 2013
The Christie NHS Foundation Trust
I’M Really
IMRT
Tired
NZIMRT: Hamilton Sep 2013
Verification: Results outside tolerance
• Error Rates (since Jan 2009)
• Prostate (414 patients - 2090 beams)
• Dose difference issue - 10 beams (0.5%)
• Gamma Analysis issue - 14 beams (0.7%)
• H&N (707 patients - 5021 beams)
• Dose difference issue - 1 beam (0.02%)
• Gamma Analysis issue - 4 beams (0.08%)
• Number of plans changed due to verification... 2!
(from over 1000 patients!)
NZIMRT: Hamilton Sep 2013
Build quality in to the process
• Technical staff tend to advocate for all patients
(Standardization)
• Oncologists tend to advocate for individual
patients (Personalization)
• Personalization can interfere with the goals of
Standardization
NZIMRT: Hamilton Sep 2013
Build quality in to the process
• Uncertainties affect outcomes.......
What approach would you prefer?
NZIMRT: Hamilton Sep 2013
What would Edwards Deming say?
• ‘Quality comes not from inspection, but from
improvement of the production process.
Inspection, scrap, downgrading, and rework are
not corrective action on the process’
• ‘Putting out fires is not improvement of the
process’
• ‘Inspection to improve quality is too late,
ineffective, and costly’
• ‘What is needed are operational definitions of
what is acceptable and what is not’
NZIMRT: Hamilton Sep 2013
Build quality in to the process
• Follow standard methodology for treatment site
whenever possible.........
• Clinical site protocol
• Standard operating procedures
• IMRT/VMAT class solutions (with suggestions for
modifications when required)
• Agreed assessment forms
• Checklists (planning + checking)
• Operational definitions / plan metrics
• Rejection codes
NZIMRT: Hamilton Sep 2013
Clinical Site Protocols
• Clinical site protocols
provide basis for clear
operational definitions.
• Should include
 Scanning
 Outlining
 Dose limits
 Roles/Responsibilities
 QA
• Need to be reviewed
after first cohort of
patients completed
NZIMRT: Hamilton Sep 2013
Operational definitions: Initial Class
Solution
• Clinical site protocols provide basis for a TP class solution
• PTVs, OARs and dummy structures
• Beam orientations
• Inverse plan optimisation parameters
Standardised using
Pinnacle Scripts
• Hints for what to do when class solution doesn’t give a
good enough solution for an individual patient
Described in quality
management system
NZIMRT: Hamilton Sep 2013
Knowing when to stop – what is
good enough?
• Why is it important to clearly know when to stop
trying to improve the plan?
 Efficiency means more patients planned with IMRT
for same effort
 Reduces variation in acceptable plans
 Reduces waste from rejecting plans (often late in the
process)
 Saves your sanity
NZIMRT: Hamilton Sep 2013
What approach would you prefer?
NZIMRT: Hamilton Sep 2013
How do we know when the
IMRT/VMAT plan is good enough?
NZIMRT: Hamilton Sep 2013
Operational definitions: Agreed
assessment values (autoforms)
• From the class solution
create clear assessment
values can be
automatically generated
& quickly evaluated from
the TPS
– If the plan meets the
assessment values and
the distribution and
DVHs look ‘normal’
then the plan is
acceptable.
How do we know that the plan is
‘normal’?
Plan Metrics
NZIMRT: Hamilton Sep 2013
• A multi-criteria score (MCS) based on
distance between adjacent leaf
positions, overall area of the field and
beam-weight developed to determine
good and bad constructions of the
intensity modulation in a plan
NZIMRT: Hamilton Sep 2013
How do we reduce variations?
How do we reduce re-work?
NZIMRT: Hamilton Sep 2013
Operational definitions: Checklists
• Useful to reduce common errors produced by the system
of work
– Limit to less than 10, preferably less than 5.
– Wherever possible produce an active rather than passive
response.
• Used extensively in aviation & surgery (See Gawande’s
book for further details)
NZIMRT: Hamilton Sep 2013
NZIMRT: Hamilton Sep 2013
Operational definitions: Recording
plan rejections to feed in to
improvement cycle
•
•
•
•
How well do you understand the system?
How well have you been trained?
Do you know whether you are doing a good job?
How do you compare to your peers?
NZIMRT: Hamilton Sep 2013
The improvement cycle – reducing
variation
Plan Rejections Sept - Dec 12
20
18
16
14
12
10
Sep-12
Oct-12
Nov-12
Dec-12
8
6
4
2
NZIMRT: Hamilton Sep 2013
12
10c
8f
8d
8b
10a
Rejection Codes
7g
7e
7c
7a
5
4c
4a
3a
2a
1a
0
Sep-12
Quality System improvement cycle
• Clinical Site Protocol
• Review of class
solution =>
operational
definition
changes
• Review of
operational
definitions =>
error/rejection
code changes
Clinical requirements of the
oncologists
Clear definitions of acceptable
doses
• Review of
clinical site
protocol =>
class solution
changes
• Class Solution
 Best starting set of parameters to achieve the
clinical site protocol
 Tips for adaptation when class solution fails
• Errors/Rejection Codes
• Operational Definitions
 Clearly defined Work Instructions
 Automated planning/assessment wherever
possible
 Agreed assessment (pass/fail)
 Checklist to reduce common failure modes
NZIMRT: Hamilton 31st Aug 2013
 Agreed list of reasons for rejection
• Review of
errors/rejection
codes =>
operational
definitions
The Christie NHS Foundation Trust
Does it work in practice?
• Have we seen an increase in the number of
patients we are able to treat with IMRT?
•
•
•
•
•
•
100 patients treated with IMRT in 2008
339 patients treated with IMRT in 2009
569 patients treated with IMRT in 2010
865 patients treated with IMRT in 2011
1048 patients treated with IMRT in 2012
~1200 patients in 2013?
NZIMRT: Hamilton Sep 2013
Edwards Deming – Systems
Thinking
NZIMRT: Hamilton Sep 2013
Workload & Stressors in Clinical
Radiation Oncology
• Mazur et al (IJROBP, 2012; 83(5):e571-576) used
assessed workload in Clinical Oncology using the NASA
Task-Load Index (TLX)
• 173 workload assessments across multi-professional workforce
• (Overall TLX score <35 low workload; >55 high workload)
• Found an association between workload & frequency of
reported radiotherapy incidents.
• Typically there are 3-5 stressors per cycle of analysed
tasks
• Interruptions (41.4%), time factors (17%), technical factors
(13.6%), teamwork issues (11.6%), patient factors (9%),
environmental factors (7.4%)
NZIMRT: Hamilton Sep 2013
NZIMRT: Hamilton Sep 2013
NZIMRT: Hamilton Sep 2013
In Summary…….
• Think about the 5 stages in the diffusion of
innovation process
• Knowledge, Persuasion, Decision, Implementation,
Confirmation
• Be clear in setting the objectives
• state goals & limitations
• Build quality in to the process
• inspection is too late & inefficient
• Define operational standards ..... what is acceptable
and what is not (reduce variation)
• Work to improve the system
NZIMRT: Hamilton Sep 2013
Finally ..... remember
‘True genius resides in the capacity for evaluation of
uncertain, hazardous, and conflicting information’
Winston Churchill
‘The difference between stupidity and genius is that
genius has its limits’
Albert Einstein
NZIMRT: Hamilton Sep 2013