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Riunione Nazionale FIL
Padova, 8-10 Novembre 2012

Quality Assurance in Radiotherapy

Patrizia	
  Ciammella	
  
Arcispedale	
  Santa	
  Maria	
  Nuova	
  
Reggio	
  Emilia	
  
Timeline	
  of	
  major	
  changes	
  of	
  RT	
  in	
  HLe	
  
RT process

Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
Timeline	
  of	
  RT team
major	
  changes	
  of	
  RT	
  in	
  HLe	
  

Radiation
Oncologists
Medical
Physicists

RT

Radiation
Technologists

Radiation
Nurses

Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
Philosophy of radiotherapy quality assurance

Scope of quality assurance protocols
-  guarantee the validity of clinical trial results
-  improve the quality of clinical practice minimising the risk of
errors
- increase the likelihood of desired health outcomes at the
population level (equality of access, consistency, etc)

Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
Philosophy of radiotherapy quality assurance
Specific considerations of QART in a
multicenter research setting
-  determination of protocol ambiguities that may affect treatment
delivery;
-  education of sites in RT-specific trial guidelines;
-  promotion of consistency between centers;
-  ensuring sites meet minimum technical and personnel
requirements;
-  ensuring accuracy and integrity of data;
-  estimation of inter-patient and inter-institutional variation;
-  identification and correction of flaws in study design
Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
Importance of QA protocols
IJROBP 1996

5-years FFTF was significantly influenced by the quality of radiotherapeutical procedures:
70% with protocol violations (PV) vs. 82% without PV
Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
Timeline	
  of	
  major	
   in radiotherapy
Quality assurancechanges	
  of	
  RT	
  in	
  HLe	
  
1975	
  	
  
EORTC	
  
founda1on	
  	
  

QA strategy of the EORTC Radiation Oncology Group (ROG)
1982-2005
-  Site visits

1986	
  

First	
  QA	
  
programme	
  

-  Evaluation of institutions’staff and infrastructure
-  Dosimetric checks of treatment units
-  Cross-check of patients charts and portal images

1995	
  
QA	
  	
  
guidelines	
  

-  Radiobiological modelling of inter-institutional differences
-  Mailed thermoluminescent dosimetry audits
2005-2011

1999	
  
QA	
  in	
  
clinical	
  
trials	
  

-  Level 1: Facility questionnaire, External reference dosimetry audit
-  Level 2: Dummy run
-  Level 3: Limited individual case Review

2006	
  
5	
  levels	
  of	
  
QA	
  

-  Level 4: Extensive individual case Review
-  Level 5: Complex dosimetry check

Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
Quality Measures
1. Target volume definition
2. Radiation dose specification
3. Fractionation specification
4. Radiation prescription point specification
5. QA process use for RT
6. QA process adherence reporting for RT
Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
Radiotherapy reporting quality

Reporting of RT in HL and NHL RCTs is deficient. Because the
interpretation, replication, and application of RCT results depend on
adequate description and QA of therapeutic interventions, consensus
standards for RT reporting should be developed and integrated into the
peer-review process.
Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
Timeline	
  of	
  major	
   in radiotherapy
Quality assurancechanges	
  of	
  RT	
  in	
  HLe	
  

In the last years radiation oncology is undergoing a rapid
and radical transformation driving an exponential growth in
the size, complexity, and quantity of data generated
during the treatment process.
The increase is due, in part, to the success of imageguided oncology programs, which generate new images at
each step in the treatment process — from diagnosis to
verification, up to follow-up.

Modern QA ◊ digital data exchange and
timely review
Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
Quality assurance in radiotherapy in the 21st
century
Database on infrastructure
To create data bank of the infrastructure of the member centres, to acquire
data on equipment, staffing levels, treatment techniques and QA
procedures

Web-based quality assurance
To use medical informatics to facilitate the education, collaboration and
peer review, providing an environment in which clinical investigators can
receive, share and analyse treatment planning digital data.

Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
Integrated modular central review platform
2012

Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
Main system requirements
Task

Parameters

General

•  Network reliability in terms of up-time and fidelity of data
transfer
•  Avoidance of local hardware and software installation
•  Web-based accessibility from any geographic location
•  Intuitive functionally evaluation tools
•  Uniformity of data submission procedures for all trials
•  Adequate firewall security
•  Central storage and archiving in a queriable database

Submission from centres
to QART office

•  Ability to upload operating-system independent
•  Reads in digital data (DICOM-RT) exported from multiple
TPS

QART office DDIQA

•  Utilize VODCA software to ensure consistency,
completeness, formatting, lack of corrution and recalculation of
DVHs

Central evaluation

•  Document assessment of RT plan via a web-based
evaluation matrix, standardize to facilitate consensus-building

Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
A scenario for a web-based radiotherapy treatment
planning system
Patients benefit

Physicians benefit

- Accessibility of advanced
radiotherapy treatment services,
minimising patient’s transportation

-  Consultation of expert colleagues
-  Cooperation with reduce
professional isolation

Organisations benefit
-  Quality assurance in terms of dummy-runs and/or
check of a real-patient treatment planning
-  Minimisation of local-audits and the cost of on-site
visit
-  Evaluation and correlation of treatment outcome with
radiotherapy parameters
Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
RTQA platforms used by RTOG, EORTC or
TROG:

• 

VodcaRT from Medical Software Solutions

• 

CERR software

• 

ITC remote review tool

• 

VelocityAI from Velocity Medical Solutions

• 

Mim software from Mimvista

• 

Artiview from Aquilab

• 

Swan

• 

(Widen)

-  2008: retrospective test
-  2009: prospective test
-  2010: currently utilize to QART
procedures on ongoing EORTC
trials
Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
VODCA 5 has been created to …
Promote in radiotherapy clinical decision-support
and knowledge management technologies in patient
care and clinical research;
Disseminate methods and tools for building
healthcare knowledge applications that comply with
the highest quality, safety and ethical standards;
Connect individuals, hospitals, research groups and
organisations who believe in the value of knowledge
management, and support the share and reuse of
clinical knowledge and data.
Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
“Prospective quality assurance program and development of
an Italian network for radiotherapy in patients affected by
lymphoma enrolled in the clinical trials” 
	
  

Proof of Concept (POC)
-  6 RT centres
-  July-September 2012
-  HL patients

Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
VODCA 5 Network

Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
VODCA 5 Network

Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
“VODCA on the cloud”

Interactive
feedback
procedure

Centre n

QA Reviewers

The	
  “VODCA	
  Online	
  Desktop”	
  is	
  a	
  powerful	
  cloud-­‐based	
  Desktop	
  with	
  a	
  customisable	
  secure	
  storage
	
  
and	
  it	
  is	
  accessible	
  from	
  anywhere,	
  including	
  tablets:	
  
Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
VODCA 5
Visualisation and Organisation of Data for Cancer Analysis

•  VODCA Control

•  VODCA DICOM Server

Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
VODCA 5
•  Databases
Every patient dataset has an unlimited amount of user
defined fields subdivided into 3 categories:
• Patient data,
• Treatment data, and
• Clinical data,

Data fields can be added or deleted at any time by the
database administrator.
Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
VODCA 5
• VODCA RT : “Patient data” display
Module and selected data
specific buttons

New hierarchical organisation of the
VOIs and DVHs

Always available operations
Data Verification Protocol
Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
VODCA 5
• VODCA RT : Module “Display”

Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
VODCA 5
• VODCA RT : Contouring

Generating Consensus Contour:
Apparent agreement:
The apparent volume overlap is the agreement probability by which a voxel is
selected by the experts.
Expectation-maximization (EM) algorithm for simultaneous truth and
performance level estimation (Warfield, 2004).

Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
VODCA 5
•  Data Modification

Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
VODCA 5
•  Module “Analysis” – DVH / DSH

Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
VODCA 5
•  Module “Analysis” – Dummy-run

Consistency Contour
The following parameters
are calculated :

•  DICE
•  Sensibility
•  Specificity
•  Volume difference
•  Isocentre difference
Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
VODCA 5
•  Data verification Protocol

Available [Module] and [Tag] are listed in
VODCA RT “Property”

Or in a format
agreed with the
EORTC HQ

Riunione Nazionale FIL
Padova, 8-10 Novembre 2012
Conclusions

QART
-  Widen RT-DICOM IELSG37
-  Prospective analysis with VODCA?

Grazie
Riunione Nazionale FIL
Padova, 8-10 Novembre 2012

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Quality Assurance in Radiotherapy

  • 1. Riunione Nazionale FIL Padova, 8-10 Novembre 2012 Quality Assurance in Radiotherapy Patrizia  Ciammella   Arcispedale  Santa  Maria  Nuova   Reggio  Emilia  
  • 2. Timeline  of  major  changes  of  RT  in  HLe   RT process Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 3. Timeline  of  RT team major  changes  of  RT  in  HLe   Radiation Oncologists Medical Physicists RT Radiation Technologists Radiation Nurses Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 4. Philosophy of radiotherapy quality assurance Scope of quality assurance protocols -  guarantee the validity of clinical trial results -  improve the quality of clinical practice minimising the risk of errors - increase the likelihood of desired health outcomes at the population level (equality of access, consistency, etc) Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 5. Philosophy of radiotherapy quality assurance Specific considerations of QART in a multicenter research setting -  determination of protocol ambiguities that may affect treatment delivery; -  education of sites in RT-specific trial guidelines; -  promotion of consistency between centers; -  ensuring sites meet minimum technical and personnel requirements; -  ensuring accuracy and integrity of data; -  estimation of inter-patient and inter-institutional variation; -  identification and correction of flaws in study design Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 6. Importance of QA protocols IJROBP 1996 5-years FFTF was significantly influenced by the quality of radiotherapeutical procedures: 70% with protocol violations (PV) vs. 82% without PV Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 7. Timeline  of  major   in radiotherapy Quality assurancechanges  of  RT  in  HLe   1975     EORTC   founda1on     QA strategy of the EORTC Radiation Oncology Group (ROG) 1982-2005 -  Site visits 1986   First  QA   programme   -  Evaluation of institutions’staff and infrastructure -  Dosimetric checks of treatment units -  Cross-check of patients charts and portal images 1995   QA     guidelines   -  Radiobiological modelling of inter-institutional differences -  Mailed thermoluminescent dosimetry audits 2005-2011 1999   QA  in   clinical   trials   -  Level 1: Facility questionnaire, External reference dosimetry audit -  Level 2: Dummy run -  Level 3: Limited individual case Review 2006   5  levels  of   QA   -  Level 4: Extensive individual case Review -  Level 5: Complex dosimetry check Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 8. Quality Measures 1. Target volume definition 2. Radiation dose specification 3. Fractionation specification 4. Radiation prescription point specification 5. QA process use for RT 6. QA process adherence reporting for RT Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 9. Radiotherapy reporting quality Reporting of RT in HL and NHL RCTs is deficient. Because the interpretation, replication, and application of RCT results depend on adequate description and QA of therapeutic interventions, consensus standards for RT reporting should be developed and integrated into the peer-review process. Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 10. Timeline  of  major   in radiotherapy Quality assurancechanges  of  RT  in  HLe   In the last years radiation oncology is undergoing a rapid and radical transformation driving an exponential growth in the size, complexity, and quantity of data generated during the treatment process. The increase is due, in part, to the success of imageguided oncology programs, which generate new images at each step in the treatment process — from diagnosis to verification, up to follow-up. Modern QA ◊ digital data exchange and timely review Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 11. Quality assurance in radiotherapy in the 21st century Database on infrastructure To create data bank of the infrastructure of the member centres, to acquire data on equipment, staffing levels, treatment techniques and QA procedures Web-based quality assurance To use medical informatics to facilitate the education, collaboration and peer review, providing an environment in which clinical investigators can receive, share and analyse treatment planning digital data. Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 12. Integrated modular central review platform 2012 Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 13. Main system requirements Task Parameters General •  Network reliability in terms of up-time and fidelity of data transfer •  Avoidance of local hardware and software installation •  Web-based accessibility from any geographic location •  Intuitive functionally evaluation tools •  Uniformity of data submission procedures for all trials •  Adequate firewall security •  Central storage and archiving in a queriable database Submission from centres to QART office •  Ability to upload operating-system independent •  Reads in digital data (DICOM-RT) exported from multiple TPS QART office DDIQA •  Utilize VODCA software to ensure consistency, completeness, formatting, lack of corrution and recalculation of DVHs Central evaluation •  Document assessment of RT plan via a web-based evaluation matrix, standardize to facilitate consensus-building Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 14. A scenario for a web-based radiotherapy treatment planning system Patients benefit Physicians benefit - Accessibility of advanced radiotherapy treatment services, minimising patient’s transportation -  Consultation of expert colleagues -  Cooperation with reduce professional isolation Organisations benefit -  Quality assurance in terms of dummy-runs and/or check of a real-patient treatment planning -  Minimisation of local-audits and the cost of on-site visit -  Evaluation and correlation of treatment outcome with radiotherapy parameters Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 15. RTQA platforms used by RTOG, EORTC or TROG: •  VodcaRT from Medical Software Solutions •  CERR software •  ITC remote review tool •  VelocityAI from Velocity Medical Solutions •  Mim software from Mimvista •  Artiview from Aquilab •  Swan •  (Widen) -  2008: retrospective test -  2009: prospective test -  2010: currently utilize to QART procedures on ongoing EORTC trials Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 16. VODCA 5 has been created to … Promote in radiotherapy clinical decision-support and knowledge management technologies in patient care and clinical research; Disseminate methods and tools for building healthcare knowledge applications that comply with the highest quality, safety and ethical standards; Connect individuals, hospitals, research groups and organisations who believe in the value of knowledge management, and support the share and reuse of clinical knowledge and data. Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 17. “Prospective quality assurance program and development of an Italian network for radiotherapy in patients affected by lymphoma enrolled in the clinical trials”    Proof of Concept (POC) -  6 RT centres -  July-September 2012 -  HL patients Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 18. VODCA 5 Network Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 19. VODCA 5 Network Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 20. “VODCA on the cloud” Interactive feedback procedure Centre n QA Reviewers The  “VODCA  Online  Desktop”  is  a  powerful  cloud-­‐based  Desktop  with  a  customisable  secure  storage   and  it  is  accessible  from  anywhere,  including  tablets:   Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 21. VODCA 5 Visualisation and Organisation of Data for Cancer Analysis •  VODCA Control •  VODCA DICOM Server Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 22. VODCA 5 •  Databases Every patient dataset has an unlimited amount of user defined fields subdivided into 3 categories: • Patient data, • Treatment data, and • Clinical data, Data fields can be added or deleted at any time by the database administrator. Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 23. VODCA 5 • VODCA RT : “Patient data” display Module and selected data specific buttons New hierarchical organisation of the VOIs and DVHs Always available operations Data Verification Protocol Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 24. VODCA 5 • VODCA RT : Module “Display” Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 25. VODCA 5 • VODCA RT : Contouring Generating Consensus Contour: Apparent agreement: The apparent volume overlap is the agreement probability by which a voxel is selected by the experts. Expectation-maximization (EM) algorithm for simultaneous truth and performance level estimation (Warfield, 2004). Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 26. VODCA 5 •  Data Modification Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 27. VODCA 5 •  Module “Analysis” – DVH / DSH Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 28. VODCA 5 •  Module “Analysis” – Dummy-run Consistency Contour The following parameters are calculated : •  DICE •  Sensibility •  Specificity •  Volume difference •  Isocentre difference Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 29. VODCA 5 •  Data verification Protocol Available [Module] and [Tag] are listed in VODCA RT “Property” Or in a format agreed with the EORTC HQ Riunione Nazionale FIL Padova, 8-10 Novembre 2012
  • 30. Conclusions QART -  Widen RT-DICOM IELSG37 -  Prospective analysis with VODCA? Grazie Riunione Nazionale FIL Padova, 8-10 Novembre 2012