Clinical audit on quality indicators in radiotherapy for Specific Tumor Site Treatment (STST) Tampere 8-10 september 2008 Antonella Rosi Health and Technology.

Clinical audit on quality indicators in radiotherapy for Specific Tumor Site Treatment (STST)

Tampere 8-10 september 2008

Antonella RosiHealth and Technology Department, Istituto Superiore di Sanità

(ROMA)

QA in Radiotherapy: ISS roleQA in Radiotherapy: ISS role

to develop guidelines on general radiotherapyto develop guidelines on general radiotherapy topics and on specific techniquestopics and on specific techniques

to organize and coordinate clinical to organize and coordinate clinical and dosimetric audits in radiotherapyand dosimetric audits in radiotherapy

to organize training Courses on topics related to organize training Courses on topics related to Quality Assurance in Radiotherapyto Quality Assurance in Radiotherapy


The tasks of the Italian National Health Institute (Istituto Superiore di Sanità ISS) include the production of technical and scientific advices to the State and Regions on problems related to the risks of ionising and non ionising radiations in the environment and/or in medical field

In this framework the ISS established a multidisciplinary Working Group for Quality Assurance in Radiotherapy :

ISS activity in RQA had been ISS activity in RQA had been addressed :addressed :

not only to:not only to:Quality Controls of equipmentsQuality Controls of equipments

but especially to:but especially to:Patient related activities Patient related activities


The first stepThe first step

Development of Guidelines for quality Development of Guidelines for quality assurance in radiotherapyassurance in radiotherapy

EvaluationEvaluation


Quality IndicatorsQuality Indicators

What is a Quality Indicator? What is a Quality Indicator? A measurable element for monitoring A measurable element for monitoring

and evaluating resources, processes or and evaluating resources, processes or outcomes of careoutcomes of careWhere are they mainly applied? Where are they mainly applied? Health Technology Assessment (HTA)Health Technology Assessment (HTA) Continuous Quality ImprovementContinuous Quality Improvement ProgramsPrograms


Measure what is measurable, what is not….make it measurableG.Galilei

Indicators to…..Indicators to…..

Indicators are designed not only to identify Indicators are designed not only to identify structures of excellence, but mainly to assess structures of excellence, but mainly to assess operative conditions and draw up plans of operative conditions and draw up plans of action to provide a continuous quality action to provide a continuous quality improvement. A comprehensive indicator improvement. A comprehensive indicator system should:system should:

encompass structural, process and outcome encompass structural, process and outcome dimensions dimensions

produce information useful for decision makingproduce information useful for decision making become both a sign and a source of motivation for become both a sign and a source of motivation for

quality commitmentquality commitment


Two points as matter of concernTwo points as matter of concern

InterconnectionInterconnection of structure, process, and patient outcome of structure, process, and patient outcome Top management and medical staff leadership Top management and medical staff leadership

must be involved in CQI programsmust be involved in CQI programs

The choice of thresholds and standardsThe choice of thresholds and standards

Professional societies, governmental agencies and in general Professional societies, governmental agencies and in general

health-care organizations health-care organizations Sharing experiences among professionals Sharing experiences among professionals


Standardthreshold

General indicators to:General indicators to: provide an overall evaluation of the Centre provide an overall evaluation of the Centre Cionini L. et alCionini L. et al Radiother Oncol. 2007 82(2):191-200Radiother Oncol. 2007 82(2):191-200

Specific Tumor Site Treatment (STST) Specific Tumor Site Treatment (STST) indicators to :indicators to : provide indications on the quality level in the provide indications on the quality level in the

treatment of a specific tumor site treatment of a specific tumor site (manuscript in (manuscript in preparation)preparation)

Indicators in RadiotherapyIndicators in Radiotherapy


The GridThe Grid

Items Definitions Topic Rationale Type of indicator Numerator Denominator Stratification Standard Data collection

What you measure Why you measure Structure, process, outcome Parameter value Reference population Recommended categories Reference value (conformity) Type (population, sample), time period, frequency, responsible of data collection, of data analysis, of the interpretation


From the grid….

RationaleRationale

Why to develope indicators on a particular Why to develope indicators on a particular topictopic

What you plan to avoid what to promote What you plan to avoid what to promote

Which the advantages you expect to improve Which the advantages you expect to improve the qualitythe quality

How relevant is the indicator for the overall How relevant is the indicator for the overall quality of your productquality of your product

From the grid…..From the grid…..StandardStandard

From From literature dataliterature data and/or from and/or from guidelines guidelines of of Scientific AssociationsScientific Associations

Empiric Empiric (on the basis of collected data)(on the basis of collected data)

UpdatedUpdated relating to technology improvment or to relating to technology improvment or to additional resources additional resources

ConsistentConsistent with Centre resources with Centre resources

Complying toComplying to minima criteria minima criteria

From the grid…

Conformity

requires a reference value to be reached (standard)

can be expressed as yes or no

requires a score attribution

allows a step by step evaluation

allows a graduated intercomparison among different Centres

Even indicators need to be evaluatedEven indicators need to be evaluated

Are they ?Are they ?

proper (able to evaluate the phenomenon to proper (able to evaluate the phenomenon to be monitored)?be monitored)?

reproducible ?reproducible ? adoptable ?adoptable ? applicable? (in terms of time and costs)applicable? (in terms of time and costs) understandable ?understandable ? able to demonstrate differences (among able to demonstrate differences (among

Centres/among subsequent evaluations)?Centres/among subsequent evaluations)?

And ……….. is it possible to exclude confounding And ……….. is it possible to exclude confounding elements during data collection?elements during data collection?


Specific Tumor Site Treatment (STST) Specific Tumor Site Treatment (STST) indicators to :indicators to : provide indications on the quality level in the provide indications on the quality level in the

treatment of a specific tumor sitetreatment of a specific tumor site

Indicators in RadiotherapyIndicators in Radiotherapy


Working GroupsWorking GroupsGynaecological tumorsGynaecological tumorsGianstefano GARDANI Gianstefano GARDANI UO di Radioterapia, Università di Milano-Bicocca, A.O. S.Gerardo, MonzaUO di Radioterapia, Università di Milano-Bicocca, A.O. S.Gerardo, MonzaLuigi BOVATILuigi BOVATI UO di Radioterapia, AO S.Gerardo, MonzaUO di Radioterapia, AO S.Gerardo, MonzaCarlo CAPIRCICarlo CAPIRCI Radioterapia Oncologica, Azienda USSL 18, RovigoRadioterapia Oncologica, Azienda USSL 18, RovigoVincenzo CERCIELLOVincenzo CERCIELLO Servizio di fisica sanitaria, Istituto Nazionale Cura Tumori Fond.Pascale, NapoliServizio di fisica sanitaria, Istituto Nazionale Cura Tumori Fond.Pascale, NapoliLuca CIONINILuca CIONINI Dipartimento di Oncologia, AO Pisana, Università degli Studi, PisaDipartimento di Oncologia, AO Pisana, Università degli Studi, PisaClaudio FIORINO Claudio FIORINO Servizio di Fisica Sanitaria IRCCS San Raffaele, MilanoServizio di Fisica Sanitaria IRCCS San Raffaele, MilanoAlberto MAJORANA Alberto MAJORANA Servizio di Fisica Sanitaria casa di Cura e Sollievo della Sofferenza San Giovanni Rotondo, FoggiaServizio di Fisica Sanitaria casa di Cura e Sollievo della Sofferenza San Giovanni Rotondo, FoggiaPaolo MONTEMAGGI Paolo MONTEMAGGI UO Radioterapia Presidio Oncologico M. Ascoli, PalermoUO Radioterapia Presidio Oncologico M. Ascoli, PalermoAldo SAINATO Aldo SAINATO UO Radioterapia, AO Pisana, PisaUO Radioterapia, AO Pisana, PisaFrancesca TORTORETO Francesca TORTORETO UO Radioterapia Ospedale San Giovanni Calibita Fatebenefratelli, RomaUO Radioterapia Ospedale San Giovanni Calibita Fatebenefratelli, RomaBreastBreastMaurizio AMICHETTIMaurizio AMICHETTI UO di Radioterapia oncologica Ospedale A.Businco, Cagliari e ATreP, Agenzia Provinciale per la Protonterapia, TrentoUO di Radioterapia oncologica Ospedale A.Businco, Cagliari e ATreP, Agenzia Provinciale per la Protonterapia, TrentoCynthia ARISTEI Cynthia ARISTEI UO Radioterapia Università Di Perugia ed Ospedale Monteluce, PerugiaUO Radioterapia Università Di Perugia ed Ospedale Monteluce, PerugiaLuisa BEGNOZZI Luisa BEGNOZZI Servizio fisica sanitaria Ospedale San Giovanni Calibita Fatebenefratelli, RomaServizio fisica sanitaria Ospedale San Giovanni Calibita Fatebenefratelli, RomaAntonella CIABATTONIAntonella CIABATTONI UO Radioterapia San Filippo Neri, RomaUO Radioterapia San Filippo Neri, RomaFranca FOPPIANO Franca FOPPIANO Servizio di Fisica Medica, Istituto per la ricerca sul Cancro, GenovaServizio di Fisica Medica, Istituto per la ricerca sul Cancro, GenovaMarina GUENZIMarina GUENZI Radioterapia, Istituto per la ricerca sul Cancro, GenovaRadioterapia, Istituto per la ricerca sul Cancro, GenovaCristina LEONARDICristina LEONARDI Divisione di Radioterapia, Istituto Europeo di Oncologia, MilanoDivisione di Radioterapia, Istituto Europeo di Oncologia, MilanoLaura LOZZA Laura LOZZA Dipartimento di Radioterapia, Istituto Nazionale per lo Studio e la Cura dei Tumori, MilanoDipartimento di Radioterapia, Istituto Nazionale per lo Studio e la Cura dei Tumori, MilanoSecondo MAGRI Secondo MAGRI Servizio di Fisica Sanitaria, Azienda Istituti Ospitalieri, CremonaServizio di Fisica Sanitaria, Azienda Istituti Ospitalieri, CremonaSofia MEREGALLI Sofia MEREGALLI UO di Radioterapia, AO S.Gerardo, MonzaUO di Radioterapia, AO S.Gerardo, MonzaAngelo Filippo MONTI Angelo Filippo MONTI Servizio di Fisica Sanitaria, Ospedale Sant’Anna, Como Servizio di Fisica Sanitaria, Ospedale Sant’Anna, ComoGiovanni PENDUZZU Giovanni PENDUZZU Divisione di Radioterapia, Ospedale Mauriziano Torino e UODivisione di Radioterapia, Ospedale Mauriziano Torino e UO di Radioterapia, IRCC, Candiolo, Torinodi Radioterapia, IRCC, Candiolo, TorinoEmanuele PIGNOLI Emanuele PIGNOLI Servizio di fisica sanitaria, Istituto Nazionale per lo Studio e la Cura dei Tumori, MilanoServizio di fisica sanitaria, Istituto Nazionale per lo Studio e la Cura dei Tumori, MilanoFrancesco SCIUMÈ Francesco SCIUMÈ UO Radioterapia Presidio Oncologico M. Ascoli, PalermoUO Radioterapia Presidio Oncologico M. Ascoli, PalermoBone Metastasis Bone Metastasis Giovanni SILVANO Giovanni SILVANO S.C.S.C. Radioterapia Oncologica - Azienda Sanitaria Locale TA/1, Taranto Radioterapia Oncologica - Azienda Sanitaria Locale TA/1, TarantoLuigi F. CAZZANIGA Luigi F. CAZZANIGA Divisione di Radioterapia, Azienda Ospedaliera, S. Anna, ComoDivisione di Radioterapia, Azienda Ospedaliera, S. Anna, ComoPietro D’ADDATOPietro D’ADDATO S.C.S.C. Radioterapia Oncologica - Azienda Sanitaria Locale TA/1, Taranto Radioterapia Oncologica - Azienda Sanitaria Locale TA/1, TarantoGianstefano GARDANI Gianstefano GARDANI UO di Radioterapia, Università di Milano-Bicocca, AO S. Gerardo, MonzaUO di Radioterapia, Università di Milano-Bicocca, AO S. Gerardo, MonzaPatrizia OLMI Patrizia OLMI Dipartimento di RadioterapiaDipartimento di Radioterapia, , Istituto Nazionale per lo Studio e la Cura dei Tumori, MilanoIstituto Nazionale per lo Studio e la Cura dei Tumori, MilanoUmberto RICARDI Umberto RICARDI Radioterapia Università di Torino, AO San Giovanni Battista di TorinoRadioterapia Università di Torino, AO San Giovanni Battista di TorinoProstateProstateRiccardo VALDAGNIRiccardo VALDAGNI Direzione Scientifica, Istituto Nazionale per lo Studio e la Cura dei Tumori, MilanoDirezione Scientifica, Istituto Nazionale per lo Studio e la Cura dei Tumori, MilanoGianfranco BRUSADINGianfranco BRUSADIN UO Radioterapia Centro di riferimento oncologico, Aviano, PordenoneUO Radioterapia Centro di riferimento oncologico, Aviano, PordenoneRita CONSORTIRita CONSORTI Servizio di fisica sanitaria San Filippo Neri, RomaServizio di fisica sanitaria San Filippo Neri, RomaAndrea CRESPIAndrea CRESPI Servizio di Fisica Sanitaria, Ospedale S. Gerardo, MonzaServizio di Fisica Sanitaria, Ospedale S. Gerardo, MonzaClaudio FIORINOClaudio FIORINO Servizio di Fisica Sanitaria IRCCS San Raffaele, MilanoServizio di Fisica Sanitaria IRCCS San Raffaele, MilanoPietro GABRIELEPietro GABRIELE Divisione di Radioterapia, Ospedale Mauriziano Torino e UODivisione di Radioterapia, Ospedale Mauriziano Torino e UO di Radioterapia, IRCC, Candiolo, Torinodi Radioterapia, IRCC, Candiolo, TorinoGiovanni MANDOLITIGiovanni MANDOLITI Radioterapia Oncologica, Azienda USSL 18, RovigoRadioterapia Oncologica, Azienda USSL 18, RovigoAlessandra MIRRIAlessandra MIRRI UO Radioterapia IFO Istituto Regina Elena, RomaUO Radioterapia IFO Istituto Regina Elena, Roma Alessio MORGANTIAlessio MORGANTI UO Complessa di RadioterapiaUO Complessa di Radioterapia Univ Cattolica del S. Cuore - Centro di Ricerca Formazione ad Alta Tecnologia nelle Scienze Biomed, Campobasso Univ Cattolica del S. Cuore - Centro di Ricerca Formazione ad Alta Tecnologia nelle Scienze Biomed, CampobassoFrancesco SCIUMÈ Francesco SCIUMÈ UO Radioterapia Presidio Oncologico M. Ascoli, PalermoUO Radioterapia Presidio Oncologico M. Ascoli, PalermoAntonella SORIANI Antonella SORIANI Laboratorio di Fisica Medica IFO Istituto Regina Elena, RomaLaboratorio di Fisica Medica IFO Istituto Regina Elena, Roma

Working GroupsWorking GroupsLung Lung

ErmannoErmanno EMILIANI EMILIANI Servizio di Radioterapia, Ospedale S. Maria delle CrociServizio di Radioterapia, Ospedale S. Maria delle Croci, , RavennaRavennaGiovanna BALASSO Giovanna BALASSO UO Radioterapia Ospedale di Circolo, VareseUO Radioterapia Ospedale di Circolo, VareseClaudio FIORINOClaudio FIORINO Servizio di Fisica Medica S.Raffaele MilanoServizio di Fisica Medica S.Raffaele MilanoPietro GABRIELE Pietro GABRIELE Divisione di Radioterapia, Ospedale Mauriziano Torino e UO di Radioterapia, IRCC, Candiolo, TorinoDivisione di Radioterapia, Ospedale Mauriziano Torino e UO di Radioterapia, IRCC, Candiolo, TorinoGianstefano GARDANIGianstefano GARDANI UO di Radioterapia, Università di Milano-Bicocca, A.O. S.Gerardo, MonzaUO di Radioterapia, Università di Milano-Bicocca, A.O. S.Gerardo, MonzaGiovanni MANDOLITIGiovanni MANDOLITI Radioterapia Oncologica, Azienda USSL 18, RovigoRadioterapia Oncologica, Azienda USSL 18, RovigoMaria MORELLI Maria MORELLI Servizio diServizio di Fisica Sanitaria, Ospedale S. Maria delle Croci, RavennaFisica Sanitaria, Ospedale S. Maria delle Croci, RavennaNicola PERNANicola PERNA Servizio di Fisica Sanitaria - Azienda Sanitaria Locale TA/1, TarantoServizio di Fisica Sanitaria - Azienda Sanitaria Locale TA/1, Taranto Emanuele PIGNOLIEmanuele PIGNOLI Servizio di Fisica Sanitaria Istituto Nazionale Tumori, MilanoServizio di Fisica Sanitaria Istituto Nazionale Tumori, MilanoEnzo RAVOEnzo RAVO Unità di Radioterapia, Ist. Naz.Cura Tumori Fond.Pascale, NapoliUnità di Radioterapia, Ist. Naz.Cura Tumori Fond.Pascale, NapoliUmberto RICARDIUmberto RICARDI Radioterapia Università di Torino - Azienda Ospedaliera San Giovanni Battista di TorinoRadioterapia Università di Torino - Azienda Ospedaliera San Giovanni Battista di TorinoRuggero RUGGIERIRuggero RUGGIERI Servizio di fisica sanitaria, Azienda Ospedaliera "BianchiServizio di fisica sanitaria, Azienda Ospedaliera "Bianchi - - Melacrino - Morelli", Reggio CalabriaMelacrino - Morelli", Reggio CalabriaFrancesco SCIUMÈFrancesco SCIUMÈ UO di Radioterapia Ospedale “G. Ascoli”, PalermoUO di Radioterapia Ospedale “G. Ascoli”, PalermoGiovanni SILVANOGiovanni SILVANO S.C.S.C. Radioterapia Oncologica - Azienda Sanitaria Locale TA/1, Taranto Radioterapia Oncologica - Azienda Sanitaria Locale TA/1, Taranto Antonella SORIANIAntonella SORIANI Laboratorio di Fisica Medica, Istituto Regina Elena, RomaLaboratorio di Fisica Medica, Istituto Regina Elena, Roma..RectumRectumCarlo CAPIRCICarlo CAPIRCI Radioterapia Oncologica, Azienda USSL 18, RovigoRadioterapia Oncologica, Azienda USSL 18, RovigoVincenzo CERCIELLOVincenzo CERCIELLO Servizio di fisica sanitaria, Ist. Naz.Cura Tumori Fond.Pascale, NapoliServizio di fisica sanitaria, Ist. Naz.Cura Tumori Fond.Pascale, NapoliAntonella CIABATTONI Antonella CIABATTONI UO Radioterapia San Filippo Neri, RomaUO Radioterapia San Filippo Neri, RomaLuca CIONINI Luca CIONINI Dipartimento di Oncologia, AO Pisana, Università degli Studi, PisaDipartimento di Oncologia, AO Pisana, Università degli Studi, PisaBrunello MORRICA Brunello MORRICA Unità di Radioterapia, Ist. Naz.Cura Tumori Fond. Pascale, NapoliUnità di Radioterapia, Ist. Naz.Cura Tumori Fond. Pascale, NapoliLuigi RAFFAELE Luigi RAFFAELE Azienda Policlinico Universitario, CataniaAzienda Policlinico Universitario, CataniaVincenzo VALENTINIVincenzo VALENTINI UO Radioterapia Università Cattolica Policlinico Gemelli, RomaUO Radioterapia Università Cattolica Policlinico Gemelli, RomaHead and neckHead and neckPatrizia OLMIPatrizia OLMI Dipartimento di Radioterapia, Istituto Nazionale per lo Studio e la Cura dei Tumori, MilanoDipartimento di Radioterapia, Istituto Nazionale per lo Studio e la Cura dei Tumori, MilanoGiovanna BALASSOGiovanna BALASSO UO Radioterapia Ospedale di Circolo, VareseUO Radioterapia Ospedale di Circolo, VareseFilippo Grillo RUGGIERIFilippo Grillo RUGGIERI UO Radioterapia Ospedale Umberto I, AnconaUO Radioterapia Ospedale Umberto I, AnconaStefania MAGGIStefania MAGGI Servizio di Fisica Sanitaria, Ospedale Umberto I, AnconaServizio di Fisica Sanitaria, Ospedale Umberto I, AnconaGiovanni PAVANATOGiovanni PAVANATO Radioterapia Oncologica, Azienda USSL 18, RovigoRadioterapia Oncologica, Azienda USSL 18, RovigoMara SCISCIOLIMara SCISCIOLI Divisione di Radioterapia, Ospedale Mauriziano Torino e UODivisione di Radioterapia, Ospedale Mauriziano Torino e UO di Radioterapia, IRCC, Candiolo, Torinodi Radioterapia, IRCC, Candiolo, TorinoCarlo SOATTI UOCarlo SOATTI UO Radioterapia, Ospedale A. Manzoni, LeccoRadioterapia, Ospedale A. Manzoni, LeccoPierluigi ZORATPierluigi ZORAT UO Radioterapia ospedale Ca’ Foncello, TrevisoUO Radioterapia ospedale Ca’ Foncello, TrevisoISSISSManuela LUZIManuela LUZI Servizio Informatico, Documentazione, Biblioteca ed Attività EditorialiServizio Informatico, Documentazione, Biblioteca ed Attività EditorialiPierluigi MOROSINIPierluigi MOROSINI Centro Nazionale di Epidemiologia, Sorveglianza e Promozione della SaluteCentro Nazionale di Epidemiologia, Sorveglianza e Promozione della SalutePaolo ROAZZIPaolo ROAZZI Servizio Informatico, Documentazione, Biblioteca ed Attività EditorialiServizio Informatico, Documentazione, Biblioteca ed Attività EditorialiAntonella ROSIAntonella ROSI Dipartimento Tecnologie e SaluteDipartimento Tecnologie e SaluteVincenza VITIVincenza VITI Dipartimento Tecnologie e SaluteDipartimento Tecnologie e Salute

7 Tumor sites 7 Tumor sites 45 indicators45 indicators

Bone MetastasisBone Metastasis 66

BreastBreast 66

Gynaecologic tumorsGynaecologic tumors 66

Head and neckHead and neck 77

LungLung 7 7

ProstateProstate 77

RectumRectum 66

30 Centres have been enruled for clinical audit (18 Centres operating in Hospitals, 8 in Universities and 4 in IRCCS (Research and Therapy

Institutes with Scientific Character)

mainly process indicatorsmainly process indicators 1 structure indicator at maximum1 structure indicator at maximum

at least 1 outcome indicatorat least 1 outcome indicatorTampere 8-10 september 2008

indicators have to comply with guidelines based on evidence criteria

STST indicators

quality indicators for the treatment of a specific tumor site are NOT a therapeutic protocol, but they imply the existence of a protocol

an indicator has to provide a tool to evaluate and to improve the procedures currently used in a Centre for the treatment of a specific tumor site

each Centre should define its own indicators indicators must be consistent with the Centre

resources


Clinical IndicatorsClinical Indicators

Gynaeco.

Multidiscipl approach Process

Acute toxicity Outcome

Anaemia monitoring Process

Dose-volume histograms Process

Overall treatment time Process

Brachy Process

Breast

Staging Process

Dose to OARs Process

Set-up verification Process


Anatomical Data (complet) Process

Patient’s satisfaction Outcome

Lung

Written protocols Process

Technical resources Structure

Staging Process

Multidiscipl Approach Process

Volume definition Process


Follow-up (radical RT) Process

Prostate

Infrastructures and methodologies Structure

Staging Process


Set-up errors Process

Follow-up (Execution) Process

Follow-up (complete) Process

Rectum toxicity Outcome

Rectum

Multidiscipl Approach Process

Set-up procedures Process


Dose-volume histograms Process

Acute Toxicity Outcome

Quality of life Process

Head-neck

Post-operative waiting time Structure/Process

Waiting time (radical RT) Structure/ Process



Multidiscipl protocols Process

Staging Process

Break (acute toxicity) Process

Bone metastases

Waiting times Structure/Process

Extension of illness Process

Fractionation Process


Follow-up (execution) Process

Follow-up (complete) Process

Waiting TimesWaiting TimesThis indicator sholud be used in general clinical audits considering the influence of team This indicator sholud be used in general clinical audits considering the influence of team

or machine numeric adequacy on waiting time for radiation treatments beginnings. It or machine numeric adequacy on waiting time for radiation treatments beginnings. It could be a method for internal clinical audit only when human and technological could be a method for internal clinical audit only when human and technological resources are appropriateresources are appropriate

Diagnostic work up and dose fractionationDiagnostic work up and dose fractionation These indicators can be applied to evaluate the structure (or the organization) of the These indicators can be applied to evaluate the structure (or the organization) of the

department (availability of procedures concerning the diagnostic work up and the department (availability of procedures concerning the diagnostic work up and the dose fractionation prescription for patients with bone metastases) or for internal dose fractionation prescription for patients with bone metastases) or for internal clinical audit (have procedures been respected). clinical audit (have procedures been respected).

Conformity was reached by more than half of Centres to indicate a high quality standard Conformity was reached by more than half of Centres to indicate a high quality standard of treatment for palliationof treatment for palliation

Multidisciplinary approachMultidisciplinary approachConformity was not reached at any Centre. Such an indicator should be Conformity was not reached at any Centre. Such an indicator should be

analyzed prospectively after a training to sensibly physicians (radiation analyzed prospectively after a training to sensibly physicians (radiation oncologist and orthopedists) to approach together a patient with critical oncologist and orthopedists) to approach together a patient with critical bone metastasisbone metastasis

Follow up informationFollow up informationAppropriate information about radiation treatment results were available by Appropriate information about radiation treatment results were available by

only one Centre to remark how difficult is to collect data about palliative only one Centre to remark how difficult is to collect data about palliative treatmentstreatments

Bone MetastasisBone Metastasis

BreastBreast

Regarding some critical issues of breast indicators, the following Regarding some critical issues of breast indicators, the following evaluations can be made:evaluations can be made:

Anatomic data acquisitionAnatomic data acquisitionThis indicator should be used in general clinical audits due to the This indicator should be used in general clinical audits due to the possibility of different data acquisition systems among different Centrespossibility of different data acquisition systems among different Centres

Dose to OARDose to OARThis indicator revealed some different interpretations and This indicator revealed some different interpretations and disagreement in the contouring of OAR among different Centresdisagreement in the contouring of OAR among different Centres

Multidisciplinary approachMultidisciplinary approachVery cross tool to use in radiotherapy as a common method in all Very cross tool to use in radiotherapy as a common method in all pathologiespathologies

Patients satisfactionPatients satisfactionCould be useful to use a validated questionnaire from Scientific Could be useful to use a validated questionnaire from Scientific Associations or Groups (such as EORTC…) to better compare Associations or Groups (such as EORTC…) to better compare results from different Countriesresults from different Countries

Gynaecologic tumorsGynaecologic tumorsThe small proportion of participants (27%) is probably due to the not wide diffusion of The small proportion of participants (27%) is probably due to the not wide diffusion of brachytherapy facilities, inasmuch as the availability of this technique is often mandatory for the brachytherapy facilities, inasmuch as the availability of this technique is often mandatory for the pathology. pathology.

Multidisciplinary approachMultidisciplinary approachThe majority of the patients (91%) are planned for radiotherapy after discussion between two The majority of the patients (91%) are planned for radiotherapy after discussion between two specialists (gynecologist and radiotherapist) but only 50% after simultaneous physical specialists (gynecologist and radiotherapist) but only 50% after simultaneous physical examinationexamination

Acute toxicityAcute toxicityThe analysis of the questionnaires revealed that two conformity index must be considered, for The analysis of the questionnaires revealed that two conformity index must be considered, for patients previously submitted to surgery and for those planned for radical treatment with radio-patients previously submitted to surgery and for those planned for radical treatment with radio-chemotherapychemotherapy

Monitoring of anemia Monitoring of anemia Very simple and easy to evaluate: the conformity index as high as 95% is clearly optimistic but Very simple and easy to evaluate: the conformity index as high as 95% is clearly optimistic but the authors consider it correct and stimulating for a necessary improvementthe authors consider it correct and stimulating for a necessary improvement

Dose Volume HistogramsDose Volume Histograms This indicator should be used not as a method for internal audit but as audit among different This indicator should be used not as a method for internal audit but as audit among different Centres; in fact the are only two possibilities: Centres always using DVH e Centres never using Centres; in fact the are only two possibilities: Centres always using DVH e Centres never using themthem

Overall radiation treatment timeOverall radiation treatment timeThis must be considered one of the most important indicators, probably as common This must be considered one of the most important indicators, probably as common audit for many other tumors. For gynaecological cancers, stratification between audit for many other tumors. For gynaecological cancers, stratification between postoperative radiotherapy and curative radio-chemotherapy is mandatorypostoperative radiotherapy and curative radio-chemotherapy is mandatory

Central boost with brachytherapy Central boost with brachytherapy As internal audit may be used only if the Centres follow specific guidelines. It may be useful for As internal audit may be used only if the Centres follow specific guidelines. It may be useful for audit among Centres when a stratification for stage of disease is considered audit among Centres when a stratification for stage of disease is considered

Head and neckHead and neck

Waiting times for radical radiotherapyWaiting times for radical radiotherapyMost Centres missed these indicators and the answering Centres get a low conformity Most Centres missed these indicators and the answering Centres get a low conformity value. Patients selected for radical radiotherapy are usually affected by low staging value. Patients selected for radical radiotherapy are usually affected by low staging tumor. In this case a reduced waiting time is essential to avoid tumor progressiontumor. In this case a reduced waiting time is essential to avoid tumor progression

Waiting times for post-operative radiotherapyWaiting times for post-operative radiotherapyWhen radiotherapy follows surgery as exclusive treatment or combined with antitumoral drugs is important to respect a treatment time from surgery to the end of radiotherapy into a maximum of 100 days to obtain better results

Multidisciplinary approach and multidisciplinary protocolsMultidisciplinary approach and multidisciplinary protocolsThe most Centres missed these indicators and even answering Centres get low The most Centres missed these indicators and even answering Centres get low conformity values indicating the necessity to stress that in clinical audit a shared conformity values indicating the necessity to stress that in clinical audit a shared approach in the clinical study of head and neck tumors is strongly suggestedapproach in the clinical study of head and neck tumors is strongly suggested

Break for acute toxicityBreak for acute toxicityThe treatment interruption due to acute toxicity could reduce the local control probability of tumor. Centres indicated different conformity value depending on stratification. To avoid treatment interruption it is suggested to support patient during treatment also with feeding tube or gastrostomy for a correct nutrition and the maintenance of blood parameters

For more details on Head and Neck indicators see poster For more details on Head and Neck indicators see poster

LungLungA general result for lung tumor is that the treatment of this patology well comply A general result for lung tumor is that the treatment of this patology well comply the standard as concern instrumental resources but it needs to be improved for the standard as concern instrumental resources but it needs to be improved for accepting and applying multidisciplinary guidelines for staging and sharing of accepting and applying multidisciplinary guidelines for staging and sharing of therapeutic decision.therapeutic decision.

Technical resourcesTechnical resourcesThis indicators depends on This indicators depends on interconnection between top management and medical interconnection between top management and medical staff leadership and can be suggested for an intercomparison among Centres staff leadership and can be suggested for an intercomparison among Centres

Staging and follow upStaging and follow upThe low conformity values get by Centres testify the difficulty to share opinion when The low conformity values get by Centres testify the difficulty to share opinion when patients are previously treated by other professional (mpatients are previously treated by other professional (many patients are referred for any patients are referred for diagnosis and staging to Oncologists or Pneumologists)diagnosis and staging to Oncologists or Pneumologists)

Volume definitionVolume definitionThe low conformity values were get by most Centres with respect to ICRU The low conformity values were get by most Centres with respect to ICRU 62. The use of score for each item of this indicator is an important tool to 62. The use of score for each item of this indicator is an important tool to monitor improvment in following audits monitor improvment in following audits

Set-up verificationSet-up verificationThe low conformity values get for this indicator are due to difficulties in The low conformity values get for this indicator are due to difficulties in volume definition which influence the set-up verification. The different volume definition which influence the set-up verification. The different conformity values obtained in the cases of technique change (different conformity values obtained in the cases of technique change (different items in stratification) suggest to separatly evaluate results of these two items in stratification) suggest to separatly evaluate results of these two different itemsdifferent items

ProstateProstate

The results obtained from data analysis indicated that already in 2004 prostate The results obtained from data analysis indicated that already in 2004 prostate cancer was treated at least with 3D CRT.cancer was treated at least with 3D CRT.

Indicators: Indicators: infrastrucure and methodologies, volume definition, execution and infrastrucure and methodologies, volume definition, execution and complete follow upcomplete follow up resulted proper and well understood resulted proper and well understood

Regarding some critical issues of two indicators, the following evaluations can be Regarding some critical issues of two indicators, the following evaluations can be made:made:

StagingStagingAmong the suggested parameters (TNM, PSA, GPS and Comorbidity) the Among the suggested parameters (TNM, PSA, GPS and Comorbidity) the TNM value was partially missed by Centres partially because most TNM value was partially missed by Centres partially because most patients underwent RT following ormonal therapy that can mask the real T patients underwent RT following ormonal therapy that can mask the real T value; partially because the urologist rarely records the initial T valuevalue; partially because the urologist rarely records the initial T value

Set-up errorsSet-up errors30% of audited Centres did not collect data for this indicator due to the 30% of audited Centres did not collect data for this indicator due to the need of additional human resources to monitor set-up errors. A strict need of additional human resources to monitor set-up errors. A strict reccomandation had be given by the working group to the involved reccomandation had be given by the working group to the involved Centres to improve in this direction taking into account the high doses Centres to improve in this direction taking into account the high doses used in prostate cancer treatment with 3D CRTused in prostate cancer treatment with 3D CRT

RectumRectumMultidisciplinary approachMultidisciplinary approach

This indicator indicated different results for patients coming from the same Centre This indicator indicated different results for patients coming from the same Centre (where systematic multidisciplinary approach was used), with respect to patients (where systematic multidisciplinary approach was used), with respect to patients coming from other different Centres coming from other different Centres

Set-up proceduresSet-up proceduresThe analysis of this point indicates that all Centres obtained the minimum score, but large The analysis of this point indicates that all Centres obtained the minimum score, but large differences in maximum score among different Centres were observed. So this indicator could be differences in maximum score among different Centres were observed. So this indicator could be use for a inter-Centres comparison use for a inter-Centres comparison

Set-up verificationSet-up verificationThe constraints for the compliance to this indicator were too selective and was not possible to The constraints for the compliance to this indicator were too selective and was not possible to describe the different procedures used. It is necessary to modify itdescribe the different procedures used. It is necessary to modify it

Dose Volume HistogramDose Volume HistogramThis indicator is not suggested for internal audit but as audit among different Centres, since some This indicator is not suggested for internal audit but as audit among different Centres, since some Centres always used DVH, others Centres never used themCentres always used DVH, others Centres never used them

Quality of life evaluationQuality of life evaluationOnly 3/14 Centres answered to this indicator. It is a strong signal for the necessity to Only 3/14 Centres answered to this indicator. It is a strong signal for the necessity to give more attention to this aspect of treatment implicationsgive more attention to this aspect of treatment implications

The AIRO association has realized a multicentric prospective study to monitor the Italian The AIRO association has realized a multicentric prospective study to monitor the Italian therapeutic approach to gastro-intestinal cancers. For rectal cancer patients all the therapeutic approach to gastro-intestinal cancers. For rectal cancer patients all the indicators are included into the request information. In Italy it is the first time that indicators are included into the request information. In Italy it is the first time that specific organ indicators are tested in a large national study. specific organ indicators are tested in a large national study.

Clinical audit on quality indicators in radiotherapy for Specific Tumor Site Treatment (STST) Tampere 8-10 september 2008 Antonella Rosi Health and Technology.

Documents

quality indicators

quality assurance

radiotherapy tampere

overall quality

quality level

quality commitment tampere

general indicators

galilei slide